HRSA Announces Application Process for the 340B Rebate Model Pilot Program and Request for Public Comment

August 5, 2025

HRSA Announces Application Process for the 340B Rebate Model Pilot Program and Request for Public Comment

The Health Resources and Services Administration (HRSA) recently announced the availability of a voluntary 340B Rebate Model Pilot Program for drugs on the CMS Medicare Drug Price Negotiation Selected Drug List for year 2026 from qualifying manufacturers meeting specific criteria.

HRSA is introducing this pilot program to test the rebate model on these drugs in a methodical and thoughtful approach to ensure a fair and transparent 340B rebate model process. HRSA is implementing this pilot to better understand the merits and shortcomings of the rebate model from the perspective of affected stakeholders, and to help shape any future 340B rebate models that align with the 340B statute and the Administration’s goals.

Click Here to Read Press Release and Learn More

CMS Seeks Comment – Proposal to Reimburse for Drug Administration Services Furnished in Excepted Off-Campus PBDs at a Physician-Equivalent-Rate, Comment by September 15

August 5, 2025

CMS Seeks Comment – Proposal to Reimburse for Drug Administration Services Furnished in Excepted Off-Campus PBDs at a Physician-Equivalent-Rate, Comment by September 15

Drug Administration includes the intravenous or intramuscular administration of a range of medicines. This proposal would not be budget neutral.

CMS estimates it would reduce OPPS spending by $280 million, with $210 million of the savings accruing to Medicare, and $70 million saved by Medicare beneficiaries in the form of reduced beneficiary coinsurance.

Comment by September 15.

Click Here to Learn More and Comment

Policy Update: CMS Proposes Updates to Medicare Physician Fee Schedule Payments for Calendar Year 2026, Comment by September 12

August 5, 2025

Policy Update: CMS Proposes Updates to Medicare Physician Fee Schedule Payments for Calendar Year 2026, Comment by September 12

This proposed rule from the Centers for Medicare & Medicaid Services (CMS), issued on July 16, 2025, seeks public comment on payment updates and policy changes to Medicare’s physician fee schedule payments and includes other proposals affecting Medicare beneficiaries.

Proposals include:

  • Removing the code and add-on payment for the Social Determinants of Health Risk Assessment,
  • Permanently adopting the definition of direct supervision that allows the physician or supervising practitioner to provide supervision through real-time audio and visual interactive telecommunications (excluding audio-only),
  • Creating optional add-on codes for Advanced Primary Care Management (ACPM) services that would provide behavioral health integration or psychiatric Collaborative Care Model (CoCM) services proposed modifications to the way that CMS will pay for skin substitutes,
  • A proposed negative 2.5 percent adjustment to certain non-time-based Relative Value Units (RVUs), and
  • A new mandatory alternative payment model, the Ambulatory Specialty Model.

The proposed rule also includes proposed updates applicable to Rural Health Clinics (RHCs), including:

  • Extending non-behavioral health telehealth flexibilities through December 31, 2026,
  • Requiring an in-person mental health service within 6 months prior to the mental-health telehealth visit and requiring an in-person mental health visit every 12-months while the patient is receiving services,
  • Requiring RHCs and FQHCs to report and bill the individual codes for BHI and CoCM rather than the current consolidated code.

Click Here to Learn More and Comment

Whitepaper: The Hidden Cost of Confusion: Using AI to Make Healthcare Bills Make Sense

August 5, 2025

Whitepaper: The Hidden Cost of Confusion: Using AI to Make Healthcare Bills Make Sense

As the cost of care increases, paying for it becomes more complicated – with many patients finding medical bills more confusing and stressful than the treatment itself.

This whitepaper, presented at Becker’s Hospital Review 15th Annual Meeting, dives into how health systems are leveraging AI to ease the burden of paying for care. From guiding patients through their bills to surfacing relevant benefits and resources, I tools are creating personalized affordability pathways.

Revenue cycle experts reveal how leading health systems are using this model to reduce costs, drive collections and reduce staff burnout.

You’ll Learn:

  • How one AI voice agent connects patients to personalized payment options before bad debt accrues,
  • What’s working to drive up digital payments and reduce support requests, and
  • The financial lift: 20% increase in collections + higher patient satisfaction.

Cost: Free

Click Here to Download Paper

Whitepaper: 3 Ways to Improve Cybersecurity Amid Healthcare’s Cyber Crisis

August 5, 2025

Whitepaper: 3 Ways to Improve Cybersecurity Amid Healthcare’s Cyber Crisis

Recently, a wave of cyberattacks forced healthcare executives to reckon with an uncomfortable truth: traditional cybersecurity strategies are no longer enough.

This report from Advisory Board shares how more than 10 experts – from provider organizations and digital health firms to consulting leaders – are redefining what cyber resilience means in an era of third-party interdependence.

It outlines a strategic shift from reactive defense to collaborative, systemwide resilience – and the practical steps leaders are taking to manage operational risk, strengthen contracts and reduce exposure across complex networks.

Download the report to learn:

  • Ways that health systems are reassessing third-party vendor contracts and performance metrics,
  • Tactics to improve communication with partners and regulators to contain risk, and
  • Examples of resilience-driven models that ensure continuity during cyber incidents.

