Federal Regulation
Once a Bill Is Signed Into Law, the Regulatory Process Begins
In a typical regulatory process:
- The governing agency issues a proposed rule.
- That proposed rule is published in the federal register noting an allotted time for the submission of public comments, typically referred to as the public comment period, normally lasting either 30 or 60 days.
- After the comment period is closed, the agency reviews the comments and begins work on the final rule.
Unless defined by law, the agency is under no mandate to issue the final rule within a specified time frame. Once the agency has completed its regulatory review, it publishes the final rule in the federal register. The information below provides you with the proposed rule, AANP’s submitted comments to that proposal and, where applicable, the final rule and AANP’s accomplishments in accordance with the agency's final regulation.
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U.S. Department of Health and Human Services
Calendar Year (CY) 2024 Medicare Physician Fee Schedule (PFS) Final Rule Resources
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Internal Revenue Service
Affordability of Employer Coverage for Family Members of Employees.
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Regulatory Resource Updates
- No Surprises Act Resources.
- Open Payments Program — Registration Open!
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2021 Archives
2021 Medicare Physician Fee Schedule Final Rule
- Final Rule.
- AANP Comments.
- CMS Final Rule Fact Sheet.
- Evaluation and Management Services Fact Sheet.
- Medicare Administrative Contractor Guidance - Evaluation and Management Services.
Regulatory Relief to Support Economic Recovery
Securing Updated and Necessary Statutory Evaluations Timely
Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
Hospital Outpatient Prospective Payment System
Home Health Prospective Payment System
COVID-19 Public Health Emergency Second Interim Final Rule
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2019 Archives
2019 Medicare Fee Schedule Final Rule: This annual rule updated the 2019 Medicare Fee Schedule, updated the Quality Payment Program (QPP) and made some changes to the Medicare Shared Savings Program (MSSP). Beginning January 1, 2019, CMS is amending documentation guidelines for outpatient and office evaluation and management (E/M) visits so that clinicians will be able to verify, instead of re-document, certain information contained in the medical record. Beginning January 1, 2021, CMS will combine E/M levels 2–4 into one blended payment rate while also reducing the level of documentation needed to bill for E/M visits. Changes to the QPP include providing clinicians with an opportunity to opt in to the QPP if they meet one, but not all, of the low-volume thresholds. CMS also finalized a new low-volume threshold of 200 Medicare Part B services billed per year. This means that if a clinician bills at least 200 Part B services in a year, that clinician will be able to elect to participate in the QPP—a significantly lower threshold than previously existed. In this final rule, CMS also finalized a change to the MSSP that authorizes patients who voluntarily align with an Accountable Care Organization (ACO) professional, including an NP, to be assigned to the ACO without requiring one primary care service from a primary care physician.
- CMS Final Rule Fact Sheet
- 2019 Medicare Fee Schedule Proposed Rule
- AANP Comments on 2019 Medicare Fee Schedule Final Rule
- AANP 2019 Medicare Fee Schedule Scorecard
Medicaid and Children's Health Insurance Plan (CHIP) Managed Care: This proposed rule would update the Medicaid and CHIP managed care programs to remove regulatory burdens and increase state flexibility.
Modernizing Medicare Part D and Medicare Advantage to Lower Drug Prices: This proposed rule would make changes to the Medicare Part D and Medicare Advantage programs with the intent of lowering drug prices and out of pocket costs.
Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction: AANP commented on this proposed rule and request for information by recommending the removal of regulatory barriers to NP practice within the Medicare and Medicaid programs.
State Relief and Empowerment Waivers: AANP commented on new guidance regarding the Affordable Care Act 1332 State Waiver process.
Policy and Technical Changes to Medicare Advantage, Medicare Part D, PACE, Medicaid Fee-for-Service and Medicaid Managed Care: AANP commented on sections of this proposed rule related to new regulations regarding the appeals and grievances requirements for Medicare Advantage plans for dually eligible individuals.
Methods for Assuring Access to Covered Medicaid Services: This proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute.
Hospital Inpatient Prospective Payment System Final Rule: This annual rule updated and revised the inpatient prospective payment system for acute hospitals and the payment system for long-term care hospitals.
Inpatient Rehabilitation Facility Prospective Payment System Final Rule: This annual rule updated the prospective payment system for inpatient rehabilitation facilities.
Home Health Prospective Payment System Final Rule: This annual rule updated the prospective payment system for home health agencies.
Hospital Outpatient Prospective Payment System Final Rule: This final rule updated the hospital outpatient prospective payment system and the ambulatory surgical center payment system.
