Health Care

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.

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.

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. 

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.

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. 

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.

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.