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.
- ANA Letter to the Department of Health and Human Services, Office for Civil Rights, concerning Nondiscrimination in Health Programs and Activities, dated November 9, 2015
On September 8, 2015, the HHS Office of Civil Rights (ONC) issued a proposed rule entitled Nondiscrimination in Health Programs and Activities. The letter commends HHS and OCR on the publication of the proposed rule, which takes important steps to end discrimination in the delivery of health care, but provides a number of recommendations to strengthen the rule. Specifically, the letter urges OCR to refrain from establishing additional exceptions for purposes of this rule; to revise the proposal to exclude employment discrimination by a health program or activity; to revise the definition of what constitutes discrimination by including regulatory language clarifying that the practice of placing all or nearly all medications to treat a certain condition on the highest tier to be discriminatory; and to clarify that the definition of who is protected under Section 1557.
- Letter from ANA to the Office of National Coordinator for Health IT concerning the 2016 Interoperability Standards Advisory Best Available Standards and Implementation Specifications, dated November 6, 2015
In response to ONC’s request for public comments on the document “2016 Interoperability Standards Advisory Best Available Standards and Implementation Specifications,” ANA reiterated comments previously submitted on the 2015 Interoperability Standards Advisory Best Available Standards and Implementation Specifications. The ANA letter provided links to two ANA Position Statements on EHR and HIT (Inclusion of Recognized Terminologies within EHRs and other Health Information Technology Solutions and Standardization and Interoperability of Health Information Technology: Supporting Nursing and the National Quality Strategy for Better Patient Outcomes). It noted ANA support for having a unique clinician identifier that can be captured across care settings for data analytics that will better inform a learning health system. With regard to care plans, the letter discussed the importance of including on the list of data elements terminologies that support nursing practice and patient-centered care.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning Reform of Requirements for Long-Term Care Facilities, dated October 13, 2015
On July 16, 2015, CMS published a proposed rule entitled Reform of Requirements for Long-Term Care Facilities. ANA’s initial comments to CMS on this matter were submitted on September 14, 2015. On October 13th, following an extension of the comment period, ANA submitted a follow-up letter supporting comments provided by ANA’s nursing colleagues at the American Association of Nurse Practitioners (AANP) and the American Association of Nurse Assessment Coordination (AANAC). The letter noted that ANA shares the concerns expressed by AANAC regarding baseline care plans (42 CFR 483.21(a)) and the recommendation for clarification of the required timing of such plans, and reiterated the recommendation to include definitions for the phrases “culturally-competent” and “trauma-informed.” The letter stated that ANA supports AANAC’s request for clarification of the discussion on basic life support (42 CFR 483.25(a)(3)), including the recommendations concerning state-specific Do-Not-Resuscitate and Physician Orders for Life-Sustaining Treatment. ANA also expressed support for AANAC’s comments concerning behavioral health services (42 CFR 483.40) and their position concerning the discussion of arbitration.
- Letter from ANA to the Center for Consumer Information and Insurance Oversight concerning Essential Health Benefits Benchmark Plans for 2017, dated September 30, 2015
The Center for Consumer Information and Insurance Oversight (CMS) published information about the proposed Essential Health Benefits benchmark plans for each state, including a summary of the plan's benefit coverage and limits, including a list of covered prescription drug categories and classes, and a list of state-required benefits. The public was offered the opportunity to comment on the plans.
ANA’s letter urged CCIIO to take the following steps with regard to the EHB benchmark plans for 2017: conduct a comprehensive review of each proposed benchmark plan to analyze the benefits and limits, prescription drug information, and evidence of coverage and other underlying plan documents to identify gaps and areas where the plan does not comply with applicable regulations and guidance; transmit this information to the states and ensure that state regulators know that qualified health plans (QHPs) are not permitted to mimic the benchmark plan in areas where gaps are identified; make this information publicly available in order to facilitate consumer advocates’ engagement in improving plan design; and conduct spot-checks of certified QHPs to ensure the plans don’t mirror identified gaps in EHB benchmarks.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning Reform of Requirements for Long-Term Care Facilities, dated September 14, 2015
On July 16, 2015, CMS published a proposed rule entitled Reform of Requirements for Long-Term Care Facilities. ANA’s letter regarding this proposed rule noted CMS’ recognition of ANA’s Principles for Nurse Staffing but asked that CMS reevaluate the position set forth in this proposed rule in light of current research on staffing issues and to consider the regulatory steps that can be taken to address this important issue. The letter also supported proposals concerning residents’ rights and a number of provisions concerning transitions of care.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016, dated September 4, 2015
On July 15, 2015, CMS published a proposed rule entitled Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. ANA’s letter to CMS expressed support for the inclusion of advance care planning codes in the recently proposed 2016 Medicare Physician Fee Schedule. With regard to clinical practice improvement activities, ANA recommended that when the clinical practice improvement requirements are finalized, they reflect the then current state of electronic health record interoperability and health information exchange as it continues to evolve.
