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 Standard Occupational Classification Policy Committee (SOCPC), U.S. Bureau of Labor Statistics, regarding the SOCPC Recommendations for the 2018, dated September 20, 2016
    In a Federal Register notice published on July 22, 2016, the Office of Management and Budget (OMB) published Notice of Standard Occupational Classification Policy Committee (SOCPC) Recommendations to OMB and solicitation of comments . The letter states that in 2014, ANA supported the National Association of Clinical Nurse Specialists (NACNS) with respect to establishing a new detailed occupation for Clinical Nurse Specialists. The SOCPC did not accept this recommendation. This letter, written in response to OMB’s notice on July 22, again supports and endorses the NACNS response to Docket number 1-0210. The letter states that ANA concurs that NACNS has demonstrated that their proposed SOC revisions for Clinical Nurse Specialists meet the requirements of SOC Classification Principle 2.

  • Letter from ANA to HHS regarding a Request for Information on Opioid Analgesic Prescriber Education and Training Opportunities, dated September 6, 2016
    In a Federal Register notice published on July 6, 2016, HHS published a request for information entitled Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities to Prevent Opioid Overdose and Opioid Use Disorder. ANA’s letter to HHS identified two important educational initiatives concerning this topic, including a series of webinars entitled Addressing the Opioid Crisis: The Nursing Education Series on Opioids, and an offering from the American Psychiatric Nurses Association entitled Effective Treatments for Opioid Use Disorder: Educating & Empowering All Registered Nurses (RN) During an Epidemic. The letter notes that both offer nurses the opportunity to earn free continuing education credit – generally an effective mechanism to generate interest and engagement in learning and educational tools.

  • Letter from ANA to CMS regarding Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, dated August 31, 2016
    In a Federal Register notice published on July 14, 2016, CMS published a proposed Medicare Program entitled Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Certain Off-Campus Outpatient Departments of a Provider; Hospital Value-Based Purchasing (VBP) Program. In discussing the Hospital Value-Based Purchasing (VBP) Program, the proposed rule notes that Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) pain management system is based on survey questions asking whether during the hospital stay the patient needed pain medicine, how often pain was well controlled, and the frequency with which hospital staff did everything they could to help with pain. In response to stakeholders concerns regarding possible links between these questions and pay adjustments provided through VBP, CMS proposes to remove the HCAHPS pain management dimension from the inpatient Hospital VBP program beginning with the fiscal year 2018 payment determination year. ANA expressed support for the proposed removal of these survey questions from the scoring methodology and the development of modified pain management questions through the standard survey development process, but urged CMS to retain in CMS's transparent public reporting the current pain questions in the survey until modified pain management questions have been developed.

  • Letter from ANA to CMS regarding Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017, dated August 31, 2016
    In a Federal Register notice published on July 15, 2016, CMS published a proposed Medicare Program entitled Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. ANA's letter to CMS expressed support for the proposed revision of §405.2413(a)(5) and §405.2415(a)(5) to state that services and supplies furnished incident to Transitional Care Management and Chronic Care Management services can be furnished under general supervision of a Rural Health Clinic and Federally Qualified Health Center practitioner. ANA also supported the proposed requirements that Medicare Advantage (MA) providers and suppliers enroll in Medicare in an approved status in order to provide health care items or services to a Medicare enrollee who receives his or her Medicare benefit through an MA organization. ANA's letter suggested that CMS tabulate provider counts by specialty (using CMS specialty designations) and publish periodically the MA enrollee/provider ratios for each MA plan, and recommended that CMS develop a de-duplicated count of MA providers by specialty. ANA reiterated the recommendation to eliminate physician-centric language from proposed rules. Finally, ANA's letter cautioned that beneficiaries may not genuinely understand that participation in the ACO is voluntary, and urged CMS to revise regulatory language to avoid miscommunication on this point.

  • Letter from ANA to SAMHSA regarding the request for Public Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women with Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance, dated August 30, 2016
    In a Federal Register notice published on August 3, 2016, SAMHSA published a Request for Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women With Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance.

