Included in this newsletter
- New Federal Rule Mandates Electronic Health Care Claims Attachments, Sunsetting Manual Processes
- 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P)
- CDC Restores Official U.S. Immunization Schedules to July 2, 2025 Versions to Comply with March 16 Court Order
- FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
- White House to Impose Major Tariffs on Patented Pharmaceuticals
- Pharmacy FAQs on Predictive Acquisition Cost
- The Trump Administration Forced to Shift Course on Medicare GLP-1 Coverage
- Compliance Tip of the Month
New Federal Rule Mandates Electronic Health Care Claims Attachments, Sunsetting Manual Processes
The Centers for Medicare & Medicaid Services (CMS) has issued a final rule under the Health Insurance Portability and Accountability Act (HIPAA) that establishes new standards for the electronic submission of health care claims attachments. This change is set to modernize a historically cumbersome and manual process, moving the healthcare industry away from faxes and mail to a fully electronic system. The rule is projected to save the healthcare industry approximately $781 million annually by reducing administrative burdens.
The final rule, titled "Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule," will be effective May 26, 2026, with a compliance deadline of May 26, 2028. This two-year period is intended to give healthcare providers, including pharmacies, ample time to update their systems and workflows.
This new regulation will significantly impact how pharmacies handle requests for additional information from payers. Previously, when a claim required supporting documentation, such as clinical notes for a compounded medication or justification for a high-cost specialty drug, pharmacies would typically fax or mail these documents. The new rule mandates a standardized, electronic process for these claim attachments. Additionally, the rule establishes a standard for electronic signatures used in conjunction with these transactions. This is to ensure the authentication of the sender, the integrity of the information, and to support non-repudiation.
Pharmacies should collaborate with their pharmacy management system vendors and update internal workflows to facilitate compliance.
CMS Rule Phases Out Fax Machines, Snail Mail to Save Taxpayers $781.98 Million a Year | CMS
2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P)
The Centers for Medicare & Medicaid Services (CMS) has released the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P), continuing its efforts to improve electronic prior authorization so patients and providers can benefit from a more expeditious, transparent, and reliable process. This proposed rule builds on the 2020 CMS Interoperability and Patient Access final rule (CMS-9115-F) and the 2024 CMS Interoperability and Prior Authorization final rule (CMS-0057-F).
While the prior authorization requirements in the 2024 final rule focused on non-drug items and services, the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule extends many of those requirements to cover prior authorizations for drugs. CMS now proposes to require impacted payers to support electronic prior authorization, to make decisions on requests within shorter timeframes that align CMS programs, and to increase transparency for the prior authorization of drugs. CMS is proposing to require impacted payers to update health information technology (health IT) standards and to report interoperability Application Programming Interfaces (API) endpoints and API usage metrics to CMS.
Under the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Department of Health and Human Services (HHS) is proposing to adopt certain Health Level Seven® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) standards and implementation specifications for transactions related to prior authorizations. These HHS proposals would apply to all HIPAA covered entities (health care providers, health plans, and health care clearinghouses) that electronically exchange prior authorization requests and decisions. The proposed rule will be available for public comment until June 15, 2026.
CDC Restores Official U.S. Immunization Schedules to July 2, 2025 Versions to Comply with March 16 Court Order
The CDC restored its official child and adolescent immunization schedule and its official adult immunization schedule to the July 2, 2025 versions to be in compliance with the March 2026 federal court ruling, American Academy of Pediatrics v. Kennedy. These versions reflect the decisions of the ACIP through its April 2025 meeting, before the replacement of those 17 members with new members in June 2025. The appointments of the new members and their subsequent decisions were stayed by the court. Some CDC web pages are still being updated to reflect the change. See the Common Health Coalition’s summary for more information.
IZ Express Issue 1871 | Immunize.org
FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
The FDA reminds compounders certain conditions must be met for compounded drugs to qualify for the exemptions under sections 503A and 503B of the FD&C Act. Read full FDA article here.
White House to Impose Major Tariffs on Patented Pharmaceuticals
The White House announced on April 2, 2026 that the administration would impose “a 100 percent tariff on patented pharmaceutical products and ingredients,” to take effect in 120 days for certain large companies and 180 days for smaller companies. The order does not affect generic medicines and there are carveouts for certain companies based on whether they have reached various kinds of trade agreements with the administration and their country of origin. You can read the White House fact sheet here.
White House to impose major tariffs on patented pharmaceuticals | NCPA
Pharmacy FAQs on Predictive Acquisition Cost
If you have questions about using Predictive Acquisition Cost (PAC) to evaluate third party reimbursement, Glass Box Analytics, the company that maintains PAC, has shared this PAC FAQ for independent pharmacy owners. PAC has been around for almost 15 years. The FAQ has helpful information for pharmacies that self-contract with one or more PBMs.
