Category: Current Affairs

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

CMS Updates Mental Health & Substance Use Disorder Telehealth Coverage Guidance

July 8, 2025

CMS Updates Mental Health & Substance Use Disorder Telehealth Coverage Guidance

The Centers for Medicare and Medicaid Services (CMS) released a revised version of its Medicare & Mental Health Coverage booklet, incorporating several important updates related to telehealth and digital mental health services.

Notable changes include notating telehealth coverage for:

  • Caregiver training,
  • Depression screening, and
  • Tobacco cessation counseling.

In addition, CMS added new HCPCS/CPT codes eligible for telehealth and outlined coverage criteria for digital mental health treatment (DHMT) devices when used “incident to” behavioral health services. Due to the possibility that the current Medicare telehealth waivers are not extended or changed, the guidance confirms that starting October 1, 2025, Medicare will require:

  • An in-person visit within six months before initiating telehealth-based mental health services, and
    • Follow-up in-person visits every 12 months.
      • For rural health clinics (RHCs) and federally qualified health centers (FQHCs), this requirement is delayed until January 1, 2026, for services delivered to patients in their homes.

CMS does not mention in the document that current permanent federal law still allows Medicare mental health services to be delivered without an in-person visit if the patient is located at an eligible facility in a geographically rural area or a rural health professional shortage area. Providers can check geographic eligibility using HRSA’s telehealth tool.

In-person visit exemptions also remain in place for patients with substance use disorder and co-occurring mental health conditions.

Finally, an exception to the subsequent 12 month in-person requirement described in the 2022 Final Physician Fee Schedule is also not explicitly addressed by CMS in the booklet-specifically that the requirement can be waived if the patient and practitioner agree that the risks and burdens associated with an in-person service outweigh the benefits of an in person visit.

Click Here to Access Medicare & Mental Coverage booklet

Click Here to Use HRSA’s Telehealth Tool

Click Here to View 2022 Final Physician Fee Schedule

Request for Information: Inviting Comments on the NIH Artificial Intelligence (AI) Strategy, Comment by July 15

June 23, 2025

Request for Information: Inviting Comments on the NIH Artificial Intelligence (AI) Strategy, Comment by July 15

The National Institutes of Health (NIH) is crafting an ambitious institute-wide strategy to guide its use and development of artificial intelligence (AI) technologies – and they are now seeking public input. Through its recently issued Request for Information (RFI): Inviting Comments on the NIH Artificial Intelligence Strategy, the NIH is calling on researchers, health systems, developers, and stakeholders across sectors to help shape the direction of biomedical AI over the coming decade.

Information Requested

NIH welcomes input on any relevant topic, especially the areas below:

  • Strategic Architecture
  • Research & Innovation Actions
  • Intramural-Extramural Synergy
  • Operational Excellence
  • Facilitating & Validating AI in Healthcare Delivery
  • Reproducibility & Trust
  • Partnerships & Ecosystem Building

The deadline for submitting comments is July 15, 2025.

How to Submit a Response

  • Email: ai-rfi@nih.gov
  • Subject Line: “RIF Response – NIH AI Strategy”
  • Format: 7 pages (PDF, Word, or plain-text); include section headers that correspond to the bullets, such as those above, when feasible.

Responses must be received by 11:59 p.m. ET on July 15, 2025. All submissions are voluntary; do not include proprietary, classified, or personally identifiable information you do not wish to make public. NIH may post anonymized summaries or use content to inform future solicitations or policy documents.

Click Here to Learn More

DHSS Recognizes World Elder Abuse Awareness Day

June 9, 2025

DHSS Recognizes World Elder Abuse Awareness Day

June 15 is World Elder Abuse Awareness Day, an event that seeks to unite communities around the world to raise awareness about elder abuse. In Missouri, the Department of Health and Senior Services (DHSS) receives and investigates reports of abuse, neglect, bullying and exploitation of some of the state’s most vulnerable individuals – the elderly and disabled. Last year, DHSS received and investigated 41,929 reports, an average of about 115 each day. That number is on the rise, though the crimes are vastly underreported.

“As people age, it can become increasingly difficult for them to stay involved and connected to their communities and families. As a result, older people are more likely to experience social isolation, which increases the likelihood of abuse, neglect and exploitation,” said Sarah Willson, director of DHSS.

Elder abuse is widespread. Every year an estimated 1 in 10 older Americans are victims of elder abuse, neglect or exploitation.

“This all-too-common tragedy impacts aging adults wherever they call home and in communities throughout Missouri,” says Willson.

Despite its prevalence, experts believe that elder abuse is significantly underreported, in part because so many communities lack the social supports that would make it easier for those who experience abuse to report it. Sadly, research estimates that for every reported adult abuse or neglect case, 23 go unreported to the authorities.

Together, communities can address the issue of elder abuse and help prevent it by strengthening education and social support and by reducing social isolation.

Anyone who suspects a senior or disabled Missourian is being abused, neglected, bullied or exploited, should report to the Missouri Adult Abuse and Neglect Hotline at 1-800-392-0210, which is operational from 7 a.m. through 8 p.m., 365 days a year. Online reporting is also available 24/7 at Health.Mo.Gov/abuse.

Everyone is encouraged to wear purple and communities across Missouri are encouraged to display World Elder Abuse Awareness Day banners, posters and yard signs along with purple ribbons, flags or pinwheels to bring awareness to this public health issue.

For more information about how to make a difference, visit Health.Mo.Gov/weaad.

New Guidance for Hospital Price Transparency

May 29, 2025

New Guidance for Hospital Price Transparency

The Centers for Medicare & Medicaid Services (CMS) released new guidance on how hospitals should calculate the estimated allowed amount values for their online machine-readable files as part of the Hospital Price Transparency requirements.

Whenever possible, hospitals should:

  • Use electronic remittance data to determine the average dollar amount received over the last 12-month period.
    • If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure.
  • Hospitals will no longer be able to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year.

Click Here to View Entire Guidance Document

Missouri DHSS Issues Emergency Waiver to Assist Missourians Impacted by Severe Weather

May 22, 2025

Missouri DHSS Issues Emergency Waiver to Assist Missourians Impacted by Severe Weather

The Missouri Department of Health and Senior Services (DHSS) has issued an emergency waiver to assist Missourians in need of critical prescription medications following the devastating tornadoes and sever weather that struck Missouri on May 16.

The action comes after Governor Mike Kehoe issued Executive Order 25-24 authorizing DHSS to temporarily waive or suspend any statutory or administrative rule under its purview to allow medical professionals to better assist those affected by storms.

The provisions of §195.010-195.100 and their attendant regulations and 195.060, RSMo, are partially waived to allow pharmacists to fill controlled substance prescriptions for patients in disaster-impacted areas without the presentation of a written prescription and if the pharmacist determines within his or her professional judgment that an extended supply is needed to avoid interruptions to patient care.

This will ensure that individuals whose prescriptions or prescription records were lost or destroyed, or whose original prescribing physician is unavailable, can continue to receive needed medications even if the pharmacy has not previously dispensed or refilled the prescription.

Click Here to View the Waiver