    ANA's letter to SAMHSA expressed strong support for a collaborative approach to safe treatment of pregnant and breastfeeding women with substance use disorder, noted that ANA had advocated for pregnant and breastfeeding women with substance use disorder for many years, and shared the current ANA position statement, Non-punitive Alcohol and Drug Treatment for Pregnant and Breast-feeding Women and their Exposed Children (2011). The letter supported the need for additional guidelines, educational programs, resources, webinars, and training in mental health and substance use disorder for nurses and other providers; noted that the report will be a valuable tool for all health care providers caring for this population; and expressed overall support for the report. ANA's letter also provided the following specific comments for consideration:

    • Page 4 & 75, Appendix 4: Key Features of Medications Approved for Treating Opioid Use Disorders. The language should reflect the current status of nurse practitioner prescribing authority for buprenorphine. Comprehensive Addiction and Recovery Act, Public Law 114-198.
    • Page 10, Safeguarding Against Discrimination and Stigmatization. ANA acknowledges that socioeconomics, class, race, and ethnicity may influence how women are cared for in the maternal child health setting related to this issue, and compels fairness in drug screening (universal versus selective), treatment, and rehabilitation services. Practice considerations for health care providers should include assessment of individual bias (which may largely be unintended) to safeguard against discrimination and stigmatization.
    • Page 10, Safeguarding Against Discrimination and Stigmatization. Research has demonstrated the stressful effect that caring for pregnant women with substance use disorder can have on the health care provider.  Mechanisms for identifying personal and professional challenges and interventions amongst health care providers when caring for this population should be incorporated into the guidelines.
    • Page 12, Need for Collaboration Among Multiple Agencies. Current research indicates that susceptibility to the criminal justice system may also result in a pregnant women's reluctance to seek treatment, therefore possibly harming the pregnant woman and fetus.
    • Page 21, A Guide for Collaborative Planning. It is essential to have a multidisciplinary team for effective collaboration, as mentioned on pages 18-19. Within this model, the voice of the pregnant woman should not be absent. In a shared decision making framework, the patient's perspective is critically valuable, even in policy considerations. ANA commends the inclusion of the patient as a core stakeholder.
    • Page 67, Appendix 3: Training Needs and Resources. ANA is essential in providing specific guidance to nurses in all aspects of practice. Nurses are the largest population of health care providers in the industry and therefore ANA recommends the current position statement Non-punitive Alcohol and Drug Treatment for Pregnant and Breast-feeding Women and their Exposed Children is included as a resource in this report.
  • Letter from ANA to CMS regarding a proposed rule entitled Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements, dated August 26, 2016
    In a Federal Register notice published on July 5, 2016, CMS requested comments on a proposed rule entitled Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. ANA's comment letter asked CMS to carefully evaluate the concerns expressed by the Alliance for Home Health Quality and Innovation (the Alliance) regarding the impact of payment reductions on vulnerable populations; the recommendation to eliminate the per day and per week caps on certain patient groups; and the impact of outlier policy changes on insulin-dependent diabetic patients. ANA supported the Alliance's call for additional information on the proposed use of a Linear Exchange Function to translate a home health agency's Total Performance Score into a value-based payment adjustment percentage. ANA expressed support for CMS' efforts to streamline measures to develop a parsimonious set of high-impact Home Health Value Based Purchasing measures, as well as the rationale to remove four current measures. The letter supported the concerns expressed by the Alliance on proposed IMPACT Act measures. The ANA letter also emphasized and supported a number of comments and recommendations from the Visiting Nurse Associations of America (VNAA), including concerns regarding the potential impact of the proposed negative payment reduction; the four-year phase-in of rebasing; the implementation of a 0.97 percent reduction to the national, standardized 60-day episode rate in CY 2017; the proposed adjustments to the case mix weights; and the comments regarding the proposed reduction of the estimated market basket adjustment. ANA also supported VNAA comments concerning the Home Health Conditions of Participations use of OASIS assessments.