In addition, ANA participated in a letter to CMS from an APRN workgroup. The letter expressed support for the steps CMS has taken to further include all stakeholders, including APRNs and the public, in the creation and evaluation of relative value unit values for all new, revised, and potentially misvalued codes; encouraged CMS to include APRNs as covered advance care planning (ACP) providers; recommended that CMS establish modifiers to be used to identify both when a line item in a claim was provided incident-to as well as the licensure of the actual rendering provider; asked CMS to expand the provision offering incentives from hospital organizations to physicians by allowing APRN practices in the geographic areas of the incentivizing hospital organization to receive such incentives; requested that CMS ensure equal treatment among APRNs and Physicians Under Clinical Practice Improvement Activities; asked CMS to refrain from public reporting of performance rates on measures on the Physician Compare website unless they have been vetted by all appropriate eligible professionals affected by the measure; requested that the search function on the Physician Compare Website be more inclusive of all qualified healthcare providers; requested the involvement of APRNs in the development of alternative payment models and promote full scope of practice in models; requested that provider neutral oversights be corrected in final rule; and recommended replacing the term “Nonphysician” with “APRNs” or “Part B Healthcare Practitioners” in publication of the final rule.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning the Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services, dated September 4, 2015
On July 14, 2015, CMS published a proposed rule entitled Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services, which proposed to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity. ANA’s letter expressed support for the recommendations set forth in the comment letter submitted by the Visiting Nurse Associations of America. ANA also worked with colleagues from ANA’s Organizational Affiliates, the National Association of Orthopaedic Nurses and the Association of Rehabilitation Nurses, to address additional concerns.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning Home Health Prospective Payment System Rate Update, dated August 28, 2015
On July 10, CMS published a proposed rule entitled CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model. ANA’s comment letter supports the positions and recommendations set forth in the comment letter submitted by the Visiting Nurse Associations of America, including comments on case-mix adjustment, the methodology for calculating the case-mix adjustment, and the impact of aggregate cuts on Home Health Providers; comments on the proposed Home Health Value-Based Purchasing Program; and proposed revisions regarding the Home Health Quality Reporting Program.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning Hospital Outpatient Prospective Payment System, dated August 28, 2015
On July 8th CMS published a proposed rule entitled Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. ANA’s letter urges CMS to avoid the use of physician-centric language (except in provisions that relate only to physicians) and to consistently use broader provider language when describing provisions of the rule that are pertinent to non-physician providers. In addition, ANA signed a joint letter asking CMS to finalize the proposed changes to the “two-midnights” rule and use its authority to eliminate remaining time-based criterion for hospital admissions exceeding the two-midnight threshold.
- Letter from ANA to the Department of Health and Human Services, CMS, concerning, the End-Stage Renal Disease (ESRD) Prospective Payment System, dated August 25, 2015
On July 1, 2015, CMS published a proposed rule entitled End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), which updated and revised the case-mix adjusted bundled prospective payment system for renal dialysis services furnished by ESRD facilities. ANA’s letter to CMS expresses support for the positions and recommendations set forth in the comment letter submitted by the American Nephrology Nurses’ Association, including comments on the proposed revision of the payment adjustments under the ESRD PPS and the proposed ESRD PPS update, as well as comments on the ESRD Quality Incentive Program.
- Letter from ANA to the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) regarding Medicaid and Children’s Health Insurance Program (CHIP) Programs, dated July 17, 2015
On June 1, 2015, CMS published a rule to update and modernize the Medicaid managed care regulations, implement statutory changes, revise Medicaid managed care payment rates, and strengthen quality of care initiatives. ANA’s letter expressed support for the overall proposal to align the rules governing Medicaid and CHIP managed care plans with qualified health plans; incorporate new and revised beneficiary protections; and strengthen provider networks, accountability and program integrity safeguards. ANA’s letter recommended expanding the definition of primary care case manager to include clinical nurse specialists (CNSs) and RNs; supported the requirement to develop common terminology for terms such as primary care provider and primary care physician; and recommended revising a section to include references to non-physician providers. The letter supported the development and enforcement of network adequacy standards, including time and distance standards for the essential categories of providers, and also recommended several changes to ensure that the prevalence of certified nurse-midwives is consistently recognized in network adequacy standards. In order to promote consistency between state programs, ANA’s letter supported having measures required at the national level.
- Letter from ANA to the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), concerning vaccine information statement for influenza vaccines, dated July 14, 2015
On May 20, 2015, CDC requested comments on updated vaccine information statements for inactivated and live attenuated influenza vaccines. ANA recommended revising both statements to include provider neutral language.
- Letter from ANA to the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), concerning vaccine information statement pneumococcal conjugate vaccine, dated July 14, 2015
On May 20, 2015, CDC requested comments on an updated vaccine information statement pneumococcal conjugate vaccine. ANA recommended revising the statement to include provider neutral language.
- Letter from ANA to the Centers for Medicare & Medicaid Services (CMS) regarding Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program, dated June 15, 2015
On April 30, 2015, HHS/CMS published the proposed rule referenced above. In a June 15, 2015 letter to CMS, ANA requested that ANA’s two critical safety structural measures, nurse staffing and skill mix, be added to the CMS Inpatient Quality Reporting (IQR) Program for timely national transparent public reporting. ANA also requested inclusion of ANA’s critical outcome safety measures, falls and falls with injury, for public reporting in the CMS IQR Program for timely national reporting, or in the alternative, timely CMS support for electronic clinical measures development on falls. ANA’s letter also recommends additional high impact robust safety measures for IQR.