U.S. Department of Health and Human Services (HHS) Regulatory Burden Request for Information: As part of the initiative to reduce regulatory burdens in the health care system, HHS released a request for information for stakeholders to identify regulatory barriers that impact the health care marketplace. AANP took this opportunity to address the federal barriers related to NP practice that impede competition in the marketplace.
Cancellation of Cardiac Rehabilitation Incentive Payment Model Final Rule: CMS had approved a cardiac rehabilitation incentive payment model under the previous administration that would have allowed NPs participating in the model to order and supervise cardiac rehabilitation. The current administration proposed to cancel the model due to concerns about the model’s methodology and the mandatory nature of the model. AANP encouraged the administration to move forward with the model, but CMS finalized its proposal to cancel this payment model.
- Cancellation of Cardiac Rehabilitation Payment Model Proposed Rule
- AANP Comments on Cardiac Rehabilitation Payment Model Proposed Rule
CMS Innovation Center Request for Information: CMS requested stakeholder feedback on the new direction of the Centers for Medicare and Medicaid Innovation (CMMI).
Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs for Contract Year 2019: This is an annual rule that revises the regulations for the Medicare Advantage and Prescription Drug Benefits Programs.
Medicare Advantage (MA) 2019 Rate Notice: This is an annual rule that updates the rates for the MA program and makes other program changes.
Clinical Laboratory Improvement Amendments (CLIA) Revisions to Personnel Regulations Request for Information: CMS requested feedback on revisions to the personnel regulations for CLIA.
Short-term, Limited-duration Insurance: CMS proposed to lengthen the maximum duration of a short-term, limited-duration insurance plans to 12 months.
2020 Medicare Physician Fee Schedule Final Rule: This annual rule updated the 2020 Medicare Fee Schedule and the Quality Payment Program (QPP). Notably, the final rule corrected a disparity in documentation requirements for APRN/PA preceptors and APRN/PA students and teaching physicians and medical students (see primer below). The final rule revised requirements for E/M documentation and billing that were finalized in the 2019 fee schedule, and CMS will no longer collapse level 2-4 E/M visits into one blended payment rate. The final rule expands the list of approved telehealth services, implements Medicare coverage for opioid treatment programs, adds nurse practitioners to the Open Payments program (effective 2022) and proposed a new pathway for clinician reporting within the Quality Payment Program that would go into effect in 2021.
- AANP Comments on 2020 Fee Schedule Proposed Rule
- AANP Analysis of Student Documentation Changes in Final Rule
- CMS Fact Sheet on 2020 Medicare Physician Fee Schedule
2019 Medicare Shared Savings Program (MSSP) Proposed Rule: As you are aware, under the current structure of the MSSP, NPs are authorized accountable care organization (ACO) professionals. However, in order for an NP’s patient to be attributed to an ACO in the MSSP, the patient must receive at least one primary care service from a participating primary care physician in the ACO. In the latest MSSP Proposed Rule, HHS is proposing a pathway in which a patient can be assigned to an ACO without requiring one primary care visit from a primary care physician. Under this proposal, a patient can select an NP as their primary ACO clinician in the MSSP, and the patient will no longer need to see a primary care physician in order to be assigned to the ACO. CMS has directly requested feedback on this proposal.
FDA Opioid Policy Steering Committee Request for Comments: The FDA requested stakeholder feedback on suggestions and recommendations for how the FDA can best use its authority to combat the opioid crisis.
FDA Request for Information on Updating Existing Regulations: The FDA requested stakeholder feedback on FDA regulations that were outdated and could be updated, repealed or modified.
FDA Requests for Comments on Draft Guidance for Communications and Labeling: The FDA requested comments on draft guidance related to communications and labeling for multiple products. AANP responded and highlighted the need for provider-neutral language in all FDA communications and labeling requirements.
- Medical Product Communications Draft Guidance
- AANP Comments
- Drug and Device Manufacturer Communications Draft Guidance With Payors
- AANP Comments
- Nonprescription Drug Product Draft Guidance
- AANP Comments
- Human Prescription and Biological Products Draft Guidance
- AANP Comments
- Medical Device Labeling Regulations
- AANP Comments
- Medication Prescription Guide
- AANP Comments
Health Insurance Portability and Accountability Act of 1996 (HIPAA) Request for Information (RFI): HHS requested feedback on how to modernize the HIPAA regulations to improve the transition to value-based care and improve care coordination.
HHS Notice of Benefit and Payment Parameters for 2020: Annual proposed rule to update the parameters of the American Health Benefit Exchanges established by the Patient Protection and Affordable Care Act.
