ANA Advises Federal Agencies
ANA staff from the Health Policy Department review and analyze federal agency decisions, regulations, and rules affecting registered nurses, our profession, our patients, and the public health. The Administrative Procedures Act requires Executive Branch departments and agencies to publish these in the Federal Register, allow an opportunity for public comments, and take those into account when issuing a final rule or regulation. Once final, rules and regulations become part of the Code of Federal Regulations. Notices of public meetings and requests for nominees to federal panels are also published in the Federal Register.
ANA often provides feedback to federal policymakers through written comments. These are often collaborative efforts both within ANA and with our Constituent/State Nursing Associations, organizational affiliates, and other nursing and healthcare organizations. The Affordable Care Act requires many agencies and departments to implement regulations to carry out its policies. ANA is especially vigilant regarding Health Care Reform, now called "ACA" (short for the full title of the law, the Affordable Care Act) actions that impact nursing, especially those that offer the chance to overcome longstanding barriers to optimal nursing practice.
Resources for Submitting Regulatory Comments & Letters
We encourage ANA members, Constituent/State Nursing Associations, and organizational affiliates to submit comments on agency decisions. Some resources are provided below to help you with that process.
2020 ANA Regulatory Comments
Letter from ANA to the Centers for Medicare and Medicaid Services in response to the Request for Information regarding Maternal and Infant Care in Rural Communities, dated Access to Rural Health Care, dated April 6, 2020.
On February 12, 2020, the Centers for Medicare and Medicaid Services (CMS) sought public comment on opportunities to improve care, quality and outcomes for women and infants in rural communities. ANA submitted a response urging CMS strengthen roles for nurses and support nurse-led models in programs to improve maternal health care delivery in rural areas. Comments also suggested CMS leverage Medicaid initiatives to incentivize states to expand practice authority for advanced practice registered nurses such as certified nurse midwives and nurse practitioners.
In a Federal Register notice dated February 18, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule for policy and technical changes to the Medicare Advantage (MA) program for contract years 2021 and 2022. In the proposed rule, CMS invited input on steps the agency can take to expand access to MA plans in rural areas. In comments, ANA recommended that CMS consider rule changes and subregulatory guidance to encourage MA plans to contract with more advanced practice registered nurses (APRNs), for instance by removing burdensome supervision requirements, and developing new network adequacy standards and review processes.
Letter from ANA to the Department of Health and Human Services regarding proposed changes to 45 CFR Part 87 governing religious organizations providing services under HHS grants, dated February 4, 2020
In a Federal Register notice dated January 17, 2020, the Department of Health and Human Services (HHS) proposed a number of changes to 45 CFR Part 87, Equal Treatment for Faith-Based Organizations, in order to extend additional protections to religious organizations that provide social services under HHS social services grants. ANA commented that the proposed rule could reduce access to HHS services while potentially placing nurses in untenable ethical positions. Specifically, ANA urged HHS not to eliminate the requirement for faith-based grantees to “undertake reasonable efforts to identify and refer the beneficiary to an alternative provider” in cases where the beneficiary objects to the religious character of an organization. ANA cited the Code of Ethics for Nurses which requires nurses making conscience-based care refusals to arrange accommodations to meet patient needs.
Letter from ANA President Ernest Grant to the Centers for Medicare and Medicaid Services regarding implementation of the President’s Executive Order (EO) #13890 on Protecting and Improving Medicare for Our Nation’s Seniors, dated January 17, 2020
On December 26, 2019, the Centers for Medicare and Medicaid Services (CMS) invited public input concerning implementation of the President’s October 3, 2019, Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors. CMS specifically sought suggestions for eliminating unnecessary regulatory burdens on advanced practice registered nurses (APRNs). In response, ANA identified a number of specific Medicare requirements that restrict APRN practice, and expressed strong support for regulatory reform in this area. The letter further urged CMS to purse collaborative solutions with Congress in order to expand access to APRN care in Medicare.
2019 ANA Regulatory Comments
Letter from 11 APRN Organizations to the Medicaid and CHIP Payment and Access Commission regarding Prescribing Authority for Medication-Assisted Treatment of Opioid Use Disorders, dated December 9, 2019.
As part of its 2019 work plan, the Medicaid and CHIP Payment and Access Commission (MACPAC) conducted policy analysis related to access to medication-assisted treatment (MAT) for opioid use disorders (OUDs). Specifically, MACPAC examined the positive impact of federal legislation expanding prescribing authority for Nurse Practitioners (NPs) and Physician Assistants (PAs). In public comment, a letter signed by ANA among 11 groups representing Advanced Practice Registered Nurses (APRNs) urged MACPAC to recommend further legislative expansion of APRN authority to prescribe MAT in order to continue improving access to OUD treatment in Medicaid. In particular, the letter asks for a MACPAC recommendation for legislation to extend permanent prescribing waivers to Certified Nurse Midwives, Clinical Nurse Specialists and Certified Registered Nurse Anesthetists.
Letter from ANA to the Department of Health and Human Services and Centers for Medicare & Medicaid Services regarding Executive Order, Protecting and Improving Medicare for Our Nation’s Seniors, dated October 31, 2019.
On October 3, the Administration released an Executive Order directing the Department of Health and Human Services (HHS) to propose regulations enabling Advance Practice Registered Nurses (APRNs) to practice in Medicare to the full extent of their education and clinical training. In a letter to the Secretary of HHS and the Administrator of the Centers for Medicare & Medicaid Services (CMS), ANA voiced full support of the initiative to eliminate unnecessary practice barriers that Medicare places on APRNs. ANA further urged CMS to use its waiver authority to promote expanded practice authority for APRNs in alternative payment models in Medicare.
The Substance Abuse and Mental Health Services Administration, within the Department of Health and Human Services,, proposed rule changes in order to align regulations with advances in the U.S. health care delivery system, which retaining important privacy protections for individuals seeking treatment for substance use disorders.
ANA believes that protection of privacy and confidentiality is essential to maintaining the trusting relationship between health care providers and patients. However, more clarity can be provided to clinicians regarding the confidentiality of substance use disorder patient records.
In a Federal Register Notice published on August 14, 2019, CMS requested comments on a proposed rule entitled “Medicare Program: CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations”.
ANA in its comment letter expresses support for CMS’ progress to reduce barriers to practice for non-physician practitioners in the Medicare program. We urge CMS in the final rule to recognize the importance of full practice authority for APRNs.
On August 22, 2019, the Health Resources and Services Administration (HRSA) sought public comment on access to health care in rural areas, including questions about service and workforce needs. ANA submitted a response urging HRSA to leverage nursing care in crafting policy solutions to reduce disparities and overcome barriers to care in rural areas. ANA’s letter recommended steps the federal government could take to encourage rural states to expand practice scope for APRNs. Comments also urged HRSA to consider care coordination and telehealth models that utilize nursing skill and capacity without unnecessary restrictions on nursing practice.
The Bipartisan Policy Center's Rural Health Task Force requested policy recommendations and solutions that support reforming America's rural healthcare system.
ANA's comments focus on how nurses are and can continue to transform rural healthcare systems through removing the barriers to full scope of practice, care coordination management, and through the use of telehealth technologies.
Letter from Nine Nursing Organizations to the Centers for Medicare & Medicaid Services in Response to the Request for Information Regarding Reducing Administrative Burden to Put Patients Over Paperwork, dated August 12, 2019.
In a Federal Register notice published on June 11, 2019, the Centers for Medicare & Medicaid Services (CMS) sought public comment from interested parties on how to reduce administrative burdens on clinicians and the patients they serve. Nine nursing organizations – including ANA – submitted a response that identified four regulatory barriers that currently impede patient access to APRN care, and contribute to higher healthcare costs. Specifically, the letter recommends that CMS 1) Remove credentialing and privileging barriers to practice and care; 2) Remove costly and unnecessary physician supervision requirements; 3) Address incident-to billing and acknowledge the licensure of the rendering provider; and 4) Provide equity in reimbursement in educational settings for APRNs.
In a Federal Register notice published on June 14, 2019, the Secretary of the Department of Health and Human Services (HHS) issued a proposed rule to revise a number of nondiscrimination regulations, including the 2016 Final Rule implementing Section 1557 of the Affordable Care Act (ACA). HHS is proposing significant changes which ANA believes will significantly undermine protections against discrimination in health care. For instance, various forms of discrimination based on gender identity or sex-stereotyping would no longer be prohibited. In comments, ANA 1) discussed how the proposed changes are inconsistent with nursing values and ethical obligations, and 2) emphasized that existing rules are necessary to ensure access to care, especially for those who have encountered barriers due to discrimination. ANA urged HHS to rescind the proposed rule in entirety.
Letter from ANA to Centers for Medicare and Medicaid Services in Response to the Proposed Rule Regarding the Fiscal Year 2020 Acute Care Inpatient Hospital Prospective Payment System and Long-Term Care Hospital Prospective Payment System, dated June 24, 2019
In a Federal Register Notice published on May 3, 2019, CMS requested comments on a proposed rule entitled, “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals”.
ANA’s comment letter urges CMS to: recognize the importance of appropriate nurse staffing levels by recognition of two NQF-endorsed staffing measures in the Hospital Inpatient Quality Reporting Program for public reporting; require inpatient hospitals that participate in the Medicare program to implement meaningful programs that prevent workplace violence; and include the Safe Use of Opioids – Concurrent Prescribing eCQM measure in the Hospital IQR Program eCQM measure set.
On June 22, the Membership Assembly of the American Nurses Association (ANA) voted overwhelmingly to express its displeasure and utmost concern to the United States Department of Homeland Security (DHS) and U.S. Customs and Border Protection (CBP) regarding the conditions and treatment of migrant families at the border. ANA, and the more than 4 million nurses it represents, requests the agency act immediately to ensure that immigrant detainees have access to basic hygiene needs, appropriate health care, including mental health care services, and adequate sleeping arrangements.
Letter from 10 Nursing Organizations to the Centers for Medicare & Medicaid Services in Response to the Request for Information Regarding the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts, dated May 6, 2019
In a Federal Register notice published on March 11, 2019, the Centers for Medicare & Medicaid Services (CMS) sought public comment from interested parties on how to eliminate barriers to and enhance health insurance issuers' ability to sell individual health insurance coverage across state lines, primarily pursuant to Health Care Choice Compacts.
Ten nursing organizations – including ANA – submitted a letter focused on the tenet that access to medically necessary services is a crucial component of a stable healthcare system. These organizations specifically urged CMS to ensure comprehensive coverage, strengthen protections for individuals with pre-existing conditions, and to ensure provider non-discrimination for APRNs with respect to state scope of practice laws.
The CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment invited public comments for the record in advance of the Committee’s May 14-15, 2019, meeting. ANA’s comments focus on collaboration across responsibilities, responding to the Administration’s stated goal of reducing new HIV reducing new HIV infections by 75 percent in the next five years and by 90 percent in the next 10 years. In its comment letter, ANA urges the Committee to make specific recommendations for the Department of Health and Human Services to elevate and promote the role of nurses, including APRNs, in programs and initiatives to prevent HIV.
For example, ANA recommends collaboration between the Health Resources and Services Administration (HRSA) and the Centers for Medicare and Medicaid Services to develop a payment model for nurses coordinating HIV care, as well as HRSA programs in HIV care that encourage APRN practice at the full scope of their training and education. ANA further supports expanded resources to support nursing leadership in HIV programs administered by the Centers for Disease Control and Prevention (CDC).
Letter from ANA to the Department of Health and Human Services, Pain Management Task Force in response to the Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations dated March 22, 2019
The Pain Management Best Practices Inter-Agency Task Force - under the direction of the U.S. Department of Health and Human Services, U.S. Department of Veterans Affairs and the U.S. Department of Defense - was created to determine whether gaps or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices.
ANA’s comments focus on the role of the nurse in the care team to treat acute and chronic pain. Because RNs and APRNs practice in a variety of direct-care, care-coordination, leadership, and executive roles, they are often in key positions to help patients and their families understand the risks and benefits of pain treatment options. Moreover, ANA encourages CMS and payors to reimburse for pain management using a chronic disease management model, recognizing the role of the care team and the care team leader for the patient care. ANA and its members are committed to working with the Task Force, the Agencies, and all health care providers to address the gaps and recommendations found in this report.
Letter from ANA to the U.S. Department of Health and Human Services Office of HIV/AIDS and Infectious Disease Policy in response to the Request for Information on Improving Efficiency, Effectiveness, Coordination, and Accountability of HIV and Viral Hepatitis Prevention, Care, and Treatment Programs, dated March 11, 2019
The Office of HIV/AIDS and Infectious Disease Policy on February 8, 2019 issued a Request for Information (RFI) on Improving Efficiency, Effectiveness, Coordination, and Accountability of HIV and Viral Hepatitis Prevention, Care, and Treatment Programs. This RFI specifically requested recommendations regarding the National HIV/AIDS Strategy of the United States: Updated to 2020 and recommendations to improve the coordination of funding and delivery of HIV services.
ANA’s comments focus on the front-line role that RNs have historically filled in care for persons living with HIV/AIDS and the crucial role that they continue to play in both care and prevention. ANA specifically urges HHS to focus on utilizing the care coordination expertise of RNs to achieve the goals of the National HIV/AIDS Strategy for the United States: Updated to 2020 (NHAS), specifically to expand the promotion and use of pre-exposure prophylaxis (PrEP) to prevent infections; improve efforts to decrease health disparities among demographic groups on whose shoulder the burden of the HIV/AIDS epidemic primarily lies – specifically the African-Americans and LGBTQ+ populations; and focus on geographic areas determined to have high prevalence of HIV/AIDS infection.
Letter from ANA to the U.S. Senate Committee on Health, Education, Labor, and Pensions in response to the Committee’s request regarding recommendations on lowering health care costs, dated March 1, 2019
U.S. Committee on Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN) on December 11, 2018 solicited feedback on controlling America’s rising health care costs. The HELP Committee requested comments on steps Congress can take to address America’s rising health care costs and recommendations that Congress can make to the Trump Administration and state governments that incentivize care that improves the health and outcomes of patients and increase the ability for patients to access information about their care to make informed decisions.
ANA’s comments focus on an expansion of the role that RNs play in care coordination in both Medicare and Medicaid and note that this represents a major opportunity to slow health care costs and improve patient outcomes. These comments focus specifically on care coordination models that the Center for Medicare and Medicaid Innovation (CMMI) has established, CMMI waiver authority, and Medicaid care coordination to provide a template for potential RN care coordination models.
Letter from ANA to the Centers for Medicare & Medicaid Services in response to the proposed rule “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020”, dated February 19, 2019
The Centers for Medicare & Medicaid Services (CMS) on January 24, 2019 sought public comment on its proposed rule entitled, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020”, that proposed policy changes related to the individual health insurance exchange, the health insurance Navigator program, and program integrity, among other policy issues.
ANA’s comments focus on CMS’ decision to continue to permit silver loading of exchange plans for calendar year 2020, CMS’ proposal to change the calculation of the ACA’s premium adjustment factor, and CMS’ efforts to increase access to medication-assisted treatment for opioid-use disorder.
On behalf of the nation’s more than 4 million registered nurses, including the many who dedicate their lives to the health and wellbeing of children, the American Nurses Association (ANA) and the American Academy of Nursing (AAN) call on Congress to take swift action to address the needs of migrant, refugee, and asylum-seeking children and families impacted by the Administration’s separation policy at the border.
Letter from ANA to the Department of Health and Human Services, Office for Civil Rights in response to the proposed rule entitled “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care”, dated February 8, 2019
The Office for Civil Rights within the Department of Health and Human Services sought public comment on its Proposed Rule entitled, “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care”, to determine whether privacy and security regulations could be revised to better allow for value-based care and coordinated care among individuals and covered entities, while preserving and protecting the privacy and security of such information and individuals’ rights with respect to it.
ANA’s comments focused on the underlying principle that the protection of privacy and confidentiality is essential to maintaining the trusting relationship between healthcare providers and patients. As the Code of Ethics for Nurses with Interpretative Statements states, the nurse must protect the patient’s rights to privacy and confidentiality. The nurse must, however, balance these obligations with timely coordinated care for patients. Care coordination has long been a core professional standard and competency for nurses and, therefore, nurses must continue to facilitate coordinated care within the confines of the HIPAA law.