Background and Update on ANA’s Four Safety Measures – ANA’s Leadership to Advance Patient Safety via Inclusion of Nursing Sensitive Safety Measures in CMS Public Reporting Programs: ANA’s four critical hospital nursing-sensitive safety measures (i.e., nurse staffing, nurse skill mix, falls and falls with injuries) are endorsed by the National Quality Forum (NQF). All four ANA measures recommended by the NQF-convened Measure Application Partnership in February, 2015 for inclusion in CMS’s IQR Program, upon the condition of final NQF endorsement of these measures at the new hospital-level reporting. On June 17th, all four ANA measures received a recommendation by the NQF Safety Measures Steering Committee (> 60% vote) for endorsement of these critical safety measures at both the unit and new hospital-level reporting. NQF will advance ANA’s measures in their process via NQF’s additional review processes per the NQF Standards for final endorsement consideration to be announced later this year. For more information, check out the following links:
- Letter from ANA to the Centers for Medicare & Medicaid Services (CMS) regarding comments on Modifications to Meaningful Use in 2015 through 2017, dated June 12, 2015
On April 15, 2015, HHS/CMS published a proposed rule entitled "Electronic Health Record Incentive Program - Modifications to Meaningful Use in 2015 through 2017." An associated CMS factsheet states that the rule will "align Stage 1 and Stage 2 objectives and measures with the long-term proposals for Stage 3, to build progress toward program milestones, to reduce complexity, and to simplify providers' reporting." The ANA letter supports the CMS vision to align Stage 1 and Stage 2 objectives and measures with long-term proposals for Stage 3 in order to reduce reporting burden, eliminate redundant and duplicative reporting and ensure future sustainability of the Medicare and Medicaid EHR Incentive Program. The letter expresses support for the proposal to change the 2015 Meaningful Use Program reporting requirements to any continuous 90-day period within the calendar year to allow providers time and flexibility to plan for the changes proposed in this rule. The ANA letter expresses concern regarding the proposal to remove the 5 percent threshold for Measure 2 from the Eligible Professional, eligible hospital, and Critical Access Hospital Stage 2 Patient Electronic Access (VDT) objective, including the provision holding the provider accountable for a patient's use of technology. ANA recommends that CMS consider flexibility and provide further guidance on this topic. ANA supports proposed changes to "allow providers to work toward meaningful patient engagement through health IT using the methods best suited to their practice and their patient population," but encourages CMS to consider an incrementally phased-in approach towards measure thresholds to balance the challenges facing providers with the need to promote patient engagement. The letter expresses support for CMS efforts to align quality measure reporting between quality programs such as MU, IQR, and PQRS to reduce the existing reporting burden. Finally, the letter asks that all APRN providers be eligible for the EHR incentive payment, not only under Medicaid, but also under Medicare.
- Letter from ANA to the Centers for Medicare & Medicaid Services (CMS), regarding comments on Stage 3 Meaningful Use (MU) Rules, dated May 27, 2015
On March 30, 2015 HHS/CMS published a proposed rule entitled: “Electronic Health Record Incentive Program Stage 3.” The proposed rule specifies the meaningful use criteria that eligible professionals (including APRNs), eligible hospitals, and critical access hospitals must meet in order to qualify for Medicare and Medicaid electronic health record incentive payments and avoid downward payment adjustments. ANA’s letter supports the vision of MU Stage 3, to focus on the advanced use of EHR technology to promote improved patient outcomes and health information exchange. In addition, ANA supports the proposal to continue to improve program efficiency, effectiveness, and flexibility by making changes to the Medicare and Medicaid EHR Incentive Programs that simplify reporting requirements and reduce program complexity. ANA’s letter comments on general concerns with the uneven treatment of APRNs; the Proposed Reduction in Program Complexity; the Eight Meaningful Use Objectives; and Clinical Quality Measurement Reporting.
- ANA Response to Call for Public Comment on the Draft National Pain Strategy dated May 19, 2015
In April 2015 the Department of Health and Human Services published notice soliciting public comment on the draft National Pain Strategy developed by the National Institute of Neurological Disorders and Stroke, Office of Pain Policy. ANA’s letter to HHS applauds and strongly supports the main elements of the National Pain Strategy. It provides specific recommendations to clarify key concepts and work toward common understanding of key terms, and suggests strategies to control diversion and abuse of opioids while avoiding unintended barriers to care. ANA’s letter emphasizes the importance of providing pain management services in an interdisciplinary manner. It also notes that while some professional health care education programs devote limited time to education and training about pain and pain care, the concept of pain management remains a core element in basic nursing education. Finally, the letter states that the Guiding Principles for Big Data in Nursing should guide implementation of IT-related components of the National Pain Strategy.
ANA was also one of ten nursing organizations signing a joint letter to HHS regarding this call for public comments. The joint letter highlights the critical role that APRNs play in ensuring patient access to high quality, cost effective healthcare and providing pain management; emphasizes the importance of having APRNs serve as major stakeholders in the plan; recommends that the strategy address barriers to practice and ensure that APRNs are able to practice to the full extent of their education and training; and recommends that APRN educational programs and professionals be granted the same seat at the policymaking leadership table as the Accreditation.
Letter from ANA to the Office of National Coordinator for Health IT (ONC), regarding comments on the 2015 Interoperability Standards Advisory, dated April 29, 2015
ONC requested public comments on a document entitled: "2015 Interoperability Standards Advisory Best Available Standards and Implementation Specifications." The document represents the model ONC will use to coordinate the identification and assessment of the best available interoperability standards and specifications. The 2015 Advisory is an "open draft" designed to begin an interactive process that will result in a list of standards and implementation specifications for a broad range of clinical health IT interoperability purposes. The ANA letter notes that ANA supports the broad mission of the 2015 Interoperability Standards Advisory. The letter reiterates some of the suggestions that were in two recent letters ANA sent to ONC (including comments on Strategic Plan submitted in February 2015 and the comments on the Roadmap submitted in April 2015). The letter also references the content from two ANA's Position Statements (Inclusion of Recognized Terminologies within EHRs and other Health Information Technology Solutions and Standardization and Interoperability of Health Information Technology: Supporting Nursing and the National Quality Strategy for Better Patient Outcomes).
