Tag Archives: 340B

CMS Finalizes Reimbursement Cuts for 340B Hospitals

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its earlier proposal to significantly reduce Medicare reimbursement for separately payable outpatient drugs purchased by hospitals under the 340B program.  The final rule … Continue reading this entry

Proposed Rule Would Slash Medicare Payment for 340B Drugs

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six percent to ASP minus 22.5%.  This reimbursement cut — almost 30% in the aggregate— would significantly reduce the savings available to … Continue reading this entry

340B Program Omnibus Guidance Withdrawn

omnibus guidance
The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have … Continue reading this entry

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased … Continue reading this entry

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have … Continue reading this entry

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the … Continue reading this entry

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

Please note, Cheryl Storey, CPA with Moss Adams LLP is also a co-author of this post. CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will  be published in the Federal Register on July 14, 2016. One highly-anticipated section of the Proposed Rule … Continue reading this entry

340B Program Update

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 of the publication of a Medicaid Covered Outpatient Drug Final Rule (“Final Rule”), the Centers for Medicare and Medicaid … Continue reading this entry

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 in the 340B Drug Pricing Program (340B Program). Currently, hospitals are paid the same rate by Medicare for drugs whether … Continue reading this entry

Transforming Oncology Care: What’s Working and What Lies Ahead

Oncology providers and payors are undertaking bold initiatives to transform our system of “sick” care into a component of the value-based system of the future. The evolving system focuses on proactively monitoring and coordinating care by a team of providers working in concert to deliver care more efficiently and keep patients healthier. From payment changes … Continue reading this entry

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 key initiatives related to the 340B Program.… Continue reading this entry

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Regulatory-Developments
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Dug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when purchasing orphan drugs for a non-orphan use. In addition to its significant financial impact on hospital covered entities subject to the rule, … Continue reading this entry

Kickoff Call: 340B Drug Pricing Program Covered Entity Coalition

Foley has scheduled a call on Thursday, September 24, 2015 at 8am PST/10am CST/11am EST to convene 340B Program covered entities that may be interested in forming a “coalition” to develop a response to HHS/HRSA’s recently proposed comprehensive 340B Program guidance, beginning with (but not necessarily limited to) the preparation of comments on the guidance. Interested … Continue reading this entry

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new – guidance for 340B Drug Pricing Program (340B Program) covered entities (including providers such as disproportionate share hospitals, critical access hospitals, … Continue reading this entry

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June 17, 2015. The proposed rulemaking, required under the Affordable Care Act, address 340B drug ceiling price calculations and penalties that may be imposed … Continue reading this entry

CMS Proposes Major Update to Medicaid Managed Care Regulations

The Centers for Medicare and Medicaid Services (“CMS”) released, on May 26, 2015, the a far-ranging proposal for revising the Medicaid managed care regulations (“Proposed Rule”).  The number of individuals enrolled in Medicaid managed care plans has increased to over 40 million. Federal Medicaid managed care regulations have not been substantially revised since they were issued … Continue reading this entry

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs:" Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been drafted by HHS and sent to the White House Office of Management and Budget for review in April, but had not been made available … Continue reading this entry

340B Drug Pricing Program Interpretative Rule Survives (for Now)

Preparing for the Conversion to ICD-10
A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance of regulations for the 340B Drug Pricing Program (the 340B Program). The dispute relates narrowly to the 340B Program’s treatment of orphan drugs purchased by … Continue reading this entry

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain hospital covered entities participating in the 340B Drug Pricing Program (340B Program). The new rule is available on HRSA’s website, and … Continue reading this entry

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

Regulatory-Developments
A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not been granted authority by Congress to issue the regulation. While the invalidated regulation addressed a narrow issue applicable only to certain 340B … Continue reading this entry