Health Care

When acquiring a health care company doing business abroad, there is no such thing as being too thorough with anti-corruption due diligence. The Department of Justice and the Securities and Exchange Commission have the health care industry on their radar screens for FCPA enforcement. 

This week the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an update that was more than thirteen years in the making.

The Massachusetts Department of Public Health Public Health Council approved, by unanimous vote, final regulations for the implementation of the medical marijuana ballot initiative law that will allow qualifying patients with certain medical conditions to obtain and use marijuana for medicinal purposes.

CMS wants to change the way that it rewards non-qui tam whistleblowers who report alleged fraudulent or unlawful conduct related to Medicare or Medicaid. 

Gun violence is a hot topic in the wake of the Newtown shootings and the aftermath of last week’s Boston Marathon bombings, and now health privacy has joined the debate.

Individuals and entities subject to the Civil Monetary Penalty Law (CMP) have received clarification regarding the process for disclosing and resolving potentially unlawful conduct involving the federal health care programs (FHCP).

The Department of Health and Human Services Office of Inspector General (“OIG”) has published an updated Provider Self-Disclosure Protocol (the “Updated SDP”) that offers health care providers guidance on how to disclose potential fraud, avoid prosecution, and mitigate potential penalties under the OIG’s civil money penalty (CMP) authority. 

After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013.

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources.

The Health Resources and Services Administration ("HRSA") has issued a final rule ("HRSA Rule") that will eliminate duplicative federal reporting requirements of provider sanctions and other adverse actions taken against health care practitioners, providers, and suppliers. 

Last week, the IRS issued a Notice of Proposed Rulemaking (“2013 Proposed Rule”) regarding the community health needs assessment (“CHNA”) requirement of 26 U.S.C. § 501(r)(3) (added to the Internal Revenue Code by the Affordable Care Act). 

The Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have proposed to extend the sunset date on the safe harbor and exception for donation of electronic health records (EHR) items and services to December 31, 2016.

On March 30, the US District Court for the District of Columbia held that three University of Pittsburgh Medical Center-affiliated hospitals were federal subcontractors to an HMO that provided a managed care health plan to federal employees under a contract with the Office of Personnel Management (“OPM”).

A recent Massachusetts Superior Court decision recognizes a claim against a hospital for “negligent credentialing.”  The court in Rabelo v. Nasif, et al found that, through the credentialing process, a hospital must "exercise reasonable care to protect its patients from incompetent or careless surgeons, ...” 

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa disclosed the results of his inquiry into the profits that three North Carolina hospitals have realized from the 340B drug discount program.

On April 1st, the Sixth Circuit reversed an $11.1 million dollar summary judgment finding entered against MedQuest Associates, a diagnostic testing company. In its opinion, the Sixth Circuit found that violation of two Medicare enrollment requirements did not warrant liability under the federal False Claims Act (the “FCA”).

The Centers for Medicare & Medicaid Services (CMS) is preparing to open its doors for another round of Accountable Care Organizations (ACOs) to participate in the Medicare Shared Savings Program (MSSP). 

Yesterday, CMS released its 2014 Final Call Letter for the Medicare Advantage and Medicare Part D programs.

Rumors are circulating that the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General for the Department of Health and Human Services (OIG) will continue to allow the donation of electronic health records (EHR) items and services to physicians past the current deadline of December 31, 2013.

The HIPAA Omnibus Rule goes into effect today, which officially starts the clock for covered entities, business associates, and their subcontractors to begin updating their agreements, forms, policies, procedures, and practices to meet approaching compliance deadlines.