News & Analysis as of

Prescription Drugs Centers for Medicare & Medicaid Services

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

SEC and U.S. Attorney’s Office Continue Their Pursuit of Criminal Actions Against Purveyors of “Political Intelligence”

by Foley & Lardner LLP on

On May 24, 2017, the United States Attorney’s Office for the Southern District of New York and the Securities and Exchange Commission (SEC) launched their latest criminal and civil salvos against prohibited insider trading by...more

Manatt on Health Reform: Weekly Highlights - June 2017

House Ways and Means Committee advances three discrete healthcare bills as part of the broader repeal and replace effort; Nevada sends Medicaid-for-all legislation to the Governor; and New York requires insurers to remain in...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a profound impact on the pharmaceutical industry. And with the Centers for...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Hogan Lovells partner Alice Valder Curran teams up with Robert Spurr of Novartis to outline the challenges and share potential solutions to consider when entering into value-based pricing arrangements. Adoption of...more

OIG Issues Top 25 Unimplemented Cost-Savings and Quality-Improvement Recommendations for HHS Programs

by Reed Smith on

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released the 2017 edition of its Compendium of Unimplemented Recommendations (“Compendium”). In the Compendium, OIG identifies...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

"Double Dip" Effectively Approved by Center for Medicare and Medicaid Services

by Hogan Lovells on

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

Seventh Circuit Grants Interlocutory Appeal in Rx Discount Program Qui Tam Suit to Answer Several Important Questions

by Ropes & Gray LLP on

In United States ex rel. Garbe v. Kmart Co., 824 F.3d 632 (7th Cir. 2016), the Seventh Circuit granted interlocutory appeal following numerous motions for partial summary judgment to consider four questions: (1) whether the...more

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

Blog: Medicare Part B Demo Declared Dead

by Cooley LLP on

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from...more

What a Trump Administration Could Mean for the 340B Drug Program

by K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

CMS Releases the First Comprehensive Overhaul of Nursing Home Conditions of Participation in Over 25 Years

by Ruder Ware on

On October 4, 2016, the Center for Medicare and Medicaid Services (CMS) published a final rule to revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. CMS...more

Manatt on Health Reform: Weekly Highlights - October 2016 #2

Kentucky receives final approval from CMS to transition its Marketplace to the HealthCare.gov platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more

House Bill Would Block CMS Proposed New Payment Model for Part B Drugs

by King & Spalding on

The Congressional Budget Office (CBO) released a report on October 4, 2016, estimating that a bill in the U.S. House of Representatives to block the implementation of CMS’s proposed payment model for Part B drugs would cost...more

Manatt on Medicaid: Monthly Expansion Recap - September 2016

National News - Growth in Prescription Drug Spending Not Linked to Medicaid Expansion, Study Finds - Medicaid expansion was not likely a “major driving force” behind the record high drug spending growth in 2014,...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

by Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Medicare Plan Finder to Indicate which MA, Part D Plans Have Been Sanctioned

by King & Spalding on

CMS revealed last week that Medicare Plan Finder soon will note for users whether a Medicare Advantage plan or Part D prescription drug plan has been sanctioned. The Medicare Plan Finder is an online tool that allows...more

Manatt on Health Reform: Weekly Highlights - September 2016 #2

CMS denies Ohio’s Medicaid 1115 waiver request citing the State’s premium proposal; HHS will use 2015 risk corridors collections for remaining 2014 payments; and Alabama closes its Medicaid budget shortfall....more

2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years. With several insurers...more

Manatt on Health Reform: Weekly Highlights - August 2016 #5

A federal report finds that Marketplace premiums are lower in expansion states; Massachusetts and Pennsylvania launch prescription drug monitoring systems; and Kentucky submits a slightly modified Medicaid expansion waiver to...more

Manatt on Medicaid: Monthly Expansion Recap - August 2016

California - Medicaid Enrollees Are Largest Share of Newly Insured - A new survey from the Kaiser Family Foundation found that 33% of Californians uninsured in 2013 are now enrolled in Medi-Cal, the State’s Medicaid...more

GAO Calls For Mandatory Medicare Drug ASP Reporting, CMS Verification of Drug Pricing

by Reed Smith on

A recent Government Accountability Office (GAO) report, “Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs,” questions the reliability of pricing for Medicare...more

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