ADA supports proposed rules to update federal Anti-Kickback Statute, Stark Law

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Washington — The American Dental Association supports a new safe harbor for cybersecurity technology and services and modifying the existing safe harbor for electronic health records to add protections for cybersecurity.

This was in response to the Office of the Inspector General and Centers for Medicare & Medicaid Services’ proposed changes to the federal Anti-Kickback Statute and Stark Law exceptions.

These were two of the proposed changes the Association favored in formal comments filed Dec. 31. The ADA also urged OIG and CMS to simplify and coordinate the final rules “to the greatest extent possible in order to reduce uncertainty and compliance burdens on stakeholders” and to consider the potential burdens and benefits of the rules to providers that are small businesses or located in rural and medically underserved areas, and their patients, when developing final rules.

The ADA also commented on the following in regards to the proposed rules:

Durable Medical Equipment, Prosthetics/Orthotics, and Supplies, or DMEPOS.
The ADA requested for OIG and CMS to exempt dentists from “any prohibition on a DMEPOS supplier” acting as a donor or recipient. “Dentists may, as part of their dental practice, supply oral sleep apnea devices as DMEPOS suppliers,” wrote ADA President Chad P. Gehani and Executive Director Kathleen T. O’Loughlin. “Dentists supplying oral sleep apnea devices have direct patient contact and relationships with their patients, in some cases as both a provider and a supplier, that distinguishes them from DMEPOS suppliers generally.”

Cybersecurity technology and services. The ADA told the two agencies that it appreciates efforts to address the growing threat of cyberattacks and supports amending the anti-kickback statute safe harbors and Stark Law exceptions to permit health care organizations to “assist doctors in the acquisition of cybersecurity technology and services such as anti-virus software and incident response and training services to help improve the cybersecurity posture of the health care industry, protect patient information from attack, and to protect recipients from liability for fines, ransom, and litigation risk.” (The Stark Law is the more common descriptor of the Physician Self-Referral Law.) The ADA urged OIG and CMS to “permit, with appropriate safeguards, both nonmonetary and monetary remuneration for the purchase of cybersecurity technologies and services.” The Association said permitting monetary remuneration could help alleviate unintended adverse effects of the final rule on competition.

The Association used the example where a donor wanted to supply cybersecurity technology to two competing small providers where one of the providers had already purchased the technology but the other had not and said, “Permitting monetary reimbursement of the first provider and an in-kind donation to the second provider would be more fair than permitting the donor to benefit one competitor and not the other,” according to the letter. The ADA also urged the agencies to extend the anti-kickback statute safe harbor and the Stark Law exception to “include cybersecurity hardware without the requirement of a cybersecurity risk assessment; while donors should be free to require and even donate a cybersecurity risk assessment, adopting such a requirement could slow the provision of cybersecurity technology.” The ADA urged OIG and CMS not to adopt a contribution requirement but said donors would be free to require recipients to contribute to the cost of donated cybersecurity technology. “Omitting a contribution requirement would help permit providers with limited resources to receive protected cybersecurity donations. If adopted, any contribution requirement should at a minimum exempt rural and small practices as well as those in medically underserved areas and federally qualified health centers.”

Electronic health records. The ADA urged OIG and CMS to “adopt the proposed changes to existing rules concerning the donation of interoperable electronic health records software or information technology and training services and to insure as much consistency as possible between the final rules.” The ADA also asked the agencies not to impose a contribution requirement

Personal services and management contracts. The ADA supports OIG’s proposal to modify the existing safe harbor for personal services and management contracts and believes the proposed changes will improve flexibility and ease compliance burdens.

Warranties. The ADA supports OIG’s proposal to update the existing safe harbor for warranties to “protect warranties for one or more items and related services upon certain conditions (bundled warranties), exclude beneficiaries from the reporting requirements applicable to buyers, and define warranty directly and not by reference.” The ADA urged the agency not to require all federally reimbursable items and services be subject to the bundled warranty be reimbursed by the same federal health care program and in the same payment because “such a requirement might inhibit warranties pertaining to items used across a patient population that are not reimbursed in the same payment.” The Association also asked OIG not to cap the remuneration.

Local transportation. The ADA is in favor of the proposal to modify the existing safe harbor for local transportation to expand the distance which residents of rural areas may be transported from 50 miles to 75 miles but urged the agency to permit transportation “up to 50 miles for all patients, and up to 100 miles if a patient lives in a rural area to promote access to care and support patient choice of provider.” The ADA also urged OIG not to add a requirement to demonstrate financial, medical, or transportation need on the part of the patient and agreed that use of ride-sharing services should be permitted under the safe harbor.

Stark law: Providing flexibility for limited reimbursement to a physician. The ADA urged CMS to adopt the proposed provision protecting limited remuneration to a physician “provided certain conditions are met, whether or not the remuneration violates the anti-kickback or other federal or state law,” and said it agrees that such remuneration “is unlikely to cause overutilization or similar harms.” The ADA urged CMS “to extend the protection to items and services provided under the doctor’s supervision or direction, and not to restrict the protection to items and services provided by the doctor” and also urged the agency to adopt the proposed 90-day period to comply with certain writing and signature requirements.

Stark Law clarification: fundamental terminology and requirements. The ADA commented that it appreciated CMS’s intention to reduce the burden of compliance with the Stark law and to provide clarification where possible. “In particular, ADA appreciates the clarification that the determination that an arrangement is commercially reasonable does not turn on whether the arrangement is profitable,” wrote Drs. Gehani and O’Loughlin, adding that ADA supports CMS’s proposal to clarify “in regulation text that an arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties.”

Stark Law: Recalibrating the scope and application of the regulations. The ADA wrote that it supports CMS’s proposal to “remove from the regulatory exceptions the requirement that the arrangement not violate the anti-kickback statute or any federal or state law governing billing or claims submission wherever such requirements appear.” The ADA said it agrees this previous requirement resulted in a compliance burden that could make it “unreasonably difficult for entities to meet their burden of proof under the Stark Law.”

The ADA also supported the agency’s proposal to “deem the writing or the signature requirement of an applicable compensation arrangement exception to be satisfied if the compensation arrangement satisfies all requirements of an applicable exception other than the writing or signature requirement(s)” and the parties obtain the required writing or signature(s) within a certain time frame. The ADA urged CMS to include specific regulation text to reflect the agency’s policy on electronic signatures and documents.

Lastly, the ADA agreed with CMS’ and OIG’s proposals on the rental of office space and equipment, physician recruitment, and payments by a physician.

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