Letter from ANA to the Office of the National Coordinator for Health Information Technology in response to the draft report entitled “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs”, dated January 24, 2019
The Office of the National Coordinator for Health Information Technology (ONC) sought public comment on its draft report entitled, “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs” as required by the 21st Century Cures Act. ONC’s draft report outlined several broad strategies and recommendations to address issues and challenges in the areas of clinical documentation, health IT usability and the user experience, EHR reporting, and public health reporting.
ANA’s comments focused on: support for clinical documentation burden reduction and the need for ONC and CMS to include RNs and APRNs as key stakeholders as they continue to revise clinical documentation and payment policies; the inclusion of recognized terminologies supporting nursing practice within EHRs and other Health IT solutions; parity for RNs and APRNs in the definitions of eligible providers for reporting requirements and incentives to achieve interoperability; and support for increased interoperability among state prescription drug monitoring programs (PDMPs) to better monitor the prescription of opioids.
Letter from ANA to the Food and Drug Administration in response to the Proposed Rule Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, dated January 9, 2019
In a Federal Register Notice published on November 15, 2018, FDA requested comments on a proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” FDA proposed to allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule would permit an Institutional Review Board to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
While ANA supports a strong health research agenda, safeguards must remain in place for all research and clinical investigations. In its comments, ANA requests more clarification of the proposed rule as it would be implemented in practice.
2018 ANA Regulatory Comments
The Medicare Payment Advisory Commission (MedPAC) held discussions throughout the fall of 2018, regarding issues such as payment policies for APRNs and the opioid epidemic among other issues that affect the Medicare program and its beneficiaries.
ANA supports MedPACs recommendation that “The Congress should require APRNs and PAs to bill the Medicare program directly, eliminating “incident to” billing services they provide.” ANA also supports the desires of the Commission for more radical and bold approaches to fighting the opioid epidemic including full practice authority for all APRNs and increasing access to complimentary and alternative therapies for Medicare beneficiaries.
Letter from 12 Nursing Groups to the Centers for Medicare & Medicaid Services in Response to the Proposed Rule Regarding Regulatory Provisions to Promote Medicare and Medicaid Program Efficiency, Transparency, and Burden Reduction, dated November 16, 2018
In a Federal Register Notice published on September 20, 2018, CMS requested comments on a proposed rule entitled, “Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction”. CMS proposed to reform Medicare regulations that it identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. CMS also aimed through this proposed rule to increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.
The 12 nursing groups – including ANA – that signed this comment letter focused on removing barriers for APRNs to practice to the full extent of their education and training and creating an equitable reimbursement standard for APRNs. Specifically, this letter urges CMS to remove credentialing and privileging barriers to practice and care; remove costly and unnecessary physician supervision requirements; establish modifiers on claims to identify incident-to billing and acknowledge the licensure of the rendering provider; reform policy definitions of the word “physician” so that patients have access to the services of qualified APRNs; and create equity in reimbursement in educational settings for APRNs.
Letter from ANA to the Department of Homeland Security in response to the proposed rule regarding Apprehension, Processing, Care, and Custody of Alien Minors and Unaccompanied Alien Children, dated November 1, 2018.
In the Federal Register Notice published on September 7, 2018, the U.S. Department of Homeland Security and Department of Health and Human Services (collectively “Departments”) requested comments on a proposed rule entitled: Apprehension, Processing, Care, and Custody of Alien Minors and Unaccompanied Alien Children. The Departments propose to amend regulations relating to the apprehension, processing, care, custody, and release of alien juveniles. The rule would terminate the Flores Settlement Agreement, while adopting provisions that parallel the relevant substantive terms of the FSA with modifications to reflect intervening statutory and operational changes.
ANA in its comment letter expresses the need for an expert task force, to include nurses, to address unknown variables, including the uncertainty around “longer detention for certain minors”, that the proposed rule has not addressed. Nurses have the knowledge, experience, and ethical obligations under the Code of Ethics for Nurses to will ensure that all vulnerable populations will be protected and cared for while balancing other regulatory and policy challenges.
In the Federal Register Notice published on September 6, 2018, the U.S. Centers for Disease Control (CDC) requested comments regarding the Surgeon General’s document/Call to Action with a working title “Community Health and Prosperity”. The goals of the Call to Action are to clearly demonstrate that investments in community health have the potential to improve the health and prosperity of communities and issue a call to action to the private sector and local policy makers for investments in communities, unilaterally or as part of multi-sector or other consortium, to improve community health.
ANA in its comment letter shared successes of nurses in both clinical and community settings that highlight the need to support healthcare professionals to inspire community health. Through the Healthy Nurse Health Nation Grand Challenge, the Robert Wood Johnson Foundation, and the American Academy of Nursing Edge Runners, nurses across the country are positively impacting the well-being of communities through investments in building cultures of health and innovative programs to bring care to all members of society.
In a Federal Register Notice published on July 30, 2018, OSHA requested comments on a proposed rule entitled, “Tracking of Workplace Injuries and Illnesses”. OSHA proposes to rescind the requirement under a May 2016 final rule that requires employers with 250 or more employees to electronically report OSHA Forms 300 and 301; these forms contain case-level data and sensitive worker information. OSHA contends that this sensitive worker information could be made public through Freedom of Information Act (FOIA) requests and proposes that employers only be required to submit the summary Form 300A that does not contain sensitive worker information.
ANA in its comment letter expresses its shared concern regarding the potential disclosure of sensitive worker information through FOIA requests. However, ANA stresses the importance of case-level data to perform root-cause analyses to prevent incidents of workplace injuries and illnesses, particularly in the context of workplace violence, needlesticks and sharps injuries, and musculoskeletal injuries associated with patient handling. ANA notes the significant barriers to reporting these incidents and encourages OSHA to maintain a robust audit process to ensure that employers take steps necessary to prevent such incidents in the future. ANA also seeks to clarify the viability to continue to require electronic submission of OSHA Form 300 for needlestick and sharp injuries, as OSHA standard 1904.8(a) requires protection of employees’ privacy by way of not entering the employee’s name on the form.
In a Federal Register Notice published on July 27, 2018, CMS requested comments on a proposed rule entitled, “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program”.
Proposed changes include: changes to coding and documentation for Evaluation & Management (E/M) visits; changes to Medicare reimbursement for telehealth and virtual communication services; the creation of a bundled episode of care for substance use disorder treatment; and changes to the Quality Payment Program and Merit-based Incentive Payment System (MIPS), including the addition of a third criterion for qualification for the MIPS low-volume threshold.
ANA in its comment letter expresses support for reducing the documentation burden associated with E/M visits and for several of the other changes CMS proposes; however, ANA urges caution with respect to CMS’ proposal to streamline reimbursement for levels 2 through 5 E/M visits and CMS’ proposal to streamline E/M documentation guidelines. ANA notes its support for the expansion of telehealth services for Medicare beneficiaries, and provides recommendations as to how CMS should implement a bundled episode of care for substance use disorder patients. Finally, ANA urges CMS to move toward full parity of resources for APRNs participating in Medicare Part B and to eliminate incident to billing.
Letter from ANA and 14 Co-Signatories to Centers for Medicare and Medicaid Services in Response to the Proposed Rule Regarding the Fiscal Year 2019 Acute Care Inpatient Hospital Prospective Payment System and Long-Term Care Hospital Prospective Payment System, dated June 25, 2018
In a Federal Register Notice published on May 7, 2018, CMS requested comments on a proposed rule entitled, “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims”.
Changes proposed include: the removal of a number of duplicative quality measures (currently reported to at least one of CMS’ other quality reporting programs) from the Hospital Inpatient Quality Reporting (IQR) Program in order to reduce burden; the complete removal of a safe surgery checklist quality measure from the Hospital IQR Program; and the inclusion of a hospital harm opioid-related quality measure for public reporting through the Hospital IQR Program. CMS also includes in the proposed rule a Request for Information regarding interoperability and electronic healthcare information exchange in the Medicare and Medicaid programs.
ANA in its comment letter expresses support for clinician burden reduction and CMS’ Meaningful Measure Initiative. We do, however, urge caution in removing measures from any quality reporting programs to ensure positive patient outcomes, and use the removal of the safe surgery checklist as an example of a quality measure that is still valuable despite meeting CMS’ removal criteria. We express our strong disappointment that CMS did not propose to include ANA’s two nurse staffing quality measure for public reporting through the Hospital IQR Program, despite meeting several of the Meaningful Measure Initiative’s criteria for inclusion. Finally, we conditionally support the initial voluntary reporting of the hospital harm opioid-related measure.
Letter from ANA and the Alliance for Nursing Informatics to Centers for Medicare and Medicaid Services in Response to the Request for Information Regarding Interoperability and Electronic Healthcare Information Exchange, dated June 25, 2018
In its proposed rule regarding the Fiscal Year 2019 Acute Care Inpatient Hospital Prospective Payment System and Long-Term Care Hospital Prospective Payment System, published on May 7, 2018, CMS included a Request for Information titled “Promoting Interoperability and Electronic Healthcare Information Exchange Through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers”.
ANA and ANI – as nursing stakeholders - fully endorse the objective to promote interoperability and electronic health information exchange by addressing the obstacles that persist across the continuum of care, and specifically recommend the following: engaging nurses as key stakeholders to promote successful interoperability; ensuring parity of resources and incentives as a critical path to promote interoperability; decreasing provider burden and minimizing workflow disruptions; aligning policies for fully interoperable health IT and EHR systems; and establishing a patient-centered approach to ensure patients’ rights to information.
In a Federal Register Notice published February 21, 2018, the U.S. Department of Health and Human Services (HHS), Centers for Medicare and Medicaid Services requested public comments on a proposed rule: Short-Term, Limited Duration Insurance.
The proposed rule would expand the sale and use of short-term, limited duration health insurance plans by extending the maximum duration of the plans from three months to twelve months; it would also modify the disclaimer required under current regulations for these types of health insurance plans.
ANA is concerned the proposed rule, combined with the repeal of the individual mandate in December 2017, would result in a higher rate of uninsured Americans, increased individual health insurance premiums in the ACA individual market, and a bifurcated individual insurance market which makes it more difficult for individuals with complex and chronic health conditions to access affordable health insurance coverage.
ANA proposes that the U.S. Departments of the Treasury, Labor, and Health and Human Services withdraw the proposed rule and work with the United States Congress to enact lasting solutions to stabilize the healthcare system.
Letter from ANA and American Academy of Nursing to U.S. Department of Health and Human Services Office for Civil Rights Regarding Proposed Rule: Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, dated March 23, 2018
In a Federal Register notice published January 26, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) requested comments on a proposed rule: Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.
The proposed rule strengthens the authority of OCR to enforce statutory conscience rights under the Church Amendments, Coats-Snowe Amendment, the Weldon Amendment, and other federal laws. ANA and AAN express their shared concern that the proposed rule would lead to inordinate discrimination against certain patient populations, particularly individuals seeking reproductive health care services and those who identify as lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ).
ANA and AAN strongly believe that the proposed rule should be rescinded and HHS should develop a standard for accommodation for conscientious objection to certain services that does not limit the ability of patients to receive timely, affordable, quality, and compassionate care. OCR should implement guidelines for individual providers, practices, agencies, health systems, and institutions to accommodate both employees and patients and ensure that moral or ethical objections to providing health care services are addressed by an organized plan for patients to easily access required quality, affordable, compassionate, and comprehensive health care.
Letter from ANA and Six Co-Signatory State Nursing Associations to U.S. Department of Labor Employee Benefits Security Administration Regarding Proposed Rule: Definition of Employer under Section 3(5) of ERISA-Association Health Plans, dated March 2, 2018
In a Federal Register Notice published January 5, 2018, the U.S. Department of Labor (DOL) Employee Benefits Security Administration requested public comments on a proposed rule: Definition of Employer under Section 3(5) of ERISA-Association Health Plans (AHP).
The proposed rule makes several changes related to the formation and functioning of AHPs which would in effect allow a greater number of employers to form AHPs, to evade some of the ACA's essential health benefits requirements, and to discriminate against individuals with pre-existing conditions.
Expanding AHPs in this way would allow them to select younger and healthier individuals and price out older and less healthy individuals. This coverage mechanism is not in line with ANA's vision of universal access to a standard package of health care services for all citizens and residents and its implementation is opposed. ANA urges the Trump administration to work with Congress on bipartisan solutions to strengthen the individual health insurance marketplace, restore crucial cost-sharing reduction payments and take meaningful steps to ensure lower healthcare costs overall.
The National Advisory Council sought input on the substance use prevention workforce and opioid use prevention. ANA supports the Substance Abuse and Mental Health Services Administration in its mission to promote effective substance abuse prevention practices through innovative strategies and programs, increased education for the interdisciplinary healthcare team, removal of barriers to effective pain and substance use disorder treatment, and proper storage and disposal of all medications.
Following a conversation with Mathematica and the Lewin Group, ANA responded to a request regarding the potential opioid overuse measure, in which the Centers for Medicare and Medicaid would be the measure's steward. The comments suggested that the developer should continue with additional testing across provider groups and specialties to identify variations in care and differences in patient populations that would suggest revisions to the denominator and/or exclusions.
Additionally, ANA recommended the consultation of additional providers, including Advanced Practice Registered Nurses with prescribing authority working in specialized care areas. Consultations should address the potential impact and consequences for patient populations.
Letter from ANA to Centers for Medicare and Medicaid Services Regarding Advance Notice of Methodological Changes to Calendar Year (CY) 2019 for Medicare Advantage (MA)Capitation Rate, Part C and Part D Policies and 2019 Draft Call Letter
In a notice published on February 1, 2018, the Centers of Medicare and Medicaid Services (CMS) requested comments regarding Advanced Notice of Methodological Changes to Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rate, Pact C and Part D Policies and 2019 Draft Call Letter.
In the above referenced letter, ANA urges caution in supporting a cut off at a specific Morphine Milligram Equivalent in the absence of consensus that arbitrary hard stops are effective. ANA recommends that CMS review concurrent increases in pain complaints and a push for third party payment for non-opioid pain management strategies, including complementary and alternative medicine.
ANA and Alliance for Nursing Informatics Comments to The Office of the National Coordinator for Health Information Technology Regarding Draft US Core Data for Interoperability (USCDI) and Proposed Expansion
In January 2018, The Office of the National Coordinator for Health Information Technology requested comments related to a Draft US Core Data for Interoperability (USCDI) and Proposed Expansion Process.
In response to the Draft USCDI, ANA and the Alliance for Nursing Informatics (ANI) submitted two recommendations: 1) Adequate Pilot Testing and 2) Include Nursing and Consumer representation in the Trusted Exchange Framework and Common Agreement (TEFCA) and USCDI Workgroups. Additionally, ANA and ANI asked the National Coordinator and working committees to evaluate: 1) the data categories and classes that if exchanged easily, will make the most difference in improving individual and population health; 2) the difference the type of data makes to individuals and their authorized care givers, for care coordination across transitions of care, time and settings; 3) the contributions to a person’s longitudinal comprehensive health story/record made by emerging, candidate, and required data classes, and 4) the contributions of each annual cycle of USCDI data class determination (emerging, candidate and required) to the Cures Act provisions, requiring the availability of all electronic health information from a patient’s record.
In January 2018, The Office of the National Coordinator for Health Information Technology (ONC) requested comments related to a Draft Trusted Exchange Framework and Common Agreement (TEFCA).
In response to the Draft TEFCA, ANA and the Alliance for Nursing Informatics (ANI) fully supported the following expected outcomes: 1) Providers can access health information about their patients, regardless of where the patient received care; 2) Patients can access their health information electronically without any special effort; 3) Providers and payer organizations managing benefits and the health of populations can receive necessary and appropriate information on a group of individuals without having to access one record at a time; and 4) The health IT community has open and accessible application programming interfaces to encourage entrepreneurial, user-focused innovation to make health information more accessible and to improve electronic health record usability.
ANA and ANI offered ONC four recommendations as follows: 1) Frame TEFCA implementation relative to its impact on providing individual and population health from a person-centered perspective; 2) Articulate clear roles for the individual in partnership with the entire healthcare team within the health data exchange ecosystem; 3) Advance a Do No Harm focus to health information exchange throughout the health data-sharing ecosystem; and 4) Include Nursing and Consumer representation in the TEFCA and US Core Data for Interoperability Federal Advisory Committee Act Workgroups.
