Health Care

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. 

To incentivize whistleblowers to bring false claims promptly to the government’s attention, the False Claims Act (FCA) includes a so-called “first-to-file rule" (31 U.S.C § 3730(b)(5)), which bars a person other than the government from “bring[ing] a related action based on the facts underlying” a pending action alleging violation of the FCA.

As health information technology (HIT) advancements proliferate, so too must governing regulations. 

Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in the Federal Register on May 17. This final rule reverses previous regulations that prohibited MFCUs from using federal matching funds for data mining.

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required.

Earlier this week we attended the National Institute of Standards and Technology (NIST) and HHS Office for Civil Rights (OCR) 6th Annual Safeguarding Health Information Conference in Washington, D.C. (the NIST-OCR Conference).

Last week, CMS published a final rule implementing the ACA's medical loss ratio (“MLR”) requirements that will apply to the Medicare Advantage (Part C) and prescription drug (Part D) programs beginning in contract year 2014.

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.

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. 

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). 

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”).