Section 340B

News & Analysis as of

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

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

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

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

Potential Part B Drug Payment Cuts for 340B Hospitals

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

Blog: Key Health-Related Provisions Tucked into Year End Spending Bill

Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion...more

Health Update - December 2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

MedPAC Assesses Payment Adequacy for Medicare Services and Status of Medicare Advantage Program

On December 10-11, 2015, the Medicare Payment Advisory Commission (MedPAC) held a public meeting to report on the status of a number of Medicare payment systems, and to develop draft recommendations for payment updates that...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming...more

OIG Reports on, Proposes Alternatives to Medicare Part B Reimbursement for 340B Drugs

In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more

OIG Proposes Alternative Part B Payment Methodologies for 340B Drugs: Is This the End of 340B As We Know It?

Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program. The means of delivery was an OIG Report on Medicare Part B payments for 340B drugs which...more

OIG Examines Medicare Part B Payments for 340B Purchased Drugs

A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program. The OIG describes the report as “an independent analysis to inform the ongoing...more

HHS Posts Fall 2015 Regulatory Agenda Listing Rules in Pipeline

The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda includes numerous pending HHS proposed...more

OIG Report Examines Potential Scenarios for Restructuring 340B Program

Restructuring the 340B Drug Discount Program and Part B payment rules could reduce Medicare drug expenditures by up to $1.1 billion, the HHS Office of Inspector General (OIG) reported last week. The 340B Program requires...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

MedPAC Met to Discuss Part B Drug Payment Policies and Other Issues

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

Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more

Hello Budget Agreement; Goodbye Provider-Based Status?

H.R. 1314, the Bipartisan Budget Act of 2015, was signed into law by President Obama on November 2, 2015. The two-year budget framework, which raises the federal debt limit through March 2017, partially rolls back the Budget...more

Passage of the Bipartisan Budget Act: What You Should Not Do Now

Tips on preserving the provider-based status for existing clinics. The Bipartisan Budget Act of 2015 (H.R. 1314) was signed into law on Monday, November 2. Notwithstanding significant concerns raised by the hospital...more

Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Health Care Update - October 2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

New Budget Bill May Signal End of Provider-Based Status

Hospitals that seek to establish provider-based OPDs should complete their work soon. A near-final discussion draft of a House budget bill, which the White House has apparently agreed to in principle, would end the...more

Proposed Budget Deal Would Add Medicaid Inflation Rebates for Generic Drugs

As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes...more

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

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