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Keeping you afloat amidst the rising sea of regulations

OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer on Direct-to-Patient Discount Sales Program

On July 28, 2014, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable opinion concerning a drug manufacturer’s program to offer a certain branded drug via an online, mail order pharmacy directly to cash-paying customers at a discounted price.

Amendments to Reform ‘Burdensome’ Medicare Regulations Now Effective

On July 11, 2014, amendments designed to reform Medicare regulations that the Centers for Medicare and Medicaid Services (CMS) has identified as “unnecessary, obsolete, or excessively burdensome on health care providers and suppliers” became effective.

DC Circuit Provides Guidance on Preserving Attorney-Client Privilege in an Internal Investigation

The DC Circuit recently held that the attorney-client privilege applies to internal investigations, even when the investigations are mandated by law and are not conducted with the sole purpose of obtaining or providing legal advice.

The DOJ Intervenes in ‘Reverse False Claims Act’ Case

Government Steps in After Hospital System’s Alleged Failure to Promptly Return Medicaid OverpaymentsOn June 27, 2014, the US Department of Justice (DOJ) intervened in a False Claims Act suit against Continuum Health Partners and the Mount Sinai Health System, alleging that the health system failed to return hundreds of thousands of dollars of overpayments to the government in a timely manner. This is one of the first “reverse False Claims Act” cases where the DOJ has filed a complaint-in-intervention claiming a health care provider violated 31 U.S.C.

US Supreme Court Grants Cert in Closely Watched False Claims Act Case

The US Supreme Court this morning granted cert in a closely watched False Claims Act (FCA) case, Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter — a case that raises important questions about wartime suspension of the FCA’s statute of limitations, and about how the FCA’s “first-to-file bar” operates.

Is Anyone Listening? CMS Appoints Provider Relations Coordinator to Field Gripes about RACs

The CMS announced this week the appointment of a Provider Relations Coordinator “to help increase program transparency and offer more efficient resolutions to providers affected by the medical review process.” The “medical review process” garnering the most attention these days is the Recovery Audit Contractor (RAC) program.

OIG Releases Supplemental Guidance for Bona Fide, Charitable Patient Assistance Programs

On May 21, 2014, the Department of Health and Human Services Office of Inspector General (OIG) released a Supplement Specialty Advisory Bulletin entitled “Independent Charity Patient Assistance Programs” (the Supplemental SAB, available here), to supplement its Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees (2005 SAB) (70 Fed. Reg. 70623) (Nov. 22, 2005, available here).

Initiative to Amend California’s Medical Injury Compensation Reform Act Qualifies for the November Ballot

On May 15, 2014, an initiative to amend California’s Medical Injury Compensation Reform Act (MICRA) and other statutes qualified for the November ballot. If passed, the initiative titled “The Troy and Alana Pack Patient Safety Act of 2014,” would make several amendments to California law, including:

New York-Presbyterian and Columbia Hospitals to Pay Record HIPAA Settlement

On May 7, 2014, the US Department of Health and Human Services Office of Civil Rights (OCR) announced settlements with two New York-based hospitals totaling $4.8 million for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. The settlements related to the hospitals’ failure to secure the electronic protected health information (ePHI) of thousands of patients held on their networks and are the latest example of OCR’s increased enforcement action.

The Federation of State Medical Boards Adopts Guidelines to Govern the Safety of Telemedicine

On April 26, 2014, the Federation of State Medical Boards approved updated model guidelines addressing the use of telemedicine technology.