On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more
On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more
On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more
Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost than evidence generated...more
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
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
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
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
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
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
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
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
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
On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more
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
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Pricing ,
FDA Approval ,
Healthcare Reform ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Life Sciences ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Most-Favored Nations ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Vaccinations
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
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
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
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
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
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
Through several recently published rules, the Centers for Medicare & Medicaid Services (CMS) is making it possible for Medicare beneficiaries to have greater access to health care services provided remotely through telehealth...more
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
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
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
10/24/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Compelled Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Registration Requirement ,
Regulatory Oversight ,
Television Commercials ,
Trump Administration