Stuart Langbein on Centers for Medicare & Medicaid Services (CMS)

Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway...more

8/14/2024 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Medicare

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

7/30/2024 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Manufacturers , Medicare Part B , OIG , Pharmaceutical Industry , Popular , Prescription Drugs

Tortoise and Hare: Congress may overtake CMS in years-long race to set Medicare breakthrough device coverage

On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare beneficiaries one step closer to timely...more

7/3/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Medical Devices , Medicare , Medicare Administrative Contractors (MAC)

CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more

7/5/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Popular , Prescription Drugs

A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies (TCET) pathway. 88 Fed. Reg. 41,633 (Jun. 27,...more

6/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medical Devices , Medicare

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to evaluate changes to the criteria for clinical...more

2/23/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare

CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of 2022...more

2/14/2023 / Centers for Medicare & Medicaid Services (CMS) , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs

World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more

6/30/2022 / Biotechnology , Center for Biologics Evaluation and Research (CBER) , Centers for Medicare & Medicaid Services (CMS) , FDA Approval , Food and Drug Administration (FDA) , Health Care Providers , Medicare , Regenerative Medicine

Panelists discuss present & future reimbursement mechanisms for AI health care products

At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Stuart Langbein moderated a panel discussion on AI policy and reimbursement issues. Joined by representatives from CMS Medicare Administrative...more

6/29/2022 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicaid , Medicare , Medicare Administrative Contractors (MAC)

Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of Innovative Technology (MCIT) and...more

5/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Medical Devices , Medicare , Medicare Part A , Medicare Part B , Reasonable and Necessary Expenses

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

3/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , FDA Approval , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Medical Devices , Medicare , Pharmaceutical Industry

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and...more

1/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Health Technology , Healthcare Reform , Medical Devices , Reasonable and Necessary Expenses

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Medicare links Part B payment rates to international prices: Most Favored Nation Model

On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more

11/24/2020 / Biologics , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Drug Pricing , Health Insurance , Healthcare Reform , Interim Final Rules (IFR) , Medicare Part B , Most-Favored Nations , Pharmaceutical Industry , Prescription Drug Coverage , Reimbursements

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

11/20/2020 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare Reform , Regulatory Agenda , Regulatory Flexibility Act , Regulatory Requirements , Rulemaking Process , Sunset Provisions

CMS proposes “reasonable and necessary” definition, expedited breakthrough device coverage process

On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more

9/2/2020 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Insurance , Healthcare Reform , Medical Devices , Medicare , Medicare Program Integrity Manual (MPIM) , Pharmaceutical Industry , Regulatory Standards , Scope of Coverage

CMS Innovation Center seeks input on Oncology Care Model sequel

In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM). ...more

11/8/2019 / Bundled Services , Cancer , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Health Care Providers , Healthcare Reform , Life Sciences , Payment Methods , Regulatory Agenda , Regulatory Requirements , Request For Information , Rulemaking Process

CMS Radiation Oncology Model proposed rule – summary and early insights

Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (RO Model), which would make fundamental (but temporary) changes to the...more

7/19/2019 / Bundled Payments , Cancer , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Health Insurance , Life Sciences , Medicare , Physician Medicare Reimbursements , Proposed Rules , Rulemaking Process

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

4/29/2019 / Add-ons , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Life Sciences , Long Term Care Facilities , Medical Devices , Payment Systems , Regulatory Agenda , Request For Information , Rulemaking Process

CMS releases annual health insurance exchanges final rule

On 18 April 2019 the Centers for Medicare & Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters final rule for 2020 (2020 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more

4/23/2019 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Health Insurance , Health Insurance Exchanges , Qualified Health Plans

CMS considers linking Medicare drug payment rates to international prices

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more

10/30/2018 / Advanced Notice of Proposed Rulemaking (ANPRM) , Biologics , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , Pharmaceutical Industry , Physician Medicare Reimbursements , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump yesterday touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on...more

10/26/2018 / Advanced Notice of Proposed Rulemaking (ANPRM) , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Healthcare Reform , Medicare , Medicare Part B , Pharmaceutical Industry , Physician Medicare Reimbursements , Prescription Drugs

CMS Releases Major MA/Part D Proposed Rule

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

11/27/2017 / Biologics , Centers for Medicare & Medicaid Services (CMS) , Generic Drugs , Health Insurance , Medicare , Medicare Part D , Pharmacies , Prescription Drug Coverage , Prescription Drugs

Slow but Steady: CMS Proposes to Simplify and Slow Down the Quality Payment Program Rollout

On Tuesday, June 20, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to continue the rollout of the Quality Payment Program (QPP), an initiative to adjust Medicare payments to eligible clinicians...more

6/26/2017 / Alternative Payment Models (APM) , CEHRT , Centers for Medicare & Medicaid Services (CMS) , Electronic Health Record Incentives , Medicare Access and CHIP Reauthorization (MACRA) , MIPS , Quality Payment Program (QPP)

Stuart Langbein

Hogan Lovells

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