What Does Health Care Rulemaking Look Like This Year?


Even Congress tries to complete $4.5T in domestic policy changes plus appropriations in the next 3 months, the Biden Administration is cranking away on health care rulemaking.  Here’s a quick overview of some key rules on the horizon from the Department of Health and Human Services (HHS).

Go deeper:  Refresh your memory on OMB and rulemaking here.

Below are the health care rules currently under review at  At the moment, the public is unable to comment on the any of the rules listed until their publication in the Federal Register.

Title Category Type Status
Streamlining HHS
Guidance Practices
Internal HHS Policy Proposed Rule Received at OMB on
Reporting Requirements Related to Air
Ambulance and Agent
and Broker Services and HHS Enforcement
Insurance Proposed Rule Received at OMB on
Hearing Aids and
Aligning Other
Medical Devices Proposed Rule Received at OMB on
Medicare Coverage of
Innovative Technology (MCIT) and Definition of “Reasonable and
Medicare Proposed Rule Received at OMB on
Securing Updated and Necessary Statutory
Evaluations Timely
Internal HHS Policy Proposed Rule Received at OMB on
Premarket Tobacco
Product Applications
and Recordkeeping
Tobacco Products Final Rule Received at OMB on
Format and Content of Reports Intended to
Substantial Equivalence
Tobacco Products Final Rule Received at OMB on
Medical Device De
Novo Classification Process
Medical Devices Final Rule Received at OMB on
Updating Payment
Parameters and
Improving Health
Insurance Markets for
2022 and Beyond
Insurance Final Rule Received at OMB on

Don’t Be Caught “Surprised”

HHS has more rules coming out on the No Surprises Act.

  • By October 1, the Biden administration is required to publish a rule on an audit process to ensure that plans and insurers are complying with the QPA calculation and requirement.
  • By December 27, the administration must outline the details of an independent dispute resolution (IDR) process if providers and health plans fail to agree on an out-of-network rate.

Annual Payment Rules

Expected around late October/early November, CMS will post the final Medicare payment policies and reimbursement rates for FY 2022, including the Home Health Prospective Payment System, the Hospital Outpatient Prospective Payment System (HOPPS), and the Physician Fee Schedule.

  • Stakeholders can still comment on the proposed HOPPS and Physician Fee Schedule at through September 13 and September 17, 2021, respectively.

All eyes may be on Congress this fall as lawmakers work to finish FY 2022 appropriations, a $1.2T bipartisan infrastructure bill, and a $3.5T “human” infrastructure package.  However, keen observers would be remiss to ignore the Executive Branch, where forthcoming rulemaking will surely impact health care providers of all stripes.

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