On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to documents requested in discovery as part of a qui tam False Claims Act (FCA) case. In United States ex rel. Wollman v. Massachusetts General Hospital, Inc. et al., Case Number 1:15-cv-11890-ADB, the court reviewed the purpose of the peer review privilege and precedent addressing the applicability of state privileges under the Federal Rules of Evidence, and concluded that the privilege should not apply because the “goal of the peer review privilege would not be thwarted if it was not applied” in a case predicated on alleged billing fraud. The court’s decision is instructive for health care providers and whistleblowers in connection with discovery and the applicability of medical peer review privileges to FCA cases. Continue Reading Massachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.

Continue Reading Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

The Office for Civil Rights (OCR) recently settled a tenth case under its right-to-access initiative with California-based Riverside Psychiatric Medical Group (RPMG), for $25,000.

Although a relatively small settlement in the amount paid, it shows that the OCR is taking patients’ requests for access to their medical records seriously, and that no complaint is too small to investigate and enforce. Continue Reading OCR’s Tenth Right to Access Settlement Is Small but Meaningful

The Office for Civil Rights (OCR) issued a press release on November 12, 2020, announcing that it had settled its eleventh enforcement action in its HIPAA Right-of-Access Initiative. The settlement with Dr. Rajendra Bhayani, an otolaryngologist (ENT) practicing in Regal Park, New York, included a payment of $15,000, a corrective action plan and two years of monitoring by the OCR. Continue Reading OCR Settles Another Right-of-Access Initiative Case

Excerpt of a contributed article published in Medical Economics on November 18, 2020.

Past Special Fraud Alerts have portended heightened enforcement activity.

On November 16, 2020, the Office of Inspector General of the Department of Health & Human Services (OIG) issued a Special Fraud Alert (Alert) highlighting the fraud and abuse risks posed by speaker programs sponsored by pharmaceutical and medical device companies. The Alert appears to be a clear signal to health care professionals, as well as pharmaceutical and medical device companies, that the OIG will closely scrutinize remuneration exchanged or offered as part of a speaker program under the Anti-Kickback Statute (AKS) and pursue sanctions against all parties to impermissible arrangements thereunder. Read the full article.

New Jersey Attorney General (AG) Gurbir S. Grewal announced on November 2, 2020, that his office has settled with ShopRite’s parent company, Wakefern Food Corp. (Wakefern) and two of its supermarket entities for $235,000 for a data breach that occurred in 2016.

According to the press release, the AG alleged that Wakefern violated HIPAA and the New Jersey Consumer Fraud Act (CFA) by “failing to properly dispose of electronic devices used to collect the signatures and purchase information of pharmacy customers” in its Kingston and Millville ShopRite stores. Continue Reading ShopRite Settles with New Jersey AG for Data Breach

Health care providers interested in applying for additional CARES Act Provider Relief funding from the Phase 3 General Distribution have until November 6, 2020 to submit an application to the Department of Health & Human Services (HHS). Continue Reading REMINDER: November 6 Deadline for New CARES Act Funding Approaches

On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here. Continue Reading CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

Excerpt of a contributed article published in Medical Economics on November 3, 2020.

These waivers could lead to lasting flexibilities for physicians — if a few bad apples don’t spoil the bunch

On October 19, 2020, the Administrator of the Centers for Medicare & Medicaid Services (CMS) highlighted recent actions taken by the federal government to criminally charge, and revoke billing privileges of, health care providers nationwide for alleged involvement in fraudulent schemes. The recent crackdown resulted from coordination between the Department of Justice (DOJ), the Office of Inspector General (OIG) and CMS, and demonstrates the government’s continued focus on enforcing federal fraud and abuse laws and targeting abusive arrangements despite relaxations of such laws in response to the COVID-19 pandemic. To the extent the fraud and abuse waivers have the potential to lead to lasting flexibilities under current fraud and abuse regulations, the proliferation of abusive arrangements could threaten the prospect of long-term change. Read the full article.

On October 27, 2020, the FBI and the Department of Homeland Security (DHS) warned the health care industry about “an imminent cybercrime threat to U.S. hospitals and healthcare providers.”

According to the warning, which was shared during a conference call, the government has received “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” The information was being shared with participants so that they can take timely precautions to protect their networks from the threat. Continue Reading Warning to Hospitals of Imminent Threat Released by U.S. Government