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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.

2018 ANA Regulatory Comments

2017 ANA Regulatory Comments

2016 ANA Regulatory Comments

  • 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.
    In addition, ANA, along with other nursing and APRN organizations, signed a joint letter to CMS concerning the proposed rule, Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.
  • 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

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:

  • 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 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

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

    Background

    "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.

    Recommendations

    • 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

2010 ANA Regulatory Comments

Affordable Care Act

Other Issues

Related Resources

Conditions of Participation

The Conditions of Participation are important to nurses because they are the rules hospitals must abide by. Changes in the conditions of participation are occurring. The voice of nursing is critical to ensure these changes are successful.

 

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