ANA Advises Federal Agencies

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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

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

2010 ANA Regulatory Comments

Affordable Care Act

Other Issues