McDermottPlus Check-Up: December 3, 2021

This Week’s Dose

Congress returns from its Thanksgiving recess and works to stop a authorities shutdown by passing an 11-week Persevering with Decision (CR) by way of February 18, 2022.  Negotiations proceed within the Senate on the Construct Again Higher (BBB) Act, and the Administration’s vaccine mandate for well being care amenities faces authorized roadblocks.

Congress

Congress Passes CR Lasting By February 18, With out Well being Care Extenders. The primary deadline-driven motion upon Congress’ return from the Thanksgiving recess was to go a short lived funding measure to stop a federal authorities shutdown on December 3—the expiration date of the earlier CR.  The seemingly easy course of was delayed all through the course of the week by disagreements between Democrats and Republicans over the size of the brand new CR, in addition to threats from a bunch of conservative Republicans in protest of the Biden Administration’s vaccine mandates.

Appropriators launched an 11-week CR the morning of December 2, offering stopgap funding by way of Friday, February 18, 2022. The identical day, the Home permitted the CR by a vote of 221-212 and the Senate adopted swimsuit later within the night by a vote of 69-28, sending the measure to President Biden’s desk and averting a authorities shutdown.

Notably for the healthcare group, the CR does not tackle numerous threats to Medicare funds, together with people who might start at year-end.  If Congress doesn’t act by way of one other legislative automobile this yr, a detrimental 3.75% replace to the Medicare Doctor Payment Schedule and a 2% Medicare sequestration reduce will go into impact January 1, 2022. A 4% lower underneath statutory Pay-As-You-Go (“PAYGO”) guidelines can be anticipated to take impact in early 2022.  The two% and 4% cuts would have an effect on all Medicare suppliers, along with physicians. Physicians face the extra 3.75% reduce, bringing complete potential reductions to Medicare funds for doctor providers to just about 10% if Congress doesn’t intervene.  Finish-of-year funding measures usually function autos to keep away from fee cuts like these, and far of the healthcare group hoped, if not anticipating, Congress to make use of this CR to resolve these looming threats. The CR additionally doesn’t tackle another expiring well being provisions, resembling telehealth protection extensions.

This so-called “clean” CR will increase the probability that Congress might not take motion on the looming reimbursement cuts earlier than they take impact within the New 12 months, although there may be nonetheless the likelihood that Congress will act on a stand-alone measure to handle these well being care extenders this month. 

Whereas the Facilities for Medicare and Medicaid Providers (CMS) can direct Medicare Administrative Contractors (MACs) to quickly maintain claims if legislative motion is pending, they can not accomplish that by way of February 18, 2022. There may be extra flexibility on timing for the across-the-board statutory PAYGO reduce relying upon the time it takes for the Workplace of Administration and Finances (OMB) to certify and implement it. 

Senate Negotiations Proceed on BBB. Following Home passage of BBB on November 19, the $1.7 trillion laws—which incorporates the social spending (or “soft infrastructure”) priorities of President Biden and Congressional Democrats—awaits consideration within the Senate, the place its final scope and end result stay unsure.

The Home-passed BBB is predicted to alter significantly earlier than reaching the Senate flooring because of the have to have all 50 Senate Democrats—each progressives and moderates—on board to go the invoice.  Additional, Senate management should take care of the so-called “Byrd Rule,” which dictates what forms of provisions can advance in laws thought-about underneath the finances reconciliation course of.  Such selections are made by the Senate Parliamentarian, who has been assembly with Senators and is predicted to start issuing steerage and rulings within the coming days.

Senate Majority Chief Schumer (D-NY) has indicated that he want to have BBB on the Senate flooring the week of December 13, pending completion of the Parliamentarian’s work. Ought to Senate Democrats finally agree upon and advance a revised model of BBB, the laws would wish to return to the Home for a last vote earlier than reaching President Biden’s desk. Timing stays very unsure presently.  If consideration of BBB will not be accomplished this yr, it might probably roll into 2022.

Administration 

CMS Vaccine Mandate Faces Authorized Roadblocks.  Two U.S. District Courts issued preliminary injunction (PI) orders this week, barring CMS’ implementation of the Ominibus COVID-19 Well being Care Workers Vaccination Rule (“CMS Vaccine Mandate”). 

On November 29, the U.S. District Court docket for the Japanese District of Missouri, Japanese Division, granted a Preliminary Injunction (PI) enjoining CMS from implementing and imposing its vaccination mandate for well being care amenities in 10 plaintiff states—Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming—pending a trial on the deserves of the case. The subsequent day, the U.S. District Court docket within the Western District of Louisiana issued a separate order offering for a nationwide PI.  The courtroom famous that limiting its injunction to simply these plaintiff states wouldn’t be ample, stating: “In addressing the geographic scope of the preliminary injunction, due to the nationwide scope of the CMS Mandate, a nationwide injunction is necessary due to the need for uniformity.”

The Biden Administration is interesting each rulings together with the injunction issued in opposition to the big employer mandate issued by the Occupational Security and Well being Administration (OSHA).  Whereas the final word destiny of those guidelines is unclear, it seems that the injunctions will stay in place previous the primary compliance date of December 6. Within the meantime, the Biden Administration on December 2 paused implementation and enforcement of the CMS mandate whereas these preliminary injunctions are in impact.

Biden Publicizes New Actions to Fight COVID-19 Variants. President Biden announced a number of new public well being actions that try and fight rising concern over the emergence of the Omicron COVID-19 variant and the approaching winter months. These actions embody growing entry to and promotion of boosters for all U.S. adults, working to enhance COVID-19 prevention and vaccination insurance policies for school-age youngsters, increasing free at-home testing, and growing the availability of remedy tablets for COVID-19 to stop hospitalization and dying. The Administration additionally plans to take vital steps to organize for the emergence of future COVID-19 variants and different pandemic situations.

Fast Hits

  • The Supreme Court docket heard oral arguments this week on instances that tackle Medicare disproportionate share hospital (DSH) funds and reimbursement cuts to the 340B program.  The latter case, along with the technical fee points, additionally offered vital challenges to the Chevron deference authorized doctrine, which might have vital implications for federal rulemaking.  Selections are usually not anticipated till summer time.

  • The Supreme Court docket additionally heard oral arguments this week on Mississippi’s 15-week abortion ban—a case that would have a major influence on abortion protections underneath Roe v. Wade

  • The Home Power and Commerce Well being Subcommittee held a December 2 hearing on the opioid epidemic and an interagency proposal to fight illicit fentanyl-related substances.

  • The Home Power and Commerce Well being Subcommittee announced a December 8 listening to on the way forward for biomedicine.

  • CMS issued a Request for Information (RFI) to solicit stakeholder suggestions that will probably be used to tell potential adjustments and future rulemaking to enhance the organ transplantation system and to reinforce the standard of lifetime of these dwelling with organ failure.

  • CMS introduced it is not going to transfer ahead with the Severely Sick Inhabitants (SIP) Part of the Primary Care First (PCF) Model, stating that the proposed SIP outreach technique is unlikely to end in ample beneficiary uptake to permit for mannequin analysis.

Subsequent Week’s Analysis

Negotiations proceed amongst Senate Democrats on BBB, and between Democratic and Republican leaders on an settlement to handle the debt ceiling, which the Treasury Secretary estimates may very well be reached by December 15, as Congress heads into its last, frantic weeks of legislative enterprise for 2021.

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