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FTC Granted 2-Week Reprieve in Effort to Block Pennsylvania Hospital Merger

May 13, 2016 | Blog

The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle Health System (“Pinnacle”) is anti-competitive. 
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Alternative Payment Models (APMs) Under MACRA Proposed Rule

May 6, 2016 | Blog | By Lauren Moldawer

Continuing our blog series on CMS’s massive proposed rule for the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), we dedicate this post to examining the Advance Payment Model (APM) provisions of the proposed rule.
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Four Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 6, 2016 | Blog | By Theresa Carnegie

Here in Washington, it seems everyone has an idea on a drug “fix”:  amendments to the provisions governing Medicare reimbursement, new rebate requirements, changes to price reporting measures, revisions to the 340B Drug Discount Program, etc. Proposals are interesting, but will Congress actually do anything?  If anything is actually going to pass, it has to get through the Senate.
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Already Enormous False Claims Act Penalties Set to Increase

May 6, 2016 | Blog | By Brian Dunphy, Samantha Kingsbury

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device manufacturers, and life sciences companies subject to the FCA.
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Five Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 5, 2016 | Blog | By Theresa Carnegie

Following our first panel discussing Drug Pricing Challenges and Opportunities, the second panel, which Theresa is moderating involves a subject near and dear to the heart of many of our clients: The New Wave of Value-Based Pricing and Contracting.
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CMS Proposes “Advancing Care Information” Program to Replace Meaningful Use

May 5, 2016 | Blog | By Dianne Bourque

The Medicare Access and CHIP Reauthorization Act (MACRA) proposes a new approach, with new branding labels, to paying clinicians for the value and the quality of care that they provide by replacing a patchwork of existing quality-related programs, including the Electronic Health Records (EHRs) Incentive Programs, also known as “Meaningful Use.” 
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Six Days Until The Mintz/ML Strategies Pharmacy Industry Summit

May 4, 2016 | Blog | By Theresa Carnegie

We are thrilled that our inaugural Pharmacy Industry Summit is now less than a week away.  The Summit is next Tuesday May 10th, 2016, here in our DC offices.  Since we started planning for the Summit many months ago, this hottest of topics that we chose to cover, drug pricing, has become even hotter.
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New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

May 3, 2016 | Blog | By Joanne Hawana

Last month, the FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.
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CMS Releases Proposed Rule for MACRA Implementation – Overview and Merit-Based Incentive Payment Systems (MIPS)

May 3, 2016 | Blog

On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would put in place key parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
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CMS Increases Oversight of Medicaid Managed Care Contracts

April 28, 2016 | Blog

As noted in a post published yesterday, CMS issued the final rule regarding Medicaid managed care earlier this week. With this rule, CMS is taking a much more active role in overseeing states’ Medicaid managed care contracts.
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After New York, Florida Curbs Surprise Bills for Emergency and Out-of-Network Services

April 28, 2016 | Blog

It is generally understood that if a managed care member utilizes the services of a non-participating provider, the member could incur significant out of pocket expenses. However, there are instances where a member may unknowingly receive services from an out-of-network provider, such as a radiologist or anesthesiologist, while receiving emergency or non-emergency care at an in-network hospital. 
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The IMD Exclusion: Changes Now and Changes to Come

April 27, 2016 | Blog

On Monday, CMS finalized their long-awaited Medicaid managed care regulation. Deep in the regulation was a change to allow Medicaid reimbursement for facilities that had previously been excluded from receiving payments. Known as the Institution for Mental Disease (IMD) Exclusion, this change has a significant impact on mental health and substance abuse treatment now and in the future.
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FDA Extends Comment Period on Third-Party Medical Device Servicing

April 27, 2016 | Blog | By Benjamin Zegarelli

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA's notice of extension, comments are now due by June 3, 2016.
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Justices Grapple with Limits of False Claims Act Liability in Implied Certification Cases

April 26, 2016 | Blog

Last week the Supreme Court heard oral argument in a False Claims Act (“FCA”) case in which the Court is considering the validity of the so-called implied false certification theory. This theory attaches FCA liability when a person submits a claim for payment notwithstanding a violation of an underlying law or regulation, but without a factually false claim form.
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FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

April 22, 2016 | Blog | By Benjamin Zegarelli

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing of medical devices by entities other than the officially listed manufacturer.
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Massachusetts Establishes Road-Map for New ACO Program

April 22, 2016 | Blog | By Bridgette Keller, Daria Niewenhous

Massachusetts Secretary of Health and Human Services, Marylou Sudders, held a public meeting earlier this week to receive feedback on the proposal of the Executive Office of Health and Human Services (EOHHS) to overhaul the Massachusetts Medicaid program, known as MassHealth. 
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OCR Releases New HIPAA Audit Protocol and Other Audit-Related Materials

April 20, 2016 | Blog | By Dianne Bourque

Earlier this month the Department of Health and Human Services Office for Civil Rights (OCR) released a revamped audit protocol that now addresses the requirements of the 2013 Omnibus Final Rule. OCR will be using the audit protocol for its impending Phase 2 audits of covered entities and business associates, which are set to begin next month.
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Hospitals Settle DOJ Suit Alleging Illegal Division of Marketing Territories

April 18, 2016 | Blog | By Dionne Lomax

Two West Virginia hospital systems settled a lawsuit filed yesterday by the Department of Justice (“DOJ” or “Department”) alleging that they agreed to allocate territories for marketing health care services in violation of Section 1 of the Sherman Act.
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Mintz's Health Care Enforcement Defense Group Publishes New Qui Tam Update

April 14, 2016 | Blog | By Samantha Kingsbury

Yesterday, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update.  This Update covers 42 health care-related False Claims Act qui tam cases that have been unsealed since the last Health Care Qui Tam Update.
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CMS Announces New Alternative Payment Model for Primary Care

April 13, 2016 | Blog

Earlier this week, CMS announced the launch of an initiative aimed at transforming the way primary care is delivered. The Comprehensive Primary Care Plus (CPC+) model will be a voluntary 5 year program accommodating some 5,000 physician practices across 20 geographic regions.
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