Request for Information Regarding the 21st Century Cures Act Electronic Health Record Reporting Program: AANP responded to this request for information by recommending that all electronic health records (EHRs) be “nurse-practitioner inclusive” by removing any physician-centric language or requirements and to focus on reducing clinician burden.
Surgeon General's Call to Action: "Community Health and Prosperity": AANP commented on an upcoming Surgeon General’s Call to Action that focuses on community health and prosperity. AANP highlighted the important role that NPs play in delivering health care in their communities and took the opportunity to address existing barriers to NP practice.
Coal Workers' Health Surveillance Program: The Centers for Disease Control and Prevention (CDC) requested comments on improving the utility of the Coal Workers’ Health Surveillance Program.
Pain Management Best Practices Inter-Agency Task Force: HHS held the inaugural meeting of the Pain Management Best Practices Inter-Agency Task Force and solicited public comment on clinical best practices, gaps in prevention and treatment and other agenda items.
Increase Innovation and Investment in the Health Care Sector: HHS solicited public comment on a planned initiative of the Office of the Deputy Secretary of HHS to develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the health care industry.
Draft-National Occupational Research Agenda for Respiratory Health: The CDC solicited public comment on its draft of the National Occupational Research Agenda for Respiratory Health.
VA Schedule for Rating Disabilities: Musculoskeletal System and Muscle Injuries: The VA is in the process of updating its disabilities rating schedules, and AANP commented on this proposed rule to ensure that language was not inserted into the schedule that would require a physician prescription for a bracing or assistance device. The final rule is still pending.
Authority of Health Care Providers to Practice Telehealth: This proposed rule would increase the ability of VA health care providers, including NPs, to provide telehealth to VA beneficiaries. AANP supported this proposed rule, and the VA adopted the proposals in its final rule.
- Authority of Health Care Providers to Practice Telehealth Proposed Rule
- AANP Comments Authority of Health Care Providers to Practice Telehealth
Civilian Health and Medical Program of the Department of Veterans Affairs Proposed Rule: The VA issued a proposed rule to clarify and update the regulations for CHAMPVA.
Definition of "Employer" Under Section 3(5) of ERISA—Association Health Plans Proposed Rule: The DOL proposed to expand the definition of employer to broaden the criteria for when employers may join together to sponsor a health plan.
DOT Notification of Regulatory Review: The DOT is conducting a review of its existing regulations and has requested stakeholder feedback on outdated regulations that could be updated. AANP took this opportunity to comment on outdated regulatory language that prevents NPs from serving as medical examiners and medical review officers in various agencies under the DOT’s authority.
Medical Certification of Disability Exception: AANP commented on the need to update the Medical Certification for Disability Exceptions form for naturalization applicants so that NPs are authorized to complete the form.
TRICARE: Addition of Physical Therapy Assistants and Occupational Therapy Assistants as Authorized Providers: AANP commented on some language changes to provide clarity in the DOD regulations regarding authorized providers.
Connected Care Pilot Program: AANP commented on the need to ensure that NPs are full participants in the FCC Connected Care Pilot Program and supported the program’s goal of increasing access to telehealth services for low-income families and veterans.
Promoting Telehealth in Rural America: The FCC requested comment in this proposed rule on how to maximize the ability of the Rural Health Care program to provide rural health care providers with access to telehealth services.
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2018 Archives
Quality Payment Program (QPP) 2018 Final Rule: The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) repealed the sustainable growth rate and established the QPP. Clinicians participating in the QPP will select one of two tracks: the Merit-based Incentive Payment System (MIPS) track or the Advanced Alternative Payment Models (AAPM) track. This final rule is an annual rule that updates the QPP regulations for the 2018 calendar year. This final rule also requested additional comments on certain topics, which AANP responded to in addition to our comments on the proposed rule.
- QPP 2018 Proposed Rule
- AANP Comments on Proposed Rule
- AANP Comments on Final Rule
- Final Rule Outcome
Physician Fee Schedule 2018 Final Rule: This annual rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies, such as changes to the Medicare Shared Savings Program.
Home Health 2018 Final Rule: This is an annual rule that updates the payment rates for home health agencies. In this rule, CMS proposed implementing the Home Health Groupings Model beginning in 2019.
Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule: This is an annual rule to update and revise the OPPS and Medicare ambulatory surgical center payment system. The proposed rule contained a provision, which AANP supported, to reinstate the nonenforcement of direct supervision instruction for outpatient therapeutic services in critical access hospitals and small rural hospitals. The provision was included in the final rule.