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On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities.  The amount of blanket waivers ending is notable; while there have been terminations of waivers previously, these were usually limited to a single waiver.

CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” CMS reported that findings from onsite surveys at these facilities “revealed significant concerns with resident care that are unrelated to infection control.” Accordingly, CMS is acting to remove certain operational flexibilities not directly related to infection control.…

Continue Reading CMS Ending Numerous COVID-19 Blanket Waivers for SNFs, Inpatient Hospice, ICF/IIDs, and ESRD Facilities

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On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the Medicare program will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305).

The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. Instead, CMS chose an alternate pathway known as Coverage with Evidence Development (“CED”).  If the proposal is adopted by CMS, it would set in motion a detailed regulatory process that includes temporary Medicare coverage for the drug but only for certain Medicare beneficiaries who are enrolled in an additional clinical trial intended to test whether these drugs will have a significant benefit for Medicare beneficiaries.  CMS expects to issue a decision by April 11, 2022 to approve or reject the CED process after reviewing comments from interested parties. …
Continue Reading CMS “Splits the Baby” on Aduhelm—Medicare Coverage but Only with Evidence Development for Now

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On the evening of Wednesday, December 22, 2021, the Supreme Court of the United States announced that it will hold a special session on January 7, 2022, to hear oral argument in cases concerning whether two Biden administration vaccine mandates should be stayed. One is an interim final rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”); the other is an Emergency Temporary Standard (“ETS”) issued by the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”). The CMS interim final rule, presently stayed in 24 states, would require COVID-19 vaccination for staff employed at Medicare and Medicaid certified providers and suppliers. The OSHA ETS, which requires businesses with 100 or more employees to ensure that workers are vaccinated against the coronavirus or otherwise to undergo weekly COVID-19 testing, was allowed to take effect when a divided panel of the United States Court of Appeals for the Sixth Circuit, to which the consolidated challenges had been assigned by the Judicial Panel on Multidistrict Litigation issued a ruling, on December 17, 2021, lifting a stay that had been previously entered by the Fifth Circuit. Multiple private sector litigants and states immediately challenged the decision.
Continue Reading Rare Hearing by the Supreme Court as to Stays in Vaccine Mandate Cases

As we previously reported, the Centers for Medicare & Medicaid Services’ (CMS’s) interim final rule (the “Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) was effectively stayed nationwide on November 30, 2021, by the U.S. District Court for the Western District of Louisiana (the “Louisiana Court”).  In yet another twist to the ongoing legal battles, the U.S. Court of Appeals for the Fifth Circuit lifted the nationwide stay and held that the Louisiana Court only had authority to block the vaccine mandate in the fourteen plaintiff states that brought suit in that court. Those states are Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.

Due to the litigation in the Eastern District of Missouri, as reported here, enforcement of the vaccine mandate is also blocked in ten other states:  Alaska, Arkansas, Kansas, Iowa, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.  In total, the vaccine mandate under the Rule is now stayed in twenty-four states, but is now in effect in the remaining twenty-six states.…

Continue Reading Update: CMS Interim Final Rule Stay Lifted Nationwide, Still in Effect in Twenty-Four Plaintiff States

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Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.…

Continue Reading CMS Issues Guidance on COVID-19 Testing in the Workplace

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.…

Continue Reading Courts Grant Preliminary Injunctions Placing CMS Interim Final Rule on Hold

[UPDATE, Nov. 30, 2021: The District Court for the Eastern District of Missouri grants injunction for the ten plaintiff states listed in the First Complaint.]

As we previously reported, effective November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (the Rule) requiring full COVID-19 vaccination for staff…

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Today, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) goes into effect.[1] Published September 10 with a comment period that also closed today, the new rule expands CMS’s “program integrity enhancement” capabilities by introducing new revocation and denial authorities and increasing reapplication and enrollment bars as part of the Trump Administration’s efforts to reduce spending. While CMS suggests that only “bad actors” will face additional burdens from the regulation, the new policies will have significant impacts on all providers and suppliers participating in Medicare, Medicaid, and CHIP.[2]

AN OVERVIEW OF THE NEW RULE

The New “Affiliations” Revocation Authority

The new “affiliations” enforcement framework—the regulation’s most significant expansion of CMS’s revocation authority—permits CMS to revoke or deny a provider’s or supplier’s enrollment in Medicare if CMS determines an “affiliation” with a problematic entity presents undue risk of fraud, waste, or abuse. Generally to bill Medicare, providers and suppliers not only must submit an enrollment application to CMS for initial enrollment, but also must recertify enrollment, reactivate enrollment, change ownership, and to change certain information.[3] In the rule’s current form, providers or suppliers submitting an enrollment application or recertification to CMS (“applicants”) will be required to submit affiliation disclosures upon CMS’s request if the agency determines the entity likely has an affiliation with a problematic entity as described below.[4] CMS will base its request on a review of various data, including Medicare Provider Enrollment, Chain, and Ownership System data and other CMS and external databases that might indicate problematic behavior, such as patterns of improper billing.[5] Upon CMS’s request, applicants identified as having at least one affiliation with a problematic entity would be required to report any current or previous direct or indirect “affiliations” to CMS.[6]…

Continue Reading New Program Integrity Rule Expanding Medicare Revocation and Denial Authorities Takes Effect Today

The Medicare Payment Advisory Commission (“MedPAC”) held its monthly public meetings in Washington, D.C., on November 1-2, 2018. The purpose of this and other MedPAC public meetings is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two…