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CMS Benefit and Payment Rule: What is Success for the ACA?
April 17, 2018 | Blog
On Monday, CMS published a number of policies changing the dynamics of the individual market, including the Benefit and Payment Parameters for 2019 Final Rule, guidance on hardship exemptions, and a bulletin on transitional (grandmothered) plans. When interpreting all of these policies it’s important to keep in mind the following: What is success? And who is defining it?
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Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative Remedies
April 17, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman
The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.
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ML Strategies Health Care Preview - Week of April 16th
April 16, 2018 | Blog
Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention.
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Report Details Uneven Implementation of the New Drug Tracing Law
April 13, 2018 | Blog
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.
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State Action on Potential 1115 Medicaid Waivers
April 11, 2018 | Blog
In a previous blog, we reviewed pending and approved 1115 waivers in 8 states. We also highlighted the trends we see in 1115 waivers, such as changes to coverage requirements, a time limit on how long certain beneficiaries can receive Medicaid coverage, lock-outs if an individual fails to pay a premium or meet the work requirement, and drug testing requirements.
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ML Strategies Health Care Preview - Week of April 9th
April 9, 2018 | Blog
This week, Congress returns from recess with its eyes set on addressing the opioid crisis. We expect to see some form of bipartisan legislation considered between now and Memorial Day. We will also see Congress dive into appropriations which will eat up plenty of time, not to mention nominations of Cabinet officials and appointments to the federal bench.
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Federal Commission Recommends Streamlining Medicaid Waiver Authorities
April 9, 2018 | Blog
In March, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its biannual report to Congress. MACPAC is an independent congressional agency that advises Congress on issues relating to Medicaid. In its report, the Commission made a three part recommendation in regards to streamlining Medicaid managed care authorities.
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Alabama Enacts Data Breach Notification Law
April 5, 2018 | Blog | By Ryan Cuthbertson
Earlier this week, Mintz Levin’s Privacy & Security Matters blog posted an update that Alabama has become the 50th state to enact a data breach notification law.
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MedPAC Recommends Significant Changes to MACRA
April 5, 2018 | Blog
In March, the Medicare Payment Advisory Commission (MedPAC) released its biannual report to Congress on matters affecting the Medicare program. MedPAC is an independent congressional agency that advises Congress on issues relating to Medicare.
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The California Attorney General and Sutter Health Face Off in an Antitrust Lawsuit
April 5, 2018 | Blog | By Dionne Lomax
On March 29, 2018, the Attorney General of California filed an antitrust action against Sutter Health and its affiliates (“Sutter”) alleging Sutter engaged in various anti-competitive conduct in violation of California’s Cartwright Act.[1] According to the Complaint, healthcare costs in California have rapidly increased, and prices in Northern California are higher than in other areas of the State.
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CMS Releases 2019 MA and Part D Final Rules and Call Letter
April 4, 2018 | Blog | By Tara E. Dwyer
Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter.
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What Lessons Can We Take From The Administration’s Refusal to Allow Idaho to Dismantle the ACA Marketplaces?
April 2, 2018 | Blog | By Xavier Hardy
In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans.
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Trends in 1115 Medicaid Waivers and Summaries of Each Pending Application
March 28, 2018 | Blog
As of March 2018, there are twenty-four Medicaid 1115 waivers pending CMS approval. Medicaid 1115 waivers, Research and Demonstration Projects, give states experimental, pilot, or demonstration projects likely to assist in promoting the objectives of Medicaid.
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Join Mintz & ML Strategies for the 3rd Annual Pharmacy & Pharmaceutical Industry Summit
March 22, 2018 | Blog
Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker.
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The Uncertain State of the 340B Program: Where Are We Now?
March 21, 2018 | Blog
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change.
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Mintz’s Health Care Enforcement Defense Group Releases Latest Qui Tam Update
March 21, 2018 | Blog
Mintz Levin’s Health Care Enforcement Defense Group released its most recent Health Care Qui Tam Update yesterday. This Update analyzes 56 qui tam cases unsealed in October and November of last year. None of the 56 cases in this Update were unsealed within the statutorily-mandated 60 days, but one case was unsealed in 71 days.
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ML Strategies Health Care Preview - Week of March 19th
March 19, 2018 | Blog
Congress has until Friday to finalize a government spending bill. Over the next couple of days it will decide whether to move forward with a number of consequential health care issues, market stabilization and drug pricing chief among them.
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CMS to Begin Issuing New Medicare Cards Next Month
March 15, 2018 | Blog
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that new Medicare cards would be issued starting next month. As we previously reported, the government has been planning to revamp the card to reduce fraud.
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Client Alert Addresses Antitrust Risk of Referrals Within a Health Care System
March 14, 2018 | Blog | By Ryan Cuthbertson
On Monday, our colleagues Bruce Sokler and Farrah Short released a client alert: Attempted Monopolization Suit Based on Alleged Referral Steering Moves Forward with Court’s Acceptance as Plausible of a Geographic Market Limited to a Single Hospital.
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Recent FCA Settlement Shows That What’s Old Is New in Health Care Fraud Enforcement
March 13, 2018 | Blog | By Samantha Kingsbury
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had violated the False Claims Act by purchasing lavish meals for physicians to induce them to use heart pumps manufactured by the Company.
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