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November 9, 2020

Health Headlines – November 9, 2020


Proposed Rule Would Require Retroactive Review of HHS Regulations – On November 4, 2020, HHS issued a notice of proposed rulemaking that would require HHS to review its regulations every ten years to determine whether or not the regulations are subject to agency review under the Regulatory Flexibility Act (RFA). The RFA requires government agencies to review certain regulations every ten years to determine whether the regulation is still necessary and whether it is having its intended effect. The proposed rule also sets expiration dates for regulations that are not assessed and reviewed if subject to the RFA.

The RFA was enacted in the 1980s to limit the impact of regulations on small businesses. Under the RFA, each agency is tasked with publishing in the Federal Register a plan for periodically reviewing regulations “that have or will have a significant economic impact upon a substantial number of small entities.” 5 U.S.C. § 610(a). In reviewing the regulation, the agency is asked to consider, among other factors, any overlap with other rules, the need for the rule, public comment, and changes in economic and technological conditions.

To encourage HHS to assess and review regulations on a periodic basis, the proposed rule would set expiration dates for all regulations issued by the agency in Titles 21 (Food and Drug), 42 (Public Health), and 45 (Public Welfare) of the Code of Federal Regulations. If not assessed and reviewed, each regulation would expire at the latter of: (1) two calendar years after the proposed rule became effective; (2) ten calendar years after the regulation was promulgated; or (3) ten calendar years after HHS assessed and reviewed the regulation. These provisions would require that regulations promulgated more than 10 years ago would have to be assessed and reviewed within two years after the proposed rule goes into effect. HHS would list on a website the regulations that are being assessed and reviewed and the public will be able to submit comments.

For each regulation reviewed that must be rescinded or amended, HHS would have two years to amend or rescind the regulation. During that two-year period, the proposed rule states that HHS will use its discretion to determine whether to enforce the regulations that need amendment or rescission.

Certain regulations would be exempt from the provision requiring that the regulation expire within a certain time if it is not assessed and reviewed. Exempt regulations include: (1) regulations whose expiration would violate federal law; (2) regulations with a military or foreign affairs function; (3) regulations related solely to internal agency management or personnel matters; (4) regulations concerning federal government procurement; and (5) regulations issued jointly with other federal agencies because of a legal requirement to consult another agency.

The proposed rule states that the statutory authority for implementing these expiration dates derives from HHS’ primary rulemaking authorities that authorize HHS to promulgate regulations for the efficient enforcement and administration of certain federal statutes. In addition, HHS also cites to the RFA for the authority to require periodic review of regulations that have a significant economic impact on small businesses and explains that that authority permits HHS to decide which regulations would have an economic impact on small entities.

The deadline for submitting electronic or written comments is December 4, 2020. Comments must be electronically submitted here. The proposed rule is available here.  For more information about the proposed rule, see the HHS Press Release.

Reporter, Taylor Whitten, Sacramento, +1 916 321 4815, twhitten@kslaw.com.

CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule – On November 2, 2020, CMS issued a final rule updating Medicare payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services for 2021. Under the final rule, the 2021 ESRD PPS base rate will be $253.13, which represents an increase of $13.80 to the 2020 base rate. CMS estimates this equates to an approximately $210 million increase in ESRD expenditures for 2021. The rule also sets a payment rate of $253.13 for treatment of acute kidney injuries provided by dialysis facilities and updates the ESRD Quality Incentive Program by (1) changing the scoring methodology for the Ultrafiltration Rate reporting measure and (2) updating the National Healthcare Safety Network (NHSN) validation study requirements.

In addition, CMS will expand eligibility for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) “to include certain capital-related assets that are home dialysis machines when used in the home for a single patient.” CMS will evaluate TPNIES applications to determine whether the home dialysis machine represents an advance that substantially improves the diagnosis or treatment of Medicare beneficiaries, and meets the other requirements under 42 C.F.R. § 413.236(b).

The final rule also includes the following additional updates:

  • an update to the ESRD PPS wage index to adopt the 2018 Office of Management and Budget delineations with a transition period;
  • an addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment; and
  • a change to the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 Public Health Emergency.

The final rule is available here.  The CMS press release regarding the final rule is available here.

Reporter, Nicholas Kump, Sacramento, +1 916 321 4817, nkump@kslaw.com.