Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more
As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more
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
In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more
On October 6-7, 2016, the Medicare Payment Advisory Commission (MedPAC), a federal agency that advises Congress on Medicare pay policies, held a public meeting, with one session titled “Biosimilars in Medicare Part D.” This...more
In June, the Medicare Payment Advisory Commission (MedPAC) released their final annual report to Congress detailing recommendations on a variety of Medicare payment system issues....more
McCarter & English, LLP’s Health Care Group presents Issue 8 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - New Payment Model for Part B Drugs Proposed -...more
This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more
On March 15, 2016, the Medicare Payment Advisory Commission (MedPAC) released its latest report to Congress that included 340B Implications for Medicare Part B Drugs along with a quick fact sheet regarding the report. Key...more
Proposed Rule - Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether...more
The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels...more
For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more
The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating...more
On November 5 and 6, 2015, MedPAC held its monthly meeting in Washington, D.C. to discuss Medicare issues and policy questions, develop and approve reports, and make recommendations to Congress. Among the topics discussed...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
On October 26, 2015, Congressional and White House budget negotiators released the legislative text of the Bipartisan Budget Act of 2015. The Act is aimed primarily at lifting the Federal debt limit and avoiding a looming...more
Cuts in Mandatory Entitlement Programs Center of Budget Negotiations: As budget negotiators from both sides of the Hill come together to work out a two-year budget deal, determining how sequestration relief will be paid for...more
On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more
This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more
The Medicare Payment Advisory Commission (MedPAC) released its “Report to the Congress: Medicare and the Health Care Delivery System” on June 15, 2015. As previously reported, the report makes recommendations for policy...more
In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more