By writer to www.jdsupra.com
As mentioned in a earlier McGuireWoods alert, the U.S. Division of Well being and Human Companies (HHS) revealed closing guidelines anticipated to be efficient Jan. 19, 2021, that considerably amend the Doctor Self-Referral Regulation (Stark Regulation), the federal Anti-Kickback Statute (AKS) and the Civil Financial Penalties (CMP) Regulation. This shopper alert, the primary in McGuireWoods’ abstract sequence on these closing guidelines, focuses on three key revisions to the AKS and the CMP Regulation associated to affected person inducement and affected person kickback insurance policies.
These coverage modifications embody (1) a brand new protected harbor for affected person engagement and help for individuals in value-based preparations, (2) enlargement round affected person transportation protections and (3) incorporation of the statutory exception for furnishing telehealth applied sciences to sure in-home dialysis sufferers. By implementing these modifications, the Workplace of the Inspector Basic (OIG) is permitting extra flexibility round beneficiary inducement and affected person engagement instruments that could possibly be deemed to violate the AKS, which prohibits remuneration with the intent to induce or reward referrals, or the CMP Regulation, which imposes penalties in opposition to any particular person providing or transferring remuneration to a federal healthcare program beneficiary that’s prone to affect the beneficiary’s collection of a specific supplier. Importantly, these modifications have an effect on the kinds of further providers that could be supplied to sufferers, resembling transportation and telehealth, the necessity for which has turn into solely extra essential through the COVID-19 pandemic.
The ultimate guidelines embody a number of amendments associated to the AKS protected harbors, which shield suppliers beneath each the AKS and the CMP Regulation, in addition to the beneficiary inducement CMPs. Notably, the ultimate guidelines don’t embody a lot of the optionally available circumstances that OIG had requested commenters to contemplate in its proposed rule, mentioned in a Oct. 29, 2019, McGuireWoods alert. Slightly, the ultimate rule typically tracks the circumstances as proposed, with sure key modifications to the proposals mentioned under.
1. New Affected person Engagement and Help Secure Harbor
Within the closing guidelines, OIG finalized a brand new protected harbor at 42 CFR § 1001.952(hh) to guard “affected person engagement instruments and helps furnished by a participant in a value-based enterprise [(VBE)] to a affected person in a goal affected person inhabitants.” This new protected harbor is meant to assist suppliers hold sufferers concerned of their care and to assist sufferers take steps to make knowledgeable healthcare selections and preserve or enhance their well being, with out AKS and beneficiary inducements CMP obstacles. Though these modifications broaden the help providers that may be supplied to members of the goal inhabitants, it stays vital to adjust to the foundations for VBEs, that are advanced and designed to make sure two or extra suppliers collaborate to realize sure enumerated provisions, as can be additional mentioned in a forthcoming alert on value-based preparations.
Particularly, beneath the brand new protected harbor, “remuneration” won’t embody a “affected person engagement device or help furnished by a VBE participant to a affected person within the goal affected person inhabitants of a value-based association to which the VBE participant is a celebration” if the protected harbor parts are glad. A number of the key necessities with respect to the engagement device or help are that the retail worth of the per-patient engagement device or help can not exceed $500 (to be adjusted yearly), and the device or help should: (i) be an in-kind merchandise, good or service; (ii) have a “direct connection” to the coordination and administration of the goal affected person inhabitants’s care; (iii) not be money or a money equal; (iv) not “end in medically pointless or inappropriate gadgets or providers reimbursed” by authorities healthcare applications; (v) represent one thing that was really useful by the affected person’s healthcare skilled; and (vi) advance a number of VBE objectives. Whereas OIG eliminated sure obstacles and didn’t incorporate optionally available safeguards that had been proposed, resembling returning the device on the finish of care or the VBE, the OIG did add that the affected person’s insurance coverage protection couldn’t be thought of in figuring out whether or not to supply the device or help if it might obtain protected harbor safety.
