Last week CMS issued its final rule “CMS Interoperability and Prior Authorization” (CMS-0057-F), unchanged from its proposed rule in 2022, which addresses prior authorizations. Prior authorization, a “utilization management” technique, requires a health insurer to consent to a doctor’s proposed course of treatment for a patient before the insurer agrees to
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New York May Be Paving the Way for State-level Cybersecurity Regulations on Health Care Facilities
Last month, a cyberattack forced two New York hospitals to divert and even discharge some patients to other facilities, while the affected hospitals shut down their IT systems to address the issue and restore their secure network. [cite] In the wake of this event, New York Governor Kathy Hochul has proposed a cybersecurity…
Provider Charged with Receiving and Paying Millions in Kickbacks in Connection with Sober Homes
On Friday, September 15th, the United States Attorney’s Office for the District of Massachusetts (United States) and the Massachusetts Attorney General’s Office (Massachusetts) filed a joint complaint in the United States District Court for the District of Massachusetts against a Massachusetts-based substance abuse treatment provider. According to the complaint, the United States seeks to recover…
UnitedHealthcare’s Changing Approach to Prior Authorizations
Prior authorizations, one of health insurers’ many “utilization management” techniques, is a hot topic amongst practicing physicians, patients, and regulators, to name a few. The prior-authorization process requires a health insurer to consent to a doctor’s proposed course of treatment for a patient before the insurer agrees to pay for any medical services the physician…
HHS Proposes $9 Billion Lump Sum Payment for Hospitals to Remedy Unlawful 340B Payment Reductions
On Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions.
Background: In 2018, CMS significantly reduced the Average Sales Price (ASP) plus six-percent (6%) formula for calculating 340B drug payments to ASP minus 22.5%. After conflicting decisions from the District of Columbia’s federal District and…
Will The Standard of Liability Under The 60-Day Repayment Rule Change?
At the end of last year, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the so-called 60-day repayment rule. The proposed changes include eliminating the current “reasonable diligence” standard that applies to providers in connection with potential liability for overpayments and replacing it with “actual knowledge” or “acting with reckless disregard.” The…
New Protections for Employees of Certain New Jersey Health Care Entities
Health care entities, home health care agencies, and staffing registries considering a transaction in New Jersey will need to keep in mind new obligations to certain employees. On August 18, 2022, Governor Murphy signed into law New Jersey Senate Bill No. 315 (the “Act”), which created broad protections for many employees in the health care…
En Banc Fourth Circuit Affirms Dismissal of False Claims Act Lawsuit and Vacates Panel Opinion
We previously reported that the Fourth Circuit, via a 2-1 decision in United States ex rel. Sheldon v. Allergan Sales, LLC, 24 F.4th 340 (4th Cir. 2022), affirmed the dismissal of a False Claims Act (“FCA”) qui tam lawsuit against Forest Laboratories, LLC (“Forest”). The plaintiff alleged that Forest had underpaid states by over $680…
Industry Interactions with Physicians Continue to be a Hot Topic for Civil False Claims Act Enforcement Actions under Private Qui Tam Litigation
In a continuing wave of fraud and abuse civil enforcement actions brought by qui tam relators, big pharma giant, Biogen, is the latest corporate actor to reach a mega settlement with the U.S. Department of Justice (DOJ) for allegations of False Claims Act liability for paying bribes to physicians who participated in Biogen’s sales and…
HIPAA “Right of Access” Enforcement Trend Continues
The Office of Civil Rights of the Department of Health and Human Services (“OCR”) announced the resolution of three more right of access cases, bringing the total to a whopping 41 since the start of its drive to increase compliance with this Health Insurance Portability and Accountability Act (“HIPAA”) requirement over two years ago. From…