Washington Watch for November 2021

Carter L. Alleman, J.D.

OSHA, CMS Release Vaccine Mandate Regulations
The Occupational Safety and Health Administration (OSHA) has released its emergency temporary standard (ETS) mandating COVID-19 vaccinations or weekly testing of workers at companies with 100 or more employees. The rule requires covered employers to develop, implement, and enforce a mandatory COVID-19 vaccination policy or require employees to undergo regular COVID-19 testing and wear a face covering at work.

The ETS was announced in conjunction with an interim final rule with comment period (IFC) from the Centers for Medicare and Medicaid Services (CMS) to require health care workers at approximately 76,000 Medicare and Medicaid participating hospitals and other facilities to be vaccinated. This regulation does not offer an option for workers to get tested regularly instead of vaccination, but (like the ETS) it does provide for medical or religious exemptions. The health-care worker vaccine mandate also follows a phased-approach, where all staff must be vaccinated by January 4.

House Passes Infrastructure Package, Tees Up Consideration of Reconciliation Package
The House of Representatives passed the $1 trillion bipartisan infrastructure package on Friday by a vote of 228-206. The bill contains traditional infrastructure-related provisions to fund roads, bridges, transit, and broadband build-out with nearly $550 billion in new funding. The Infrastructure Investment and Jobs Act (H.R. 3684), having previously passed the Senate, will now be sent to the President’s desk to be signed into law.


The House also passed the rule providing for consideration of H.R. 5376, the Build Back Better Act. The latest version of the social spending package currently stands at $1.85 trillion and is expected to be considered the week of November 15 following this week’s House committee work period.


Lawmakers Urge Revision of Surprise Billing Regulation
More than 150 members of Congress have signed a letter to the secretaries of Health and Human Services, Treasury, and Labor expressing concerns with the interim final rule (IFR) released on September 30 to implement the No Surprises Act. The lawmakers argue that the parameters of the independent dispute resolution process (IDR) process laid out in the IFR do not reflect the way the law was written. The letter urges the administration to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all the factors outlined in the statute without disproportionately weighting one factor.

Bipartisan Senators Urge CMS to Review MA Prior Authorization Process
Sens. Sherrod Brown (D-Ohio) and John Thune (R-S.D.) led a letter to the Centers for Medicare and Medicaid Services (CMS) urging the administration to reform the Medicare Advantage (MA) prior authorization process. They request an update on CMS’ “recommended next steps for improving and streamlining prior authorization processes in a manner that benefits providers, health plans, and taxpayers, but especially beneficiaries – including MA enrollees,” and ask the agency to use its regulatory authority to improve prior authorization across health plans in line with their Improving Seniors’ Timely Access to Care Act.

HRSA Releases Health Workforce Strategic Plan
The U.S. Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) have released the Health Workforce Strategic Plan, as required by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of the strategic plan will involve evaluating the performance of health workforce development programs, identifying opportunities to strengthen programs, eliminating redundancies where possible, and implementing improvements. HHS will produce a report to Congress on those activities, as required by the CARES Act.


Lawmakers Urge Changes to MPFS, RO Payment Model

In three separate letters to the administration, members of Congress are calling for action to mitigate an estimated $300 million in cuts contained in the proposed 2022 Medicare physician fee schedule (MPFS) and the proposed radiation oncology (RO) payment model. The lawmakers warn that the payment cuts and the new payment model could adversely

impact patient access to care.

A letter led by Senators Debbie Stabenow (D-Mich.) and Richard Burr (R-N.C.) expresses concerns that devaluing radiation oncology services “could have chilling effects on patient access to life-saving care” and urges CMS to mitigate the impact on radiation oncology providers. A group of 67 lawmakers in the House of Representatives signed on to a similar letter led by Representatives Brian Fitzpatrick (R-Pa.) and Brian Higgins (D-N.Y.), which questions whether the “severe cuts” stemming from the proposed MPFS cuts and the parameters of the radiation oncology model would “create instability and undermine the transition to value-based payment.” A third letter from Representatives Bobby Rush (D-Ill.) and Tony Cardenas (D-Calif.) on behalf of the Congressional Black, Hispanic, Asian Pacific American, and Native American caucuses argues that the “proposed combined payment cuts undermine the promise of the RO Model and the chance to improve health equity.”

