Health Care Counsel Blog

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.

In an important development, the Centers for Medicare and Medicaid Services (CMS) has issued additional final regulations implementing the Stark Law as part of the Physician Fee Schedule for calendar year 2016 (see 80 Fed. Reg. 70,886 (Nov. 16, 2015)).

Federal regulations require institutions and institutional review boards (IRB) that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings.

The Center for Medicaid and CHIP Services, a division of the Centers for Medicare & Medicaid Services, issued a Medicaid Drug Rebate Program notice to state Medicaid contacts emphasizing appropriate access to, and coverage of, direct-acting antiviral drugs used to treat hepatitis C virus.

On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 into law. The two year budget deal increases overall spending limits and prevents the United States from defaulting on its debts by suspending the debt limit through March 2017.

The Department of Justice recently announced that Tuomey Healthcare System has agreed to pay $72.4 million and enter into a five-year Corporate Integrity Agreement to finally resolve the long-running U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc. False Claims Act/Stark Law litigation.

US Department of Health and Human Services Office of Inspector General released an OIG Alert reminding the public that electronic health records furnished to referral sources may not meet the federal anti-kickback statute’s EHR safe harbor if EHR system has limited or restricted interoperability.

Health care providers and their contractors have been put on notice by the Office for Civil Rights (OCR) that the next round of HIPAA compliance audits will begin in early 2016.  The previous round of HIPAA audits was completed in 2014.

The United States District Court for the District of Columbia issued a ruling which could have significant positive implications for those drug manufacturers unhappy with a particular Department of Health and Human Services Health Resources and Services Administration’s interpretive rule.

The 7th Circuit just denied ERISA rights to medical providers, but this doesn’t have to be the result.

AB 465, the California bill that sought to eliminate arbitration agreements as a condition of employment and in other settings, was vetoed by Governor Jerry Brown. AB 465 will go back to the House for further consideration and will require a two-thirds vote by both houses to overturn the veto.

Preventing falls is a perpetual task for health care facilities and those who regulate or accredit them. The Joint Commission issued a Sentinel Event Alert addressing fall-prevention and fall-related injuries, providing recommendations to supplement its existing fall-prevention standards.

On September 21, 2015, the US DOJ and whistleblowers’ counsel announced that Florida-headquartered Adventist Health System (Adventist) had agreed to pay $118.7 million to resolve allegations that it violated the FCA by submitting claims in violation of the Stark law and by miscoding claims.

Joyce Branda, the Deputy Assistant Attorney General for the Commercial Litigation Branch of the DOJ, gave the keynote address on September 28, 2015, at the American Health Lawyers Association Fraud and Compliance Forum in Baltimore, providing conference attendees with an update from DOJ.

The US Department of Justice (DOJ) recently announced that Columbus Regional Healthcare System (Columbus Regional) has agreed to pay up to $35 million and enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General.

New York insurer Excellus BlueCross BlueShield became the most recent health care company to announce it was the victim of a sophisticated cyberattack after hackers gained access to the Social Security numbers, mailing addresses, and financial information of as many as 10 million customers.

The US Department of Health and Human Services, Office for Civil Rights announced a new settlement for $750,000 with Cancer Care Group, P.C. to resolve potential violations of the HIPAA Privacy and Security Rules identified as the result of the theft of a laptop and backup media.

On September 2-3, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) hosted the 8th Annual Safeguarding Health Information: Building Assurance through HIPAA Security conference.

After surviving two challenges that resulted in U.S. Supreme Court decisions that essentially preserved the law, the Affordable Care Act will face additional judicial scrutiny as a federal district court has denied the administration’s motion to dismiss the case brought by the House last year.