Pharmacy FAQs on Predictive Acquisition Cost | NCPA
West Virginia’s Next-Level PBM Reform
HB 5430 was signed into law by Gov. Patrick Morrisey. This is the latest PBM reform triumph in West Virginia. The legislation prohibits spread pricing, authorizes oversight of the Public Employment Insurance Agency plan to the Office of the Insurance Commissioner, addresses rebate concerns from offshore group purchasing organizations, and requires a Medicaid cost of dispensing survey every three years starting in 2026.
West Virginia’s next-level PBM reform | NCPA
CMS Removes Fiasp and Novolog Products from MDPNP Effective 2027
Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill will be removed from the Medicare Drug Price Negotiation Program (MDPNP) effective Jan. 1, 2027.
CMS removes Fiasp and NovoLog products from MDPNP effective 2027 | NCPA
The Trump Administration Forced to Shift Course on Medicare GLP-1 Coverage
The Trump administration is delaying a Medicare pilot program, BALANCE, to cover weight-loss drugs after health insurance companies voiced concerns about participating. It's a blow to the administration after President Trump last year touted deals with Eli Lilly and Novo Nordisk to cut prices on GLP-1 drugs in exchange for access to a new pool of patients.
Medicare is barred by law from covering weight-loss drugs. The BALANCE program was intended as a workaround, allowing Medicare beneficiaries to access the drugs for just a $50 co-pay. Medicare will still cover the drugs for weight loss through a transitional program, Medicare GLP-1 Bridge, starting in July 2026 and now extended through the end of 2027, but it will foot the bill on its own. Insurers had until April 20, 2026 to opt in, but large insurers like UnitedHealth Group and CVS declined to participate.
The transitional program means seniors can still get expanded coverage and participating Medicare drug plans will not be exposed to any financial risk. But without the pilot program, Medicare patients who have been prescribed GLP-1s for weight loss can’t apply a $50 co-pay towards their deductible or out-of-pocket maximum. That change could pose a financial barrier for some. The product list currently includes Foundayo®, Wegovy® (injection and tablets), and Zepbound® (KwikPen®). Pharmacies will be reimbursed by the CMS Bridge central processor at the wholesale acquisition cost of a drug, less the beneficiary copay, plus a dispensing fee and, as applicable, sales tax.
CMS is still moving forward with the Medicaid portion of the pilot and states can apply through July 31, 2026 to participate.
Trump admin shifts course on Medicare GLP-1 coverage
CMS kicks the can on weight loss GLP-1 drugs | NCPA
DocStation Partnership Announced
As more independent pharmacies expand into billing immunizations and DMEPOS under Medicare, having the right billing solution is critical. Through our collaboration with DocStation, pharmacies have access to a medical billing platform designed specifically to support clinical services and durable medical equipment billing. If you’re exploring options to streamline medical claims and get paid accurately for these services, DocStation is a solution worth considering. [Click here to read our partnership announcement] or visit docstation.co to learn more.
R.J. Hedges & Associates named to Pharmacy500
R.J. Hedges & Associates is proud to share that we have been recognized in the 2026 Pharmacy500, presented by RXinsider.
The Pharmacy500 highlights 500 pharmacy supply chain businesses and associations that have made a meaningful impact on dispensing pharmacies across the United States over the past year. The recognition reflects organizations that actively support pharmacy operations, patient care, and the evolving needs of the industry.
We are honored to be included alongside so many outstanding companies and individuals who are dedicated to strengthening and supporting independent pharmacy.
For more than 20 years, R.J. Hedges & Associates has focused on helping independent pharmacies navigate the complexities of regulatory compliance. From ever-changing federal requirements to accreditation and operational readiness, our goal has always been to provide clear, practical guidance that allows pharmacy teams to focus on what matters most - caring for their patients.
“This recognition is especially meaningful because it reflects the impact our staff has on the pharmacies we serve,” said Becky Templeton, Director of Operations at R.J. Hedges & Associates. “We’re grateful for the trust our clients place in us every day and proud to support the important work they do in their communities.”
As the pharmacy landscape continues to evolve, the need for reliable compliance support remains critical. We are proud to stand alongside industry partners who are committed to helping pharmacies adapt, grow, and succeed.
Thank you to RXinsider for this recognition, and congratulations to the other organizations included in the 2026 Pharmacy500.
Most importantly, thank you to our clients; your trust and partnership over the past 20 years are what make recognition like this possible.
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Compliance Tip of the Month
If it isn’t documented, it didn’t happen. Ensure prescriptions and all supporting records are complete before dispensing and billing.
