Prescription Drugs Centers for Medicare & Medicaid Services

News & Analysis as of

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

Health Care Outlook for 2016

In 2016, the Affordable Care Act will continue to be a contentious issue involving opposing legislative efforts and presidential debates. It has already been a major talking point in the campaigns of multiple 2016...more

Also In The News - Health Headlines - January 2016 #3

CMS Finalizes Medicaid Prescription Drug Rule – On January 21, 2016, CMS finalized a rule detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs, which the agency estimates “will save...more

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

CMS Issues Final Rule on Covered Outpatient Drugs

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

The Challenge of Non-Interference

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator. Essentially, they are without...more

Manatt on Health Reform: Weekly Highlights - January 2016 #3

Louisiana's Governor pushes ahead on Medicaid expansion, while expansion is blocked by Wyoming's Legislature; Massachusetts plans to submit a 1332 waiver application to preserve its merged markets; and CBO lowers its 2016...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

CMS Releases Long-Awaited Final Medicaid Covered Outpatient Drug Rule

After months of speculation and waiting, CMS yesterday released its final rule to revise Medicaid reimbursement for covered outpatient drugs and reform Medicaid drug rebate requirements. While we are still digesting what the...more

Health Update - December 2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

Washington Healthcare Update

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more

Health Care Advisory: Highlights of the OIG’s 2016 Work Plan

On November 2, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its Work Plan for Fiscal Year 2016 (“2016 Work Plan”).1 The 2016 Work Plan outlines the areas of...more

Also In The News - Health Headlines - November 2015 #5

GAO Releases Report on Increasing Medicare Part B Prescription Drug Prices – On November 20, 2015, the Government Accountability Office (GAO) released a report on costs for new Medicare Part B drugs. The GAO found that...more

GAO Examines Trends in Medicare Part B Expenditures for New Drugs and Biologicals

The Government Accountability Office (GAO) has issued a report describing trends in Medicare Part B spending and utilization for “new” drugs and biologicals (approved by the FDA from 2006 through 2013). The GAO’s analysis is...more

CMS Finalizes 2016 HCPCS Update

CMS has posted its final Level II HCPCS application determinations for 2016, addressing applications for new and revised codes for DMEPOS, surgical supplies, drugs, biologicals, radiopharmaceuticals, and radiologic imaging...more

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Washington Healthcare Update

Bicameral Bill Introduced to Provide HHS Authority to Reject Proposed Insurance Rates - Before Congress left for its Columbus Day recess, Rep. Jan Schakowsky (D-IL) and Sen. Diane Feinstein (D-CA) introduced the Health...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

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