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
Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues. Today President-elect Trump’s transition team released … Continue Reading
A number of recent Congressional hearings have focused on health policy issues, including: Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics. A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” … Continue Reading
A number of Congressional committees have recently considered legislation and/or held hearings on various health policy proposals. The Ways and Means Committee approved seven bills related to health care coverage and tax policy, including various bills to: expand access to health reimbursement arrangements and health savings accounts; ease employer insurance coverage mandates for students and … Continue Reading
A number of recent Congressional hearings have focused on health policy topics, including the following: A House Energy and Commerce Subcommittee on Health hearing on “Medicare Access and CHIP Reauthorization Act of 2015: Examining Physician Efforts to Prepare for Medicare Payment Reforms.” A House Judiciary Constitution and Civil Justice Subcommittee hearing on oversight of the False … Continue Reading
The Senate Special Committee on Aging recently held a hearing on the status of efforts to find a cure for Alzheimer’s disease, and the panel plans an April 27, 2016 hearing to examine prescription drug price increases. In addition, the House Education and Workforce Subcommittee on Health plans an April 14 hearing entitled “Innovations in … Continue Reading
Congressional committees have held hearings recently on various health policy issues, including: Energy and Commerce Committee hearings on CMS implementation of the Medicare physician fee schedule reform provisions included in the Medicare Access and CHIP Reauthorization Act (MACRA), financing and delivery of long-term care, and the public health response to the Zika virus. A Ways … Continue Reading
Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes should be enacted in connection with repealing and replacing “ObamaCare.” Specifically, the plan states that Congress must: Remove barriers to … Continue Reading
The Senate HELP Committee is holding a January 28, 2016 hearing on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.” Separately, on February 4, the House Committee on Oversight and Government Reform has scheduled a hearing on “Developments in the Prescription Drug Market: Oversight.” Other recent Congressional health policy hearings have included … Continue Reading
CMS has posted the payment amounts that will apply to Medicare Part B covered drugs for the first quarter of 2016. According to CMS, prices for the top Part B drugs increased by 0.9% on average compared to the previous quarter, with prices for 17 of the top 50 drugs decreasing and four remaining the … Continue Reading
A number of recent Congressional hearings have focused on health policy issues, including the following: A Senate Special Committee on Aging hearing titled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines.” A Senate Health, Education, Labor & Pensions Committee hearing on “Opioid Abuse in America: Facing the Epidemic and Examining Solutions.” A … Continue Reading
Several Congressional hearings are scheduled next week and into December on health policy issues, including: A November 17 Senate Finance Committee hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” A November 17 House Judiciary Subcommittee on Regulatory Reform hearing on “The State of Competition in the Pharmacy Benefit Manager and Pharmacy … Continue Reading
On November 20, 2015, the Department of Health and Human Services (HHS) is hosting a public forum in Washington DC to explore pharmaceutical innovation, access, affordability and better health. While attendance is by invitation only, an invitation can be requested by contacting hhspharmforum@mitre.org. There will also be a live webcast of the event.… Continue Reading
Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading
The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading
Recent Congressional health policy hearings have addressed the following issues: The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on generic drug pricing; The House Oversight and Government Reform Committee focused on its concerns associated with transparency in passage and implementation of the Affordable Care Act in a hearing featuring CMS Administrator Marilyn … Continue Reading
