Health Care

Yesterday morning, the U.S. Supreme Court announced its decision in the much anticipated Burwell v. Hobby Lobby case, holding that closely-held corporations are protected by the Religious Freedom Restoration Act of 1993 (“RFRA”), and therefore cannot be required to pay for employee health plans that cover contraceptives if the corporation’s owners have religious objections.

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 

The most recent Office for Civil Rights (OCR) HIPAA enforcement action serves as an important reminder to health care providers of the security risks associated with a mishandled medical records custody transfer and the risks of leaving paper records in the driveway.

Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a decision in Walsh et al. v. Amerisource Bergen Corp. et al denying the Relator’s motion to dismiss a counterclaim that alleged the Relator breached a confidentiality agreement by filing the underlying qui tam case.

Last week the HHS Office of Civil Rights (OCR) released two reports required by the Health Information Technology for Economic and Clinical Health (HITECH) Act: (i) the Annual Report to Congress on Breaches of Unsecured Protected Information (Breach Report); and (ii) the Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance (Compliance Report).

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Last week, the American Medical Association (AMA) released new guiding principles on the provision of telemedicine services. The AMA’s guiding principles come on the heels of the Federation of State Medical Board’s (FSMB) adoption of its new model telemedicine guidelines and largely echoes the state boards’ views with a few notable exceptions.

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations. 

The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help refocus stakeholders on HHS's goals for the use of health IT in the U.S. health care system.

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for Medicare and Medicaid Services (“CMS”) has issued additional guidance on Phase 2 reports.

Health care companies and their counsel handling health care fraud investigations or False Claims Act (“FCA”) cases should consider the potential strategic implications of a decision compelling an FCA defendant to produce attorney work product to a relator.  United States ex rel. Garbe v. Kmart Corp., No. 3:12-cv-00881-MJR-PMF, 2014 U.S. Dist. LEXIS 73261 (S.D. Ill. May 29, 2014). 

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Because health care companies operate in such a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with applicable laws and regulations.

Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 58 recently unsealed health care–related qui tam cases, with an in-depth look at four cases, including an off-label marketing settlement and a notable decision applying the Rule 9(b) requirements for pleading fraud to a claim for violation of the False Claims Act.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for so-called orphan drugs.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 

In the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date, two New York hospitals have agreed to pay $4.8 million to settle allegations that they failed to secure thousands of patients' electronic protected health information (ePHI) held on their shared network.

The FDA will hold a public workshop on May 13-15, 2014, to discuss the Proposed Strategy and Recommendations for a Risk-Based Framework issued by the Food and Drug Administration, National Coordinator for Health Information Technology, and Federal Communications Commission on April 3, 2014.