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|Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide Contraceptive Coverage|
Bridgette A. Wiley; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
September 4, 2014, previously published on September 3, 2014The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of Health and Human Services (“HHS”) determined that...
|340B Drug Pricing Program Interpretative Rule Survives (for Now)|
Elizabeth S. Elson, Anil Shankar; Foley & Lardner LLP;
September 4, 2014, previously published on September 2, 2014A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance of regulations for the 340B Drug Pricing Program (the 340B Program)....
|The Increasingly Murky World of 340B: What’s Next?|
Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
September 4, 2014, previously published on September 2, 2014For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier.
|Considering Sex-Specific Variation for Personalized Medicine|
Antoinette F. Konski; Foley & Lardner LLP;
September 4, 2014, previously published on September 2, 2014Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical...
|Aspiring Medicinal Marijuana Business Owners in Illinois Should Understand and Plan for the Potential Tax Pitfalls|
Mark Milton; Husch Blackwell LLP;
September 3, 2014, previously published on August 27, 2014On September 8, 2014, the state of Illinois begins accepting applications for medicinal marijuana dispensary and cultivation center permits. Under the state’s Compassionate Use of Medical Cannabis Pilot Program Act, passed last year, Illinois will grant one cannabis cultivation permit for...
|September 22, 2014 Deadline for Business Associate Agreements|
Margaret Young Levi; Wyatt, Tarrant & Combs, LLP;
September 2, 2014, previously published on August 22, 2014The final HIPAA Omnibus Rule (Omnibus Rule), published in the Federal Register on January 25, 2013, substantially increased the privacy and security responsibilities of a “business associate” of a “covered entity”, as those terms are defined by the Health Insurance...
|End of Year Planning and Compliance Deadlines for Health Plans|
Bret Busacker, John Franklin Clark; Holland & Hart LLP;
September 2, 2014, previously published on August 29, 2014Now that fall is in the air and school has started, we thought this would be a good time to summarize some of the key health and welfare benefit deadlines that are approaching this fall:
|Settlement a Harbinger of Escalating Stark Law Exposure for Physician Compensation?|
Rick L. Hindmand, Jane Pine Wood; McDonald Hopkins LLC;
September 2, 2014, previously published on August 29, 2014A cardiology group practice recently agreed to pay $1.3 million to resolve allegations that it violated the Stark federal physician self-referral law and the False Claims Act by paying its physicians under a compensation formula that considered their referrals for nuclear and CT scans. On Aug. 4,...
|The Affordable Care Act—Countdown to Compliance for Employers, Week 18: Emerging Strategies to Reduce or Eliminate Exposure for Assessable Payments under the Affordable Care Act’s Pay-or-Play Rules|
Alden J. Bianchi; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
September 2, 2014, previously published on August 25, 2014The Affordable Care Act’s employer shared responsibility, or “pay-or-play,” rules require “applicable large employers” (generally employers with 50 or more full-time and full-time equivalent employees) to offer group health plan coverage (i.e., “play”) or...
|Healthcare Reform in the U.S. Territories; Prepayment of Taxes for Puerto Rico Retirement Plans|
Karen N. Brandon, Grace Huang Ristuccia; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
September 1, 2014, previously published on August 28, 2014The summer of 2014 has brought further guidance for health plan coverage in the U.S. territories and for retirement plan coverage in Puerto Rico. Issuers and employer sponsors of Puerto Rico group health plans and employer sponsors of Puerto Rico retirement plans should review their plans to ensure...