Health Care

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Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).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

On October 14, 2014, the US Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services.

William Gallagher Associates, a Boston-based insurance broker, has announced the rollout of a new policy to cover Ebola-related losses at hospitals and other healthcare providers involved in primary care emergency treatment.

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members.

Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over 150,000 claims) by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).

Last Friday, the HHS Office of the Inspector General issued a highly anticipated proposed rule that provides new and modified regulatory safe harbors to the Anti-Kickback Statute, amends regulatory provisions related to enforcement of the Beneficiary Inducement Civil Monetary Penalty Law (CMP) provisions, and attempts to narrow the prohibitions covered by the Gainsharing CMP.

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 first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). 

Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).

Dionne Lomax and Helen Kim, our colleagues in the Antitrust Practice, have authored an article in Competition Policy International's September 2014 edition of the Antitrust Chronicle observing that, even in the wake of the Affordable Care Act, which is intended to encourage efficiencies in health care delivery to improve health care quality overall.

As a service to our readers we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance through HIPAA Security” into three phrases: (i) risk assessment, (ii) workforce training, and (iii) adequate encryption.

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).

A False Claims Act suit can be a company’s worst nightmare, as it may potentially result in large settlements and awards on account of the statute’s trebled damages provision.