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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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ML Strategies Health Care Preview - Week of March 12th
March 12, 2018 | Blog
This week, Congress returns to Washington with 11 days to finalize a government spending bill. Standing in the way are a number of unresolved health care issues, including drug pricing and market stabilization.
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DOJ Announces Roundtable Series on Competition and Deregulation
March 8, 2018 | Blog | By Dionne Lomax
The Department of Justice ("DOJ") Antitrust Division recently announced plans to hold a series of public roundtable discussions to analyze the relationship between competition and regulation, and its implications for antitrust enforcement policy.
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Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?
March 7, 2018 | Blog | By Benjamin Zegarelli
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).
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ML Strategies Health Care Preview - Week of March 5th
March 5, 2018 | Blog
Congress has three weeks to finalize an omnibus spending package. There are a number of issues that are expected to come up, including market stabilization and drug pricing, among other issues. There's also activity at the state level on Medicaid waivers and work requirements. We cover this and more in this week's preview.
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DOJ Intervenes in False Claims Act Case Against a Compounding Pharmacy and a Private Equity Firm
March 5, 2018 | Blog | By Xavier Hardy, Karen Lovitch
The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of co-payment waivers, and to physicians who submitted prescriptions without seeing patients.
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CMS's Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic
March 1, 2018 | Blog | By Bridgette Keller, Tara E. Dwyer
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.
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ML Strategies Health Care Preview - Week of February 26th
February 26, 2018 | Blog
Congress is back in session and will begin its work in finalizing a final spending bill for fiscal year 2018. Both chambers are considering new ways to address the opioid crisis, and we should expect a renewed push around gun control and mental health.
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HIPAA Enforcement Survives Closure of Business
February 26, 2018 | Blog
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. (Filefax) was an Illinois company that provided storage and delivery services for medical records held by covered entities.
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Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct
February 20, 2018 | Blog | By Samantha Kingsbury
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.
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Mintz’s Antitrust and Federal Regulatory Practice Releases Alert on DOJ Settlement With Allegiance
February 16, 2018 | Blog | By Xavier Hardy
Mintz’s Antitrust & Federal Regulatory Practice recently published a Health Care Antitrust Alert on the DOJ Antitrust Division’s announced settlement with Henry Ford Allegiance Health (“Allegiance”).
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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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