Representatives Jackie Speier (D-California) and Dina Titus (D-Nevada) have delivered HR 2143, the Promoting Integrity in Medicare Act of 2019 (PIMA), which – if enacted – would narrow the “Stark” regulation’s exceptions and have a direct impact on the services furnished with the aid of physicians who self-refer for the performance of sure designated health offerings. The 2019 invoice is much like previous proposals delivered via Representative Speier in previous years.
PIMA could reinforce the Stark law by means of excluding specific complex “non-ancillary services” from the Stark regulation’s in-office ancillary offerings (IOAS) and physicians’ services exceptions, increasing consequences for violations, and adding compliance overview provisions. With sure exceptions, PIMA might define non-ancillary offerings as advanced diagnostic imaging studies; anatomic pathology services; radiation remedy offerings and substances; physical remedy offerings; and some other carrier the Secretary determines “isn’t generally furnished and finished as part of the office go to to a physician’s office in which the carrier is decided to be essential.” Note that the definition of detailed non-ancillary carrier could now not encompass: (1) offerings provided in a city area to a man or woman who is living in a rural location at the equal day as the patient’s preliminary office go to; (2) services supplied as part of a Medicare shared savings program or responsible care organization; (3) offerings supplied beneath a CMS Innovation Center model; or (4) services furnished by using an included multi-uniqueness organization exercise (as described within the legislation).
Furthermore, for functions of the Stark law and the Medicare anti-markup rule, PIMA would restrict the exclusion contained within the contemporary definition of the term “entity” in the Stark regulations from applying to the technical element or the professional element of an exact non-ancillary service. Such an exchange could basically bar referring doctor practices from billing Medicare for remote interpretations of advanced diagnostic imaging studies provided with the aid of contractors through teleradiology.
The proposed rules could provide for elevated consequences for Stark regulation violations related to these specific non-ancillary services, offering that:
Any person that presents or causes to be offered a bill or a claim for a provider that such man or woman is aware of or must recognize is for a service for which charge won’t be made… or for which money back has not been made… shall be difficulty to a civil cash penalty of now not more than $15,000 for every such service until such invoice or declare covered a bill or claim for a specified non-ancillary service, in which case the civil cash penalty shall be no longer extra than $25,000 for every such carrier….
Any health practitioner or different entity that enters into an association or scheme… which the health practitioner or entity knows or must realize has a primary motive of assuring referrals by the physician to a particular entity which, if the health practitioner directly made referrals to such entity, could be in violation of this phase, will be problem to a civil cash penalty of now not extra than $one hundred,000 (or $150,000 if such referrals are for targeted non-ancillary offerings)….
These amendments could observe to offerings furnished about 12 months after enactment. The regulation also would direct the Secretary, in consultation with the Office of Inspector General, to check compliance of referrals for positive non-ancillary offerings inside a hundred and eighty days of the bill’s enactment. The compliance assessment must: (1) target certain varieties of entities which might be taken into consideration an “excessive hazard of noncompliance” with recognize to billing for non-ancillary services and (2) consist of prepayment opinions, claims audits, focused clinical assessment, and laptop algorithms designed to become aware of price or billing anomalies.
