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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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Registration for the 2016 Mintz/ML Strategies Pharmacy Industry Summit is Open! (May 10, 2016)
April 12, 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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LSU Hospital Operator May Proceed with Antitrust Suit Against Competing Health System
April 11, 2016 | Blog | By Dionne Lomax
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 was filed last July by BRFF Shreveport, a competing healthcare provider, and Vantage Health Plan, a health insurer.
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Talking about The Challenge of Quality in Health Care Policy Development
April 11, 2016 | Blog
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. The challenge of policy making on the Hill is that many people know that quality is important. Policymakers know they need to be talking about health care quality. Unfortunately, too often quality is just a buzz word.
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Recent Updates to State Breach Notification Laws - Tennessee
April 8, 2016 | Blog
My colleagues in the Privacy and Security Group recently updated the Mintz Matrix, a summary of U.S. state data breach notification laws. While we often discuss HIPAA on Health Law and Policy Matters, health care organizations must be aware of separate state notification requirements and other privacy and security laws that may apply in the event of a data breach.
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FDA Differentiates Biosimilar Labeling from Generic Drug Labeling
April 4, 2016 | Blog | By Joanne Hawana , Lauren Moldawer
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 products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA.
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Biosimilar Developments Continue at a Rapid Pace
April 1, 2016 | Blog | By Joanne Hawana
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 efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product.
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Judge Sides with AseraCare, Grants Summary Judgment in $200 Million FCA Case
April 1, 2016 | Blog | By Laurence Freedman, Samantha Kingsbury
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 Phase I that would address “falsity” and Phase II that would address “knowledge” and other FCA elements.
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Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?
March 31, 2016 | Blog | By Bridgette Keller, Karen Lovitch
As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most significant changes to the Medicare Part B payment structure for laboratories since implementation of the Medicare Clinical Laboratory Fee Schedule (MCLFS) in 1984.
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CMS Seeks Input on Medicare's Value-Based Insurance Design Model
March 29, 2016 | Blog
Last week, CMS asked Medicare Advantage Organizations for feedback on the Medicare Advantage Value-Based Insurance Design model test that will begin on January 1, 2017.
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Ready or Not, It’s Time For Phase 2 HIPAA Audits
March 22, 2016 | Blog | By Dianne Bourque
On March 21st, the HHS Office for Civil Rights (“OCR”) officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails from OCR that will begin the audit process.
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