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Health Care Enforcement Defense Advisory on Escobar Holding
June 20, 2016 | Blog | By Bridgette Keller
Earlier today, my colleagues Tom Crane and Larry Freedman released a Health Care Enforcement Defense Advisory regarding the Supreme Court's long-awaited, unanimous decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”).
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New York DOH Proposes Updated Provider Contract Guidelines
June 17, 2016 | Blog
The NYS Department of Health (DOH) has proposed new guidelines for the provider contract submission and review process to reflect Value Based Payment arrangements pursuant to the New York State Value Based Payment (VBP) Roadmap (Roadmap) and the Regulatory Impact Subcommittee.
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The Supreme Court Adopts Broad Scope of False Claims Act Liability
June 16, 2016 | Blog | By Brian Dunphy
A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States ex rel. Escobar et al., No 15-7.
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FTC Suffers Another Hospital Merger Loss in Advocate-NorthShore
June 15, 2016 | Blog | By Dionne Lomax
On Tuesday, June 14, 2016, the U.S. District Court for the Northern District of Illinois declined to temporarily block the proposed merger of Advocate Health Care Network and NorthShore University HealthSystem in the Chicago area, handing the FTC its second hospital merger loss this year.
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New Rules for ACOs in the MSSP
June 15, 2016 | Blog | By Bridgette Keller, Daria Niewenhous
CMS issued a final rule, published in the Federal Register on Friday, June 10, 2016, updating how the performance of ACOs participating in the Medicare Shared Savings Program (MSSP) is measured and compensated.
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Anti-Steering Restrictions in Payor Contracts Face Antitrust Challenge by DOJ and NC
June 10, 2016 | Blog | By Dionne Lomax
A popular weapon used to contain health care expenditures is the creation by payors and employers of tiered provider networks, which by differentiated co-pays attempt to steer insureds to less expensive choices.
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Legislation to Reduce Consumer Cost-Sharing Takes a Back Burner in the Drug Pricing Debate
June 9, 2016 | Blog | By Carrie Roll
As discussed in our recent post, states have turned up the heat on drug companies through both legislation and voter initiatives that would require drug companies to disclose their pricing mechanisms for certain high-cost drugs.
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Employers, Join Us for a Webinar: The New White-Collar Overtime Rule
June 9, 2016 | Blog | By Brian Dunphy
Is your company trying to understand the Department of Labor’s (DOL) new white-collar overtime rule before the rule’s December 1st effective date? My colleagues from Mintz Levin’s Employment, Labor, and Benefits group are hosting a one-hour webinar on June 21, 2016 at 2pm (ET) to discuss the DOL’s recently released overtime rule.
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ML Strategies Health Care Congressional Outlook
June 8, 2016 | Blog
The next six weeks are shaping up to be the final work period before the summer recess, with both chambers scheduled to leave D.C. by July 15th for party conventions followed by the August recess.
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Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates
June 7, 2016 | Blog | By Lauren Moldawer
Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the program.
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Mintz/ML Strategies Pharmacy Summit White Paper Highlights Drug Development Process
June 7, 2016 | Blog
The pharmaceutical industry is facing the prospect of a rapidly evolving landscape, one that challenges its regulatory understanding and business model.
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States Step Up Efforts on Drug Pricing Initiatives
June 6, 2016 | Blog | By Carrie Roll
A few months ago, we noted that states were jumping into the drug pricing fray largely driven by a lack of federal action and a rising tide of public discontent.
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No More Bidding - CMS 2, EGWPs 1
June 2, 2016 | Blog | By Tara E. Dwyer
Under the new payment methodology, EGWPs will no longer be paid based on their bid and applicable benchmark, rather they will be paid an amount established by comparing non-EGWP bids to the applicable benchmark (all adjusted for location, Star Ratings, and risk scores). This change was proposed for 2017, but CMS delayed the full implementation until 2018.
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Study Finds Widespread HIPAA Violations Occurring on Yelp
June 2, 2016 | Blog
It is no secret that the Health Insurance Portability and Accountability Act (HIPAA) is a trap for the unwary. A recent study by the non-profit ProPublica has uncovered that the online review site Yelp (as well as other rating sites) are making it easier for covered entities to be ensnared.
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Research Opens a Door for Disability Policy
June 2, 2016 | Blog
One of the challenges of policy making is that bills must go before the Congressional Budget Office (CBO). CBO has one of the toughest jobs in Washington. Their job is to dispassionately look at policy and evaluate the cost of the bill to the federal treasury. Sometimes that means splashing cold water on the high-minded aspirations of policy makers.
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FTC Wins Stay of Pennsylvania Hospital Merger Pending Appeal in Third Circuit
May 26, 2016 | Blog | By Dionne Lomax
The Third Circuit granted on Tuesday the Federal Trade Commission’s (“FTC”) request for an injunction pending appeal of the proposed merger between Penn State Hershey Medical Center and Pinnacle Health System.
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Check Your Inbox: OCR Continues to Verify Entity Contact Information for Phase 2 HIPAA Audits
May 23, 2016 | Blog
Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive verification emails in May.
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Recap: 2016 Mintz/ML Strategies Pharmacy Industry Summit
May 19, 2016 | Blog | By Theresa Carnegie
The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement and program integrity.
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FDA Releases Draft Guidance for 3D Printed Medical Devices
May 17, 2016 | Blog | By Joanne Hawana
On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing.
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OIG Issues Favorable GPO Advisory Opinion
May 16, 2016 | Blog | By Ryan Cuthbertson
The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health System (the “Proposed Arrangement”).
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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