2017 ANA Regulatory Comments
Organizations representing the interests of Advanced Practice Registered Nurses responded to the Centers for Medicare and Medicaid Services subregulatory guidance which excluded non-physician practitioners from serving on Medicare Carrier Advisory Committees. ANA and 11 cosignatories urged removal of a clause in the Medicare Program Integrity Manual prohibiting inclusion of other practitioners on the committee and recommended revisions specifically permitting the inclusion of other healthcare providers, including advanced practice registered nurses.
The Medicare Payment Advisory Commission held discussions throughout the fall of 2017, recognizing the role that Advanced Practice Registered Nurses (APRNs) play in filling the void in primary care providers. ANA encourages the Commission to continue to support APRNs and Registered Nurses (RNs) caring for patients in urban and rural communities and reimburse all providers at levels that reflect the fullest extent of the care provided.
Furthermore, ANA asked the commission to support the implementation and expansion of care coordination models and the role of the RN within each model. ANA also expressed support for expansion of telehealth services provided by APRNs and RNs for Medicare beneficiaries.
Letter from ANA to US Food and Drug Administration Regarding Public Comment to Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation; Public Hearing Request for Comments [FDA – 2017 – N – 6502]
In a Federal Register notice published on December 13, 2017, the US Food and Drug Administration (FDA) requested comments to inform the Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation; Public Hearing Request for Comments.
FDA's proposed language seeks to improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics. ANA is cautious to support arbitrary threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity. ANA encourages the use of consensus and evidence based de-escalation guidelines to minimize abrupt changes in the pain management of patients. ANA also supports the consideration of additional measures intended to improve the safety of patient storage and handling of opioid analgesics.
In a Federal Register notice published October 2, 2017, the Department of Veterans Affairs (VA) requested comments on the Authority of Health Care Providers to Practice Telehealth.
ANA supports the above referenced proposed rule that would amend the VA's medical regulations by standardizing the delivery of care by VA health care providers through telehealth. The proposed rule clarifies that VA health care providers may exercise their authority to provide care through telehealth, notwithstanding any state laws, rules, licensure, registration or certification requirements to the contrary. ANA also supports the VA's consistent use of provider neutral terms when referencing VA employees authorized to provide care through the use of telehealth.
In a Federal Register notice published October 31, 2017, the US Food and Drug Administration (FDA) requested comments on the role of packaging, storage, and disposal options titled Packaging, Storage, and Disposal Options to Enhance Opioid Safety – Exploring the Path Forward; Public Workshop; Request for Comments.
ANA supports the FDA's action plan proposing steps toward reducing the impact of opioid abuse in communities across America. ANA encourages the FDA to align its activities with regard to prescribing, storage and disposal to all agencies and partners who are fighting the opioid epidemic, including: allowing providers with prescribing authority to practice to the full extent of their license and supporting patient educational programs that include safe disposal media campaigns. In order to address opioid abuse, ANA supports regulations that are not overly burdensome and programmatic strategies that are effective and do not create additional barriers.
In a Federal Register notice published on July 20, 2017, CMS requested comments on a proposed rule entitled, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.”
In the rule, CMS makes several proposals related to quality measures and the public reporting of such. ANA’s comment letter focuses on two such measures. ANA supports the proposed removal of a pain management measure on the basis of operating under an abundance of caution in the context of the ongoing, nationwide opioid epidemic. ANA also supports the proposed public reporting of a measure on the length of time between emergency department admission and discharge for psychiatric/mental health patients, which would fill a reporting gap for said patients.
In a Federal Register notice published on July 21, 2017, CMS requested comments on a proposed rule entitled, “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program.”
CMS’ proposal includes language which maintains outdated language requiring physician supervision of APRNs and maintains incident to billing, which requires APRNs to mark their services as provided only incident to the care of a physician. ANA, in its comment letter, urges CMS to adopt provider neutral language and to modify incident to billing on the basis of realizing full practice authority for APRNs, lessening the regulatory burden, and providing greater transparency.
In a Federal Register Notice published on April 28, 2017, CMS requested comments on a proposed rule entitled, "Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices."
Changes proposed include revising the Medicare hospital inpatient prospective payment system (IPPS) for operating and capital-related costs of acute care hospitals for FY 2018, implementing provisions found in legislation including the 21st Century Cures Act, updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals for FY 2018, and updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. ANA’s comment letter strongly encourages the continued implementation and expansion of care coordination models, strongly supports the adoption of a falls with injury measure to support the HAC Reduction Program, strongly supports the collection of standardized patient assessment data, supports proposed revisions related to national Accrediting Organizations, supports modified pain management questions, and supports the defined role of paraprofessionals in the health care delivery system within the boundaries of their scope of practice.
The above Medicare Inpatient Prospective Payment Systems proposed rule also includes a proposal to include two nurse staffing measures – Skill Mix Measure (NQF #0204) and Nursing Hours per Patient Day Measure (NQF #0205) – through the Inpatient Quality Reporting (IQR) Program to be included in the criteria that go into determining hospital Star Ratings on Hospital Compare. ANA – along with 26 cosignatories - submitted a separate comment letter which expresses our strong support for inclusion of these staffing measures in the IQR. The inclusion of these staffing measures is critical to ensuring patient safety and quality outcomes in inpatient settings.
In a Federal Register notice published on December 7, 2016, the Occupational Safety and Health Administration (OSHA) published a Request for Information (RFI) entitled Prevention of Workplace Violence in Healthcare and Social Assistance. ANA’s letter expressed support for the creation of a workplace violence prevention standard and noted that any standard must follow the recommendations laid out in ANA’s 2015 Position Statement on Bullying, Incivility, and Workplace Violence and include input and participation by both employers and employees.The letter also stated that ANA looks forward to working in collaboration with OSHA and other stakeholders on the development of such a standard.
ANA's comments focused on the issue of Network Adequacy. In the proposed rule CMS announced a retreat from an active federal role in assessing network adequacy. ANA has repeatedly recommended that CMS take a more active role in assuring QHP's network adequacy performance. While health insurance plans have recently been accused of ignoring consumer preferences through creation of narrow networks, there is a longer period of insurers' development of what may be called narrow-minded networks. In particular, it is well documented that many insurers continue to exclude APRNs from private health insurance networks.
There is no legitimate business purpose in such restrictions. In fact, there is an additional concern that applies when the markets in question are based on the Affordable Care Act. Plans in those markets are required to abide by PPACA §1201 [now §2706(a) of the U.S. Public Health Service Act], Non-Discrimination in Health Care: Providers. §2706(a) states that a "group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider's license or certification under applicable state law." ANA's interest is not for preferred treatment but for a level playing field. Plans with blanket exclusion rules with respect to categories of clinicians should not be allowed to participate in the Exchanges.
In April 2017, The Office of the National Coordinator for Health Information Technology (ONC) requested comments related to a Proposed Interoperability Standards Measurement Framework.
In response to the draft interoperability framework, ANA and the Alliance for Nursing Informatics (ANI) fully endorsed the objective related to determining the nation’s progress in implementing interoperability standards in health information technology (health IT) and the use of the standards as a tool to measure progress and identify barriers to nationwide interoperability. ANA and ANI also offered comments related to: 1) voluntary, industry-based measure; 2) alternative mechanisms to reporting on the measurement framework; 3) objectives, goals, and measurement areas required to inform progress on whether appropriate technical requirements are in place to support interoperability; 4) existing gaps in the proposed measurement framework; 5) identification of appropriate stakeholders to support data collection; 6) monitoring the implementation and use of measures; 7) annual reporting of implementation and/or use of interoperability standards; 8) determining standards that should be monitored; 9) developing method for ONC to work with data holders to select standards for measurement and establish a common definition for measures to ensure consistent reporting; and 10) selecting measures to track level of conformance or customization of standards once implemented in the field.
In September 2017, ANA, along with several other groups, co-signed a comment letter that was submitted to The Office of the National Coordinator for Health Information Technology (ONC) regarding electronic health records (EHRs) and the implementation of the 21st Century Cures Act.
The comments addressed safety issues unique to the pediatric patient population (i.e. weight-based medication doses) when using EHR technology. The signatories encouraged ONC to promptly begin work on pediatric EHR certification criteria that includes provisions to monitor and test for safety through all stages of EHR development.
In September 2017, The Centers for Medicare and Medicaid Services (CMS) Innovation Center issued a Request for Information (RFI) related to CMS Innovation Center New Direction.
ANA and the Alliance for Nursing Informatics submitted comments in response to the CMS Innovation Center New Direction RFI focusing on the following Guiding Principles: 1) Choice and competition in the market; 2) Provider choice and incentives; 3) Patient-centered care; 4) Benefit design and transparency; 5) Transparent model design and evaluation; and 6) Small scale testing. In the letter, the objective to promote patient-centered care and test market-driven reforms empowering beneficiaries as consumers, provide price transparency, and increase choices and competition to drive quality, reduce costs and improve outcomes was fully endorsed. CMS was urged to promote models that fully integrate the registered nurse and Advanced Practice Registered Nurse as care leaders and team members and empower them to practice at the full scope of their education and training within each care model.
2016 ANA Regulatory Comments
Letter from ANA to CMS Concerning the Proposed Rule, Programs of All-Inclusive Care for the Elderly (PACE), dated October 11, 2016
In a Federal Register notice published on August 16, 2016, CMS published a proposed rule entitled Programs of All-Inclusive Care for the Elderly (PACE). ANA's letter expressed support for the proposed changes to allow nurse practitioners and other providers to furnish primary care services, and to change "primary care physician" to "primary care provider" in several sections of the proposed rule. The letter stated that ANA strongly supports these changes and commends CMS for taking steps to recognize the essential role of nurse practitioners and other providers in furnishing primary care services to PACE participants.
Letter from ANA to CMS on Advancing Care Coordination Through Episode Payment Models, Cardiac Rehabilitation Incentive Payment Model, and Changes to the Comprehensive Care for Joint Replacement Model (CJR), dated September 26, 2016
In a Federal Register notice published on August 2, 2016, CMS published a proposed rule entitled, Advancing Care Coordination through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR); Proposed Rule. ANA's letter expressed support for the comments submitted by the Association of Rehabilitation Nurses, an Organizational Affiliates of ANA, regarding care coordination, transitional care services and discharge planning. In addition, the letter reiterated comments recommending that CMS include a waiver to allow APRNs to certify hospitalized patients for home health care services. ANA also urged CMS to require more specific identification of all the clinicians whose services are billed incident to.
Letter from ANA to the Standard Occupational Classification Policy Committee (SOCPC), U.S. Bureau of Labor Statistics, regarding the SOCPC Recommendations for the 2018, dated September 20, 2016
In a Federal Register notice published on July 22, 2016, the Office of Management and Budget (OMB) published Notice of Standard Occupational Classification Policy Committee (SOCPC) Recommendations to OMB and solicitation of comments. The letter states that in 2014, ANA supported the National Association of Clinical Nurse Specialists (NACNS) with respect to establishing a new detailed occupation for Clinical Nurse Specialists. The SOCPC did not accept this recommendation. This letter, written in response to OMB's notice on July 22, again supports and endorses the NACNS response to Docket number 1-0210. The letter states that ANA concurs that NACNS has demonstrated that their proposed SOC revisions for Clinical Nurse Specialists meet the requirements of SOC Classification Principle 2.
Letter from ANA to HHS regarding a Request for Information on Opioid Analgesic Prescriber Education and Training Opportunities, dated September 6, 2016
In a Federal Register notice published on July 6, 2016, HHS published a request for information entitled Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities to Prevent Opioid Overdose and Opioid Use Disorder. ANA's letter to HHS identified two important educational initiatives concerning this topic, including a series of webinars entitled Addressing the Opioid Crisis: The Nursing Education Series on Opioids, and an offering from the American Psychiatric Nurses Association entitled Effective Treatments for Opioid Use Disorder: Educating & Empowering All Registered Nurses (RN) During an Epidemic. The letter notes that both offer nurses the opportunity to earn free continuing education credit – generally an effective mechanism to generate interest and engagement in learning and educational tools.
Letter from ANA to CMS regarding Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, dated August 31, 2016
In a Federal Register notice published on July 14, 2016, CMS published a proposed Medicare Program entitled Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Certain Off-Campus Outpatient Departments of a Provider; Hospital Value-Based Purchasing (VBP) Program. In discussing the Hospital Value-Based Purchasing (VBP) Program, the proposed rule notes that Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) pain management system is based on survey questions asking whether during the hospital stay the patient needed pain medicine, how often pain was well controlled, and the frequency with which hospital staff did everything they could to help with pain. In response to stakeholders concerns regarding possible links between these questions and pay adjustments provided through VBP, CMS proposes to remove the HCAHPS pain management dimension from the inpatient Hospital VBP program beginning with the fiscal year 2018 payment determination year. ANA expressed support for the proposed removal of these survey questions from the scoring methodology and the development of modified pain management questions through the standard survey development process, but urged CMS to retain in CMS's transparent public reporting the current pain questions in the survey until modified pain management questions have been developed.
Letter from ANA to CMS regarding Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017, dated August 31, 2016
In a Federal Register notice published on July 15, 2016, CMS published a proposed Medicare Program entitled Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. ANA's letter to CMS expressed support for the proposed revision of §405.2413(a)(5) and §405.2415(a)(5) to state that services and supplies furnished incident to Transitional Care Management and Chronic Care Management services can be furnished under general supervision of a Rural Health Clinic and Federally Qualified Health Center practitioner. ANA also supported the proposed requirements that Medicare Advantage (MA) providers and suppliers enroll in Medicare in an approved status in order to provide health care items or services to a Medicare enrollee who receives his or her Medicare benefit through an MA organization. ANA's letter suggested that CMS tabulate provider counts by specialty (using CMS specialty designations) and publish periodically the MA enrollee/provider ratios for each MA plan, and recommended that CMS develop a de-duplicated count of MA providers by specialty. ANA reiterated the recommendation to eliminate physician-centric language from proposed rules. Finally, ANA's letter cautioned that beneficiaries may not genuinely understand that participation in the ACO is voluntary, and urged CMS to revise regulatory language to avoid miscommunication on this point.
Letter from ANA to SAMHSA regarding the request for Public Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women with Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance, dated August 30, 2016
In a Federal Register notice published on August 3, 2016, SAMHSA published a Request for Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women With Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance.
ANA's letter to SAMHSA expressed strong support for a collaborative approach to safe treatment of pregnant and breastfeeding women with substance use disorder, noted that ANA had advocated for pregnant and breastfeeding women with substance use disorder for many years, and shared the current ANA position statement, Non-punitive Alcohol and Drug Treatment for Pregnant and Breast-feeding Women and their Exposed Children (2011). The letter supported the need for additional guidelines, educational programs, resources, webinars, and training in mental health and substance use disorder for nurses and other providers; noted that the report will be a valuable tool for all health care providers caring for this population; and expressed overall support for the report. ANA's letter also provided the following specific comments for consideration:
- Page 4 & 75, Appendix 4: Key Features of Medications Approved for Treating Opioid Use Disorders. The language should reflect the current status of nurse practitioner prescribing authority for buprenorphine. Comprehensive Addiction and Recovery Act, Public Law 114-198.
- Page 10, Safeguarding Against Discrimination and Stigmatization. ANA acknowledges that socioeconomics, class, race, and ethnicity may influence how women are cared for in the maternal child health setting related to this issue, and compels fairness in drug screening (universal versus selective), treatment, and rehabilitation services. Practice considerations for health care providers should include assessment of individual bias (which may largely be unintended) to safeguard against discrimination and stigmatization.
- Page 10, Safeguarding Against Discrimination and Stigmatization. Research has demonstrated the stressful effect that caring for pregnant women with substance use disorder can have on the health care provider. Mechanisms for identifying personal and professional challenges and interventions amongst health care providers when caring for this population should be incorporated into the guidelines.
- Page 12, Need for Collaboration Among Multiple Agencies. Current research indicates that susceptibility to the criminal justice system may also result in a pregnant women's reluctance to seek treatment, therefore possibly harming the pregnant woman and fetus.
- Page 21, A Guide for Collaborative Planning. It is essential to have a multidisciplinary team for effective collaboration, as mentioned on pages 18-19. Within this model, the voice of the pregnant woman should not be absent. In a shared decision making framework, the patient's perspective is critically valuable, even in policy considerations. ANA commends the inclusion of the patient as a core stakeholder.
