News

Recent happenings in the regulated markets space, including updated regulatory guidance and policy changes.

legislation

White House Event Focuses on Lowering Cost of Health Care

On April 3, President Biden alongside Sen. Bernie Sanders (I-VT), delivered remarks on lowering health care costs for Americans at the White House. Sen. Sanders highlighted the Senate Committee on Health, Education, Labor, and Pensions (HELP) Committee’s investigation into the price of inhalers, with Sanders and Biden referencing three inhaler manufacturers’ commitments to capping the […]
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May 1, 2024

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legislation

HHS Finalizes 340B Administrative Dispute Resolution Updates

On April 18, HHS finalized updates to the 340B Program’s administrative dispute resolution (ADR) process. These updates come after the 2020 final rule was successfully challenged by drug manufacturers. The updated ADR process loosens the standards for claims, making it more likely that there will be a substantial uptick in ADR filings. The rule also […]
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May 1, 2024

marketplace

legislation

HHS Releases New List of Inflation-Capped Medicare Part B Drugs

On March 26, HHS announced 41 drugs available through Medicare Part B will have a lowered Part B coinsurance rate from April 1 – June 30, if the drug company raises prices faster than the rate of inflation. Beginning last April, as a result of the Inflation Reduction Act, people with Medicare started to see […]
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May 1, 2024

legislation

HHS Secretary Testifies before House and Senate Committees on Budget Request

The Secretary of the Department of Health and Human Services (HHS), Xavier Becerra, testified twice before Congress on the 2025 Budget Request for HHS. However, these hearings are rarely limited to the budget request because members often take the opportunity to highlight their own health policy priorities or ask questions on top-of-mind issues. During the […]
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May 1, 2024

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legislation

Washington First State to Pass a Version of Uniform Law Commission’s Telehealth Model Act

Washington Gov. Jay Inslee (D) signed into law Senate Bill 5481, Washington’s modified version of the Uniform Telehealth Act (UTA). While the new law has widespread support in the telehealth community, it was amended to exclude the model act’s telehealth registration section, which would have allowed a provider licensed in another state, and in good […]
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May 1, 2024

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Guidance

HHS and CMS Extend Marketplace SEP for Individuals Losing Medicaid

On March 28, CMS issued guidance on the Temporary Special Enrollment Period (SEP) for Consumers losing Medicaid or Children’s Health Insurance Program (CHIP) coverage due to unwinding of the Medicaid Continuous Enrollment Condition Operations for plan year 2024. CMS announced the Unwinding SEP end date will be extended to Nov. 30. Under the updated guidance, […]
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May 1, 2024

marketplace medicaid Medicare

legislation

Congress Finishes FY 2024 Appropriations

In March, President Biden signed into law the final fiscal year (FY) 2024 appropriations bills, including a small funding boost for the Departments of Labor, HHS, and Education. Federal funding will last until Sept. 30, when Congress will need to either extend existing funding (most likely) or pass new appropriations bills. A package of health […]
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May 1, 2024

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perspectives

Cigna Comments on Medicare Prescription Payment Plan Draft Two Guidance

On March 15, The Cigna Group submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the Medicare Prescription Payment Plan (MPPP) Draft Part Two Guidance. The MPPP was created by the Inflation Reduction Act and beginning in 2025 will enable Medicare Part D enrolled beneficiaries to elect to “smooth” their copays over […]
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May 1, 2024

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legislation

US Chamber of Commerce Sues to Block FTC Ban on Noncompete Clauses

Business groups led by the US Chamber of Commerce sued the Federal Trade Commission (FTC) on April 24 seeking to block a finalized rule that would prohibit noncompete provisions that restrict workers from switching jobs within an industry. In a complaint filed in a Texas federal court, the nation’s largest business lobby, along with Business Roundtable and several Texas business groups, […]
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May 1, 2024

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legislation

Nevada Requests Pause of 1332 Waiver Application

The Nevada Department of Health and Human Services has submitted a formal request to CMS to pause its consideration of the pending 1332 State Innovation Waiver application that pertains to the state’s public option law. In the request, the department stated that it is currently developing an amendment to the application to reflect more accurate […]
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May 1, 2024

marketplace

legislation

CMS Finalizes 2025 Program and Payment Policies for MA and Part D Plans

In April, CMS published the 2025 MA and Part D Final Rate Announcement establishing final payment policies for MA and Part D plans. In 2025, average MA plan revenue will decline 0.16% compared with 2024. There are several factors driving the slight rate cut, including the continued phase-in of the new MA risk adjustment model, […]
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May 1, 2024

EGWP marketplace medicaid Medicare

legislation

House Energy & Commerce Holds Hearing on Improper Medicare & Medicaid Payments

The House Energy & Commerce Oversight & Investigations Subcommittee held a hearing to discuss programmatic oversight, overpayments, and efficient use of taxpayer funds in the Medicare and Medicaid programs. Hearing witnesses were in agreement about drivers of improper payments, identifying issues such as duplicate or ineligible payments, incentives for MA plans to record more diagnoses, […]
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May 1, 2024

medicaid Medicare

legislation

Senators Discuss Use of Artificial Intelligence in Health Care

On Feb. 9, the Senate Finance Committee convened a hearing to examine the integration of artificial intelligence (AI) into patient care and the necessary regulations. The hearing highlighted the potential of AI in health care while addressing the need for regulations and adequate guardrails, consistent reimbursement policies, standards, and accountability measures to ensure its effective […]
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March 6, 2024

legislation

Senate Committee Releases White Paper on Drug Shortages

On Jan. 25, the Senate Finance Committee (SFC) released a white paper and legislative framework to prevent and mitigate shortages of generic drugs. The Committee noted that the white paper reflects the concerns heard at its Dec. 2023 hearing, as well as areas of interest the SFC will explore to address the factors contributing to […]
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March 6, 2024

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legislation

New York Proposes Rules for Network Adequacy and Access Standards for Behavioral Health Services

The New York Department of Financial Services (DFS) published a proposed rule (Insurance Regulation 230) establishing network adequacy standards for behavioral health services starting Jan. 1, 2025. The DFS proposal mirrors the Department of Health proposal published earlier in the month. Among other things, the rules would establish business-day requirements for initial appointments and appointments […]
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March 6, 2024

marketplace

legislation

House Committee Hearing on Legislative Proposals to Support Patients with Rare Diseases

The House Committee on Energy & Commerce held a legislative hearing on proposals to support patients with rare diseases. Researchers and academics from the American Society of Gene and Cell Therapy, Harvard Medical School, and Johns Hopkins testified before the Committee. Two bipartisan bills under consideration are aimed at altering Medicare’s drug price negotiation program […]
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March 6, 2024

EGWP Medicare

legislation

Bipartisan Lawmakers Push Back on Possible Expansion of March-In Rights

A bipartisan group of 28 lawmakers sent a letter to President Biden cautioning against the use of march-in rights under the Bayh-Dole Act of 1980, warning the approach could “hamstring” U.S. innovation. March-in rights permit the government to grant patent licenses to other parties – or obtain the licenses for themselves – if the patent owner’s research […]
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March 6, 2024

EGWP Medicare

legislation

U.S. Launches Antitrust Probe into UnitedHealth Group

The Justice Department has launched an antitrust investigation into UnitedHealth Group, raising questions about the relationship between the company’s UnitedHealthcare insurance unit and its Optum health services arm, which owns physician groups, among other assets. Optum includes about 90,000 physicians – a tenth of all doctors in the U.S., as well as surgery centers, health […]
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March 6, 2024

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legislation

CMS Releases Calendar Year 2025 MA and Part D Rate Notice; Senators Urge CMS to Protect MA

On Jan. 31, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. In the advance notice, CMS is proposing rate updates and payment policies that, collectively, the agency estimates will result in average MA plan revenues declining 0.16% in […]
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March 6, 2024

EGWP Medicare

legislation

CMS Announces First Model to Negotiate Outcomes-Based Arrangements with Cell and Gene Therapy Manufacturers for Medicaid

In response to CGT affordability concerns, on Jan. 30, CMS announced that sickle cell disease (SCD) will be the first focus of a new voluntary model designed to tie the cost that state Medicaid programs pay for CGTs to improved health outcomes. Via the CMS Innovation Center, the agency plans to negotiate outcomes-based arrangements (OBAs) […]
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March 6, 2024

medicaid

legislation

The Cigna Group Responds to Sen. Cassidy RFI on Cell and Gene Therapies

On Jan. 22, The Cigna Group responded to a request for information (RFI) regarding cell and gene therapies (CGTs) from Sen. Bill Cassidy (R-LA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee. The RFI sought information on a broad range of topics including coverage and reimbursement practices; plan and payer […]
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March 6, 2024

medicaid

legislation

House Committee Hearing on Health Care Spending

The House Committee on Energy & Commerce’s Health Subcommittee held a hearing on health care spending in the U.S., with witnesses from the Congressional Budget Office (CBO), Families USA, New Jersey State Policemen’s Benevolent Association, American Enterprise Institute, and the Health Care Cost Institute. The discussion ranged from the need for more price transparency for […]
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March 6, 2024

medicaid Medicare

legislation

Colorado Prescription Drug Affordability Review Board (PDAB) Moves Forward on Upper Payment Limits

Last week, the Colorado PDAB voted to proceed with establishing an Upper Payment Limit (UPL) on Enbrel, a rheumatoid arthritis drug. This is the first instance of a state PDAB establishing a UPL for any drug. The UPL, if it withstands anticipated legal challenges and takes effect, will establish a maximum price that can be […]
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March 6, 2024

marketplace

legislation

Senator Grassley Calls on FTC and PBMs to Complete Study

Sen. Chuck Grassley (R-IA) is calling on Majority Leader Chuck Schumer (D-NY) to immediately hold floor votes on PBM reform bills passed by key committees throughout 2023, noting a lackluster update Federal Trade Commission (FTC) Chair Lina Khan sent in response to his earlier request for an update on the FTC’s investigation into common PBM […]
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March 6, 2024

medicaid

legislation

The Cigna Group Comments on MA and Part D Proposed Rule

On Jan. 5, The Cigna Group submitted comments in response to the 2025 MA and Part D Program Policy and Technical Changes proposed rule. We offered detailed comments and discussion around CMS’ proposed changes to broker compensation and recommended CMS not finalize its proposals at this time, but rather work with stakeholders to gather more […]
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January 10, 2024

Initiatives

New On “Whats Possible Health” 

Recently, health policy debates on drug pricing have led to important questions about the PBM business model and how the value they create reaches patients.
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October 21, 2023

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