ANA Advises Federal Agencies

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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.

2016 ANA Regulatory Comments

  • 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

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

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