- Page 67, Appendix 3: Training Needs and Resources. ANA is essential in providing specific guidance to nurses in all aspects of practice. Nurses are the largest population of health care providers in the industry and therefore ANA recommends the current position statement Non-punitive Alcohol and Drug Treatment for Pregnant and Breast-feeding Women and their Exposed Children is included as a resource in this report.
Letter from ANA to CMS regarding a proposed rule entitled Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements, dated August 26, 2016
In a Federal Register notice published on July 5, 2016, CMS requested comments on a proposed rule entitled Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. ANA's comment letter asked CMS to carefully evaluate the concerns expressed by the Alliance for Home Health Quality and Innovation (the Alliance) regarding the impact of payment reductions on vulnerable populations; the recommendation to eliminate the per day and per week caps on certain patient groups; and the impact of outlier policy changes on insulin-dependent diabetic patients. ANA supported the Alliance's call for additional information on the proposed use of a Linear Exchange Function to translate a home health agency's Total Performance Score into a value-based payment adjustment percentage. ANA expressed support for CMS' efforts to streamline measures to develop a parsimonious set of high-impact Home Health Value Based Purchasing measures, as well as the rationale to remove four current measures. The letter supported the concerns expressed by the Alliance on proposed IMPACT Act measures. The ANA letter also emphasized and supported a number of comments and recommendations from the Visiting Nurse Associations of America (VNAA), including concerns regarding the potential impact of the proposed negative payment reduction; the four-year phase-in of rebasing; the implementation of a 0.97 percent reduction to the national, standardized 60-day episode rate in CY 2017; the proposed adjustments to the case mix weights; and the comments regarding the proposed reduction of the estimated market basket adjustment. ANA also supported VNAA comments concerning the Home Health Conditions of Participations use of OASIS assessments.
Letter from ANA to CMS regarding a proposed rule on the End-Stage Renal Disease Prospective Payment System, dated August 23, 2016
In a Federal Register notice published on June 30, 2016, CMS requested comments on a proposed rule entitled End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and other matters. ANA's letter supported the positions and recommendations set forth in the comment letter submitted by the American Nephrology Nurses' Association (ANNA), including their positions with regard to the proposed revision of the payment adjustments under the CY 2017 ESRD PPS and the proposed payment policy for renal patients with acute kidney injury. ANA's letter reiterated ANNA's recommendation that CMS adopt evidence-based ESRD measures and urged CMS to work with stakeholders in the nursing community and the Kidney Care Quality Alliance when developing and implementing measures. ANA also addressed the need to involve nurses in the development and implementation of the Comprehensive ESRD Care Model and other alternative payment models.
- Letter from ANA to the CMS regarding a proposed rule on the Hospital and Critical Access Hospital Changes, dated August 15, 2016
In a Federal Register notice published on June 16, CMS requested comments on a proposed rule entitled "Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care." The proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. Highlights from ANA's letter include the following:
- Section 482.130 (Patient's Rights): ANA supports new nondiscrimination provisions and a proposed change in terminology (from "licensed independent practitioner" to "licensed practitioner") for ordering restraints and seclusion.
- Section 482.21 (Quality assessment and performance improvement program): ANA recommends clarifying that the data collection requirements pertain to information already collected from existing programs.
- Section 482.23 (Nursing services): ANA -
- Supports the removal of the reference to bedside care from section 482.23(b).
- Urges CMS to consider adding additional provisions to section 482.23(b) to ensure safe and adequate nurse staffing.
- Supports the proposed revision to section 482.23(b)(4) to add language requiring that the plan reflect the patient's goals and the nursing care to be provided.
- Supports proposed changes in section 482.23(b)(6) to clarify that all licensed nurses providing services in the hospital must adhere to hospital policies and procedures and that there must be adequate supervision, evaluation and assessment of the clinical activities of all nursing personnel within the responsibility of the nursing service.
- Recommends revising section 482.23 to clarify that policies addressing requirements to have a RN present in outpatient departments must be approved by the director of nursing.
- Recommends that CMS consider addressing the issue of texting orders in subsection 482.23(c)(3)(i) (verbal orders).
- Section 482.42 and Section 485.640 (infection control): ANA supports the new requirements on infection prevention and control and antibiotic stewardship programs.
- Section 482.22(a): ANA urges CMS to require hospitals and medical staff to include practitioners other than physicians on their medical staffs.
- Section 485.631(d) (staffing and staff responsibilities): ANA urges CMS to ensure that the evaluation of the quality and appropriateness of the care provided by all practitioners (including peer review, professional practice evaluations and focused professional practice evaluations) include input from a reviewer (either a staff member or contract provider) with qualifications comparable to the provider under review (such as a practitioner of the same profession or discipline with similar education, training and qualifications who can address the practitioner's skills and clinical judgment).
- Section 485.641 (Quality assessment and performance improvement program): ANA notes a number of unique challenges facing CAHs, including the length of time facilities will need to implement the new initiatives; the need for education and training on appropriate collection of data; and potential challenges due to low service volume.
Letter from ANA to the Department of Veterans Affairs regarding a proposed rule entitled Advanced Practice Registered Nurses, dated July 19, 2015
In a Federal Register notice that has received unprecedented attention, , the Department of Veterans Affairs (VA) published a proposed regulation that would amend VA's medical regulations to permit full practice authority (FPA) for all four APRN roles when acting within the scope of their VA employment and would authorize the use of APRNs to provide primary health care and other related health care services to the full extent of their education, training, and certification, without the clinical supervision or mandatory collaboration of physicians. It would preempt conflicting state law with the exception of certain limitations imposed by the Controlled Substances Act.
ANA's letter applauds the VA for taking this important step to standardize the practice of APRNs in the VA system and allow APRNs to practice to the full extent of education, training and certification. ANA's letter addresses some of the opposition to the proposal and makes the following points:
- The VA proposed rule is consistent with the 2010 IOM report, "The Future of Nursing: Leading Change, Advancing Health," and with the recently released report from the Commission on Care.
- The proposed rule is consistent with other efforts to improve access to high-value patient-centered care.
- The proposed rule would not limit efforts to further team-based care.
- The proposed rule recognizes that supervision requirements are unnecessary and costly. It is consistent with current practice in 21 States and the District of Columbia, federal IHS and DOD facilities, and most VA Medical Centers.
- The proposed rule includes separate descriptions of FPA for each of the four APRN roles. ANA urges the VA to carefully consider the recommendations and comments from the experts in each APRN organization and to work closely with these experts to ensure that FPA for each APRN role is appropriately described in the regulations and any VHA guidance issuances.
- ANA recommends clarifying the language on collaboration (in section 17.415(b)) to state that "FPA means the authority of an APRN to provide services described in paragraph (d) of this section without clinical oversight of a physician or mandatory collaboration, regardless of State or local law restrictions…"
- ANA supports the proposal to exercise Federal preemption of state laws.
Letter from ANA to Presidential Commission for the Study of Bioethical Issues, regarding the role of past, present, and future national bioethics advisory bodies, dated June 28, 2016
In a Federal Register notice dated March 1, 2016, the Commission requested comments on the role of past, present, and future national bioethics advisory bodies. ANA's letter supports the past and present work of the Commission including education, reports and opinions on ethical issues in practice and national bioethics crises. The letter emphasized the influence that national bioethics advisory bodies have on public policy and are heavily relied upon by health care providers. The letter expressed the need for the future Commission to be representative of the diverse health care providers in the U.S. and encompass different disciplines and areas of practice. Lastly, ANA recognizes the necessity of a national bioethics advisory body to provide guidance to the President, public and health care community regarding emerging advances in science, medicine and technology.
Letter from ANA to CMS on the Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models, dated June 27, 2016
In a Federal Register notice published on May 9, 2016, CMS requested comments on a proposed rule entitled "Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models."
This proposed rule would establish the new Merit-based Incentive Payment System (MIPS) for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System, the Physician Value-based Payment Modifier, and the Medicare Electronic Health Record Incentive Program for Eligible Professionals. The proposed rule would also establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee. ANA's letter addresses a number of topics in the proposed rule:
- In response to the request for comment on the use of certified EHR technology (CEHRT) within APMs, ANA's letter urges CMS to include in guidelines for CEHRT a requirement for attribution of the work of non-physician providers, such as APRNs; urges CMS to avoid any guidance that would assign to the nurse the role of acting as a scribe for physicians; expresses support for efforts to advance interoperability; and expresses general support of the proposed attestation requirements.
- The letter discusses the effects of MACRA on APRNs enrolled as Medicare Part B Providers, noting that APRN services have not been effectively utilized and at best have only partially been recognized.
- In discussing APMs, the letter notes that while nurse practitioners, certified registered nurse anesthetists, and clinical nurse specialists were included in the description of APMs under MACRA, there is no requirement that APMs include APRNs in their networks as independent providers eligible for direct billing and participating in potential incentives. The letter also notes that opportunities for an enrolled APRN Medicare Part B provider to meaningfully join an APM may be severely limited based on both rural location and on the lack of welcoming behavior with respect to APM networks.
- The letter reiterates the request that CMS ensure that each service provided to a patient is associated with the actual provider of the service; asks CMS to afford APRNs the same opportunities as physicians to develop, implement, and evaluate clinical practice improvement activities; and urges CMS to reconsider the decision against broadening the definition of physician-focused payment models to include APRNs.
- The letter urges the Secretary to include certified nurse-midwives as eligible clinicians in the third and subsequent years of MIPS.
Letter from ANA to CMS on the 2017 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, dated June 17, 2016
In a Federal Register notice published on April 27, 2016, CMS requested comments on a proposed rule entitled "Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services." Changes proposed include revising of the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; updating the payment policies and the annual payment rates for the Medicare prospective payment system for inpatient hospital services provided by long-term care hospital; and updating policies relating to the Hospital Value-Based Purchasing Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition Reduction Program. ANA's letter requests the addition of critical safety structural measures (nurse staffing and skill mix) to the CMS Inpatient Quality Reporting Program; requests timely inclusion of critical safety clinical measures (falls and falls with injury) for public reporting in the CMS Inpatient Quality Reporting (IQR) Program or timely CMS support for electronic clinical measures development; and requests that CMS retain IQR public reporting for participation in a systematic clinical database registry for nursing. The letter also expresses support for the proposed update of the MORT-30-STK measure to include the NIH Stroke Scale as a measure of stroke severity in the risk-adjustment in future rulemaking.
Letter from ANA to the Substance Abuse and Mental Health Services Administration, Department of Health and Human Services, regarding Medication Assisted Treatment for Opioid Use Disorders, dated May 23, 2016
In a Federal Register notice published on March 31, HHS/SAMHSA requested comments on a proposed rule entitled "Medication Assisted Treatment for Opioid Use Disorders." The proposed rule would expand access to medication-assisted treatment (MAT) by allowing eligible practitioners to request approval to treat up to 200 patients under the Controlled Substances Act. It also includes requirements to minimize the risk that the medications are misused or diverted, and to ensure that patients receive the full array of evidence-based MAT services. The rule notes that allowing non-physician practitioners to prescribe buprenorphine would require a statutory change to the Controlled Substances Act. Legislation to authorize such a change is currently pending in Congress. ANA's letter acknowledges that SAMSHA does not have the authority to change this requirement through regulations, but urges SAMSHA/HHS, if asked to provide agency views on proposed legislative changes to the CSA, to support allowing advanced practice registered nurses and other non-physician providers to be eligible practitioners.
Letter from ANA to the National Coordinator for Health Information and Technology, concerning the Interoperability Pledge, dated April 19, 2016
The Office of the National Coordinator for Health Information Technology (ONC) has asked private sector partners (including health information technology developers, health systems, and provider, technology and consumer organizations) to sign an Interoperability Pledge addressing three shared commitments around interoperability including consumer access, no data blocking and standards. The April 19th letter articulates ANA's commitment to the three shared principles around interoperability including consumer access, no data blocking and standards, describes ANA's policy and advocacy work and Position Statements related to health information technology, and briefly describes past and present health IT initiatives to include the 2016 Culture of Safety pertaining to Transitions of Care and Data and Systems Thinking (e.g. planned webinar on consumer access to digital health information and support of the GetMyHealthData initiative).
Letter from ANA to SAMHSA concerning Confidentiality of Substance Use Disorder Patient Records, dated April 7, 2016
On February 9th, the Substance Abuse and Mental Health Services Administration, published notice in the Federal Register on a proposed rule on the Confidentiality of Substance Use Disorder Patient Records. ANA's letter supports SAMHSA's goal to update and modernize the regulations concerning the confidentiality of substance use and disorder patient records while maintaining strong privacy protections. The letter notes that information sharing is essential to support the coordination of patient care, which is necessary to advance the delivery of health care, improve quality, and further the priorities of the triple aim: improving health care quality; improving population health; and reducing unnecessary health care. The letter also notes the importance ensuring that patients receiving care for substance use disorder can do so without fear of suffering adverse consequences from inappropriate disclosure of information. In order to fully achieve these goals, ANA urges SAMHSA to carefully consider the comments, concerns and recommendations set forth in the letter submitted by the American Medical Informatics Association.
Letter from ANA to the Centers for Disease Control and Prevention concerning proposed vaccine information statements for hepatitis A and hepatitis B vaccines, dated April 6, 2016
On February 8, 2016, the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, published notice in the Federal Register requesting comments on updated vaccine information statements for hepatitis A and hepatitis B vaccines. ANA's letter noted that the vaccine information statements include references to both "health care providers" and to "doctors." The letter emphasized the importance of using provider neutral language to prevent confusion among health care consumers who use APRNs as their primary care provider, and recommended revising the statements to consistently refer to "healthcare providers."
Letter from ANA to CMS concerning the Draft Quality Measures Development Plan, dated March 1, 2016
On December 18, 2015, CMS released the Draft CMS Quality Measure Development Plan to build on CMS's efforts to shift Medicare payments from volume to value. Comments were requested by March 1, 2016. ANA's letter expressed support for the intent of this draft MDP to transition to the Merit-based Incentive Payment System and Alternative Payment Models, including the use of quality measures that are transparent, actionable, evidence-based, patient-centered and consensus-driven. ANA expressed support for the promotion of broader consistency in the measure development process and the goals to coordinate across CMS programs and achieve greater alignment of measures in the private sector and other public programs. The letter also notes ANA's concern that the language in the plan does not fully recognize or acknowledge the essential role and expertise of clinicians other than physicians in the design and implementation of MACRA, including the substantial roles APRNs play in Medicare Part B. The letter states that quality measures should include and account for the professional roles of APRNs and all appropriate stakeholders who provide clinical services to Medicare beneficiaries, and urges CMS to advance a MACRA incentive program for APRNs to ensure that their records are incorporated (inter-operatively) into the complex of EHRs for all Medicare patients from all of their clinicians.
Letter from ANA to the Senate Finance Committee's Bipartisan Chronic Care Working Group, dated January 26, 2016
In December 2015, the Bipartisan Chronic Care Working Group issued a policy document outlining policies under consideration as a part of the Committee's effort to improve how Medicare treats beneficiaries with multiple, complex chronic illnesses. A statement from the Committee provides additional details on this initiative. ANA's letter addressed efforts to improve care management services for individuals with multiple chronic conditions and recommended additional analysis of this issue to ensure that a high-severity chronic care management code appropriately targets Medicare resources to beneficiaries with the greatest need for chronic care management. The letter recommended that the group include APRNs as eligible clinicians to bill for a high severity chronic care code. The letter supported the recommendation to have the Government Accountability Office (GAO) conduct a study on the current status of the integration of behavioral health and primary care among Accountable Care Organizations. ANA's letter also supported the recommendation for a GAO study evaluating appropriate measures for chronic care management. Finally ANA's letter supported the proposal to waive co-payments for the current and contemplated chronic care management services.
Letter from ANA to CMS concerning a Request for Information "To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Long-Term Care Hospitals," dated January 19, 2016
On November 20, 2015, CMS published a Request for Information on the design and development of a survey concerning experiences with care received in Long-Term Care Hospitals. ANA's letter urged CMS, in developing these survey questions, to remain cognizant of the important role of nursing in patient engagement, and to devise survey questions that elicit information concerning the role of nurses.
