On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more
8/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Price Inflation ,
Rebates ,
Section 340B
On October 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to conduct market research regarding the “availability and potential technical ability of health-care related...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).
How can stakeholders respond to, implement, and comply...more
On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more
On June 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued instructions for the process by which a manufacturer may submit a request for a qualifying single-source drug to be considered for the Small Biotech...more
On May 12, 2023, the Centers for Medicare & Medicaid Services (CMS) issued Draft Guidance on the Part D Manufacturer Discount Program (“Discount Program”)—a key component of the Part D Redesign provisions of the Inflation...more
On May 11, the U.S. Senate Committee on Health, Education, Labor and Pensions (the “HELP Committee” or the “Committee”) passed a bipartisan bill to expand federal regulation of pharmacy benefit managers (“PBMs”) for group...more
The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.
What key compliance issues must industry stakeholders consider as these provisions are put...more
On April 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an Information Collection Request (ICR) addressing the “Drug Price Negotiation Process” for the Medicare Drug Price Negotiation Program, including...more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
The Centers for Medicare & Medicaid Services (CMS) has issued an information collection request (ICR) addressing the collection of data elements CMS must use to determine its offer amount when negotiating a selected drug’s...more
IRA Provision: The Medicare Drug Price Negotiation Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more
IRA Provision: The Medicare Prescription Drug Inflation Rebate Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and a list of 27 Part B “rebatable drugs”...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D...more
On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more
Impact on Pharmacies, Part D Payors, Pharmacy Benefit Managers, and Drug Manufacturers -
On April 29, 2022, the Centers for Medicare and Medicaid Services (CMS) issued its final rule, Medicare Advantage and Part D Final...more
On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”)....more
12/6/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Gag Clauses ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules
On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more
On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more
1/5/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Generic Drugs ,
Hospitals ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Proposed Rules
The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service,...more
On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more