  • Letter from ANA to CMS regarding a proposed rule on the End-Stage Renal Disease Prospective Payment System, dated August 23, 2016
    In a Federal Register notice published on June 30, 2016, CMS requested comments on a proposed rule entitled End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and other matters. ANA's letter supported the positions and recommendations set forth in the comment letter submitted by the American Nephrology Nurses' Association (ANNA), including their positions with regard to the proposed revision of the payment adjustments under the CY 2017 ESRD PPS and the proposed payment policy for renal patients with acute kidney injury. ANA's letter reiterated ANNA's recommendation that CMS adopt evidence-based ESRD measures and urged CMS to work with stakeholders in the nursing community and the Kidney Care Quality Alliance when developing and implementing measures. ANA also addressed the need to involve nurses in the development and implementation of the Comprehensive ESRD Care Model and other alternative payment models.

  • Letter from ANA to the CMS regarding a proposed rule on the Hospital and Critical Access Hospital Changes, dated August 15, 2016
    In a Federal Register notice published on June 16, CMS requested comments on a proposed rule entitled "Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care." The proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. Highlights from ANA's letter include the following:
    • Section 482.130 (Patient's Rights): ANA supports new nondiscrimination provisions and a proposed change in terminology (from "licensed independent practitioner" to "licensed practitioner") for ordering restraints and seclusion.
    • Section 482.21 (Quality assessment and performance improvement program): ANA recommends clarifying that the data collection requirements pertain to information already collected from existing programs.
    • Section 482.23 (Nursing services): ANA -
      • Supports the removal of the reference to bedside care from section 482.23(b).
      • Urges CMS to consider adding additional provisions to section 482.23(b) to ensure safe and adequate nurse staffing.
      • Supports the proposed revision to section 482.23(b)(4) to add language requiring that the plan reflect the patient's goals and the nursing care to be provided.
      • Supports proposed changes in section 482.23(b)(6) to clarify that all licensed nurses providing services in the hospital must adhere to hospital policies and procedures and that there must be adequate supervision, evaluation and assessment of the clinical activities of all nursing personnel within the responsibility of the nursing service.
      • Recommends revising section 482.23 to clarify that policies addressing requirements to have a RN present in outpatient departments must be approved by the director of nursing.
      • Recommends that CMS consider addressing the issue of texting orders in subsection 482.23(c)(3)(i) (verbal orders).
    • Section 482.42 and Section 485.640 (infection control): ANA supports the new requirements on infection prevention and control and antibiotic stewardship programs.
    • Section 482.22(a): ANA urges CMS to require hospitals and medical staff to include practitioners other than physicians on their medical staffs.
    • Section 485.631(d) (staffing and staff responsibilities): ANA urges CMS to ensure that the evaluation of the quality and appropriateness of the care provided by all practitioners (including peer review, professional practice evaluations and focused professional practice evaluations) include input from a reviewer (either a staff member or contract provider) with qualifications comparable to the provider under review (such as a practitioner of the same profession or discipline with similar education, training and qualifications who can address the practitioner's skills and clinical judgment).
    • Section 485.641 (Quality assessment and performance improvement program): ANA notes a number of unique challenges facing CAHs, including the length of time facilities will need to implement the new initiatives; the need for education and training on appropriate collection of data; and potential challenges due to low service volume.
  • Letter from ANA to the Department of Veterans Affairs regarding a proposed rule entitled Advanced Practice Registered Nurses, dated July 19, 2015
    In a Federal Register notice that has received unprecedented attention, , the Department of Veterans Affairs (VA) published a proposed regulation that would amend VA's medical regulations to permit full practice authority (FPA) for all four APRN roles when acting within the scope of their VA employment and would authorize the use of APRNs to provide primary health care and other related health care services to the full extent of their education, training, and certification, without the clinical supervision or mandatory collaboration of physicians. It would preempt conflicting state law with the exception of certain limitations imposed by the Controlled Substances Act.