Letter from ANA to CMS concerning a Request for Information "To Aid in the Design and Development of a Survey Regarding Patient and Family Member Experiences With Care Received in Inpatient Rehabilitation Facilities," dated January 19, 2016
On November 20, 2015, CMS published a Request for Information on the design and development of a survey concerning experiences with care received in Inpatient Rehabilitation Facilities. ANA's letter urged CMS, in developing these survey questions, to remain cognizant of the important role of nursing in patient engagement, and to devise survey questions that elicit information concerning the role of nurses.
Letter from ANA to the Department of Housing and Urban Development (HUD) concerning a proposed rule Instituting Smoke-Free Public Housing, dated January 11, 2016
On November 17, 2015, HUD published a proposed rule that would require each public housing agency to implement a smoke-free policy. ANA's letter expressed support for the proposed rule and noted a number of barriers to implementation. In addition, ANA recommended that HUD should provide resources for all lessees to quit tobacco use, and further recommended including a prohibition on waterpipe tobacco smoking in public housing.
Letter from ANA to HHS concerning comments to the Common Rule, dated January 6, 2016
On September 8, 2015, HHS and 15 other federal agencies requested comments on proposed updates to the Common Rule, a common set of Federal regulations developed to promote uniformity, understanding, and compliance with human subject protections as well as to create a uniform body of regulations across federal departments and agencies. ANA's letter to the Director of the HHS Office for Human Research Protections expressed support for the intent to better protect human subjects involved in research while facilitating valuable research and reducing burden, delay, and ambiguity for investigators, as well as the broad goal to modernize, simplify, and enhance the current system of oversight. ANA's letter noted, however, that the proposed rule lacks clarity and precise definitions and concepts on a number of important topics. ANA urged OHRP refrain to from including in the final rule topics that are undeveloped in this proposed rule. ANA's letter also noted that informed consent should be simple and offer more meaningful, culturally appropriate engagement, and that the proposed rule does not provide clear definitions of broad consent or adequate explanation for how and when such consent should be used. The letter also expressed concerns about the proposed exclusions and exemptions and recommended clarification concerning the guidelines for obtaining a waiver of consent.
2015 ANA Regulatory Comments
Letter from ANA to CMS concerning discharge planning, dated December 21, 2015
On November 3, 2015, CMS published a proposed rule entitled Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies. This proposed rule would revise the discharge planning requirements that hospitals, including long-term care hospitals and inpatient rehabilitation facilities, critical access hospitals, and home health agencies must meet in order to participate in the Medicare and Medicaid programs. The proposed rule would also implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014. ANA's letter to CMS applauded the emphasis on involving patients, families and their caregivers in the discharge planning process, the focus on the goals and preferences of the patient, and the emphasis on coordination during the development of the discharge plan. In addition, ANA's letter expressed support for the comment letter submitted by the Association of Rehabilitation Nurses (ARN), an Organizational Affiliate of ANA. ANA's letter noted that registered nurses with rehabilitation training and experience play an essential in the development of discharge policies for acute care facilities, and rehabilitation nurses also play a critical role prior to and during discharge in discussing the patient's post-acute care (PAC) goals and treatment preferences. ANA's letter also highlighted ARN's recommendation that CMS delineate acceptable methods for hospitals to communicate information at discharge and require hospitals to communicate the capabilities and limitations of PAC facilities to ensure a match between patients' clinically assessed needs and the available level of care.
Letter from ANA to HHS concerning the HHS Notice of Benefits and Payment Parameters for 2017 proposed rule, dated December 21, 2015
On December 2, 2015, HHS published a Notice of Benefit and Payment Parameters for 2017. The proposed rule set forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also addressed standards for the annual open enrollment period; essential health benefits; cost-sharing requirements; qualified health plans; standards for Exchange consumer assistance programs; network adequacy; patient safety standards; the Small Business Health Options Program; stand-alone dental plans; acceptance of third-party payments; the definitions of large employer and small employer; fair health insurance premiums; guaranteed availability; student health insurance coverage; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions and appeals; and other related topics. ANA's letter to CMS expressed concerns regarding several of the approaches in the proposed rule and made the following points:
By endorsing a continuation of existing private insurance practices CMS endorses extending discrimination against APRNs.
The continued exclusion of APRNs from credentialing into private Qualified Health Plan networks violates Public Health Services Act Sec. 2706(a), Non-Discrimination in Health Care, 42 USC §300gg-5.
Patients of the resulting out-of-network APRNs face higher copayment rules, potentially disrupting patient/clinician relationships.
CMS sanctioning of exclusion of APRNs endorses anti-competitive practices within Federally Facilitated Exchanges.
The letter also noted that while ANA is encouraged by the proposed rules for maintenance provider directories, strict enforcement of those rules will be required.
Letter from ANA to National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, concerning ANA comments on proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine, dated December 10, 2015
On October 22, 2015, CDC requested comments on proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine. ANA's letter recommended revising the form to include provider-neutral language throughout the statement.
Letter from ANA to National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, concerning ANA comments on proposed revised Vaccine Information Materials for Meningococcal ACWY and Serogroup BMeningococcal Vaccines, dated December 10, 2015
On October 14, 2015, CDC requested comments on updates to vaccine information statements for meningococcal ACWY and serogroup B meningococcal vaccines. ANA's letter recommended revising the form to include provider-neutral language throughout the statement.
Letter from ANA to the Food and Drug Administration concerning the use of the term "Natural" in the labeling of human food products, dated December 7, 2015
On November 12, 2015, FDA issued a request for information entitled Use of the Term "Natural" in the Labeling of Human Food Products; Request for Information. ANA's letter urged the FDA to prohibit the use of the term "natural" in the labeling of human food products that are genetically engineered or contain ingredients produced through the use of genetic engineering, and requested that the FDA require clear, appropriate food labeling including the country-of-origin and any genetic modification of any of the food's ingredients.
Letter from ANA to the Department of Health and Human Services, CMS, concerning ANA comments on implementation of the Medicare Access and CHIP Reauthorization Act (including the Merit-Based Incentive Payment System, Alternative Payment Models and Incentive Payments), dated November 16, 2015
On October 1, 2015, CMS issued a Request for Information (RFI) regarding implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models. The RFI concerns implementation of section 101 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The ANA letter recommended using a single system of identifiers (the National Provider Identifier); urged HHS and CMS to maintain the NPI as a disciplined data set with rules and expectations with respect to NPI holders; urged HHS to ensure that each service provided to a patient is associated with the actual provider of the service (rather than using billing procedures of a group practice); and stated that a new payment system designed to incentivize high quality, value-based services must clearly and consistently identify the provider responsible for rendering a service. In addition, ANA participated in a letter to CMS from an APRN workgroup. The letter expressed the following points:
MACRA implementation should ensure robust patient access to APRN services, and APRNs should be an integral part of its planning and implementation
Ensure that each service provided to a patient is associated with the actual provider of the service
Performance mechanisms should be subject to all appropriate stakeholders' review in order to qualify for use as a reporting mechanism for quality indicators
Do not include participation in the Network of Plans in the Federally-Facilitated Marketplace as part of the subcategory of promoting health equity and continuity as participation in a network may be beyond an EPs control
Ensure equal treatment among APRNs and physicians under Clinical Practice Improvement Activities
Do not exclude APRNs from the definition of Physician-Focused Payment Models
Evaluate whether Physician-Focused Payment Models promote full scope of practice
ANA Letter to the Department of Health and Human Services, Office for Civil Rights, concerning Nondiscrimination in Health Programs and Activities, dated November 9, 2015
On September 8, 2015, the HHS Office of Civil Rights (ONC) issued a proposed rule entitled Nondiscrimination in Health Programs and Activities. The letter commends HHS and OCR on the publication of the proposed rule, which takes important steps to end discrimination in the delivery of health care, but provides a number of recommendations to strengthen the rule. Specifically, the letter urges OCR to refrain from establishing additional exceptions for purposes of this rule; to revise the proposal to exclude employment discrimination by a health program or activity; to revise the definition of what constitutes discrimination by including regulatory language clarifying that the practice of placing all or nearly all medications to treat a certain condition on the highest tier to be discriminatory; and to clarify that the definition of who is protected under Section 1557.
Letter from ANA to the Office of National Coordinator for Health IT concerning the 2016 Interoperability Standards Advisory Best Available Standards and Implementation Specifications, dated November 6, 2015
In response to ONC's request for public comments on the document "2016 Interoperability Standards Advisory Best Available Standards and Implementation Specifications," ANA reiterated comments previously submitted on the 2015 Interoperability Standards Advisory Best Available Standards and Implementation Specifications. The ANA letter provided links to two ANA Position Statements on EHR and HIT (Inclusion of Recognized Terminologies within EHRs and other Health Information Technology Solutions and Standardization and Interoperability of Health Information Technology: Supporting Nursing and the National Quality Strategy for Better Patient Outcomes). It noted ANA support for having a unique clinician identifier that can be captured across care settings for data analytics that will better inform a learning health system. With regard to care plans, the letter discussed the importance of including on the list of data elements terminologies that support nursing practice and patient-centered care.
Letter from ANA to the Department of Health and Human Services, CMS, concerning Reform of Requirements for Long-Term Care Facilities, dated October 13, 2015
On July 16, 2015, CMS published a proposed rule entitled Reform of Requirements for Long-Term Care Facilities. ANA's initial comments to CMS on this matter were submitted on September 14, 2015. On October 13th, following an extension of the comment period, ANA submitted a follow-up letter supporting comments provided by ANA's nursing colleagues at the American Association of Nurse Practitioners (AANP) and the American Association of Nurse Assessment Coordination (AANAC). The letter noted that ANA shares the concerns expressed by AANAC regarding baseline care plans (42 CFR 483.21(a)) and the recommendation for clarification of the required timing of such plans, and reiterated the recommendation to include definitions for the phrases "culturally-competent" and "trauma-informed." The letter stated that ANA supports AANAC's request for clarification of the discussion on basic life support (42 CFR 483.25(a)(3)), including the recommendations concerning state-specific Do-Not-Resuscitate and Physician Orders for Life-Sustaining Treatment. ANA also expressed support for AANAC's comments concerning behavioral health services (42 CFR 483.40) and their position concerning the discussion of arbitration.
Letter from ANA to the Center for Consumer Information and Insurance Oversight concerning Essential Health Benefits Benchmark Plans for 2017, dated September 30, 2015
The Center for Consumer Information and Insurance Oversight (CMS) published information about the proposed Essential Health Benefits benchmark plans for each state, including a summary of the plan's benefit coverage and limits, including a list of covered prescription drug categories and classes, and a list of state-required benefits. The public was offered the opportunity to comment on the plans.
ANA's letter urged CCIIO to take the following steps with regard to the EHB benchmark plans for 2017: conduct a comprehensive review of each proposed benchmark plan to analyze the benefits and limits, prescription drug information, and evidence of coverage and other underlying plan documents to identify gaps and areas where the plan does not comply with applicable regulations and guidance; transmit this information to the states and ensure that state regulators know that qualified health plans (QHPs) are not permitted to mimic the benchmark plan in areas where gaps are identified; make this information publicly available in order to facilitate consumer advocates' engagement in improving plan design; and conduct spot-checks of certified QHPs to ensure the plans don't mirror identified gaps in EHB benchmarks.
Letter from ANA to the Department of Health and Human Services, CMS, concerning Reform of Requirements for Long-Term Care Facilities, dated September 14, 2015
On July 16, 2015, CMS published a proposed rule entitled Reform of Requirements for Long-Term Care Facilities. ANA's letter regarding this proposed rule noted CMS' recognition of ANA's Principles for Nurse Staffing but asked that CMS reevaluate the position set forth in this proposed rule in light of current research on staffing issues and to consider the regulatory steps that can be taken to address this important issue. The letter also supported proposals concerning residents' rights and a number of provisions concerning transitions of care.
Letter from ANA to the Department of Health and Human Services, CMS, concerning Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016, dated September 4, 2015
On July 15, 2015, CMS published a proposed rule entitled Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. ANA's letter to CMS expressed support for the inclusion of advance care planning codes in the recently proposed 2016 Medicare Physician Fee Schedule. With regard to clinical practice improvement activities, ANA recommended that when the clinical practice improvement requirements are finalized, they reflect the then current state of electronic health record interoperability and health information exchange as it continues to evolve.
In addition, ANA participated in a letter to CMS from an APRN workgroup. The letter expressed support for the steps CMS has taken to further include all stakeholders, including APRNs and the public, in the creation and evaluation of relative value unit values for all new, revised, and potentially misvalued codes; encouraged CMS to include APRNs as covered advance care planning (ACP) providers; recommended that CMS establish modifiers to be used to identify both when a line item in a claim was provided incident-to as well as the licensure of the actual rendering provider; asked CMS to expand the provision offering incentives from hospital organizations to physicians by allowing APRN practices in the geographic areas of the incentivizing hospital organization to receive such incentives; requested that CMS ensure equal treatment among APRNs and Physicians Under Clinical Practice Improvement Activities; asked CMS to refrain from public reporting of performance rates on measures on the Physician Compare website unless they have been vetted by all appropriate eligible professionals affected by the measure; requested that the search function on the Physician Compare Website be more inclusive of all qualified healthcare providers; requested the involvement of APRNs in the development of alternative payment models and promote full scope of practice in models; requested that provider neutral oversights be corrected in final rule; and recommended replacing the term "Nonphysician" with "APRNs" or "Part B Healthcare Practitioners" in publication of the final rule.
Letter from ANA to the Department of Health and Human Services, CMS, concerning the Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services, dated September 4, 2015
On July 14, 2015, CMS published a proposed rule entitled Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services, which proposed to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity. ANA's letter expressed support for the recommendations set forth in the comment letter submitted by the Visiting Nurse Associations of America. ANA also worked with colleagues from ANA's Organizational Affiliates, the National Association of Orthopaedic Nurses and the Association of Rehabilitation Nurses, to address additional concerns.
Letter from ANA to the Department of Health and Human Services, CMS, concerning Home Health Prospective Payment System Rate Update, dated August 28, 2015
On July 10, CMS published a proposed rule entitled CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model. ANA's comment letter supports the positions and recommendations set forth in the comment letter submitted by the Visiting Nurse Associations of America, including comments on case-mix adjustment, the methodology for calculating the case-mix adjustment, and the impact of aggregate cuts on Home Health Providers; comments on the proposed Home Health Value-Based Purchasing Program; and proposed revisions regarding the Home Health Quality Reporting Program.
Letter from ANA to the Department of Health and Human Services, CMS, concerning Hospital Outpatient Prospective Payment System, dated August 28, 2015
On July 8th CMS published a proposed rule entitled Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. ANA's letter urges CMS to avoid the use of physician-centric language (except in provisions that relate only to physicians) and to consistently use broader provider language when describing provisions of the rule that are pertinent to non-physician providers. In addition, ANA signed a joint letter asking CMS to finalize the proposed changes to the "two-midnights" rule and use its authority to eliminate remaining time-based criterion for hospital admissions exceeding the two-midnight threshold.
Letter from ANA to the Department of Health and Human Services, CMS, concerning, the End-Stage Renal Disease (ESRD) Prospective Payment System, dated August 25, 2015
On July 1, 2015, CMS published a proposed rule entitled End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), which updated and revised the case-mix adjusted bundled prospective payment system for renal dialysis services furnished by ESRD facilities. ANA's letter to CMS expresses support for the positions and recommendations set forth in the comment letter submitted by the American Nephrology Nurses' Association, including comments on the proposed revision of the payment adjustments under the ESRD PPS and the proposed ESRD PPS update, as well as comments on the ESRD Quality Incentive Program.
Letter from ANA to the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) regarding Medicaid and Children's Health Insurance Program (CHIP) Programs, dated July 17, 2015
On June 1, 2015, CMS published a rule to update and modernize the Medicaid managed care regulations, implement statutory changes, revise Medicaid managed care payment rates, and strengthen quality of care initiatives. ANA's letter expressed support for the overall proposal to align the rules governing Medicaid and CHIP managed care plans with qualified health plans; incorporate new and revised beneficiary protections; and strengthen provider networks, accountability and program integrity safeguards. ANA's letter recommended expanding the definition of primary care case manager to include clinical nurse specialists (CNSs) and RNs; supported the requirement to develop common terminology for terms such as primary care provider and primary care physician; and recommended revising a section to include references to non-physician providers. The letter supported the development and enforcement of network adequacy standards, including time and distance standards for the essential categories of providers, and also recommended several changes to ensure that the prevalence of certified nurse-midwives is consistently recognized in network adequacy standards. In order to promote consistency between state programs, ANA's letter supported having measures required at the national level.