Ways and Means Leadership Criticizes Surprise Billing Regulation
House Ways and Means Committee Chair Richard Neal (D-Mass.) and Ranking Member Kevin Brady (R-Texas) have sent a letter to the Biden administration criticizing the latest regulation to implement the No Surprises Act, which aims to avoid patient receipt of surprise medical bills and provide an independent dispute resolution (IDR) process for disputes between plans and providers over payment. The lawmakers argue that the recent rule outlining how the (IDR) process will work to resolve billing disputes between providers and insurers does not “reflect the law that Congress passed.” Neal and Brady state that the rule “biases the IDR entity toward one factor (a median rate) as opposed to evaluating all factors equally as Congress intended.” They ask the administration to provide additional justification for how the proposed implementation of the IDR process is in line with the No Surprises Act statute. House Energy and Commerce Chair Frank Pallone (D-N.J.) and Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) applauded the rule for establishing “a fair payment resolution process between providers and insurers while finally taking patients out of the middle.”

MA Prior Authorization Bill Continues to Gain Support
A majority of members in the House of Representatives have signed on as cosponsors of the Improving Seniors’ Timely Access to Care Act (H.R. 3173). The bill would make changes to prior authorization in the Medicare Advantage (MA) program by establishing an electronic prior authorization process, minimizing the use of prior authorization for services that are routinely approved, requiring plans to report on the extent of their use of prior authorization and the rate of delays and denials, ensuring prior authorization requests are reviewed by qualified medical personnel, and ensuring that plans adhere to evidence-based medicine guidelines. H.R. 3173 currently has 227 cosponsors, with 129 Democrats and 98 Republicans in support of the bill introduced by Representative Suzan DelBene (D-Wash.).

President Signs Short-Term Increase to Debt Limit
The House of Representatives voted last week to raise the debt ceiling until December 3. The debt limit bill was previously passed by the Senate and signed into law by President Joe Biden on Thursday. It would increase the nation’s borrowing ability by $480 billion. In absence of the legislation, the government would have breached its borrowing limit and defaulted on its debt obligations around October 18. While the bill prevents an immediate crisis, it sets the stage for another partisan fight over raising the debt limit to coincide with the current deadline to fund the federal government for fiscal year (FY) 2022.

More than Half of Congress Urges House Leaders to Act on Impending Medicare Cuts
Nearly 200 national and state organizations supported a bipartisan effort in Congress led by Representatives Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN) to write House Speaker Nancy Pelosi and Minority Leader Kevin McCarthy urging action before the end of the year to mitigate Medicare provider cuts. 247 bipartisan Members of Congress co-signed the letter – more than half of the U.S. House of Representatives. The proposed 2022 Medicare Physician Fee Schedule (MPFS) would eliminate a one-time increase of 3.75% provided in 2021 in response to the COVID-19 public health emergency (PHE). The moratorium on the 2% Medicare sequester is also set to expire at the end of the year. Passage of the American Rescue Plan and pay-as-you-go requirements may necessitate additional payment cuts of up to 4% next year.

PHE Declaration Extended
As a result of the continued COVID-19 pandemic, the U.S. Department of Health and Human Services (HHS) has renewed the public health emergency (PHE) declaration effective October 18. The renewal lasts for 90 days and may be extended again by the HHS Secretary. Previously, President Bident has told state officials that he plans to extend the PHE through 2021 and provide a 60-day notice to states when he plans not to renew the PHE. The nationwide PHE was first declared on January 27, 2020.