Letter from ANA to the Occupational Safety and Health Administration (OSHA) regarding an information collection request titled, "Bloodborne Pathogens Standard," dated April 1, 2015
On March 18, 2015, OSHA published an information collection request titled, "Bloodborne Pathogens Standard." ANA's letter expressed concern about the lack of compliance with the Needlestick Safety and Prevention Act (NSPA) and noted that the language within the NSPA related to employee input is lacking. ANA recommended that the information collected be enhanced to include the requirement to document within the Exposure Control Plan efforts to engage all employees responsible for direct patient care.
Letter from ANA to the National Coordinator, Office of National Coordinator for Health IT (ONC), regarding comments on "Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0," dated April 2, 2015
On January 30, 2015, ONC issued the draft nationwide health IT Interoperability Roadmap – a proposal to deliver better care through the safe and secure exchange and use of electronic health information. ANA appreciates the efforts of the ONC to develop a Roadmap identifying critical actions for public and private stakeholders to advance the development of an interoperable health information technology (HIT) ecosystem and facilitate the secure, efficient and effective sharing and use of electronic health information. ANA supports the broad outline of the Roadmap, particularly the person-centric vision set forth in the document, and offers comments on several questions posed by ONC, including "Priority Use Cases," "Governance" and "Measurement."
Letter from ANA to the National Institute for Occupational Safety and Health, dated March 19, 2015
On January 23, 2015, the National Institute for Occupational Safety and Health published a document entitled "Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures." ANA's letter suggests a number of corrections to the document (including the need to recognize and address risks to health care workers disposing of hazardous drugs and to discuss risks to both men and women of reproductive age). The ANA letter also discusses the need for greater effort to ensure all health care workers, patients, and communities have easy access to relevant and current information on the hazardous drugs to which they are exposed; describes needed steps to improve worker protection; and describes the need to review the potential health effects of new and older hazardous drugs.
Letter from ANA to the Department of Health and Human Services concerning the Draft National Adult Immunization Plan, dated March 12, 2015
On February 6, 2015, the National Vaccine Program Office (NVPO) published notice in Federal Register (80 FR 6721) seeking comments on the draft National Adult Immunization Plan. ANA recommended revising goal 2, objective 2.3, to include more inclusive provider language. ANA also urged the NVPO, to the extent possible, to identify and utilize measures that collect data on the full range of health care providers who administer vaccinations, including APRNs.
Letter from ANA to the Centers for Disease concerning the "Proposed Revised Vaccine Information Materials for Multiple Pediatric Vaccines (‘Your Baby's First Vaccines')," dated March 6, 2015
On January 6, 2015, the CDC published notice in the Federal Register (80 FR 1416) requesting comments on proposed revisions to the vaccine information materials for multiple pediatric vaccines. ANA's letter notes that the current form identifies only "doctors" as providers, and recommends revising the form to include provider-neutral language.
Letter from ANA to the Departments of Labor, Health and Human Services and the Internal Revenue Service, concerning the proposed rule, "Summary of Benefits and Coverage and Uniform Glossary, dated February 27, 2015
December 30, 2014, the Departments of Treasury, Labor and Health and Human Services published notice in the Federal Register (79 FR 78578) describing a proposed rule on health-coverage-related terms and medical terms that must be included in the uniform glossary and requirements for the Summary of Benefits. ANA's letter recommends that the Departments revise the mandatory list of terms set forth in the regulations to include a definition of APRNs, urges revision of the proposed rule to include a mandatory definition for "physician/practitioner services" and recommends that this definition specifically refer to the health care services provided by APRNs and other providers legally authorized to practice by the State.
Letter from ANA to the Department of Veterans Affairs concerning the proposed rule entitled "Expanded Access to Non-VA Care Through the Veterans Choice Program," dated February 26, 2015
On November 5, 2014, the Department of Veterans Affairs (VA) published in the Federal Register (79 FR 65571) an interim final rule expanding access to non-VA care through the Veterans Choice Program. The letter applauds VA's consistent use of provider neutral terms (such as "non-VA provider," "provider" and "health care provider") when referencing and describing the clinicians authorized to provide care to VA patients. The letter also supports VA's statement, in the Supplementary Information, that VA interpreted the Conference Report's reference to a "referring physician" as meaning "VA health care provider," noting that the consistent use of provider neutral language is essential to accurately describe the range of health care providers who provide care and services to veterans.
Letter from ANA to AHRQ regarding comments on proposed changes to the CAHPS Clinician & Group (CG–CAHPS) Survey and the Patient-Centered Medical Home Item Set, dated February 13, 2015.
On January 21, 2015, the Agency for Healthcare Research and Quality (AHRQ) requested comments on proposed changes to the CAHPS Clinician & Group (CG–CAHPS) Survey, including the Patient-Centered Medical Home (PCMH) Item Set (80 FR 2938). In response, ANA commends AHRQ for the inclusion of a new composite measure on care coordination and the consistent use of provider-neutral language.
