Health Care

The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”).

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud the U.S. government by concealing their illegal activities.

Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14, 2014). 

The health care industry remains an enforcement priority for the Federal Trade Commission ("FTC"). In a recent interview, the Director of the FTC’s Bureau of Competition, Debbie Feinstein, stated that the Bureau’s top three priorities for health care antitrust enforcement.

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing violations.

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.”  And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.”

This week, the HHS Office of Civil Rights (OCR) issued a bulletin (Bulletin) to remind covered entities and business associates that "the protections of the Privacy Rule are not set aside during an emergency."

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals were operating under a joint operating agreement, constituted a single entity incapable of conspiring in violation of Section 1 of the Sherman Act. 

As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs with a “geographic mean cost” of $100 or less.  

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS programs and operations during the current fiscal year and beyond.

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). 

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e. no deductibles, coinsurance, or co-payments).

Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”). In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation. 

Last week, the Department Health and Human Services (HHS) announced that it will invest $840 million over the next four years to support 150,000 clinicians through a combination of incentives, tools, and information to encourage clinicians and other health care providers “to move from volume-driven systems to value-based, patient-centered, and coordinated health care services.”

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business insurers are beginning to specifically exclude ebola-related losses from their standard commercial insurance policies.

On October 15, 2014, the New York State Department of Health (DOH) released proposed changes that will simplify the certificate of need (CON) process.

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 recent years, co-payment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Co-payment coupons are typically offered to commercially insured patients in order to reduce or eliminate out-of-pocket costs for specific brand name drugs with higher co-pays.

Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases.