The US Supreme Court’s January ruling allowing the Centers for Medicare & Medicaid Services to enforce its COVID-19 mandate is likely to continue to face challenges. Nevertheless, in this article published by the Health Care Compliance Association, McDermott Partner Sandra DiVarco said that the Supreme Court’s decision wasn’t a surprise.
“Many of [the CMS] providers may have slow-walked their compliance and now in theory need to be fully compliant,” DiVarco noted.
Doctors and lawmakers say reliable broadband internet is lagging for populations that could benefit the most from telehealth services. In this MetroWest Daily News article, McDermott Partner Stephen Bernstein and McDermott+Consulting Vice President Mara McDermott offer insight into the challenges—and opportunities—for virtual care as it gains popularity.
In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.
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.
For more information, please contact Meg Gilley, Mara McDermott, Kristen O’Brien, Katie Waldo, Rodney Whitlock or Eric Zimmerman.
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.
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