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2022-05-16 18:54:48

Skip to navigationSkip to contentSkip to sidebarMedicaid and the LawFoley Hoag LLPSummary and Considerations on CMS’ RFI on ‘Access to Coverage and Care in Medicaid & CHIP’Posted on April 14th, 2022 by Regina DeSantisThe Medicare and Medicaid programs themselves are not old enough to qualify for Medicare coverage (quick history lesson: President Lyndon Johnson signed the Social Security Amendments into law on July 30, 1965, and the Medicaid program launched on January 1, 1966; note that CMS traces the origin of its programs back to President Theodore Roosevelt’s advocacy for social insurance).  Over the past half-century (and then some),… MoreTags: Medicaid, medicaid expansion, CMSCategories: Medicaid, Medicaid EligibilityCommentsTrackbacksEnforcing Medicaid’s Guarantee of Access to Prescription DrugsPosted on March 14th, 2022 by Thomas BarkerOver the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid beneficiary or provider of services to a Medicaid beneficiary to challenge a state Medicaid plan’s alleged violation of a requirement of the Medicaid program has become increasingly narrow.… MoreTags: Medicaid Enforcement, 340B Drug Pricing, Medicaid Entitlement, ExondysCategories: MedicaidCommentsTrackbacksOregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid CoveragePosted on March 1st, 2022 by Alexander SomodevillaHello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the attention of many stakeholders. In the draft proposal, Oregon stated that it was considering asking CMS for approval to a) adopt a commercial-style closed drug formulary and b) exclude from Medicaid coverage certain drugs approved via the accelerated approval pathway “with limited or inadequate evidence of clinical efficacy.” Oregon proposed to “use its own rigorous review process to determine coverage of new drugs and to prioritize patient access to clinically proven,… MoreTags: drug coverage, Oregon, closed formulary, MDRP, Section 1115 Waiver, MedicaidCategories: Massachusetts, Managed Care, Waivers, Medicaid News, Medicaid, UncategorizedCommentsTrackbacksGeorgia Files Suit Against CMS for “Regulatory Bait and Switch” Over its Expansion PopulationPosted on February 2nd, 2022 by Adam SchiltBefore jumping into the latest litigation over Medicaid waivers, Medicaid and the Law would like to introduce its readers to Adam Schilt. Adam is a healthcare associate in the Washington, DC office and will be a regular contributor to the blog. In a past role, he’s written pieces of legislation that have been enacted into the Medicaid statute and continues to be very passionate about the subject,… MoreTags: Medicaid Waiver, Section 1115 Waivers, waivers, Litigation, GeorgiaCategories: Waivers, Medicaid News, Medicaid, LitigationCommentsTrackbacksJustice Breyer’s Influence on America’s Health Care SystemPosted on February 1st, 2022 by Thomas BarkerThis week’s news that Justice Stephen Breyer would step down from the Supreme Court at the conclusion of the Court’s term definitely caught our attention here at the Medicaid and the Law Blog.  Our view is that Justice Breyer – who, for whatever reason, did not get a significant amount of attention from the mainstream media – had a monumental influence on the American health care system,… MoreTags: breyer, supreme courtCategories: Litigation, Medicaid News, Supreme Court Decisions, MedicaidCommentsTrackbacksSupreme Court Hears Arguments on 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference’Posted on December 10th, 2021 by Regina DeSantisOver the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term.  Last week, the Court heard oral arguments for two noted cases: during Monday’s (November 29) arguments for Becerra v. Empire Health Foundation, the Court was asked to decide if the Administrative Procedure Act (APA) gives HHS authority to interpret the Medicare statute and recalculate payments made to disproportionate share hospitals (DSH);… MoreTags: 340B Drug Pricing, 340B, supreme courtCategories: 340B Drug Pricing Program, Supreme Court DecisionsCommentsTrackbacksDistrict Courts Issue Key Decisions in 340B Contract Pharmacy CasesPosted on November 9th, 2021 by Ross MarguliesUpdate: On November 10, 2021 Eli Lilly filed a notice of appeal in the case Eli Lilly and Company v. Becerra case challenging the October 29th decision by the Southern District of Indiana.Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA,… MoreTags: novartis, astra zeneca, 340B, novo nordisk, sanofi, eli lilly, contract pharmacy, 340B Drug Pricing, 340B Program Integrity, 340B program, ADRCategories: Litigation, Prescription Drug Coverage, 340B Drug Pricing ProgramCommentsTrackbacksHow Pfizer’s Warranty Program Gets Around Best Price?Posted on October 14th, 2021 by Ross MarguliesOn October 13th our friends over at STAT  broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a refund for any amounts paid to purchase the company’s longstanding oral lung cancer therapy XALKORI when use is discontinued in the first three months for clinical reasons.… MoreTags: Best Price, xalcori, pfizer, value based, Value Based PurchasingCategories: Best Price, Prescription Drug Coverage, AMP Rule, Value-Based Arrangements, Alternative Payment ModelsCommentsTrackbacksNew State Health Official Letter Extends Post-PHE Processing Timelines, Implements Redetermination RequirementPosted on August 18th, 2021 by Regina DeSantisWe’ve previously discussed the numerous flexibilities CMS offered state Medicaid programs to respond to local outbreaks and address health concerns associated with the COVID-19 public health emergency (PHE).Back in March 2020 (which feels like ages ago, right?) my colleague Tom discussed the enhanced 6.2% Federal Medical Assistance Percentage (FMAP) funding—authorized by the Families First Coronavirus Response Act (FFCRA) and amended by the CARES Act—including the continuous-enrollment requirement for beneficiaries who had been enrolled in Medicaid on or after March 18,… MoreTags: CMS, guidance, MedicaidCategories: COVID-19, Medicaid Eligibility, Enrollment, Medicaid News, MedicaidCommentsTrackbacksSupreme Court Will Hear Several Health Care Cases in 2022 TermPosted on July 20th, 2021 by Thomas BarkerRecently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers.  We often write about the 340B program on our blog because of the link between that program and the Medicaid prescription drug rebate program.Well, we’re doing it again:  this time, because the U.S. Supreme Court just announced that it’s going to hear a dispute between some hospitals (340B covered entities) and CMS in the Court’s next term that starts in October. … MoreTags: medicare dsh, Third Party Recovery, DSH, 340B Drug Pricing, 340B, supreme courtCategories: Supreme Court DecisionsCommentsTrackbacksOlder Posts »HomeAboutArchivesContactServicesSearchEditorsRoss MarguliesRoss Margulies focuses his practice on statutory and regulatory issues involving the Centers for...MoreThomas BarkerThomas Barker joined Foley Hoag in March 2009. Thomas focuses his practice on complex federal and...MoreAuthorsAlexander SomodevillaAlexander provides coverage, reimbursement, and compliance strategies advice to a broad range of...MoreRegina DeSantisRegina DeSantis is a policy advisor in the Administrative Law Department, resident in the...MoreHaider AndazolaHaider David Andazola helps healthcare and biotech companies navigate statutory and regulatory...MoreAbout UsFoley Hoag lawyers and healthcare policy specialists have had a direct hand in shaping virtually every healthcare law and regulation enacted over the past four decades... MoreSubscribe to BlogRSSJoin»Our Mailing ListSee» Our PublicationsTopics340B Drug Pricing ProgramACAAlternative Payment ModelsAmerican Health Care ActAMP RuleBest PriceBlock GrantsBudgetsChildrenCMMICOVID-19DSHDual EligiblesEnrollmentFinancingHome Health ServicesIMD ExclusionImmigrationindianaLegislationLitigationLong-term CareManaged CareMassachusettsMedicaidMedicaid EligibilityMedicaid ExpansionMedicaid NewsMedicarePersonal Care ServicesPrescription Drug CoverageSupreme Court DecisionsTelehealthUncategorizedValue-Based ArrangementsWaiversLinksFoley Hoag LLPAdvertising & Marketing LawCannabis & The LawCorporate Social Responsibility & The LawDrug Pricing Policy WatchEnergy & Cleantech CounselIPO, Then What?Law & The EnvironmentMassachusetts Labor & Employment LawMassachusetts Noncompete LawSecurity, Privacy & The LawState AG InsightsTrademark & Copyright LawWhite Collar Law & InvestigationsRecent PostsSummary and Considerations on CMS’ RFI on ‘Access to Coverage and Care in Medicaid & CHIP’Enforcing Medicaid’s Guarantee of Access to Prescription DrugsOregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid CoverageGeorgia Files Suit Against CMS for “Regulatory Bait and Switch” Over its Expansion PopulationJustice Breyer’s Influence on America’s Health Care System Privacy PolicyDisclaimerCopyright © 2022, Foley Hoag LLP. 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