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Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices
May 21, 2018 | Blog
On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.
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President Trump Delivers Much Anticipated Drug Pricing Speech
May 14, 2018 | Blog | By Theresa Carnegie, Tara E. Dwyer
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
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Will CMS Drive Further Changes to 340B?
May 1, 2018 | Blog
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming?
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CMS Continues to Focus Medicare Plans on Preventing Opioid Abuse
April 23, 2018 | Blog | By Bridgette Keller
As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time, so there is a lot of information for Medicare Advantage organizations and Part D plan sponsors to absorb.
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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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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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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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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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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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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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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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The Health Policy Commission’s Annual Cost Trends Hearings
November 1, 2016 | Alert | By Steven Baddour, Daniel Connelly, Julie Cox, Daria Niewenhous, Stephen Weiner, Maxwell Fathy, Elena Horvit, Parnia Zahedi
The Massachusetts Health Policy Commission conducted its fourth annual Cost Trends Hearing on October 17 and 18, 2016, under the requirements of Massachusetts’s 2012 health care reform legislation (“Chapter 224”).
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FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm
September 15, 2016 | Alert | By Joanne Hawana
As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.
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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers
February 10, 2016 | Advisory | By Theresa Carnegie, Lauren Moldawer
In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).
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Drug Costs, Risk Adjustment Drive Q2 Health Insurance Rate Increases
January 26, 2016 | Advisory | By Julie Cox, Stephen Weiner, Sasha Dudding
The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).
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FDA Invites Genome Scientists to Come Play in the precision FDA “Sandbox”
November 13, 2015 | Alert | By Joanne Hawana
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
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Recent Developments in Massachusetts Health Policy
October 23, 2015 | Alert | By Julie Cox, Sasha Dudding, Stephen Weiner
Building on the momentum of early October hearings on the state’s growing health care expenditures, the Health Policy Commission (HPC), the Joint Committee on Health Care Financing, Governor Charlie Baker, and others spent the past two weeks crafting new policies for the industry and its consumers.
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Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule
June 5, 2015 | Advisory | By Pamela Kramer, Bridgette Keller, Lauren Moldawer
On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to administer their Medicaid benefits.
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FTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior
May 4, 2015 | Advisory | By Dionne Lomax, Stephen Weiner
In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior.
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Developments in Judicial Deference of Administrative Agency Actions
April 22, 2015 | Advisory
In my post of April 2, Divided Supreme Court Restricts Provider Challenges to State Medicaid Rates, I wrote about the March 31st Supreme Court decision that providers may not sue in federal court over the adequacy of state Medicaid rates (See Armstrong v. Exceptional Child Ctr., Inc. (“Exceptional Child Center”).
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