On August 12, 2021, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in holding that the “objective reasonableness” standard for determinations of scienter, as set forth by the Supreme Court in Safeco Insurance Co. of America v. Burr, 551 U.S. 47, 70 (2007), applies in the context of False Claims Act (FCA) … Continue Reading
The House of Representatives has approved — without objection — a series of bills intended to promote prescription drug pricing transparency and invest in the health care workforce. With regard to drug pricing transparency, the House approved HR 2115, the Public Disclosure of Drug Discounts Act, as amended to include HR 3415, the Real-Time Beneficiary … Continue Reading
Three House committees have approved drug pricing legislation that is a high priority of the House Democratic leadership. Specifically, HR 3, the Lower Drug Costs Now Act of 2019, has been approved by the Energy and Commerce Committee, the Ways and Means Committee, and the Education and Labor Committee. While the details of the committee-approved … Continue Reading
October Congressional hearings have focused on the following health policy topics: A House Ways and Means Committee hearing addressed “Investing in the U.S. Health System by Lowering Drug Prices, Reducing Out-of-Pocket Costs, and Improving Medicare Benefits.” A House Energy and Commerce Committee hearing, “Sabotage: The Trump Administration’s Attack on Health Care,” featured testimony from CMS … Continue Reading
On September 25, 2019, the House Energy and Commerce Committee is holding a hearing entitled “Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans.” A background memo and text of the bills are available here. Likewise, a second House panel – the Education and Labor Health, Employment, Labor, and Pensions Subcommittee … Continue Reading
Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including: surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others. The following are highlights of recent action. Note that none of the bills … Continue Reading
The House of Representatives has approved H.R. 987, the “Strengthening Health Care and Lowering Prescription Drug Costs Act,” which packages seven prescription drug and insurance-related bills recently approved by the House Energy and Commerce Committee. The legislation is intended to: increase generic drug competition; fund Affordable Care Act “Navigator” outreach and enrollment programs and state-based … Continue Reading
Recent Congressional hearings and markups have concentrated on prescription drug pricing, insurance access, and other health topics. For instance, last week the House Ways and Means Committee unanimously approved H.R. 2113, the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act of 2019 (STAR Act). The legislation would, among other things: Require drug manufacturers to report their … Continue Reading
Reducing prescription drug prices is a major theme in the Trump Administration’s fiscal year (FY) 2020 budget proposal, with policies intended to increase competition, encourage better negotiation, incentivize lower list prices, and cut out-of-pocket costs for beneficiaries. The Administration’s projected savings from its designated prescription drug budget proposals top $69 billion over 10 years, although … Continue Reading
As we have previously reported, prescription drug pricing is an early focus for Congressional hearings this year. This week the Senate Finance Committee held its second hearing on drug pricing, and the following hearings are on the schedule next week: On March 7, 2019, the Ways and Means Health Subcommittee is holding a hearing entitled … Continue Reading
Federal health policy is an early focus for Congressional committees. In addition to several hearings held in January, Congressional hearings in February have concentrated on the Affordable Care Act (ACA) and primary care, including the following: A House Energy and Commerce Committee hearing on the Texas v. United States court case challenging the constitutionality of … Continue Reading
As the new 116th Congress gets underway, four House and Senate committees are holding hearings to examine health policy issues, including two hearings focusing on prescription drug prices. Specifically, the following hearings are all scheduled for January 29, 2019: A Senate Finance Committee hearing on “Drug Pricing in America: A Prescription for Change, Part I,” … Continue Reading
The Trump Administration is considering a controversial plan, the International Pricing Index (IPI) model, which would tie Medicare Part B prescription drug payment rates to amounts paid for such drugs in other developed countries. The Centers for Medicare and Medicaid Services’ proposed IPI model also would replace the current “buy and bill” system for Part … Continue Reading
After multiple implementation delays, the Health Resources and Services Administration (HRSA) now seeks to move up the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). By way of background, HRSA most recently delayed implementation of the 2017 rule because the Trump Administration was “developing … Continue Reading
The House of Representatives approved two “gag clause” bills on September 25, 2018 that would prevent insurers from restricting pharmacies from informing consumers about lower cost, out-of-pocket prices for their prescriptions. The bills were approved by the Senate earlier this month, and are now cleared for the President’s signature. Specifically, S 2553, the Know the … Continue Reading
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor … Continue Reading
The Health Resources and Services Administration (HRSA) is once again delaying the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). Specifically, under a final rule published June 5, 2018, HRSA is pushing back the 340B ceiling price/CMP rule’s effective date for an … Continue Reading
As previously reported, the Trump Administration has released its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.” Many of the recommendations in the Blueprint were previously made in President Trump’s fiscal year 2019 budget proposal, while numerous others are framed as open-ended questions rather than policies. While the near-term impacts on drug pricing based … Continue Reading
The Trump Administration has launched a high-profile initiative aimed at reducing prescription drug prices, including release of a blueprint containing a series of short- and long-term policy proposals and a request for public comments on additional reforms. First, on May 11, 2018 the Department of Health and Human Services released its “Blueprint to Lower Drug … Continue Reading
HHS Secretary Alex Azar has appointed two advisors to help advance Department strategy to address prescription drug pricing and the opioid crisis. Daniel M. Best, the new Senior Advisor to the Secretary for Drug Pricing Reform, is charged with leading the HHS initiative to lower the cost of prescription drugs. He recently served as Corporate … Continue Reading
The Trump Administration has released its fiscal year (FY) 2019 budget proposal, which includes extensive health policy provisions. While most of the President’s policy proposals for Department of Health and Human Services (HHS) programs would require Congressional approval, others are characterized as administrative proposals that presumably would not involve Congress.… Continue Reading
This month, Congressional committees held a number of hearings that focused on health policy issues, including the following: House Energy & Commerce Committee hearings on the drug supply chain and patient brokering/addiction treatment fraud. Senate Health, Education, Labor, and Pensions (HELP) Committee hearings on the cost of prescription drugs and implementation of the 21st Century … Continue Reading
Recent Congressional hearings focusing on health policy issues include the following: House Energy and Commerce Committee hearings on how covered entities use the 340B drug pricing program, ways to address the opioid crisis, FDA’s Expanded Access Program, and HHS’s public health preparedness for and response to the 2017 hurricane season. Senate Health, Education, Labor, and … Continue Reading
House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following: A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay,” the first of three planned hearings on prescription drug costs. A … Continue Reading