Letter from ANA to the Federal Trade Commission, dated February 12, 2015
On February 2, 2015, the Federal Trade Commission announced in the Federal Register (80 FR 5533) that FTC, with the U.S. Department of Justice, Antitrust Division, would hold a public workshop on February 24-25 regarding health care competition, and that comments in advance of the workshop would be accepted until February 16th. In a letter to FTC, ANA applauds FTC's ongoing work to address competition in the health care market, including the March, 2014 publication, "Policy Perspectives: Competition and the Regulation of Advanced Practice Nurses;" discusses issues concerning network adequacy and the lack of access to APRNs in private health insurance networks; and recommends that FTC closely monitor the role of APRNs in Accountable Care Organizations/Medicare Shared Savings Programs. In addition, ANA recommends that FTC continue to monitor the utilization of APRNs in medical homes, promote the use of provider neutral language by states, and advise against policies that refer exclusively to physicians or physician directed teams or practice.
Letter from ANA to the Office of National Coordinator (ONC) for Health IT concerning the draft Federal Health IT Strategic Plan: 2015–2020, dated February 5, 2015
On December 10, 2014, ONC published in the Federal Register (79 FR 73319) a request for comments concerning the Federal Health IT Strategic Plan: 2015–2020. ANA's letter applauds ONC's recognition and discussion of Care Coordination and Transitional Care Services, but recommends that ONC include more explicit discussion in the Strategic Plan strategies to highlight how the collecting, sharing and utilization of Health IT will further care coordination. The letter also notes that the draft Strategic Plan takes important steps to recognize the significance of telehealth technology, but recommends broadening the stated strategies to expand reimbursement mechanisms for providers and to ensure that the funding and innovation model initiatives are available to the full range of providers, including registered nurses, and to expand allowable sites of care beyond those currently recognized by the CMS. With regard to patient engagement, ANA recommends that ONC more broadly incorporate and describe the engagement of the patients/consumers, families and/or caregivers throughout the objectives and strategies of the Strategic Plan.
Letter from ANA to CMS concerning a proposed rule on the Medicare Shared Savings Program: Accountable Care Organizations, dated February 4, 2015
On December 8, 2014, CMS published in the Federal Register (79 FR 72760) a proposed rule relating to the Medicare Shared Savings Program: Accountable Care Organizations. The proposed rule addresses payment provisions for ACOs participating in the MSSP and additional flexibility for ACOs seeking to renew their participation in the program. In the letter, ANA encourages CMS to reward, encourage or incentivize ACO entities that share their savings with APRNs. The letter recommends that the two-step beneficiary assignment process include the primary care services rendered by APRNs, and notes support for the inclusion (in Step 1 of the beneficiary assignment methodology) of NPs and CNSs providing primary care services. ANA's letter notes that the Medicare Skilled Nursing Facility (SNF) three-day stay requirement is antiquated and hinders beneficiary access to post-acute care, and encourages CMS to provide a waiver of the three-day rule to all ACO entities, specifically, the Pioneer ACOs, MSSP ACOs, and the Advance Payment ACOs. The home health homebound requirement prevents beneficiaries from receiving medically reasonable and necessary care. ANA therefore urges CMS to waive the requirement that only a physician can certify home health for Medicare beneficiaries and allow APRNs, particularly NPs and CNSs within the MSSP, to certify home health. Finally, ANA urges CMS to waive the current requirement that only a physician may perform the initial SNF assessment and delegate subsequent required visits, and allow patients to have an APRN conduct their initial SNF assessment in addition to subsequent visits. In a related letter dated February 6, 2015, ANA was one of eleven nursing organizations recommending that CMS remove the requirement that a Medical Director who is a physician must oversee clinical management and oversight.
Letter from ANA to the Presidential Commission for the Study of Bioethical Issues, dated January 28, 2015.
On December 8th, HHS announced that the Presidential Commission for the Study of Bioethical Issues requested public comment on ethical considerations and implications of public health emergency response, with a focus on the current Ebola virus disease epidemic. In response to the request for ethical and scientific standards for public health emergency response, ANA's letter advised the Commission of ANA's Code of Ethics for Nurses with Interpretive Statements. Regarding the Commission's request for comment on the impact of quarantine or other movement restrictions on the availability or willingness of health workers to volunteer in disease-affected areas, the letter notes that ANA supports CDC's guidance on this topic, which is based on the best available scientific evidence. The letter notes that ANA's position emphasizing evidence and science as the foundation for decision-making extends to proposals to ban travel to the United States from West African nations affected by the Ebola outbreak. Regarding the request for input on ethical and scientific standards for collection, storage, and international sharing of biospecimens and associated data during public health emergencies, the letter notes that Section 9.4 of the Code of Ethics for Nurses supports the development of standards that would permit the collection, storage and international sharing of biospecimens and associated data during public health emergencies.
Letter from ANA to the Centers for Disease Control and Prevention, dated January 22, 2015.
On November 24th, CDC published a Federal Register notice seeking public comments on a revised version of the Vaccines Adverse Event Reporting System, which accepts mandated reports of adverse events that occur after vaccination. The form seeks information about the location where the vaccination took place and the patient's health care provider. In the letter, ANA applauds CDC's use of more inclusive provider language on the revised VAERS form, but recommends several additional changes. Specifically, ANA recommends revising the language in several questions to refer to "physician" (rather than "doctor") to more accurately identify the type of provider referenced. Similarly, ANA recommends referring to ""Clinician's office" or to "Health care provider's office" (rather that doctor's office). To improve data collection, ANA recommends tracking hospitals as a separate location from an office setting, and also recommends adding an option to capture vaccination that take place in retail clinics/convenient care clinics.
