Articles and Blogs

Last week, the D.C. Circuit Court of Appeals (the “Court”) reinstated a rule cutting reimbursement rates for drugs purchased at a substantial discount under Section 340B of the Public Health Service Act (the “340B Program”) that had previously been ruled unenforceable by the District Court. In American Hospital Association v. Azar,[1] the Court held that…Read More

On August 4, 2020, CMS posted the Hospital Outpatient Prospective System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Proposed Rule for CY 2021. The Proposed Rule will be published in the Federal Register on August 12 and comments are due by October 5, 2020. The Fact Sheet for the proposed rule can be found here. Major…Read More

As telehealth expands, so too does the need for hospitals and other health care facilities (collectively “hospitals”) to credential telehealth providers. Commonly asked telehealth credentialing questions include the following: (a) are there particular requirements for credentialing telehealth providers as part of disaster privileging; and (b) must clinical privileging forms be specific to telehealth? Earlier this…Read More

On Wednesday, July 29, 2020, the U.S. Department of Justice Drug Enforcement Administration (“DEA”) proposed a new rule that would require DEA registrants to electronically report “theft or significant loss” of controlled substances within 15 days of discovery of the circumstances requiring the report (“Proposed Rule”). This proposal is notable as currently there is no…Read More

Update as of 9/14/20: As we anticipated below, the US Department of Labor has issued revised regulations in response to the SDNY decision. Please see our post here for details. Update as of 9/10/20: As discussed below, previously, a federal judge in New York’s Southern District invalidated several aspects of the DOL’s guidance regarding the…Read More

The COVID-19 state of emergency has spurred unprecedented change in the realm of telehealth. This trend continues – but despite the headlines, there is more work to do. I. CMS Telehealth Proposals CY 2021 PFS On August 3, 2020, CMS posted the proposed Physician Fee Schedule rule (“Proposed Rule”) for CY 2021. The Proposed Rule…Read More

On July 24, 2020, President Trump announced four Executive Orders (“Executive Orders”) characterized as focusing on lowering drug prices via various mechanisms. These Executive Orders, described in more detail below, include: (1) Executive Order on Access to Affordable Life-saving Medications; (2) Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3) Executive…Read More

On July 8, 2020, the Department of Justice announced it settled a qui tam action[1] involving alleged violations of the federal and state False Claims Act (“FCA”) for $72.3 million against an Oklahoma surgical specialty hospital, its managers, a physician group and two individual physicians. Part of the factual allegations underpinning the FCA claims arose…Read More