Letter from ANA to the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), concerning vaccine information statement for influenza vaccines, dated July 14, 2015
On May 20, 2015, CDC requested comments on updated vaccine information statements for inactivated and live attenuated influenza vaccines. ANA recommended revising both statements to include provider neutral language.
Letter from ANA to the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), concerning vaccine information statement pneumococcal conjugate vaccine, dated July 14, 2015
On May 20, 2015, CDC requested comments on an updated vaccine information statement pneumococcal conjugate vaccine. ANA recommended revising the statement to include provider neutral language.
Letter from ANA to the Centers for Medicare & Medicaid Services (CMS) regarding Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program, dated June 15, 2015
On April 30, 2015, HHS/CMS published the proposed rule referenced above. In a June 15, 2015 letter to CMS, ANA requested that ANA's two critical safety structural measures, nurse staffing and skill mix, be added to the CMS Inpatient Quality Reporting (IQR) Program for timely national transparent public reporting. ANA also requested inclusion of ANA's critical outcome safety measures, falls and falls with injury, for public reporting in the CMS IQR Program for timely national reporting, or in the alternative, timely CMS support for electronic clinical measures development on falls. ANA's letter also recommends additional high impact robust safety measures for IQR.
Background and Update on ANA's Four Safety Measures – ANA's Leadership to Advance Patient Safety via Inclusion of Nursing Sensitive Safety Measures in CMS Public Reporting Programs: ANA's four critical hospital nursing-sensitive safety measures (i.e., nurse staffing, nurse skill mix, falls and falls with injuries) are endorsed by the National Quality Forum (NQF). All four ANA measures recommended by the NQF-convened Measure Application Partnership in February, 2015 for inclusion in CMS's IQR Program, upon the condition of final NQF endorsement of these measures at the new hospital-level reporting. On June 17th, all four ANA measures received a recommendation by the NQF Safety Measures Steering Committee (> 60% vote) for endorsement of these critical safety measures at both the unit and new hospital-level reporting. NQF will advance ANA's measures in their process via NQF's additional review processes per the NQF Standards for final endorsement consideration to be announced later this year. For more information, check out the following links:
Five nurse safety leaders serve on the NQF's Safety Measures Steering Committee. You can learn more about the importance of transparent public reporting on the ANA Public Reporting website.
Letter from ANA to the Centers for Medicare & Medicaid Services (CMS) regarding comments on Modifications to Meaningful Use in 2015 through 2017, dated June 12, 2015
On April 15, 2015, HHS/CMS published a proposed rule entitled "Electronic Health Record Incentive Program - Modifications to Meaningful Use in 2015 through 2017." An associated CMS factsheet states that the rule will "align Stage 1 and Stage 2 objectives and measures with the long-term proposals for Stage 3, to build progress toward program milestones, to reduce complexity, and to simplify providers' reporting." The ANA letter supports the CMS vision to align Stage 1 and Stage 2 objectives and measures with long-term proposals for Stage 3 in order to reduce reporting burden, eliminate redundant and duplicative reporting and ensure future sustainability of the Medicare and Medicaid EHR Incentive Program. The letter expresses support for the proposal to change the 2015 Meaningful Use Program reporting requirements to any continuous 90-day period within the calendar year to allow providers time and flexibility to plan for the changes proposed in this rule. The ANA letter expresses concern regarding the proposal to remove the 5 percent threshold for Measure 2 from the Eligible Professional, eligible hospital, and Critical Access Hospital Stage 2 Patient Electronic Access (VDT) objective, including the provision holding the provider accountable for a patient's use of technology. ANA recommends that CMS consider flexibility and provide further guidance on this topic. ANA supports proposed changes to "allow providers to work toward meaningful patient engagement through health IT using the methods best suited to their practice and their patient population," but encourages CMS to consider an incrementally phased-in approach towards measure thresholds to balance the challenges facing providers with the need to promote patient engagement. The letter expresses support for CMS efforts to align quality measure reporting between quality programs such as MU, IQR, and PQRS to reduce the existing reporting burden. Finally, the letter asks that all APRN providers be eligible for the EHR incentive payment, not only under Medicaid, but also under Medicare.
Letter from ANA to the Centers for Medicare & Medicaid Services (CMS), regarding comments on Stage 3 Meaningful Use (MU) Rules, dated May 27, 2015
On March 30, 2015 HHS/CMS published a proposed rule entitled: "Electronic Health Record Incentive Program Stage 3." The proposed rule specifies the meaningful use criteria that eligible professionals (including APRNs), eligible hospitals, and critical access hospitals must meet in order to qualify for Medicare and Medicaid electronic health record incentive payments and avoid downward payment adjustments. ANA's letter supports the vision of MU Stage 3, to focus on the advanced use of EHR technology to promote improved patient outcomes and health information exchange. In addition, ANA supports the proposal to continue to improve program efficiency, effectiveness, and flexibility by making changes to the Medicare and Medicaid EHR Incentive Programs that simplify reporting requirements and reduce program complexity. ANA's letter comments on general concerns with the uneven treatment of APRNs; the Proposed Reduction in Program Complexity; the Eight Meaningful Use Objectives; and Clinical Quality Measurement Reporting.
ANA Response to Call for Public Comment on the Draft National Pain Strategy dated May 19, 2015
In April 2015 the Department of Health and Human Services published notice soliciting public comment on the draft National Pain Strategy developed by the National Institute of Neurological Disorders and Stroke, Office of Pain Policy. ANA's letter to HHS applauds and strongly supports the main elements of the National Pain Strategy. It provides specific recommendations to clarify key concepts and work toward common understanding of key terms, and suggests strategies to control diversion and abuse of opioids while avoiding unintended barriers to care. ANA's letter emphasizes the importance of providing pain management services in an interdisciplinary manner. It also notes that while some professional health care education programs devote limited time to education and training about pain and pain care, the concept of pain management remains a core element in basic nursing education. Finally, the letter states that the Guiding Principles for Big Data in Nursing (http://www.himss.org/big10) should guide implementation of IT-related components of the National Pain Strategy.
ANA was also one of ten nursing organizations signing a joint letter to HHS regarding this call for public comments. The joint letter highlights the critical role that APRNs play in ensuring patient access to high quality, cost effective healthcare and providing pain management; emphasizes the importance of having APRNs serve as major stakeholders in the plan; recommends that the strategy address barriers to practice and ensure that APRNs are able to practice to the full extent of their education and training; and recommends that APRN educational programs and professionals be granted the same seat at the policymaking leadership table as the Accreditation.
Letter from ANA to the Office of National Coordinator for Health IT (ONC), regarding comments on the 2015 Interoperability Standards Advisory, dated April 29, 2015
ONC requested public comments on a document entitled: "2015 Interoperability Standards Advisory Best Available Standards and Implementation Specifications." The document represents the model ONC will use to coordinate the identification and assessment of the best available interoperability standards and specifications. The 2015 Advisory is an "open draft" designed to begin an interactive process that will result in a list of standards and implementation specifications for a broad range of clinical health IT interoperability purposes. The ANA letter notes that ANA supports the broad mission of the 2015 Interoperability Standards Advisory. The letter reiterates some of the suggestions that were in two recent letters ANA sent to ONC (including comments on Strategic Plan submitted in February 2015 and the comments on the Roadmap submitted in April 2015). The letter also references the content from two ANA's Position Statements (Inclusion of Recognized Terminologies within EHRs and other Health Information Technology Solutions and Standardization and Interoperability of Health Information Technology: Supporting Nursing and the National Quality Strategy for Better Patient Outcomes).
Letter from ANA to the Occupational Safety and Health Administration (OSHA) regarding an information collection request titled, "Bloodborne Pathogens Standard," dated April 1, 2015
On March 18, 2015, OSHA published an information collection request titled, "Bloodborne Pathogens Standard." ANA's letter expressed concern about the lack of compliance with the Needlestick Safety and Prevention Act (NSPA) and noted that the language within the NSPA related to employee input is lacking. ANA recommended that the information collected be enhanced to include the requirement to document within the Exposure Control Plan efforts to engage all employees responsible for direct patient care.
Letter from ANA to the National Coordinator, Office of National Coordinator for Health IT (ONC), regarding comments on "Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0," dated April 2, 2015
On January 30, 2015, ONC issued the draft nationwide health IT Interoperability Roadmap – a proposal to deliver better care through the safe and secure exchange and use of electronic health information. ANA appreciates the efforts of the ONC to develop a Roadmap identifying critical actions for public and private stakeholders to advance the development of an interoperable health information technology (HIT) ecosystem and facilitate the secure, efficient and effective sharing and use of electronic health information. ANA supports the broad outline of the Roadmap, particularly the person-centric vision set forth in the document, and offers comments on several questions posed by ONC, including "Priority Use Cases," "Governance" and "Measurement."
Letter from ANA to the National Institute for Occupational Safety and Health, dated March 19, 2015
On January 23, 2015, the National Institute for Occupational Safety and Health published a document entitled "Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures." ANA's letter suggests a number of corrections to the document (including the need to recognize and address risks to health care workers disposing of hazardous drugs and to discuss risks to both men and women of reproductive age). The ANA letter also discusses the need for greater effort to ensure all health care workers, patients, and communities have easy access to relevant and current information on the hazardous drugs to which they are exposed; describes needed steps to improve worker protection; and describes the need to review the potential health effects of new and older hazardous drugs.
Letter from ANA to the Department of Health and Human Services concerning the Draft National Adult Immunization Plan, dated March 12, 2015
On February 6, 2015, the National Vaccine Program Office (NVPO) published notice in Federal Register (80 FR 6721) seeking comments on the draft National Adult Immunization Plan. ANA recommended revising goal 2, objective 2.3, to include more inclusive provider language. ANA also urged the NVPO, to the extent possible, to identify and utilize measures that collect data on the full range of health care providers who administer vaccinations, including APRNs.
Letter from ANA to the Centers for Disease concerning the "Proposed Revised Vaccine Information Materials for Multiple Pediatric Vaccines (‘Your Baby's First Vaccines')," dated March 6, 2015
On January 6, 2015, the CDC published notice in the Federal Register (80 FR 1416) requesting comments on proposed revisions to the vaccine information materials for multiple pediatric vaccines. ANA's letter notes that the current form identifies only "doctors" as providers, and recommends revising the form to include provider-neutral language.
Letter from ANA to the Departments of Labor, Health and Human Services and the Internal Revenue Service, concerning the proposed rule, "Summary of Benefits and Coverage and Uniform Glossary, dated February 27, 2015
December 30, 2014, the Departments of Treasury, Labor and Health and Human Services published notice in the Federal Register (79 FR 78578) describing a proposed rule on health-coverage-related terms and medical terms that must be included in the uniform glossary and requirements for the Summary of Benefits. ANA's letter recommends that the Departments revise the mandatory list of terms set forth in the regulations to include a definition of APRNs, urges revision of the proposed rule to include a mandatory definition for "physician/practitioner services" and recommends that this definition specifically refer to the health care services provided by APRNs and other providers legally authorized to practice by the State.
Letter from ANA to the Department of Veterans Affairs concerning the proposed rule entitled "Expanded Access to Non-VA Care Through the Veterans Choice Program," dated February 26, 2015
On November 5, 2014, the Department of Veterans Affairs (VA) published in the Federal Register (79 FR 65571) an interim final rule expanding access to non-VA care through the Veterans Choice Program. The letter applauds VA's consistent use of provider neutral terms (such as "non-VA provider," "provider" and "health care provider") when referencing and describing the clinicians authorized to provide care to VA patients. The letter also supports VA's statement, in the Supplementary Information, that VA interpreted the Conference Report's reference to a "referring physician" as meaning "VA health care provider," noting that the consistent use of provider neutral language is essential to accurately describe the range of health care providers who provide care and services to veterans.
Letter from ANA to AHRQ regarding comments on proposed changes to the CAHPS Clinician & Group (CG–CAHPS) Survey and the Patient-Centered Medical Home Item Set, dated February 13, 2015.
On January 21, 2015, the Agency for Healthcare Research and Quality (AHRQ) requested comments on proposed changes to the CAHPS Clinician & Group (CG–CAHPS) Survey, including the Patient-Centered Medical Home (PCMH) Item Set (80 FR 2938). In response, ANA commends AHRQ for the inclusion of a new composite measure on care coordination and the consistent use of provider-neutral language.
Letter from ANA to the Federal Trade Commission, dated February 12, 2015
On February 2, 2015, the Federal Trade Commission announced in the Federal Register (80 FR 5533) that FTC, with the U.S. Department of Justice, Antitrust Division, would hold a public workshop on February 24-25 regarding health care competition, and that comments in advance of the workshop would be accepted until February 16th. In a letter to FTC, ANA applauds FTC's ongoing work to address competition in the health care market, including the March, 2014 publication, "Policy Perspectives: Competition and the Regulation of Advanced Practice Nurses;" discusses issues concerning network adequacy and the lack of access to APRNs in private health insurance networks; and recommends that FTC closely monitor the role of APRNs in Accountable Care Organizations/Medicare Shared Savings Programs. In addition, ANA recommends that FTC continue to monitor the utilization of APRNs in medical homes, promote the use of provider neutral language by states, and advise against policies that refer exclusively to physicians or physician directed teams or practice.
Letter from ANA to the Office of National Coordinator (ONC) for Health IT concerning the draft Federal Health IT Strategic Plan: 2015–2020, dated February 5, 2015
On December 10, 2014, ONC published in the Federal Register (79 FR 73319) a request for comments concerning the Federal Health IT Strategic Plan: 2015–2020. ANA's letter applauds ONC's recognition and discussion of Care Coordination and Transitional Care Services, but recommends that ONC include more explicit discussion in the Strategic Plan strategies to highlight how the collecting, sharing and utilization of Health IT will further care coordination. The letter also notes that the draft Strategic Plan takes important steps to recognize the significance of telehealth technology, but recommends broadening the stated strategies to expand reimbursement mechanisms for providers and to ensure that the funding and innovation model initiatives are available to the full range of providers, including registered nurses, and to expand allowable sites of care beyond those currently recognized by the CMS. With regard to patient engagement, ANA recommends that ONC more broadly incorporate and describe the engagement of the patients/consumers, families and/or caregivers throughout the objectives and strategies of the Strategic Plan.
Letter from ANA to CMS concerning a proposed rule on the Medicare Shared Savings Program: Accountable Care Organizations, dated February 4, 2015
On December 8, 2014, CMS published in the Federal Register (79 FR 72760) a proposed rule relating to the Medicare Shared Savings Program: Accountable Care Organizations. The proposed rule addresses payment provisions for ACOs participating in the MSSP and additional flexibility for ACOs seeking to renew their participation in the program. In the letter, ANA encourages CMS to reward, encourage or incentivize ACO entities that share their savings with APRNs. The letter recommends that the two-step beneficiary assignment process include the primary care services rendered by APRNs, and notes support for the inclusion (in Step 1 of the beneficiary assignment methodology) of NPs and CNSs providing primary care services. ANA's letter notes that the Medicare Skilled Nursing Facility (SNF) three-day stay requirement is antiquated and hinders beneficiary access to post-acute care, and encourages CMS to provide a waiver of the three-day rule to all ACO entities, specifically, the Pioneer ACOs, MSSP ACOs, and the Advance Payment ACOs. The home health homebound requirement prevents beneficiaries from receiving medically reasonable and necessary care. ANA therefore urges CMS to waive the requirement that only a physician can certify home health for Medicare beneficiaries and allow APRNs, particularly NPs and CNSs within the MSSP, to certify home health. Finally, ANA urges CMS to waive the current requirement that only a physician may perform the initial SNF assessment and delegate subsequent required visits, and allow patients to have an APRN conduct their initial SNF assessment in addition to subsequent visits. In a related letter dated February 6, 2015, ANA was one of eleven nursing organizations recommending that CMS remove the requirement that a Medical Director who is a physician must oversee clinical management and oversight.
Letter from ANA to the Presidential Commission for the Study of Bioethical Issues, dated January 28, 2015.
