News & Analysis as of

Drug Pricing

President's Budget on Health Care: Entitlement Reform, Opioid Funding, and Cuts to Health Programs

by Baker Donelson on

Note: All fiscal estimates cited over a ten-year budget window refer to the Fiscal Year 2019-2028 budget window. The President's fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS)...more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

340B Update: Trump Administration’s 2019 Budget and White House Council of Economic Advisors Signal Further Changes to 340B...

by K&L Gates LLP on

On February 12, 2018, the Trump Administration released its fiscal year (“FY”) 2019 budget request to Congress outlining several proposals related to the 340B Drug Pricing Program (the “340B Program”) including a modification...more

2019 White House and HHS Budgets Released: Key Changes to Drug Pricing and Reimbursement Proposed

by Hogan Lovells on

On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more

Senator Collins to Propose Legislation to Lower Drug Costs

by Goodwin on

After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the...more

White House Unveils Proposal on Drug Pricing

by Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Health Care Weekly Preview from ML Strategies – February 2018 #2

We closed last week with a budget deal that addressed nearly every health care stakeholder issue. With 2017 finally over, we begin 2018 with the next budget. This week the Administration will release its FY 2019 budget and...more

Blog: Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

by Cooley LLP on

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are...more

Health Care Weekly Preview from ML Strategies – February 2018

This week, we are back doing a familiar two-step with Congress needing to pass a government-funding bill by Thursday. For all the issues in the health space that need to be addressed this week, it is eerily quiet out there....more

Capitol Hill Healthcare Update

by BakerHostetler on

Congress is expected this week to approve a fifth stopgap budget bill to keep the government open in advance of a Thursday shutdown deadline, and key healthcare provisions could be included in the budget package. If...more

2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better

by Blank Rome LLP on

Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug...more

AGG Food and Drug Newsletter - January 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Drug Pricing May Return to HHS Agenda in 2018

by Baker Donelson on

Despite President Trump's pledge to rein in prescription drug pricing, the Administration did not take substantial action to address this issue in 2017. With the expected confirmation of Alex Azar – who is a former Eli Lilly...more

Continued Contention over CMS 340B Drug Payment Policy

by Baker Donelson on

In a major development last fall, the Centers for Medicare and Medicaid Services (CMS) finalized its proposal to pay hospitals less for certain physician-administered drugs purchased through the 340B Drug Discount Program....more

Sick of woes with Big Pharma, hospitals moving to make own generic drugs

Some big hospitals and hospital chains are on the brink of expanding into another aspect of health care. Let’s give them a rare cheer, because they’re taking on Big Pharma and its skyrocketing drug prices and too frequent...more

House Energy and Commerce Report Recommends Reform and Increased Oversight of the 340B Drug Pricing Program

by King & Spalding on

On January 10, 2018, the House Energy and Commerce (E&C) Committee released a report calling for major reforms to the 340B Drug Pricing Program (340B program). Administered by the Health Resources and Services Administration...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

Drug Pricing Continues to be a Hot Topic for State Legislatures

by Arnall Golden Gregory LLP on

Due to the recent significant increases in certain drug prices that have led to allegations of “price gouging” and antitrust violations, several state legislatures have enacted new laws aimed at controlling prescription drug...more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served...more

Manatt on Health: What’s Ahead in 2018

Congress returned from recess with a large agenda for the new year. The federal government is only funded through January 19 and the next funding bill is expected to carry with it longer-term extensions of the Children’s...more

CMS imposes massive cuts on 340B program; Hospital associations’ legal challenge dismissed

by Bricker & Eckler LLP on

On November 1, 2017, CMS issued a final rule that became effective January 1, 2018, under which hospitals serving a disproportionate share of low-income patients (DSH hospitals) will receive nearly 27 percent less in...more

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