On November 16, 2021, 12 states—Montana, Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Oklahoma, South Carolina, Utah and West Virginia—filed a complaint in the US District Court for the Western District of Louisiana requesting that the Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered healthcare facilities and staff be declared arbitrary and capricious, contrary to law and in excess of the Centers for Medicare and Medicaid Services’ (CMS) statutory authority. CMS published an IFR on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for healthcare facilities. The expansive IFR applies to more than a dozen types of healthcare providers and suppliers (facilities), affects more than 10 million healthcare staff and carries an anticipated potential price tag in excess of $1.3 billion dollars for the first year of implementation.
The US Supreme Court announced in July that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely watched, given its potentially far-reaching impacts on reimbursements to most hospitals that participate in the Medicare program, not just those that participate in the 340B Program.
Clinical laboratories continue to face challenges to obtain positive coverage decisions by government and private payers for new tests. According to McDermott+Consulting Senior Director Deborah Godes, payers require reasons to establish new coverage assays.
“[The] key to getting a positive coverage decision from payers is making a solid case through good quality evidence,” Godes notes in a recent Dark Report article. “Clinical laboratories need to demonstrate that a particular assay actually works as it is intended and also that it is used by clinicians to make decisions regarding patient care. ”
Not all payers will be persuaded by the same arguments. Each payer has its own coverage determination process, and clinical laboratories should be prepared to deal with each one individually.
“You need to determine what drives that payer’s denials and then present evidence to address those concerns,” Godes says.
President Biden’s July 9, 2021, Executive Order—which seeks to increase competition throughout the American economy—takes aim at prescription drug prices. In this article, published in Law360, McDermott partner Emily Jane Cook says Biden’s focus on drug prices is unsurprising given the “significant public interest and frustration” with drug costs.
Political divisiveness on Capitol Hill, a focus on impeachment activity and financial relief for the COVID-19 pandemic—as well as delays in confirming President Joe Biden’s nominees for cabinet and subcabinet positions—so far have caused a slowdown in the new administration’s ability to make sweeping changes affecting healthcare.
In an article for Pharmacy Practice News, McDermott partner James Kim discusses key issues to watch from Congress and the White House in 2021.
On March 10, 2021, US Congress finalized and passed the American Rescue Plan of 2021 (ARPA), the latest COVID-19 relief package that largely tracks President Joe Biden’s initial $1.9 trillion proposal. The ARPA extends unemployment insurance benefits and provides direct $1,400 stimulus payments to qualifying Americans, but it also makes several important health policy-related changes. These include providing funding for vaccine distribution and testing to combat the COVID-19 pandemic, making policy adjustments to the Medicaid program, facilitating health insurance coverage and providing more money for healthcare providers. The final bill also makes two narrowly focused technical Medicare payment changes.
This summary highlights notable health policy provisions of the final bill.
On March 11, 2021, President Joe Biden signed the American Rescue Plan Act of 2021 (ARPA) providing Consolidated Omnibus Budget Reconciliation Act (COBRA) reform provisions and an increase in Dependent Care Assistance Program (DCAP) maximum deferrals. While details from the agencies are forthcoming, here is an overview of these provisions of the ARPA.
A new president always brings new policy priorities and objectives, particularly when that president is from a different political party than their predecessor. As we begin 2021, and usher in the Biden era, we should likewise expect a significant shift in the health policy agenda.
Writing for the American Health Law Association’s Top 10 Issues in Health Law 2021, McDermott partner Eric Zimmerman discusses the top health policy priorities to watch for from the new administration.
The Democrats have control of all three levers of power—the Senate, the House and the presidency—for the first time since the early years of the Obama administration.
How will President Biden use this new concentration of power to shape healthcare policy?
A recent article in Medscape outlined seven key healthcare actions that Biden could pursue, with McDermottPlus consultant Rodney Whitlock weighing in.
On May 1, 2020, the Department of Labor (DOL) issued updated Frequently Asked Questions and revised model notices under the Consolidated Omnibus Budget Reconciliation Act (COBRA). COBRA is a federal law that permits individuals to continue group health plan coverage for a limited period of time following certain events, such as a termination of employment, that are coupled with a loss of coverage. Employers are required to notify individuals of their rights under COBRA.
The changes in the model notices are primarily designed to help Medicare-eligible individuals understand their options for healthcare coverage. The model notices, however, do not include language that addresses DOL relief issued earlier in the week that provides additional time for individuals to elect COBRA coverage through the end of the coronavirus pandemic. Plan sponsors should work with their COBRA vendors and legal counsel to determine whether the model notice updates or coronavirus relief would necessitate any updates to the notices currently used by their group health plan to notify plan participants and beneficiaries of their rights under COBRA.
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