Letter from ANA to the HHS Office for Human Research Protections, dated January 15, 2015.
On December 22nd, HHS/OHRP published Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. The Draft Guidance addresses four main topics: what are standards of care; what are "risks of research" in studies evaluating risks associated with standards of care; when is evaluating a risk in a research study considered to be a purpose of the research study; and are the risks of research associated with the purposes of studies of standards of care "reasonably foreseeable risks" that must be disclosed to prospective subjects in the informed consent process. ANA's letter urges OHRP to consider using more inclusive language when referencing and describing the term "standards of care." The draft Guidance refers to "medically recognized standards of care" throughout the document. Further, in describing what is meant by the term "standards of care," the document refers to treatments or procedures that have been accepted by medical experts, and states that "medical recognition of standards of care is typically represented by publication in a peer-reviewed journal or some other form of recognition by a professional medical society." ANA notes that the use of the phrase "medically recognized standards of care," along with references to medical experts and professional medical societies, fails to recognize that all health care providers, including nurses, physician assistants, psychologists, social workers, physical therapists, and others, have discipline-specific standards of care, and all may be involved in research concerning their unique, discipline-specific standards of care. The letter urges OHRP to revise the draft guidance to reflect the diversity of health care disciplines that engage in standard of care research.
Letter from ANA to the Centers for Medicare & Medicaid Services, dated January 5, 2015
In October 2014, HHS published a proposed rule entitled Conditions of Participation for Home Health Agencies; Proposed Rule. The proposed rule would revise the current conditions of participation that home health agencies must meet in order to participate in the Medicare and Medicaid programs. CMS described the proposed requirements as focusing on the care delivered to patients by home health agencies, reflecting an interdisciplinary view of patient care, allowing home health agencies greater flexibility in meeting quality care standards, and eliminating unnecessary procedural requirements. The proposed rule describes these changes as integral to CMS efforts to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs. The initial deadline for commenting on the proposed rule was extended until January 7th. On January 5, 2015, ANA provided comments on the proposed rule. ANA's comments focus on support for Quality Assessment and Performance Improvement provisions, home health aide training to recognize and report skin changes, and patients' rights provisions. ANA also asked CMS to allow sufficient time to implement these changes. Finally, the letter acknowledges that a statutory change is needed to allow APRNs to certify home health services, but asks for CMS support to remove this barrier.
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.
Addressed to the Administrator of the Centers for Medicare and Medicaid Services: Comments on Proposed Revisions to the Hospital Conditions of Participation (December 23, 2011)
The Conditions of Participation (CoPs) are the requirements for hospitals to participate and be reimbursed by Medicare. They drive some of the most significant policies at hospitals, and are very influential in nursing practice. The proposed revisions are designed to reduce regulatory burden on health care. ANA provided comments on the need to expand credentialing of APRNs, to reduce barriers to RN care, and better enhance the patient experience. Read more at ANA's Conditions of Participation page.
Addressed to the Office of Budget and Management: Comments on National Sample Survey of Nurse Practitioners (December 7, 2011)
Despite the growing number and roles of nurse practitioners, there are limited and inconsistent data about them available to policy makers and the health community. The Bureau of Health Professions will conduct a survey of nurse practitioners in 2012. ANA provided comments on the proposed questions to be used in the survey.
Addressed to the Centers for Medicare and Medicaid Services: Comments on State Insurance Exchanges (October 24, 2011) [pdf]
The creation of State Insurance Exchanges – an online marketplace where individuals can purchase health plans – provides an opportunity for the federal government to simplify and standardize state regulations and insurance industry policies that have been barriers to APRN practice. ANA urged that "network adequacy standards" must include the requirement that APRNs are providers, and that the list of "essential community providers" must include nurse-managed health centers, school-based health centers, and birth centers.
Letter from ANA to HHS Secretary Kathleen Sebelius regarding the use of physician-centric language (October 12, 2011) [pdf]
ANA’s letter expresses concern about the continued use of physician-centric language by federal officials within the Department of Health and Human Services (HHS). The letter explains that as our health system makes the changes necessary to provide primary and preventive care to millions more Americans, it is critical that policymakers and the public understand and have confidence in the role of registered nurses. The continued use of language that is not provider neutral renders invisible the advanced practice registered nurses, registered nurses and many other providers who are fundamental to this reform.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Rule on Medicaid Home Health Services (September 12, 2011) [pdf]
ANA applauds the aligning with the Affordable Care Act, and allowing nurse practitioners, certified nurse-midwives and physician assistants to hold the "face-to-face encounter" required to order home health services. ANA supports the proposals defining home health services beyond "homebound" patients or settings, and embracing telehealth services. However, ANA opposes the ban on certified nurse midwives ordering medical equipment and supplies.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Outpatient Prospective Payment System (August 30, 2011) [pdf]
ANA continues to challenge the need for direct physician supervision of nursing interventions in outpatient units of hospitals that participate in Medicare. ANA questions the Ambulatory Payment Classification Panel deciding which services require direct versus general supervision. ANA also strongly endorses comments from the Association of periOperative Registered Nurses regarding quality measures for the Hospital Outpatient and Ambulatory Surgical Centers Quality Reporting Programs.
Addressed to the Centers for Medicare & Medicaid Services: Comments on Proposed Conditions of Participation for Community Mental Health Centers (August 16, 2011) [pdf]
The Centers for Medicare & Medicaid Services has proposed that certain conditions be met for mental health centers to receive reimbursement from the government. ANA urges modifications to better reflect the role of registered nurses and advanced practice registered nurses, and create a better functioning team. ANA also had comments on how the government should address use of patient restraints and seclusion.
