AMARILLO, TX – As of January 17, 2024, CMS has affirmed its commitment to advancing interoperability and improving prior authorization processes with the publication of the CMS Interoperability and Prior Authorization final rule (CMS-0057-F) (the “Rule”). The Rule requires payers to implement and maintain application programming interfaces.

The payers affected include Medicare Advantage Organizations, state Medicaid and Children’s Health Insurance Program Fee-for-Service Programs, Medicaid Managed Care Plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally Facilitated Exchanges. The implementation will improve the electronic exchange of healthcare data and streamline the authorization process that is required by payers for certain procedures and treatments.

Payers that are impacted by the rule will be required to implement an HL7 FHIR Patient Access API. This will allow patients to have access to more of their data, and it will also allow patients to understand their payer’s prior authorization process and its impact on their care. This requirement must be fulfilled by January 1, 2027.

Payers must now implement and maintain a Provider Access API to share patient data with in-network providers with whom the patient has a treatment relationship. The payers will have to make individual claims and encounter data, data classes, and data elements in the United States Core Data Interoperability and specified prior authorization information available via the Provider Access API.

CMS requires payers to maintain an attribution process to associate patients with in-network or enrolled providers with whom they have a treatment relationship. The payers must also give patients the option to opt out of having their data available to providers under the requirements. The payers must provide the patient with information regarding (i) the benefits of the API data exchange with their providers and (ii) their ability to opt-out in plain language.

Payers are required to implement and maintain a Payer-to-Payer API to make claims and encounter data, data classes, data elements in the USCDI, and information about certain prior authorizations. Payers are required to share patient data with a date of service within five years of the request for data. This is designed to (i) improve continuity of care when a patient changes payers and (ii) ensure that patients have continued access to the most relevant data in their records. Payers must implement these changes by January 1, 2027.

Payers must also now implement and maintain a Prior Authorization API that (i) is populated with its list of covered items and services, (ii) can identify documentation requirements for prior authorization approval, and (iii) supports a prior authorization request and response. The Prior Authorization API will have to communicate whether the payer approves the prior authorization request, denies the prior authorization request, or requests more information. This must be implemented beginning January 1, 2027.

The rule improves the prior authorization process. Impacted payers must send prior authorization decisions within 72 hours of expedited requests and seven calendar days for standard requests.

Starting in 2026, Payers must provide a specific reason for denied prior authorization decisions, regardless of the method used to send the prior authorization request by providers. The decisions may be communicated via the portal, fax, email, mail, or phone. This does not apply to prior authorization decisions for drugs. The requirement will allow better communication and transparency between payers, providers, and patients. It will also improve providers’ ability to resubmit the prior authorization request if necessary. Payers must now also publicly report prior authorization metrics annually on their website.

The final rule is designed to improve communication between payers, providers, and patients, support better access to health information, and result in a more efficient health care system.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm based in Texas with a national health care practice. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].

Jacque K. Steelman is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Steelman can be reached at (806) 345-6316 or [email protected].

AAHOMECARE’S EDUCATIONAL WEBINAR

Copayment Collection and Patient Assistance Programs

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Matthew D. Earl, Esq., Brown & Fortunato

Tuesday, February 13, 2024

1:30-2:30 p.m. CENTRAL TIME
Federal law is clear: a DME supplier must make a reasonable effort to collect copayments. All (or virtually all) commercial insurers, including Medicare Advantage Plan, impose the same requirement. If a DME supplier routinely waives or reduces copayments, it can be held liable under the federal anti-kickback statute, federal beneficiary inducement statute, and federal False Claims Act. In fact, many federal criminal and civil cases brough against DME suppliers (often at the instigation of a whistleblower) are based, in whole or in part, on the failure to make a reasonable effort to collect copayments. In the same vein, insurers will terminate agreements with suppliers on the basis of not making a reasonable effort to collect copayments. This program will (i) discuss what it means to “make a reasonable effort” to collect copayments; (ii) discuss how a supplier can implement a financial hardship policy that allows the supplier to waive/reduce a copayment on a patient-by-patient basis; (iii) point out that the existence of such a financial hardship policy cannot be advertised; (iv) discuss how a DME supplier can implement a patient assistance program; and (v) discuss how a supplier can access charities that may be in the position to assist patients in paying their copayments.

Register for Copayment Collection and Patient Assistance Programs on Tuesday, February 13, 2024, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq., and Matthew D. Earl, Esq., of  Brown & Fortunato.

Members:  $99
Non-Members:  $129

AAHOMECARE’S EDUCATIONAL WEBINAR

Cash-Only Retail: How to Succeed

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato

Tuesday, April 16, 2024 

1:30-2:30 p.m. CENTRAL TIME
The DME industry primarily serves the elderly. This means that most DME suppliers are dependent on traditional Medicare and Medicare Advantage for most of their revenue. But as DME suppliers know from experience, it can be challenging to be so tied to Medicare. This is where retail comes in. There are 78 million Baby Boomers who are retiring at the rate of 10,000 per day. Many Boomers are willing to pay cash for “Cadillac” items rather than being limited to the “Cavalier” items paid for by Medicare. This program will present the legal parameters within which DME suppliers can move into the retail space. The issues to be presented will include the following:

• Whether the retail business should be (i) under the supplier’s existing Tax ID # or (ii) operated by a separate legal entity.
• State DME licensure.
• Selling Medicare-covered items at a discount off the Medicare allowable.
• Obtaining physician prescriptions.
• Collection and payment of sales tax.
• Qualification as a “foreign” corporation.
• Required notification to a Medicare beneficiary even though the supplier does not have a PTAN.

Registration coming soon for Cash-Only Retail: How to Succeed on Tuesday, April 16, 2024, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq., Brown & Fortunato.

Members:  $99
Non-Members:  $129