    ANA's letter applauds the VA for taking this important step to standardize the practice of APRNs in the VA system and allow APRNs to practice to the full extent of education, training and certification. ANA's letter addresses some of the opposition to the proposal and makes the following points:

    • The VA proposed rule is consistent with the 2010 IOM report, "The Future of Nursing: Leading Change, Advancing Health," and with the recently released report from the Commission on Care.
    • The proposed rule is consistent with other efforts to improve access to high-value patient-centered care.
    • The proposed rule would not limit efforts to further team-based care.
    • The proposed rule recognizes that supervision requirements are unnecessary and costly. It is consistent with current practice in 21 States and the District of Columbia, federal IHS and DOD facilities, and most VA Medical Centers.
    • The proposed rule includes separate descriptions of FPA for each of the four APRN roles. ANA urges the VA to carefully consider the recommendations and comments from the experts in each APRN organization and to work closely with these experts to ensure that FPA for each APRN role is appropriately described in the regulations and any VHA guidance issuances.
    • ANA recommends clarifying the language on collaboration (in section 17.415(b)) to state that "FPA means the authority of an APRN to provide services described in paragraph (d) of this section without clinical oversight of a physician or mandatory collaboration, regardless of State or local law restrictions…"
    • ANA supports the proposal to exercise Federal preemption of state laws.
  • Letter from ANA to Presidential Commission for the Study of Bioethical Issues, regarding the role of past, present, and future national bioethics advisory bodies, dated June 28, 2016
    In a Federal Register notice dated March 1, 2016, the Commission requested comments on the role of past, present, and future national bioethics advisory bodies. ANA's letter supports the past and present work of the Commission including education, reports and opinions on ethical issues in practice and national bioethics crises. The letter emphasized the influence that national bioethics advisory bodies have on public policy and are heavily relied upon by health care providers. The letter expressed the need for the future Commission to be representative of the diverse health care providers in the U.S. and encompass different disciplines and areas of practice. Lastly, ANA recognizes the necessity of a national bioethics advisory body to provide guidance to the President, public and health care community regarding emerging advances in science, medicine and technology.

  • Letter from ANA to CMS on the Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models, dated June 27, 2016
    In a Federal Register notice published on May 9, 2016, CMS requested comments on a proposed rule entitled "Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models."
    This proposed rule would establish the new Merit-based Incentive Payment System (MIPS) for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System, the Physician Value-based Payment Modifier, and the Medicare Electronic Health Record Incentive Program for Eligible Professionals. The proposed rule would also establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee. ANA's letter addresses a number of topics in the proposed rule:

    • In response to the request for comment on the use of certified EHR technology (CEHRT) within APMs, ANA's letter urges CMS to include in guidelines for CEHRT a requirement for attribution of the work of non-physician providers, such as APRNs; urges CMS to avoid any guidance that would assign to the nurse the role of acting as a scribe for physicians; expresses support for efforts to advance interoperability; and expresses general support of the proposed attestation requirements.
    • The letter discusses the effects of MACRA on APRNs enrolled as Medicare Part B Providers, noting that APRN services have not been effectively utilized and at best have only partially been recognized.
    • In discussing APMs, the letter notes that while nurse practitioners, certified registered nurse anesthetists, and clinical nurse specialists were included in the description of APMs under MACRA, there is no requirement that APMs include APRNs in their networks as independent providers eligible for direct billing and participating in potential incentives. The letter also notes that opportunities for an enrolled APRN Medicare Part B provider to meaningfully join an APM may be severely limited based on both rural location and on the lack of welcoming behavior with respect to APM networks.
    • The letter reiterates the request that CMS ensure that each service provided to a patient is associated with the actual provider of the service; asks CMS to afford APRNs the same opportunities as physicians to develop, implement, and evaluate clinical practice improvement activities; and urges CMS to reconsider the decision against broadening the definition of physician-focused payment models to include APRNs.
    • The letter urges the Secretary to include certified nurse-midwives as eligible clinicians in the third and subsequent years of MIPS.
    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

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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