Addressed to the Centers for Medicare and Medicaid Services: Comments on Proposed Condition of Participation for Patient Influenza Vaccination Programs (July 8, 2011) [pdf]
The Centers for Medicare & Medicaid Services has proposed that all facilities that receive Medicare payments must offer seasonal influenza vaccine to patients during the fall and winter. ANA offered comments on the use of standing orders to facilitate RNs in achieving successful programs, but also raised some concerns regarding the timing and coordination of the programs.
Addressed to the Centers for Medicare and Medicaid Services: Comments on 2012 Inpatient Prospective Payment System (June 15, 2011) [pdf]
Medicare Part B is how the government pays providers for treating patients, and these rules are updated annually. This drives how many hospitals and other facilities set up clinical practice and policy in order to ensure they get paid. In its comments, ANA concentrated on quality measurement that captures the work of nurses. It also promotes the use of NDNQI® as a database to meausure nursing care quality.
To the Centers for Medicare and Medicaid Services: Comments on Proposed Accountable Care Organization Rule (May 31, 2011) [pdf]
The Centers for Medicare Services, or CMS, has proposed the rules for formation and operation of Accountable Care Oraganizations (ACOs). ACOs, as a provision of the ACA, are a way of promoting value-oriented, patient-centered care that ultimately can provide quality care and save money. ANA recommended significant changes to maximize patient care and achieve better efficiency by articulating professional nursing's impact on leadership, care coordination, and quality.
To the Federal Trade Commission/Department of Justice Antitrust Division: Comments on Proposed Modifications of the Antiturst Laws to Develop Accountable Care Organizations (ACOs) (May 31, 2011) [pdf]
The Federal Trade Commission and the Department of Justice have proposed modifications to antitrust laws to permit otherwise independent healthcare organizations to collaborate as ACOs. ANA provided comments that stipulated RNs should be included in leadership roles in ACOs, that RN services are included in calculating the ACO patient "pool", and paperwork burdens do not divert healthcare professionals from providing direct care.
Also related to Acountable Care Organizations - Comments to the Office of Inspector General on Waiver Designs in Medicare Shared Savings Programs (June 6, 2011) [pdf]
To the Agency for Healthcare Quality and Research: Comments on Medicaid Program: Initial Core Set of Health Quality Measures for Medicaid-Eligible Adults (February 28, 2011) [pdf]
The Agency for Healthcare Quality and Research, or AHRQ, proposed a first ste of measures to ensure the quality of care of adults in Medicaid programs. Medicaid is a joint federal and state program with each state designing its own program within federal guidelines. Federal payments for Medicaid range from the minimum of 50% of the cost to nearly 75% in poorer states. ANA urged the inclusion of nursing-sensitive indicators, and other cross-cutting measures. A advised the government to adopt measures approve by the National Quality Forum, of which ANA is a member.
To the Centers for Medicare and Medicaid Services: Ensure that handbooks use provider-neutral language (February 28, 2011) [pdf]
Each year, the Centers for Medicare Services, or CMS, sends a handbook to all the millions of Americans that it covers. ANA suggested that this book use provider-neutral language (i.e. use the term "healthcare provider") to reflect the almost 200,000 APRNs that provide services to these patients.
To the Center for Medicare and Medicaid Services: Medicare Program; Emergency Medical Treatment and Labor Act: Applicability to Hospital and Critical Access Hospital Inpatients and Hospitals With Specialized Capabilities (February 22, 2011) [pdf]
The Emergency Medical Treatment and Labor Act, known as EMTALA, prohibits hospitals from turning patients that show up to the emergency room away, especially if they cannot pay. But the government agency that interprets EMTALA is reconsidering whether patients that are already admitted have EMTALA rights, especially if they are in small facilities and need to be transferred for more intensive treatment. ANA agrees that EMTALA should apply to inpatients, and quotes in its comments a story from an APRN in the field about how this affects patients.
DEA: Procedures for Surrender of Unwanted Controlled Substances by Ultimate Users (January 12, 2011) [pdf]
In comments to the Drug Enforcement Administration, ANA suggested several types of controlled substance disposal programs -- fixed repositories, mail-back programs, additional take-back events, and specialized drop-offs at landfills. Increased publicity and consumer education should support these efforts.
HHS: HIT Policy Committee Quality Measures Workgroup: New Pressure Ulcer Risk and Prevention Measures for Stages 2 and 3 Meaningful Use (December 23, 2010) [pdf]
ANA and the Alliance for Nursing Informatics (ANI) recommended adding pressure ulcer risk and prevention quality measures to the Meaningful Use clinical quality measures for use within electronic health record systems (EHRs). Investments in EHRs will result in far greater improvement in patient outcomes if steps are taken to ensure prevention of avoidable adverse events such as stages 3 and 4 pressure ulcers in acute care settings.
DEA: Propofol Controlled Substances Classification (December 23, 2010) [pdf]
ANA's comments support the proposed rule by the Drug Enforcement Administration to place the anesthetic propofol into Schedule IV of the Controlled Substances Act. Currently not classified, propofol is currently abused and diverted primarily by health care professionals.
EPA: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (November 8, 2010) [pdf]
This draft guidance was issued by the Environmental Protection Agency. ANA offered several detailed suggestions for refining the final guidance, as well as the general recommendation that the EPA "work closely with healthcare facilities and registered nurses in the United States to track, eliminate, reduce, manage and dispose of unused pharmaceutical waste in an environmentally safe manner."
