As the world emerges from the COVID-19 pandemic, healthcare fraud enforcement remains a top priority for the US Department of Justice (DOJ) and other government agencies with enforcement authority. In this Westlaw Today article, McDermott Partners Laura McLane, Tony Maida and Dana M. McSherry describe some of the areas that have assumed particularly high enforcement priority, including private equity, telehealth and pandemic relief funds.
The 340B program landscape is constantly shifting. Wednesday’s US Supreme Court American Hospital Association v. Becerra decision is of critical importance to hospitals that participate in the 340B program. The Court held that the US Department of Health and Human Services (HHS) improperly imposed a payment cut of almost 30% on 340B drugs paid by Medicare. Yet, while this decision is significant, it is not the end of the litigation surrounding the payment cut. The case has been remanded for further deliberation, which will include a determination of the remedies.
McDermott+Consulting has launched the 340B Litigation Tracking Tool, an up-to-date resource following the 30+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for updates on important case developments. This tracker, available 24/7 and routinely monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape.
On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s initiatives have not yet been implemented, President Biden reiterated his administration’s focus on nursing home reform during his March 1, 2022, State of the Union address. Accordingly, the efforts described in the Fact Sheet provide stakeholders with a peek into the regulatory crystal ball of the governmental efforts that may be forthcoming, either through new laws, regulatory action, policy changes, enforcement activities or subregulatory guidance.
A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.
“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.
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.