Tuesday, November 24, 2020
On November 20, 2020, the Division of Well being and Human Companies (HHS), Workplace of Inspector Common (OIG), and the Facilities for Medicare and Medicaid Companies (CMS) finalized three guidelines making historic modifications to a few of essentially the most important federal well being care fraud and abuse legal guidelines – the Anti-Kickback Statute, Beneficiary Inducement Civil Financial Penalty, and Doctor Self-Referral Legislation (or “Stark Legislation”). The ultimate guidelines, most of that are efficient on January 19, 2021 (with sure exceptions), create vital new flexibilities, together with a number of new protected harbors and exceptions for monetary preparations associated to value-based care preparations. Nevertheless, CMS’s revisions might create new challenges for healthcare suppliers as nicely, because of the advanced necessities of the brand new exceptions, modifications to longstanding interpretations of regulation, and voluminous new commentary addressing the authorized threat of many widespread preparations.
Polsinelli attorneys present their preliminary response to the brand new guidelines right here, however will handle a number of features of the ultimate guidelines in additional element within the close to future.
The sweeping rulemaking covers quite a lot of subjects, together with the highlights listed beneath. Due to the breadth of this rulemaking, Polsinelli will probably be producing further supplies exploring key implications of the three closing guidelines extra intently within the coming days. At a excessive stage, the rulemaking has the next implications:
Three new Anti-Kickback Statute protected harbors and a brand new Stark Legislation exception masking value-based care preparations. The protected harbors cowl in-kind remuneration underneath care coordination preparations (together with these with out draw back threat) and value-based preparations with substantial draw back threat, and each in-kind and financial remuneration underneath fashions involving full monetary threat. Sure sorts of entities (together with PBMs, labs, and DMEPOS suppliers) are expressly ineligible for the brand new Anti-Kickback Statute protected harbors. The Stark Legislation exception presents three choices for full monetary threat preparations, significant draw back threat for physicians, and value-based preparations (together with with out threat). Normally, the brand new exceptions and protected harbors shield a “value-based association” between “value-based events” to a “value-based enterprise.” The precise necessities of the relevant protected harbors and exceptions range based mostly on the diploma of threat undertaken by the events. Whereas the ultimate rule will present safety for sure “upside solely” preparations, the necessities to guard such fashions are advanced.
Landmark commentary on the Stark Legislation “group observe” definition, imposing new limits on revenue distribution methodologies based mostly on ancillary service class. These modifications might require multispecialty doctor teams to overview and replace their compensation plans.
Ending the usage of the Anti-Kickback Statute protected harbor for rebates from pharmaceutical producers to Medicare Half D plans, however including new protected harbors for sure level of sale reductions in drug costs and sure mounted charges paid by producers to pharmacy profit managers (PBMs).
Technical modifications to most of the core ideas underneath the Stark Legislation. These embody new provisions to handle short-term or inadvertent noncompliance with the Stark Legislation, together with a brand new exception for restricted remuneration as much as $5,000 per 12 months, a 90-day grace interval to place preparations in writing, elevated flexibility to show that compensation is “set upfront,” and approval of the usage of digital signatures if permitted underneath federal or state regulation CMS additionally revised interpretations of many Stark Legislation ideas, together with new definitions of “commercially cheap,” “truthful market worth,” “quantity or worth of referrals,” “designated well being companies,” and the “interval of disallowance.”
New Anti-Kickback Statute protected harbors for outcomes-based funds, affected person engagement and help instruments for members in a value-based enterprise, preparations underneath CMS-sponsored various fee fashions, and affected person incentives underneath the Medicare Shared Financial savings Program. The ultimate rule additionally modifications the present Anti-Kickback Statute protected harbors for native transportation, private service preparations and warranties.
The brand new “affected person engagement” protected harbor additionally creates broad new flexibility underneath the beneficiary inducement CMP as a result of preparations that match an Anti-Kickback Statute protected harbor are additionally excepted underneath this CMP. The rule additionally creates a brand new beneficiary inducement CMP exception for telehealth applied sciences supplied to in-home dialysis sufferers.
A brand new Anti-Kickback Statute protected harbor and Stark Legislation exception for donations of cybersecurity expertise and modifications to the protected harbor and exception for donations of digital well being report expertise (together with provisions to align “interoperability” provisions with the Cures Act and elimination of the “sundown” guidelines).
Modifications to Stark Legislation guidelines round contract administration, together with an express assertion that the “remoted transactions” exception could also be used to guard official settlements of bona fide disputes involving otherwise-compliant preparations, and a 90-day grace interval to appropriate administrative or clerical noncompliance following the termination or expiration of an association.
Revisions designed to broaden the scope of many Stark Legislation exceptions, together with by broadening the scope of the exception for “funds by a doctor” and permitting use of the short-term “truthful market worth” exception to cowl leases of workplace area.
The brand new guidelines are advanced and could have vital implications for any entity regulated underneath these legal guidelines. Whereas the foundations largely monitor the proposals issued by HHS and CMS in 2019, they differ in sure vital methods. For instance, HHS didn’t finalize a few of its proposed administrative necessities to make use of the Anti-Kickback Statute protected harbors and CMS didn’t finalize proposals that might have handled sure fixed-rate compensation as “bearing in mind the quantity or worth of referrals.” Polsinelli will produce further summaries reviewing implications of those guidelines for specific suppliers within the close to future.
© Polsinelli PC, Polsinelli LLP in CaliforniaNationwide Legislation Overview, Quantity X, Quantity 329