FDA: 2011-2015 Strategic Priorities (November 1, 2010)
ANA applauded the Food & Drug Administration's priorities, and suggested further ensuring public health through: Precautionary Principles allowing flexibility to address threats of harm; safe packaging and labeling, especially in children's products, food, and cosmetics; elimination of Bisphenol A and artificial hormones; limits on harmful phthalates; drug disposal programs; and rules for reprocessing single use medical devices.
HHS: Priorities for 2011 National Quality Strategy (October 15, 2010)
ANA supported work of the National Priorities Partnership and National Quality Forum; highlighted nurses' significant impact in achieving better care, affordable care, and healthy people and communities; and urged HHS to employ language inclusive of all stakeholders.
Bioethics Commission: Synthetic Biology (September 28, 2010)
ANA comments suggested developing ethical, legal and social considerations policies that address definitions of "natural" and "artificial"; boundaries between nature, life and technology; fair technology use and access; psychological impact; clinical issues in prevention, treatment and quality; and effects on the environment.
HHS: HIPAA-HITECH Proposed Rule (September 10, 2010) [pdf]
ANA offered comments on HHS' proposed modifications to implement recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (''the HITECH Act''), to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of these HIPAA Rules.
CDC: National Ambulatory Care Survey (September 10, 2010)
ANA urged that future surveys include care provided by non-physician healthcare providers, including APRNs.
OSHA: Infectious Diseases (July 30, 2010)
ANA offered detailed suggestions regarding vaccination and infection control policies to assist the Occupational Safety and Health Administration in limiting the spread of occupationally-acquired infectious diseases in healthcare settings.
EPA: Draft Strategic Plan for 2011-2015 (July 28, 2010)
ANA supported the Plan's goals to address climate change and improve air quality, as well as ensure safe chemicals and prevent pollution.
CMS: Hospital Conditions of Participation - Telemedicine Credentialing Proposed Rule (July 21, 2010)
ANA joined with the Oregon Nurses Association to oppose requirements for separate licensure for practitioners of telehealth services, in the state where patients are receiving those services.
NIH: Genetics Education & Training (June 30, 2010)
Comments on the Draft Report, Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers.
CMS: Medicaid Hospital Conditions of Participation for Rehabilitation & Respiratory Services (June 18, 2010)
ANA supported CMS' proposal to allow these services to be ordered by "qualified, licensed practitioners," including nurse practitioners.
CMS: Inpatient Acute & Long Term Care Proposed Rule (June 18, 2010)
ANA applauded inclusion of a nursing-sensitive care registry-based topic in the FY 2013 RHQDAPU (hospital quality reporting) measure set, and supported further adoption of several additional nursing-sensitive care measures.
OSHA: Injury and Illness Collection Process (June 11, 2010)
Our comments cited nurses' high rate of back and other work-related injuries, and gave suggestions for improved data collection, training and outreach to employers, and review of policy at the level of individual employers.
FDA: Bisphenol A (June 2, 2010)
ANA urged the FDA to ban all Bisphenol A (BPA) in food and beverage containers, as over 200 studies suggest a link between exposure and serious and diverse health effects, with children particularly vulnerable.
DEA: Electronic Prescriptions for Controlled Substances (June 1, 2010)
This interim final rule establishes a framework for e-prescribing of controlled substances, and ANA suggested creating or indentifying resources to assist nurses and other healthcare providers when questions and issues arise.
CEQ: Draft Guidance on Climate Change & Greenhouse Gas Emissions (May 24, 2010)
ANA commended the Council on Environmental Quality for taking the initiative to ensure that federal agencies consider climate change and greenhouse gas emissions, and offered additional suggestions to consider.
CMS/HHS: EHR Proposed Rule & HIT Initial Standards/Interim Final Rule (March 15, 2010)
ANA suggested improving EHR (Electronic Health Records)/HIT (Health Information Technology) policies and programs by recognizing APRN primary care providers and RNs who provide care coordination, among other issues.
OSHA: Occupational Injury & Illness Recording & Reporting Requirements (March 11, 2010)
In responding to this proposed rule, ANA advocated and provided detailed suggestions for separate reporting of musculoskeletal disorders to address back pain and other injuries incurred by nurses.
AHRQ: Children's Healthcare Quality Measures - Medicaid & CHIP (March 1, 2010)
ANA commented on the "Initial Core Set of Children's Healthcare Quality Measures for Voluntary Use by Medicaid and CHIP [Children's Health Insurance Program] Programs," and urged inclusion of data related to appropriate and adequate care by nurses.
FDA: Informed Consent Elements Proposed Rule (March 1, 2010)
ANA comments noted that many RNs and APRNs conduct or have patients who participate in clinical research, and made several suggestions on how to provide greater clarity and transparency.
EPA: Public Availability of Identities of Inert Ingredients in Pesticides (February 27, 2010)
ANA commented on this proposed rule by urging EPA to list all chemical ingredients and hazards on pesticide labels to protect workers, the public and the environment.
EPA: Dioxin in Soil at CERCLA & RCRA Sites (February 27, 2010)
Comments regarding the "Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites." ANA emphasized toxicity values, inhalation exposure, risk estimates, and the "precautionary approach" for reducing risks before full proof of harm is available, when evidence suggests a link between chemical exposure and serious or irreversible health effects.