On December 8th, HHS announced that the Presidential Commission for the Study of Bioethical Issues requested public comment on ethical considerations and implications of public health emergency response, with a focus on the current Ebola virus disease epidemic. In response to the request for ethical and scientific standards for public health emergency response, ANA's letter advised the Commission of ANA's Code of Ethics for Nurses with Interpretive Statements. Regarding the Commission's request for comment on the impact of quarantine or other movement restrictions on the availability or willingness of health workers to volunteer in disease-affected areas, the letter notes that ANA supports CDC's guidance on this topic, which is based on the best available scientific evidence. The letter notes that ANA's position emphasizing evidence and science as the foundation for decision-making extends to proposals to ban travel to the United States from West African nations affected by the Ebola outbreak. Regarding the request for input on ethical and scientific standards for collection, storage, and international sharing of biospecimens and associated data during public health emergencies, the letter notes that Section 9.4 of the Code of Ethics for Nurses supports the development of standards that would permit the collection, storage and international sharing of biospecimens and associated data during public health emergencies.
Letter from ANA to the Centers for Disease Control and Prevention, dated January 22, 2015.
On November 24th, CDC published a Federal Register notice seeking public comments on a revised version of the Vaccines Adverse Event Reporting System, which accepts mandated reports of adverse events that occur after vaccination. The form seeks information about the location where the vaccination took place and the patient's health care provider. In the letter, ANA applauds CDC's use of more inclusive provider language on the revised VAERS form, but recommends several additional changes. Specifically, ANA recommends revising the language in several questions to refer to "physician" (rather than "doctor") to more accurately identify the type of provider referenced. Similarly, ANA recommends referring to ""Clinician's office" or to "Health care provider's office" (rather that doctor's office). To improve data collection, ANA recommends tracking hospitals as a separate location from an office setting, and also recommends adding an option to capture vaccination that take place in retail clinics/convenient care clinics.
Letter from ANA to the HHS Office for Human Research Protections, dated January 15, 2015.
On December 22nd, HHS/OHRP published Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. The Draft Guidance addresses four main topics: what are standards of care; what are "risks of research" in studies evaluating risks associated with standards of care; when is evaluating a risk in a research study considered to be a purpose of the research study; and are the risks of research associated with the purposes of studies of standards of care "reasonably foreseeable risks" that must be disclosed to prospective subjects in the informed consent process. ANA's letter urges OHRP to consider using more inclusive language when referencing and describing the term "standards of care." The draft Guidance refers to "medically recognized standards of care" throughout the document. Further, in describing what is meant by the term "standards of care," the document refers to treatments or procedures that have been accepted by medical experts, and states that "medical recognition of standards of care is typically represented by publication in a peer-reviewed journal or some other form of recognition by a professional medical society." ANA notes that the use of the phrase "medically recognized standards of care," along with references to medical experts and professional medical societies, fails to recognize that all health care providers, including nurses, physician assistants, psychologists, social workers, physical therapists, and others, have discipline-specific standards of care, and all may be involved in research concerning their unique, discipline-specific standards of care. The letter urges OHRP to revise the draft guidance to reflect the diversity of health care disciplines that engage in standard of care research.
Letter from ANA to the Centers for Medicare & Medicaid Services, dated January 5, 2015
In October 2014, HHS published a proposed rule entitled Conditions of Participation for Home Health Agencies; Proposed Rule. The proposed rule would revise the current conditions of participation that home health agencies must meet in order to participate in the Medicare and Medicaid programs. CMS described the proposed requirements as focusing on the care delivered to patients by home health agencies, reflecting an interdisciplinary view of patient care, allowing home health agencies greater flexibility in meeting quality care standards, and eliminating unnecessary procedural requirements. The proposed rule describes these changes as integral to CMS efforts to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs. The initial deadline for commenting on the proposed rule was extended until January 7th. On January 5, 2015, ANA provided comments on the proposed rule. ANA's comments focus on support for Quality Assessment and Performance Improvement provisions, home health aide training to recognize and report skin changes, and patients' rights provisions. ANA also asked CMS to allow sufficient time to implement these changes. Finally, the letter acknowledges that a statutory change is needed to allow APRNs to certify home health services, but asks for CMS support to remove this barrier.
2014 ANA Regulatory Comments
Letter from ANA to the Centers for Medicare & Medicaid Services (December 19, 2014).
In November 2014, HHS published a proposed rule entitled Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016. The rule describes proposed payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It describes standards for the annual open enrollment period for the individual market for benefit years beginning on or after January 1, 2016, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential overage, the rate review program, the medical loss ratio program, and other related topics. In December 2014, ANA provided comments on the proposed rule. ANA's comments focused on the issue of Network Adequacy and urged CMS, when developing new proposals on network adequacy, to consider the important role of APRNs in meeting the increasing demand for primary care. In a related letter, ANA provided comments to the National Association of Insurance Commissioners (NAIC), which is drafting a model act to address network adequacy.
Letter from ANA to the Centers for Medicare & Medicaid Services regarding Home health Prospective Payment (September 2, 2014).
In September, ANA provided comments to CMS on the Medicare Program – CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies. ANA's letter discussed proposed changes to the face-to-face documentation requirements. Read the ANA comments letter submitted.
Letter from ANA to the Centers for Medicare & Medicaid Services regarding Medicare Program/Medicare Fee Schedule (August 29, 2014).
In September, ANA provided comments to CMS on revisions to Medicare Fee Schedules – Revision to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identification Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015. ANA's letter encouraged the use of broader provider language and discussed the following topics: potentially misvalued services under the Physician Fee Schedule; Chronic Care Management; Physician Compare Website; and Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System. Read the ANA comments letter submitted.
Letter from ANA to the Centers for Medicare & Medicaid Services (July 1, 2014)
In July ANA provided comments to CMS regarding Medicare Program; FY 2015 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements and Process and Appeals for Part D Payment for Drugs for Beneficiaries Enrolled in Hospice.
Letter from ANA to the Centers for Medicare & Medicaid Services (June 27, 2014)
In June ANA provided comments on the CMS request for comments on Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates; Quality Reporting Requirements for Specific Providers; Reasonable Compensation Equivalents for Physician Services in Excluded Teaching Hospitals; Provider Administrative Appeals and Judicial Review; Enforcement Provisions for Organ Transplant Centers; and Electronic Health Record (EHR) Incentive Program. ANA's letter focused on the All Harm Electronic (non-claims) Composite Measure.
Letter from the National Health Service Corps Stakeholder associations (including the American Nurses Association) to members of the Senate and House of Representatives (April 4, 2014)
ANA signed onto this letter with other stakeholders to urge a sustained, long-term investment in the NHSC of both mandatory and discretionary funding.
- Addressed to the Federal Trade Commission regarding their request for comments with respect to the public workshop that was held on March 20 and 21, 2014.
FTC solicited comments addressing five areas related to health care competition that are of interest to the Commission: Professional regulation of health care providers; innovations in health care delivery; advancements in health care technology; measuring and assessing quality of health care; and price transparency of health care services.
ANA applauded the FTC on the publication of "Policy Perspectives: Competition and the Regulation of Advanced Practice Nurses," which builds on the FTC state level competition advocacy comments regarding proposed legislation that restricts access to APRN practice and care. ANA supports the removal of barriers and discriminatory practices that interfere with full participation by APRNs in the health care delivery system. FTC's competition advocacy acknowledges that mandatory physician supervision requirements restrict consumer access to high quality, cost effective APRN care.
ANA's comments focused on new models of health care delivery; An informed public, interoperable health information systems, and improved efficiency; Effects on competition of information related to quality of care; and the competitive effects of price transparency.
2013 ANA Regulatory Comments
Addressed to the Centers for Medicare and Medicaid Services regarding proposed changes in the Medicare Physician Fee Schedule: "incident to" billing regulations need to be reformed; complex chronic care management services should be reserved for more complex patients; complex chronic care management services can be provided by APRNs and RNs.
ANA focused its MFS comments on telehealth, the Physician Compare website, "incident to" claims, and complex chronic care management services.
Incident to claims
"Incident to" services, although provided by NPs or CNSs, are billed under the physician's provider number (NPI); therefore the NP or CNS input is essentially invisible.
If NP or CNS services are billed under a physician's NPI, "incident to" services are reimbursed by Medicare at 100% of the physician rate.
Medicare pays nurse practitioners and clinical nurse specialists 85% of the physician rate if a service is billed using the NP's or CNS's own NPI.
ANA concurred with the Office of the Inspector General (OIG) that there should be an "incident to" modifier on Part B claims to identify the taxonomy of the performing clinician.
ANA proposed eliminating "incident to" billing for APRN services.
"When it comes to more complicated services [now being billed incident to], accountability demands that claims...should specifically identify the performing clinician if that person is not the same as the billing clinician."
ANA recommended that Congress adopt a national scope of practice for APRNs treating Medicare patients since Medicare is a National Program—not a State program.
Recommended that Congress eliminate the 15% pay reduction.
Complex chronic care management services (CCCMS)
ANA reminded CMS of the important role that APRNs and RNs play in care coordination and transitional care. The services described in the proposed regulations go far beyond medical care, and include patient counseling and education, explanation of and solicitation of informed medical consent, among other non-traditional and non-clinical services. They also include team building and effecting cooperation and collaboration among team members. These are not skills reserved for physicians only.
ANA encouraged CMS to replace all instances in which "physicians" appears alone in the text with the phrase "physicians and other eligible professionals" or simply "eligible professionals" omitting "physicians" as redundant.
CMS' proposed rule includes a statement that practices "must employ one or more advanced practical registered nurse or physician assistant." ANA recommends adding "registered nurses" to the proposed rule.
ANA recommended that CCCMS plans must address family caregivers, many of whom provide complex medical or nursing tasks.
ANA recommended that CCCMS be focused on more complex patients for whom there would be the highest return regarding reduced cost and/or improved patient care.
Addressed to the Centers for Medicare & Medicaid Services (CMS): Inpatient Prospective Payment system (IPPS) Notice of Proposed Rulemaking (NPRM)
The ANA provided comments on the Centers for Medicare & Medicaid Services (CMS) Inpatient Prospective Payment system (IPPS) Notice of Proposed Rulemaking (NPRM) for fiscal year (FY) 2014 on June 25, 2013. Read the FY 2014 IPPS Proposed Rule Home Page, including the NPRM document. This NPRM included provisions related to multiple areas of direct interest to nursing including the CMS pay for reporting program, the Inpatient quality reporting (IQR) program, and multiple pay for quality programs: 1) Hospital acquired conditions (HACs) reduction program, 2) Readmissions reduction program, 3) Hospital value-based purchasing (VBP) program. Read the ANA comments letter submitted.
Addressed to the Centers for Medicare and Medicaid Services: APRNs can provide essential health benefits to be offered in Health Insurance Exchanges (July 19, 2013)
Insurance companies that plan to offer a Qualified Health Plan (QHP) in a State Health Insurance Exchange will need to provide mandated essential health benefits to future subscribers. That means they will have to recruit clinicians of all varieties to provide those services. Unfortunately, many current private health insurers have ignored if not distained inclusion of APRNs in their networks. If that practice carries over to the Exchanges it will exacerbate problems in access to essential health benefits for patients and prospective exchange clients.
CMS's proposed remedy would allow an Exchange to decertify a QHP for failure to meet what are known as Network Adequacy Standards. ANA proposes an innovative alternative. In particular, a candidate health insurance plan that wants to become a QHP in an Exchange—State or Federal—must demonstrate that it has credentialed a number of APRNs no less than 10% of the number of APRNs recorded as independently billing Medicare Part B in that State. (Using the most recent data available from CMS—2011—plans in Hawaii would have to credential 16 APRNs; Florida plans would need 654.) This approach conveys the importance of providing access to high quality primary care and specialty services provided by APRNs, and prospective qualification will save the Exchanges time and money.
This is a standard that is easy to understand, easy to police, and easy to meet for those candidate QHPs that are serious about addressing the issue of potential strains on patient access to primary care services. ANA believes the proposed change is worth serious consideration and quick adoption.
Addressed to the Institute on Medicine: Comments on Institute on Medicine's study panel to identify core measure set based on the Triple Aim (April 8, 2013)
Comments on the Institute of Medicine's (IOM) study panel to identify core measure sets based on the Triple Aim of better health, better care, and lower cost, and to assess progress towards these aims. The triple aim was developed by the Institute of Healthcare Improvement (IHI) and is the cornerstone of the National Quality Strategy (NQS), the nation's guide star for healthcare quality improvement.
Addressed to the Centers for Medicare and Medicaid Services: Medicare Program; Request for Information (April 8, 2013)
Medicare Program; Request for Information on the Use of Clinical Quality Measures (CQMs) Reported Under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and Other Reporting Programs
2012 ANA Regulatory Comments
Addressed to the Agency for Healthcare Research and Quality: Comments on A Prototype Consumer Reporting System for Patient Safety Events (September 10, 2012)
The Administration for Healthcare Research and Quality (AHRQ) has requested funding to pilot the development of a Consumer Reporting System for Patient Safety Events. This project aims to design and test a system for collecting information from patients about health care safety events following standard definitions and formats. The project cites three goals: 1) To develop and design a prototype system to collect information about patient safety events; 2) To develop and test Web and telephone modes of a prototype questionnaire; and 3) To develop and test protocols for a follow-up survey of health care providers. The ANA recommends that AHRQ complete additional improvement work prior to implementing a pilot project, including additional investment to improve patient use of existing quality-related public reporting systems.
Addressed to the Centers for Medicare and Medicaid Services: Comments on the Proposed Physician Fee Schedule (August 30, 2012)
The system for paying physicians through Medicare is updated to reflect changes in practice and policy. In many cases in outpatient and even inpatient care, payment systems such as this drive policy, and influence the level of quality in patient care. In its comments, ANA focused on the role of advanced practice registered nurses, particularly with regard to ordering certain practices, care coordination, telehealth, and quality initiatives.
Addressed to the Centers for Medicare and Medicaid Services: Comments on the Proposed Inpatient Prospective Payment System (June 24, 2012)
The Centers for Medicare and Medicaid Services (CMS) solicited comments on the proposed rule for federal fiscal year (FY) 2013 changes to Medicare's acute care hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system. In its comments, ANA discussed the need for important and effective patient-centric team based measures (e.g., safety) and a critique of the proposed quality measures chosen by CMS. ANA provided an evidence table describing associations between ANA staffing measures and patient outcomes.
Addressed to the Department of Health and Human Services: Comments on Certain Preventive Services (June 18, 2012)
The federal government is soliciting input to ensure that employees of religious organizations have access to a full range of preventive services, including contraception. ANA's comments reference the Code of Ethics, and ANA's history of support for a fair and equitable health care delivery systems in which all Americans have access to basic health services, including services related to reproductive health.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Stage 2 Meaningful Use Proposed Rules (May 7, 2012)
The Centers for Medicare and Medicaid Services (CMS) have proposed a second stage of health information technology (HIT) regulations to improve the usefulness of information written into electronic health records. Electronic health records will permeate every area of health care, and ensuring these systems document the work of nurses will be critical to improving care and nursing's value to the interprofessional team. In its comments, ANA discussed team-based measures, inclusion of APRNs in Medicare incentives, and a critique of the proposed quality measures chosen by CMS.
Addressed to the Department of Health and Human Services: Comments on the National Providers Data Bank (April 16, 2012)
ANA has been an active member of the National Practitioner Data Bank Executive Committee. ANA commented on proposed regulations to eliminate duplicative data reporting and access requirements between the NPDB and the Healthcare Integrity and Protection Data Bank (HIPDB), and to streamline data bank operations. ANA also offered comments on one section that particularly affects APRNs, and to ensure additional language to ensure that APRNs are not reported to NPDB unless afforded equal due process rights and procedures, equivalent to those afforded physicians.
Addressed to the Food and Drug Administration: Comments on Improving Microbiological Safety of Cosmetic Products (January 23, 2012)
Many cosmetic and personal care products have been found to contain harmful chemicals, and the FDA requested comments on improving the safety of these products. ANA responded that the FDA should take certain measures to ensure that personal care products are clearly labeled and that consumer protection against harmful chemicals is optimized.
2011 ANA Regulatory Comments
Addressed to the Administrator of the Centers for Medicare and Medicaid Services: Comments on Proposed Revisions to the Hospital Conditions of Participation (December 23, 2011)
The Conditions of Participation (CoPs) are the requirements for hospitals to participate and be reimbursed by Medicare. They drive some of the most significant policies at hospitals, and are very influential in nursing practice. The proposed revisions are designed to reduce regulatory burden on health care. ANA provided comments on the need to expand credentialing of APRNs, to reduce barriers to RN care, and better enhance the patient experience. Read more at ANA's Conditions of Participation page.
