[08/07/20]
Posted on August 7, 2020 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: 340B, Drug Reimbursement, Outpatient Prospective Payment System, specified covered outpatient drugs
[08/07/20]
Posted on August 7, 2020 in Health Law News, Health Provider News
Published by: Hall Render
NATIONAL 6 hospitals laying off furloughed workers permanently 11 hospitals return $192M in CARES Act payments 1.1M+ health records breached in July 25 top safety-net hospitals in the US, ranked by Washington Monthly Magazine Appeals court sides with HHS in drug payment cuts to 340B hospitals CDC director: We weren’t involved in HHS’ decision... READ MORE
[08/06/20]
Posted on August 6, 2020 in Health Law News
Published by: Hall Render
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.... READ MORE
Tags: Ambulatory Surgical Center, ASC, Hospital Outpatient Prospective System, OPPS
[08/06/20]
Posted on August 6, 2020 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: Clinical Privileging, Telehealth
[08/06/20]
Posted on August 6, 2020 in Firm News
Published by: Hall Render
Hall Render is proud to be recognized as a Legal Influencer for Q2 in the area of health care and life sciences by Lexology. The Lexology Content Marketing Awards recognize thought leaders in the legal industry who consistently provide useful, insightful legal analysis. Using a unique process that considers the number of reads and... READ MORE
[08/05/20]
Posted on August 5, 2020 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: compliance, controlled substances, DEA, Drug Enforcement Administration
[08/05/20]
Posted on August 5, 2020 in COVID-19 Daily Updates, HR Insights for Health Care
Published by: Hall Render
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... READ MORE
[08/04/20]
Posted on August 4, 2020 in COVID-19 Daily Updates, Health Law News
Published by: Hall Render
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... READ MORE
Tags: Physician Fee Schedule, Public Health Emergency, Telehealth, telemedicine
[07/31/20]
Posted on July 31, 2020 in Health Law News
Published by: Hall Render
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)... READ MORE
Tags: 340B, AKS, Anti-Kickback Statute, Drug Pricing, PBM, PDP, pharmaceutical industry, pharmacy benefit managers, Prescription Drug Plan
[07/29/20]
Posted on July 29, 2020 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: Anti-Kickback Statute, False Claims Act, FCA, Health Care Real Estate, qui tam, Stark law