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Agencies Seek Comments to Inform Future Health IT Regulation

June 4, 2013 | Blog | By Kimberly Gold

As health information technology (HIT) advancements proliferate, so too must governing regulations. 
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Is Data Mining Coming to a State Medicaid Fraud Control Unit Near You?

June 4, 2013 | Blog | By Theresa Carnegie

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.
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FDA Delivers Its First Mobile Medical App Inquiry

May 28, 2013 | Blog | By Karen Lovitch

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.
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Highlights of the Joint NIST and OCR Safeguarding Health Information Conference

May 24, 2013 | Blog | By Dianne Bourque

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).
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CMS Issues Final MLR Rule for Medicare Advantage and Part D Programs

May 21, 2013 | Blog | By Roy Albert

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.
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Final Medical Marijuana Regulations Approved in Massachusetts

May 10, 2013 | Blog | By Kimberly Gold, Dianne Bourque, Daria Niewenhous

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.
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How to Minimize FCPA Risk in Health Care Acquisitions

May 10, 2013 | Blog | By Karen Lovitch

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. 
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CMS Proposes to Increase Awards for Non-Qui Tam Whistleblowers

April 30, 2013 | Blog | By Karen Lovitch

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. 
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Firearms Debate Triggers OCR Request for Comments

April 24, 2013 | Blog | By Theresa Carnegie, Dianne Bourque

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.
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OIG Issues Updated Self-Disclosure Protocol

April 17, 2013 | Blog | By Theresa Carnegie

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. 
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CMS Officially Launches National Physician Payment Transparency Program Website

April 15, 2013 | Blog | By Karen Lovitch

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources.
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Two Databases Become One: HRSA’s Rule on Reporting Provider Sanctions

April 11, 2013 | Blog

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. 
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IRS Provides Additional Guidance for Non-Profit Hospitals

April 10, 2013 | Blog | By Theresa Carnegie

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). 
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Extension of EHR Donation Sunset Date Proposed by OIG/CMS

April 8, 2013 | Blog | By Karen Lovitch

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.
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Negligent Credentialing Claim Recognizable Under Massachusetts Law

April 8, 2013 | Blog | By Daria Niewenhous

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, ...” 
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Grassley Questions Hospital 340B Program Profits

April 5, 2013 | Blog | By Theresa Carnegie

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.
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Sixth Circuit Rules No FCA Liability Based on Violation of Medicare Requirements

April 3, 2013 | Blog | By Karen Lovitch

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”).
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CMS Sets Dates for Accepting Another Round of MSSP ACO Applications

April 3, 2013 | Blog

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). 
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CMS Publishes 2014 Final Call Letter

April 2, 2013 | Blog | By Theresa Carnegie

Yesterday, CMS released its 2014 Final Call Letter for the Medicare Advantage and Medicare Part D programs.
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Will Federal Protection for EHR Donations Be Extended Beyond December 31, 2013?

March 29, 2013 | Blog | By Karen Lovitch

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.
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