Category Archives: Managed Care

CMS Rings in the New Year with Updated Guidance on ‘In Lieu of Services and Settings’ (ILOS) in Medicaid Managed Care

Welcome back!  We hope everyone had a great start to 2023.  A new year provides an opportunity to look back on previous successes and identify areas for growth (this said, we certainly don’t expect everyone to make—let alone adhere to—a “new year’s resolution!”).

In its recent letter to state Medicaid directors, the Centers for Medicare and Medicare Services (CMS) encourages states to build on past efforts to address Medicaid beneficiaries’ social determinants of health (SDOH) by implementing an innovative option to meet beneficiaries’ health-related social needs (HRSNs).… More

Oregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid Coverage

Hello 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,… More

CMS Releases the New Medicaid Managed Care Final Rule

On November 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced it finalized the Medicaid and Children’s Health Insurance Program (“CHIP”) Managed Care final rule (“2020 final rule”). According to CMS, the 2020 final rule advances CMS’s efforts to streamline the Medicaid and CHIP managed care regulatory framework and “reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care.”

Notably,… More

Latest HHS Financial Report Highlights Medicaid Eligibility Errors – and Foreshadows Future Actions

On November 19, 2019, CMS announced key results from the 2019 HHS Agency Financial Report, which generally provides fiscal and high-level performance data for HHS for the reporting period of October 1, 2018 through September 30, 2019. While CMS leads off its press release with the good news — payment error rates in the Medicare fee-for-service program are at their lowest level since FY 2010 —… More

Tennessee Announces First-in-Nation Block Grant Proposal

On September 17, 2019, Tennessee released its proposal to block grant most of the funding the state’s Medicaid program (TennCare) receives from the Federal government. If approved by CMS, the amendment to the state’s longstanding 1115 waiver program would make Tennessee the first state in the nation to move to a true “block grant” format for Medicaid funding. A draft of the proposed waiver is available on the state’s website —… More

HHS Prescription Drug Rebate Rule Has Medicaid Implications

On January 31, 2019 the HHS Office of Inspector General (OIIG) issued a proposed rule that will be published in the Federal Register on February 6.  The proposed rule has the potential to fundamentally re-structure the prescription drug marketplace in the United States by dramatically altering the economics of pharmaceutical pricing.  Although much of the attention surrounding the rule has been focused on its effect on the Medicare Part D prescription drug program,… More

Massachusetts Seeks Bids for Rebates from Select Drug Manufacturers

In an interesting (intriguing even?) turn of events, in late December 2018 the Massachusetts Executive Office of Health and Human Services (EOHHS) announced through its public bidding site that it was seeking bids from manufacturers of select, generally high-priced outpatient drugs for supplemental rebates in MassHealth’s fee-for-service and managed care programs. While the state has before used the public bidding process successfully to negotiate supplemental rebates for the state’s Medicaid program (for example,… More

CMS Issues New Guidance Aimed at Addressing Care for Mental Illness

Overview

On November 13, 2018 CMS (as mandated by Congress in the 21st Century cures Act) issued a State Medicaid Director Letter providing states with guidance on both: (1) existing authority for states to provide support for adults with serious mental illness (SMI) and/or children with a serious emotional disturbance (SED); and (2) a new demonstration opportunity  to permit states to offer care for certain individuals with serious mental illness residing in Institutions for Mental Disease (IMDs).… More

Blogging Live from AHLA: Calder Lynch on the Medicaid Program

During the opening session of AHLA yesterday, we had the opportunity to hear remarks for Calder Lynch, current Counselor to CMS Administrator Seema Verma and potential replacement pick for outgoing CMCS Director. Lynch reiterated the three pronged approach the current administration is taking to Medicaid (as previously outlined by administrator Verma):

  1. Accountability
  2. Flexibility
  3. Program Integrity

According to Lynch,… More

Massachusetts Secretary Sudders Takes Up Price’s and Verma’s Offer for Medicaid Flexibility

On March 22, 2017, the Massachusetts Secretary of the Executive Office of Health and Human Services (EOHHS) sent a letter to CMS Administrator Seema Verma taking her and HHS Secretary Tom Price up on their offer to grant states more flexibility under the Medicaid program.  In her letter, Secretary Sudders pointed to four aspects of the Medicaid program from which Massachusetts would like “immediate relief” and greater flexibility:

  • Flexibility in benefit design;…
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Price and Verma to State Governors: Just Come and Ask Us for Flexibility – What Providers & Drug Manufacturers Could Expect

The last several weeks have been nothing short of enthralling, like an episode of House of Cards. After seven years of campaigning on the repeal of the Affordable Care Act (ACA), Republicans were ultimately unable to create consensus for their highly anticipated repeal-and-replace legislation known as the American Health Care Act (AHCA).  But as the drama on the Hill comes to an end (at least until tax reform is picked up),… More

What the new 2-for-1 Executive Order means for the Medicaid program

On January 30, 2017, President Trump signed an executive order (“EO”) that has generated considerable confusion in the administrative law space, and has produced at least one lawsuit thus far.  The EO requires that for every new regulation issued by an executive agency, two regulations must be identified for elimination (“repeal”).  This requirement is coupled with another provision that imposes an immediate cap on net costs imposed by new regulations (“offsets”). … More

How the Medicaid expansion will be treated under a block-grant financing framework

One of the most pressing issues before the 115th Congress and newly inaugurated President Trump will be to determine how the Medicaid expansion population will fit into a broader reform package for the Medicaid program as a whole.  Many state governors in expansion states have expressed concern that the long-standing Republican proposal of block-granting Medicaid will leave them exposed to unsustainable financial pressures.

President Trump’s nominee for HHS Secretary,… More

Medicaid Waivers in Conservative States Hold Hints for What is to Come for Drug Manufacturers

Introduction

The nomination of Seema Verma by President-Elect Trump for the position of CMS Administrator sends a clear signal that the Trump Administration considers Medicaid one of its top healthcare reform priorities.  Seema Verma is the the “architect” of the Healthy Indiana Plan 2.0” waiver (HIP 2.0), a consumer-driven Medicaid expansion demonstration approved by the Obama Administration under a Section 1115 waiver.  Most recently, Verma was also involved in designing Kentucky’s proposed “Kentucky HEALTH” (“HEALTH”) Section 1115 waiver,… More

Medicaid under a Trump Administration: What the Next Four Years Might Look Like

Dear readers: this post is going to be a bit different from our regular posts, in that we are going to try to refrain from getting too far in the weeds, and avoid too much legalese. Why? Because the results of the November election will likely have major implications not only for the Medicaid program itself, but for the millions of individuals it serves. We are fortunate to have a platform here and it is our hope that,… More

CMS and Massachusetts Advance Delivery System Reform with Approval of New 1115 Waiver

On November 4, 2016, the Centers for Medicare & Medicaid Services (“CMS”) sent word to the Massachusetts Executive Office of Health and Human Services (EOHHS, referred to here as “MassHealth”) that it approved a major amendment to Massachusetts’ section 1115 demonstration project through June 30, 2017.  At the same time, CMS also approved an extension of this same demonstration through June 30, 2022. Approval of Massachusetts’ waiver amendment comes after nearly a year of negotiations and may ultimately result in the transition of the vast majority of MassHealth enrollees into newly-formed Accountable Care Organizations (“ACOs”) operating under one three models,… More

OIG Says State Methods For Preventing Duplicate Discounts Are Vulnerable

Introduction

The Office of Inspector General (OIG) recently issued a report titled “State Efforts to Exclude 340B Drugs from Medicaid Managed Care Rebates.”  In its report, OIG wanted to study the different methods that states were using to prevent illegal “duplicate discounts” that occur as a result of the interaction between the Medicaid drug rebate program and the 340B drug-discount program.  OIG revealed that the systems a majority of states have for preventing duplicate discounts are actually quite vulnerable,… More

Medicaid Managed Care Proposed Rule: Provisions Relevant to the Biopharmaceutical Industry

On May 26, 2015 the Centers for Medicare & Medicaid Services (CMS) released its long-awaited proposed rule designed to modernize the Medicaid managed care regulations (last updated in 2002) to reflect changes in the use and growth of the managed care program and to align the program more closely with other existing healthcare programs, including Medicare/Medicare Advantage and qualified health plans offered by Exchanges.

As of FY 2011,… More