Health Care Counsel Blog

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

VA recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract.

Covered entities and business associates subject to HIPAA Security Rule are closer to getting a benchmark for encryption standards with the release of the Standards and Guidelines Development Process in late March by the National Institute of Standards and Technology (NIST).

The Program Notice provides some guidance on how generic drug manufacturers are to calculate the new Additional Discount on generic drugs that will become part of the rebate due state Medicaid programs under the Medicaid Drug Rebate Program.

On April 14, 2016, the European Union formally adopted a new scheme – known as the EU General Data Protection Regulation (GDPR) – to protect the personal data of European residents.

On April 5, 2016, Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of a new web-based tool to assist developers of mobile health apps in understanding what federal laws they must comply with.

Today, the Department of Health and Human Services announced that it is re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule).

On April 11, 2016, the Centers for Medicare and Medicaid Services (CMS) announced its Comprehensive Primary Care Plus (CPC+) initiative.

The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

On March 21, 2016, the US Department of Health and Human Services Office for Civil Rights (OCR) announced it was beginning its next round of audits of covered entities and business associates for compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.

Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

If finalized, the Proposed Rule would represent the most dramatic change in Part B Drug reimbursement since the enactment of the Medicare Modernization Act.

These proposed changes to the rules governing the confidentiality of substance abuse treatment records mark the first time the regulations have been subject to revision since 1987.

As pay-for-performance programs continue to expand in both scale and scope across the US health care system, the amount of administrative and clinical resources necessary to participate in these programs has correspondingly grown.

The Centers for Medicare and Medicaid Services (CMS) intend to strengthen provider and supplier enrollment screening – meaning, scrutinizing providers and suppliers more closely during enrollment – according to a February 22, 2016 post on its blog. 

In a recent decision, a US Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) agreed with the HHS Office of Civil Rights (OCR) that Lincare, Inc. d/b/a United Medical had violated HIPAA.

Cybersecurity may have rocketed to the top of management’s priority list in the wake of the recent cyberattack on Hollywood Presbyterian Medical Center (HPMC) that left the hospital unable to access some of its computer systems for ten days.

On Friday, February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule and regulations, providing much needed guidance to providers and suppliers on how to meet the Affordable Care Act’s (ACA’s) 60-day overpayment mandate.

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).

The federal government has focused on compounding pharmacies and pharmacists for fraud and abuse investigations in recent years, and now the great state of Texas has joined in.

CMS has finalized surveyor worksheets for assessing a hospital’s compliance Quality Assessment and Performance Improvement (QAPI).

The court’s description of the facts of this case are of interest, as they reveal some of the complexity in the delivery of, and payment for, health care services. In this situation, testing by a commercial laboratory of specimens drawn at a physician’s office.

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Final Rule implementing changes to the Medicaid Drug Rebate Program (MDRP) under the Affordable Care Act (ACA).

Potentially missed among end-of-year and holiday activities, the Office for Civil Rights (OCR) has announced three resolution agreements for violations of the HIPAA Privacy and Security Rules within the past month.