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 www.reginfo.gov. 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 6/28/21 |
| Reporting Requirements Related to Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions |
Insurance | Proposed Rule | Received at OMB on 7/7/21 |
| Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations |
Medical Devices | Proposed Rule | Received at OMB on 8/18/21 |
| Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” |
Medicare | Proposed Rule | Received at OMB on 8/27/21 |
| Securing Updated and Necessary Statutory Evaluations Timely |
Internal HHS Policy | Proposed Rule | Received at OMB on 8/31/21 |
| Premarket Tobacco Product Applications and Recordkeeping Requirements |
Tobacco Products | Final Rule | Received at OMB on 4/5/21 |
| Format and Content of Reports Intended to Demonstrate Substantial Equivalence |
Tobacco Products | Final Rule | Received at OMB on 4/5/21 |
| Medical Device De Novo Classification Process |
Medical Devices | Final Rule | Received at OMB on 6/28/21 |
| Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond |
Insurance | Final Rule | Received at OMB on 8/19/21 |
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 regulations.gov 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.