Addressed to the Office of Budget and Management: Comments on National Sample Survey of Nurse Practitioners (December 7, 2011)
Despite the growing number and roles of nurse practitioners, there are limited and inconsistent data about them available to policy makers and the health community. The Bureau of Health Professions will conduct a survey of nurse practitioners in 2012. ANA provided comments on the proposed questions to be used in the survey.
Addressed to the Centers for Medicare and Medicaid Services: Comments on State Insurance Exchanges (October 24, 2011) [pdf]
The creation of State Insurance Exchanges – an online marketplace where individuals can purchase health plans – provides an opportunity for the federal government to simplify and standardize state regulations and insurance industry policies that have been barriers to APRN practice. ANA urged that "network adequacy standards" must include the requirement that APRNs are providers, and that the list of "essential community providers" must include nurse-managed health centers, school-based health centers, and birth centers.
Letter from ANA to HHS Secretary Kathleen Sebelius regarding the use of physician-centric language (October 12, 2011) [pdf]
ANA's letter expresses concern about the continued use of physician-centric language by federal officials within the Department of Health and Human Services (HHS). The letter explains that as our health system makes the changes necessary to provide primary and preventive care to millions more Americans, it is critical that policymakers and the public understand and have confidence in the role of registered nurses. The continued use of language that is not provider neutral renders invisible the advanced practice registered nurses, registered nurses and many other providers who are fundamental to this reform.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Rule on Medicaid Home Health Services (September 12, 2011) [pdf]
ANA applauds the aligning with the Affordable Care Act, and allowing nurse practitioners, certified nurse-midwives and physician assistants to hold the "face-to-face encounter" required to order home health services. ANA supports the proposals defining home health services beyond "homebound" patients or settings, and embracing telehealth services. However, ANA opposes the ban on certified nurse midwives ordering medical equipment and supplies.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Outpatient Prospective Payment System (August 30, 2011) [pdf]
ANA continues to challenge the need for direct physician supervision of nursing interventions in outpatient units of hospitals that participate in Medicare. ANA questions the Ambulatory Payment Classification Panel deciding which services require direct versus general supervision. ANA also strongly endorses comments from the Association of periOperative Registered Nurses regarding quality measures for the Hospital Outpatient and Ambulatory Surgical Centers Quality Reporting Programs.
Addressed to the Centers for Medicare & Medicaid Services: Comments on Proposed Conditions of Participation for Community Mental Health Centers (August 16, 2011) [pdf]
The Centers for Medicare & Medicaid Services has proposed that certain conditions be met for mental health centers to receive reimbursement from the government. ANA urges modifications to better reflect the role of registered nurses and advanced practice registered nurses, and create a better functioning team. ANA also had comments on how the government should address use of patient restraints and seclusion.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Condition of Participation for Patient Influenza Vaccination Programs (July 8, 2011) [pdf]
The Centers for Medicare & Medicaid Services has proposed that all facilities that receive Medicare payments must offer seasonal influenza vaccine to patients during the fall and winter. ANA offered comments on the use of standing orders to facilitate RNs in achieving successful programs, but also raised some concerns regarding the timing and coordination of the programs.
Addressed to the Centers for Medicare and Medicaid Services: Comments on 2012 Inpatient Prospective Payment System (June 15, 2011) [pdf]
Medicare Part B is how the government pays providers for treating patients, and these rules are updated annually. This drives how many hospitals and other facilities set up clinical practice and policy in order to ensure they get paid. In its comments, ANA concentrated on quality measurement that captures the work of nurses. It also promotes the use of NDNQI® as a database to measure nursing care quality.
To the Centers for Medicare and Medicaid Services: Comments on Proposed Accountable Care Organization Rule (May 31, 2011) [pdf]
The Centers for Medicare Services, or CMS, has proposed the rules for formation and operation of Accountable Care Organizations (ACOs). ACOs, as a provision of the ACA, are a way of promoting value-oriented, patient-centered care that ultimately can provide quality care and save money. ANA recommended significant changes to maximize patient care and achieve better efficiency by articulating professional nursing's impact on leadership, care coordination, and quality.
To the Federal Trade Commission/Department of Justice Antitrust Division: Comments on Proposed Modifications of the Antitrust Laws to Develop Accountable Care Organizations (ACOs) (May 31, 2011) [pdf]
The Federal Trade Commission and the Department of Justice have proposed modifications to antitrust laws to permit otherwise independent healthcare organizations to collaborate as ACOs. ANA provided comments that stipulated RNs should be included in leadership roles in ACOs, that RN services are included in calculating the ACO patient "pool", and paperwork burdens do not divert healthcare professionals from providing direct care.
Also related to Accountable Care Organizations - Comments to the Office of Inspector General on Waiver Designs in Medicare Shared Savings Programs (June 6, 2011) [pdf]
To the Agency for Healthcare Quality and Research: Comments on Medicaid Program: Initial Core Set of Health Quality Measures for Medicaid-Eligible Adults (February 28, 2011) [pdf]
The Agency for Healthcare Quality and Research, or AHRQ, proposed a first ste of measures to ensure the quality of care of adults in Medicaid programs. Medicaid is a joint federal and state program with each state designing its own program within federal guidelines. Federal payments for Medicaid range from the minimum of 50% of the cost to nearly 75% in poorer states. ANA urged the inclusion of nursing-sensitive indicators, and other cross-cutting measures. A advised the government to adopt measures approve by the National Quality Forum, of which ANA is a member.
To the Centers for Medicare and Medicaid Services: Ensure that handbooks use provider-neutral language (February 28, 2011) [pdf]
Each year, the Centers for Medicare Services, or CMS, sends a handbook to all the millions of Americans that it covers. ANA suggested that this book use provider-neutral language (i.e. use the term "healthcare provider") to reflect the almost 200,000 APRNs that provide services to these patients.
To the Center for Medicare and Medicaid Services: Medicare Program; Emergency Medical Treatment and Labor Act: Applicability to Hospital and Critical Access Hospital Inpatients and Hospitals With Specialized Capabilities (February 22, 2011) [pdf]
The Emergency Medical Treatment and Labor Act, known as EMTALA, prohibits hospitals from turning patients that show up to the emergency room away, especially if they cannot pay. But the government agency that interprets EMTALA is reconsidering whether patients that are already admitted have EMTALA rights, especially if they are in small facilities and need to be transferred for more intensive treatment. ANA agrees that EMTALA should apply to inpatients, and quotes in its comments a story from an APRN in the field about how this affects patients.
DEA: Procedures for Surrender of Unwanted Controlled Substances by Ultimate Users (January 12, 2011) [pdf]
In comments to the Drug Enforcement Administration, ANA suggested several types of controlled substance disposal programs -- fixed repositories, mail-back programs, additional take-back events, and specialized drop-offs at landfills. Increased publicity and consumer education should support these efforts.
2010 ANA Regulatory Comments
To the Director of Center for Medicare Services: Comments on Request for Information Regarding Accountable Care Organizations and the Medicare Shared Saving Program(December 3, 2010) [pdf]
The "Accountable Care Organization", or ACO, is a new attempt to structure health systems that are paid by the quality of care, not the quantity. The Centers for Medicare Services (CMS) is charged with creating the framework for the ACO. ANA believes nurse-led care coordination, inclusive leadership structures, and a continued focus on patient choice are key in ACOs, and urges CMS to include these aspects as they develop demonstration projects for this element of the ACA.
To the Secretary of Health and Human Services: Comments on Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act (September 17, 2010) [pdf]
ANA supported the Health and Human Services, or HHS, rules on preventive services that will be required by law to be at no cost to the insurance customer. Covered services include any United States Preventive Services Task Force (USPSTF) "A" (strongly recommended) or "B" (recommended) graded service. These services are essential to creating a well-care system, and nurses are fundamental to providing these services.
To the Director of Center for Medicare Services: Comments on Home Health Prospective Payment System (September 14, 2010) [pdf]
Every year, the Centers for Medicare Services, or CMS, updates the rules for how patient home care providers are paid. ANA urged CMS to make it easier for APRNs to provide home care autonomously, and also urged CMS to allow APRNs to certify patients as eligible for home care and/or hospice care. Currently, APRNs cannot do that, and is a huge impediment to seamless, efficient patient care.
To the Director of the Centers for Medicare Services: Comments on Outpatient & Ambulatory Surgical Center Services Prospective Payment Systems (August 31, 2010) [pdf]
Every year, the Centers for Medicare Services, or CMS, updates the rules for how they pay for outpatient surgery. ANA advised CMS to support more realistic direct supervision requirements, offered support for inclusion of preventive services, offered support for National Quality Forum measures for hospital quality reporting, and encouraged mandatory quality reporting for ambulatory surgical centers. Outpatient surgery is becoming very common, and many nurses and APRNs, especially CRNAs practice in these types of facilities.
To the Director of Centers for Medicare Services: Comments on Inpatient Prospective Payment System (August 24, 2010) [pdf]
Medicare Part B is how the government pays providers for treating patients, and these rules are updated annually. In its comments, ANA concentrated on the inclusion of APRNs in many elements and services that are on the reimbursement schedule for Medicare Part B, and supported comments by the RUC regarding its valuation methodology. The ability for APRNs to directly bill and be reimbursed by Medicare is still fraught with issues, and ANA highlights these as often as possible to ensure APRNs can provide care and improve access to care.
To the Centers for Disease Control and Prevention: Comments on Guidance for Influenza Control (July 21, 2010) [pdf]
The Centers for Disease Control and Prevention, or CDC, releases guidance on how hospitals and other healthcare settings (school clinics, outpatient clinics, nursing homes) can prevent seasonal influenza from occurring or spreading. ANA encouraged CDC to continue to advocate for a comprehensive program, including the availability of vaccines, personal protective equipment, and appropriate sick leave policies, to protect nurses from exposure and protect patients from becoming sick or sicker.
HHS: HIT Policy Committee Quality Measures Workgroup: New Pressure Ulcer Risk and Prevention Measures for Stages 2 and 3 Meaningful Use (December 23, 2010) [pdf]
ANA and the Alliance for Nursing Informatics (ANI) recommended adding pressure ulcer risk and prevention quality measures to the Meaningful Use clinical quality measures for use within electronic health record systems (EHRs). Investments in EHRs will result in far greater improvement in patient outcomes if steps are taken to ensure prevention of avoidable adverse events such as stages 3 and 4 pressure ulcers in acute care settings.
DEA: Propofol Controlled Substances Classification (December 23, 2010) [pdf]
ANA's comments support the proposed rule by the Drug Enforcement Administration to place the anesthetic propofol into Schedule IV of the Controlled Substances Act. Currently not classified, propofol is currently abused and diverted primarily by health care professionals.
EPA: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (November 8, 2010) [pdf]
This draft guidance was issued by the Environmental Protection Agency. ANA offered several detailed suggestions for refining the final guidance, as well as the general recommendation that the EPA "work closely with healthcare facilities and registered nurses in the United States to track, eliminate, reduce, manage and dispose of unused pharmaceutical waste in an environmentally safe manner."
FDA: 2011-2015 Strategic Priorities (November 1, 2010)
ANA applauded the Food & Drug Administration's priorities, and suggested further ensuring public health through: Precautionary Principles allowing flexibility to address threats of harm; safe packaging and labeling, especially in children's products, food, and cosmetics; elimination of Bisphenol A and artificial hormones; limits on harmful phthalates; drug disposal programs; and rules for reprocessing single use medical devices.
HHS: Priorities for 2011 National Quality Strategy (October 15, 2010)
ANA supported work of the National Priorities Partnership and National Quality Forum; highlighted nurses' significant impact in achieving better care, affordable care, and healthy people and communities; and urged HHS to employ language inclusive of all stakeholders.
Bioethics Commission: Synthetic Biology (September 28, 2010)
ANA comments suggested developing ethical, legal and social considerations policies that address definitions of "natural" and "artificial"; boundaries between nature, life and technology; fair technology use and access; psychological impact; clinical issues in prevention, treatment and quality; and effects on the environment.
HHS: HIPAA-HITECH Proposed Rule (September 10, 2010) [pdf]
ANA offered comments on HHS' proposed modifications to implement recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (''the HITECH Act''), to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of these HIPAA Rules.
CDC: National Ambulatory Care Survey (September 10, 2010)
ANA urged that future surveys include care provided by non-physician healthcare providers, including APRNs.
OSHA: Infectious Diseases (July 30, 2010)
ANA offered detailed suggestions regarding vaccination and infection control policies to assist the Occupational Safety and Health Administration in limiting the spread of occupationally-acquired infectious diseases in healthcare settings.
EPA: Draft Strategic Plan for 2011-2015 (July 28, 2010)
ANA supported the Plan's goals to address climate change and improve air quality, as well as ensure safe chemicals and prevent pollution.
CMS: Hospital Conditions of Participation - Telemedicine Credentialing Proposed Rule (July 21, 2010)
ANA joined with the Oregon Nurses Association to oppose requirements for separate licensure for practitioners of telehealth services, in the state where patients are receiving those services.
NIH: Genetics Education & Training (June 30, 2010)
Comments on the Draft Report, Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers.
CMS: Medicaid Hospital Conditions of Participation for Rehabilitation & Respiratory Services (June 18, 2010)
ANA supported CMS' proposal to allow these services to be ordered by "qualified, licensed practitioners," including nurse practitioners.
CMS: Inpatient Acute & Long Term Care Proposed Rule (June 18, 2010)
ANA applauded inclusion of a nursing-sensitive care registry-based topic in the FY 2013 RHQDAPU (hospital quality reporting) measure set, and supported further adoption of several additional nursing-sensitive care measures.
OSHA: Injury and Illness Collection Process (June 11, 2010)
Our comments cited nurses' high rate of back and other work-related injuries, and gave suggestions for improved data collection, training and outreach to employers, and review of policy at the level of individual employers.
FDA: Bisphenol A (June 2, 2010)
ANA urged the FDA to ban all Bisphenol A (BPA) in food and beverage containers, as over 200 studies suggest a link between exposure and serious and diverse health effects, with children particularly vulnerable.
DEA: Electronic Prescriptions for Controlled Substances (June 1, 2010)
This interim final rule establishes a framework for e-prescribing of controlled substances, and ANA suggested creating or identifying resources to assist nurses and other healthcare providers when questions and issues arise.
CEQ: Draft Guidance on Climate Change & Greenhouse Gas Emissions (May 24, 2010)
ANA commended the Council on Environmental Quality for taking the initiative to ensure that federal agencies consider climate change and greenhouse gas emissions, and offered additional suggestions to consider.
CMS/HHS: EHR Proposed Rule & HIT Initial Standards/Interim Final Rule (March 15, 2010)
ANA suggested improving EHR (Electronic Health Records)/HIT (Health Information Technology) policies and programs by recognizing APRN primary care providers and RNs who provide care coordination, among other issues.
OSHA: Occupational Injury & Illness Recording & Reporting Requirements (March 11, 2010)
In responding to this proposed rule, ANA advocated and provided detailed suggestions for separate reporting of musculoskeletal disorders to address back pain and other injuries incurred by nurses.
AHRQ: Children's Healthcare Quality Measures - Medicaid & CHIP (March 1, 2010)
ANA commented on the "Initial Core Set of Children's Healthcare Quality Measures for Voluntary Use by Medicaid and CHIP [Children's Health Insurance Program] Programs," and urged inclusion of data related to appropriate and adequate care by nurses.
FDA: Informed Consent Elements Proposed Rule (March 1, 2010)
ANA comments noted that many RNs and APRNs conduct or have patients who participate in clinical research, and made several suggestions on how to provide greater clarity and transparency.
EPA: Public Availability of Identities of Inert Ingredients in Pesticides (February 27, 2010)
ANA commented on this proposed rule by urging EPA to list all chemical ingredients and hazards on pesticide labels to protect workers, the public and the environment.
- EPA: Dioxin in Soil at CERCLA & RCRA Sites (February 27, 2010)
Comments regarding the "Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites." ANA emphasized toxicity values, inhalation exposure, risk estimates, and the "precautionary approach" for reducing risks before full proof of harm is available, when evidence suggests a link between chemical exposure and serious or irreversible health effects.
- EPA: Dioxin in Soil at CERCLA & RCRA Sites (February 27, 2010)
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