ANA Government Affairs staff review and analyze federal agency decisions, regulations, and rules affecting registered nurses, our profession, our patients, and the public health. The Administrative Procedures Act requires Executive Branch departments and agencies to publish these in the Federal Register, allow an opportunity for public comments, and take those into account when issuing a final rule or regulation. Once final, rules and regulations become part of the Code of Federal Regulations. Notices of public meetings and requests for nominees to federal panels are also published in the Federal Register.
ANA often provides feedback to federal policymakers through written comments. These are often collaborative efforts both within ANA and with our Constituent/State Nursing Associations, organizational affiliates, and other nursing and healthcare organizations. The Affordable Care Act requires many agencies and departments to implement regulations to carry out its policies. ANA is especially vigilant regarding Health Care Reform, now called "ACA" (short for the full title of the law, the Affordable Care Act) actions that impact nursing, especially those that offer the chance to overcome longstanding barriers to optimal nursing practice.
Resources for Submitting Regulatory Comments & Letters
We encourage ANA members, Constituent/State Nursing Associations, and organizational affiliates to submit comments on agency decisions. Some resources are provided below to help you with that process.
2013 ANA Regulatory Comments
2012 ANA Regulatory Comments
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.
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.
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.
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.
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.
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.
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
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.
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.
• 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.
2010 ANA Regulatory Comments
Affordable Care Act
To the Director of Center for Medicare Services: Comments on Request for Information Regarding Accountable Care Organizations and the Medicare Shared Saving Program (December 3, 2010) [pdf]
The "Accountable Care Organization", or ACO, is a new attempt to structure health systems that are paid by the quality of care, not the quantity. The Centers for Medicare Services (CMS) is charged with creating the framework for the ACO. ANA believes nurse-led care coordination, inclusive leadership structures, and a continued focus on patient choice are key in ACOs, and urges CMS to include these aspects as they develop demonstration projects for this element of the ACA.
To the Secretary of Health and Human Services: Comments on Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act (September 17, 2010) [pdf]
ANA supported the Health and Human Services, or HHS, rules on preventive services that will be required by law to be at no cost to the insurance customer. Covered services include any United States Preventive Services Task Force (USPSTF) "A" (strongly recommended) or "B" (recommended) graded service. These services are essential to creating a well-care system, and nurses are fundamental to providing these services.
To the Director of Center for Medicare Services: Comments on Home Health Prospective Payment System (September 14, 2010) [pdf]
Every year, the Centers for Medicare Services, or CMS, updates the rules for how patient home care providers are paid. ANA urged CMS to make it easier for APRNs to provide home care autonomously, and also urged CMS to allow APRNs to certify patients as eligible for home care and/or hospice care. Currently, APRNs cannot do that, and is a huge impediment to seamless, efficient patient care.
To the Director of the Centers for Medicare Services: Comments on Outpatient & Ambulatory Surgical Center Services Prospective Payment Systems (August 31, 2010) [pdf]
Every year, the Centers for Medicare Services, or CMS, updates the rules for how they pay for outpatient surgery. ANA advised CMS to support more realistic direct supervision requirements, offered support for inclusion of preventive services, offered support for National Quality Forum measures for hospital quality reporting, and encouraged mandatory quality reporting for ambulatory surgical centers. Outpatient surgery is becoming very common, and many nurses and APRNs, especially CRNAs practice in these types of facilities.
To the Director of Centers for Medicare Services: Comments on Inpatient Prospective Payment System (August 24, 2010) [pdf]
Medicare Part B is how the government pays providers for treating patients, and these rules are updated annually. In its comments, ANA concentrated on the inclusion of APRNs in many elements and services that are on the reimbursement schedule for Medicare Part B, and supported comments by the RUC regarding its valuation methodology. The ability for APRNs to directly bill and be reimbursed by Medicare is still fraught with issues, and ANA highlights these as often as possible to ensure APRNs can provide care and improve access to care.
To the Centers for Disease Control and Prevention: Comments on Guidance for Influenza Control (July 21, 2010) [pdf]
The Centers for Disease Control and Prevention, or CDC, releases guidance on how hospitals and other healthcare settings (school clinics, outpatient clinics, nursing homes) can prevent seasonal influenza from occurring or spreading. ANA encouraged CDC to continue to advocate for a comprehensive program, including the availability of vaccines, personal protective equipment, and appropriate sick leave policies, to protect nurses from exposure and protect patients from becoming sick or sicker.
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.