Cost:  Free

Click Here to Download Paper

CMS Proposes to Decrease Hospital Outpatient Payments for Non-Drug Items and Services to Offset Higher Payments Made as a Result of 340B Payment Policy, Comment by September 15

July 25, 2025

CMS Proposes to Decrease Hospital Outpatient Payments for Non-Drug Items and Services to Offset Higher Payments Made as a Result of 340B Payment Policy, Comment by September 15

Between 2028 and 2022, the Centers for Medicare & Medicaid Services (CMS) decreased Medicare reimbursements to hospitals paid under the outpatient prospective payment system (OPPS) for drugs acquired through the 340B Drug Pricing Program (“340B Program”), a Health Resources and Services Administration (HRSA) program that allows covered entities to purchase certain outpatient drugs at discounted prices from drug manufacturers.

To maintain budget neutrality, CMS redistributed the savings to all hospitals paid under the OPPS by increasing their payment rates for non-drug items and services. In 2022, the Supreme Court held that because CMS did not conduct a survey of hospitals’ acquisition costs, they could not vary the payment rates for outpatient prescription drugs by hospital group.

In response, CMS finalized in the Final Remedy Rule that 340B hospitals would receive a one-time lump sum payment reimbursing them for the decreased drug payments and CMS would reduce payments for non-drug items and services to all OPPS providers by 0.5 percent starting in 2026 until the total offset was reached (estimated to be about 16 years).

Click Here to Read More and Submit Comment

How Health Systems are Staying Ahead of Drug Shortages

July 25, 2025

How Health Systems are Staying Ahead of Drug Shortages

With hundreds of drug shortages persisting across the U.S., pharmacy leaders are adopting more coordinated strategies to manage supply disruptions and mitigate financial losses. These include expanding on-hand inventory for critical injectable medications, centralizing supply chain operations and embedding clinical decision tools. The goal is to ensure supply chains are “not only operationally sound but also clinically meaningful.”

Hospital labor expenses tied to managing these shortages increased from $359 million in 2019 to $894 million in 2024, according to a June Vizient report. Pediatric facilities were hit especially hard, tracking 25% more shortages and more frequently exceeding pharmacy budgets than other hospitals.

Vizient researchers in 2019 also estimated that drug shortages cost hospitals an additional $359 million annually in labor alone and $200 million more each year from purchasing higher-priced substitute medications.

Ten pharmacy leaders were asked “What strategies are most effective in mitigating persistent drug shortages.”

Click Here to Read the Responses

2025 340B Program Hospital Recertification Announcement

July 24, 2025

2025 340B Program Hospital Recertification Announcement

The 2025 340B Program Recertification period for hospitals will be August 1 – September 8, 2025.

Prior to being able to recertify, Authorizing Officials (AOs) and Primary Contacts (PCs) must set up a user account in the 340B office of Pharmacy Affairs Information System (340B OPAIS). Failure to set up user accounts will result in not being able to view accounts or conduct recertification, thus termination from the 340B Program.

AOs and PCs must create individual user accounts; they will not be able to share access.

All active 340B ID’s associated with an AOs user account must be updated for recertification to be completed by the established deadline. Failure to recertify by the established deadline will result in termination from the 340B Program.

For assistance with the 340B OPAIS, it is strongly encouraged to utilize the online help that is available for your convenience. In addition, the Health Resources and Services Administration (HRSA) has information and tutorials available on their website at https://www.hrsa.gov/opa/340b-opais/index.html.

For further assistance please contact the 340B call center operated by the 340B Prime Vendor Program at apexusanswers@340bpvp.com or call 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m.)

There will be a recertification webinar on August 6, 2025, from 1:00 p.m. – 2:00 p.m. EST.

Webinar Details

When: Wednesday, August 6, 1:00 p.m. – 2:00 p.m. EST

Providers Should Be Aware of Medicare Fraud Scheme

July 23, 2025

Providers Should Be Aware of Medicare Fraud Scheme

The Centers for Medicare & Medicaid Services (CMS) has identified a fraud scheme targeting Medicare providers and suppliers.

Scammers are impersonating CMS and sending phishing requests for medical records or payment of alleged Medicare debts, often via fax or email, falsely claiming to be part of a Medicare audit or debt collection efforts.

CMS generally does not initiate audits via fax or email unless a provider requests it, and Medicare overpayment collections are handled through the Medicare Administrative Contractors (MACs).

If you receive a suspicious request, don’t respond. Work with your Medical Review Contractor to confirm if a medical records request is real or with your MAC to discuss overpayment collections.

Click Here to Learn More

Click Here to Find Your Medicare Administrative Contractor (MAC)

Click Here to Find Your Medical Review Contractor

CMS Wasteful and Inappropriate Service Reduction (WISeR) Model – Apply by July

July 15, 2025

CMS Wasteful and Inappropriate Service Reduction (WISeR) Model – Apply by July

Last week, the Centers for Medicare & Medicaid Services (CMS) announced the new Wasteful and Inappropriate Service Reduction (WISeR) Model. CMS will partner with companies specializing in enhanced technologies to test ways to provide an improved and expedited prior authorization process relative to Original Medicare’s existing processes.

The WISeR Model will test a new process on whether enhanced technologies, including artificial intelligence (AI), can expedite the prior authorization processes for select items and services that have been identified as particularly vulnerable to fraud, waste, and abuse, or inappropriate use.

Companies selected to participate in the model must have clinicians with appropriate expertise to conduct medical reviews and validate coverage determinations. CMS has issued a Request for Applications for companies interested in participating in the WISeR Model.

Additional information is available in the Model Overview Fact Sheet and on the Federal Register.

Click here to Learn More

Click Here to see Request for Applications

Click Here to view Model Overview Fact Sheet

Click Here to go to Federal Register