Mintz Levin - Health Law & Policy Matters

CMS Increases Oversight of Medicaid Managed Care Contracts

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. …more
| Health

After New York, Florida Curbs Surprise Bills for Emergency and Out-of-Network Services

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…more
| Consumer Protection, Health, Insurance

The IMD Exclusion: Changes Now and Changes to Come

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…more
| Health

FDA Extends Comment Period on Third-Party Medical Device Servicing

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…more
| Health, Science, Computers, & Technology

Justices Grapple with Limits of False Claims Act Liability in Implied Certification Cases

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…more
| Civil Procedure, Government Contracting, Health

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

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…more
| Health, Science, Computers, & Technology

Massachusetts Establishes Road-Map for New ACO Program

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…more
| Business Organizations, Health

OCR Releases New HIPAA Audit Protocol and Other Audit-Related Materials

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…more
| Health, Privacy

Hospitals Settle DOJ Suit Alleging Illegal Division of Marketing Territories

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…more
| Antitrust & Trade Regulation, Health

CMS Announces New Alternative Payment Model for Primary Care

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…more
| Government Contracting, Health

Talking about The Challenge of Quality in Health Care Policy Development

Last week, I spoke at the National Quality Forum Annual Conference in Washington, D.C. about the role of health care quality in policymaking on the Hill…more
| Elections & Politics, Health

LSU Hospital Operator May Proceed with Antitrust Suit Against Competing Health System

The antitrust suit against Willis Knighton Medical Center will continue following the denial of its motion to dismiss. BRFHH Shreveport v. Willis Knighton Med. Ctr., case number 5:15-cv-02057 (W.D. La. Mar. 31, 2016). The case…more
| Antitrust & Trade Regulation, Business Organizations, Civil Procedure, Health, Mergers & Acquisitions

Judge Sides with AseraCare, Grants Summary Judgment in $200 Million FCA Case

Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial into…more
| Civil Procedure, Health, Government Contracting

Biosimilar Developments Continue at a Rapid Pace

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and…more
| Health, Science, Computers, & Technology

FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar…more
| Communications & Media Law, Health, Science, Computers, & Technology
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