ANA Government Affairs staff 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.
2015 ANA Regulatory Comments
- 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.
DME Face-to-Face Encounters Rule Letter [pdf]
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 crticial 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.
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 meausure 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 Oraganizations (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 Antiturst 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 Acountable 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
Affordable Care Act
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 indentifying 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.