News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) Centers for Medicare & Medicaid Services Pharmaceutical Industry

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -

Capitol Hill Healthcare Update

by BakerHostetler on

The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump’s nominee to be Health & Human Services (HHS) secretary. Trump announced...more

Manatt on Health: August 2017

Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more

340B Update: CMS Proposes to Reduce 340B Drug Reimbursement; Draft Executive Order Could Mean Further Changes to the 340B Program

by K&L Gates LLP on

The Trump administration is considering significant changes relating to the 340B Drug Pricing Program (“340B Program”), which allows certain categories of safety net providers to access discounted pricing on covered...more

Ten Things Investors Need to Know About Value-Based Healthcare

by Ropes & Gray LLP on

This article highlights key business and legal issues related to value-based healthcare for investors considering opportunities in the healthcare industry. 1. Value-Based Arrangements Are Here to Stay Value-based...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

"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

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

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

What the Administration Actually Can Do on Drug Pricing

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

by Mintz Levin on

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

by Foley & Lardner LLP on

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

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

by Morgan Lewis on

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

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

by King & Spalding on

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

Washington Healthcare Update

by McGuireWoods LLP on

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

Manatt on Health Reform: Weekly Highlights - November 2015 #2

With the election of a new Governor, the future of Kentucky’s Marketplace and Medicaid expansion is uncertain; CMS questions Iowa on its Medicaid managed care transition timeline; and the Supreme Court agrees to hear a case...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Also In The News - Health Headlines - July 2015

by King & Spalding on

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

by King & Spalding on

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

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