Nonetheless, there are limitations on who can provide these affected person engagement instruments or helps. Sure entities are ineligible for protected harbor safety. The protected harbor makes use of the identical ineligible entities checklist because the value-based protected harbors — together with, for instance, pharmaceutical producers, wholesalers and distributors; PBMs; laboratory firms; compounding pharmacies; and DMEPOS suppliers — however notably features a pathway for producers of units or medical provides that present digital well being expertise. Additional, OIG revised language within the closing rule to make clear {that a} supplier’s agent may present the device or help (e.g., contracting with a vendor to put in bathe deal with bars to forestall affected person harm from falls) if sure circumstances are met.
2. Modifications to Affected person Transportation Secure Harbor
OIG has acknowledged that transportation performs a big function in sufferers’ “entry to care, high quality of care, healthcare outcomes, and efficient coordination of take care of sufferers, significantly for sufferers who lack their very own transportation or who stay in ‘transportation deserts.’” Within the new guidelines, OIG finalized a number of modifications to the prevailing protected harbor for native transportation at 42 CFR § 1001.952(bb), which embody increasing mileage limits for rural areas (as much as 75 miles as a substitute of 50 miles) and eliminating mileage limits on the transportation of a affected person “discharged from an inpatient facility following an inpatient admission or launched from a hospital” after the affected person was beneath commentary standing for at the very least 24 hours to the affected person’s place of residence (which is broadly outlined). Within the closing guidelines, OIG factors out that the protected harbor is accessible for transportation supplied by rideshare preparations, if that’s how an eligible entity needs to make transportation obtainable. These modifications ought to permit extra use of the protected harbor safety to the AKS and CMP Regulation than the earlier model mentioned in a Jan. 11, 2017, McGuireWoods alert.
3. Safety for Telehealth Applied sciences for In-Dwelling Dialysis Sufferers
The ultimate rule amends 42 CFR §1003.110 to formally implement the Finances Act of 2018 amendments to the beneficiary inducements CMP definition of “remuneration,” permitting sure telehealth applied sciences to be supplied to at-home dialysis sufferers. Particularly, these modifications permit Medicare Half B beneficiaries with end-stage renal illness (ESRD) to obtain sure telehealth applied sciences from their suppliers to furnish at-home dialysis if the next circumstances are met:
- The telehealth applied sciences are furnished to the person by the supplier of providers that’s at the moment offering care to the affected person, or has been chosen by the person to supply providers. This can be a change from the proposed rule the place OIG was planning to require care to have begun (and never simply chosen).
- The telehealth applied sciences “aren’t supplied as a part of any commercial or solicitation.”
- The telehealth applied sciences “are supplied for the aim of furnishing telehealth providers associated to the person’s [ESRD].”
As well as, for functions of this safety, OIG revised its proposed definition of telehealth applied sciences to: “{hardware}, software program, and providers that help distant or distant communication between the affected person and supplier, doctor, or renal dialysis facility for prognosis, intervention, or ongoing care administration.” Notably, this revised definition is expertise agnostic and wouldn’t require that there be two-way, real-time interplay because the proposed rule recommended. This implies, for instance, fax machines theoretically may qualify, however the supplier must decide that the expertise meets all relevant circumstances, together with that the expertise was supplied to furnish telehealth providers for the affected person’s ESRD.
OIG declined to impose sure proposed circumstances that may have considerably restricted the safety’s sensible use by suppliers for his or her sufferers. Proposed circumstances not adopted within the closing rule included, amongst others, necessities that the donated expertise “contribute considerably” to the supply of ESRD-related telehealth providers, that the expertise not be of “extreme worth,” and that it not be duplicative of expertise the affected person already owns. This elevated flexibility could replicate the rising function telehealth performs within the context of the COVID-19 pandemic. Additional, OIG acknowledged that there could possibly be sensible the explanation why a supplier would furnish duplicate expertise, resembling a single platform for all sufferers or conditions by which a affected person’s current expertise has some, however not all, of the capabilities essential for providers.
To benefit from this new exception to the definition of remuneration within the beneficiary inducements CMP, the ESRD affected person will need to have obtained the telehealth expertise on or after Jan. 1, 2019.
With the implementation of those closing guidelines, OIG seeks to take away particular AKS and CMP Regulation burdens on suppliers in partaking with their sufferers, with out creating substantial threat of elevated fraud or abuse. Whereas a few of these affected person instruments aren’t getting the identical focus because the value-based association modifications, the modifications may have equally massive impacts in permitting extra care coordination and decreasing general prices to the healthcare system.
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