In the face of ever-increasing documentation and reporting requirements, reduced reimbursement, and the general hassle of managing EHRs, some physicians are reevaluating their relationships with Medicare. Towards this end, they may be exploring whether to switch from “participating” to “non-participating” status (where the physician may elect to accept assignment on claims or charge the patient a fee up to the applicable limiting charge), or to opt out of Medicare (entering into private contracts with patients wherein the physician’s services will not be reimbursed at all by Medicare, and they may charge what they please). In investigating these options, however, physicians may encounter additional information regarding how to “withdraw” from Medicare, which may lead to some confusion. Which status is the right status: non-participating, opted out, or withdrawn? And what is the difference between withdrawing from Medicare and the other statuses? Withdrawal from Medicare is appropriate when a physician is voluntarily terminating involvement in Medicare altogether, such as when the physician retires, or closes a practice location and wishes to terminate permanently the billing privileges for that location. It is not meant to be the same thing as switching to non-participating status, nor for opting out and entering into private contracts with patients.

In May, 2021, CMS withdrew its long-standing billing rule regarding split/shared visits. In broad strokes, the rule that existed prior to the May, 2021 withdrawal permitted evaluation and management (E/M) services to be performed in a hospital setting where a non-physician practitioner (NPP) such as a nurse practitioner or physician assistant would see the patient for part of the visit, and a physician in the same group would see with the patient later to complete the visit. After the physician spent a “substantive portion” of the visit with the patient the total service was billable by the physician. CMS withdrew the rule in response to several intersecting factors. First, the Supreme Court’s decision in the Allina case took the position that CMS cannot regulate by using sub-regulatory guidance (e.g., FAQs, Local Coverage Determinations, and Medicare manuals). The split/shared visit rule had never been proposed in regulations and was instead a creation of the Medicare Carrier’s Manual which was later cross-walked to the Claims Processing Manual. Second, in response to the Allina decision, CMS adopted a new policy whereby petitions could be submitted to withdraw certain guidance documents that had not been proposed through the regulatory process. Third, a petitioner proposed that CMS withdraw the split/shared rule, and CMS agreed. In response to the petitioner, CMS noted that the incident-to rule still exists (which is recognized in Medicare’s regulations), but that the split/shared visit rule had been removed.

CMS has proposed new split/shared regulations in the Proposed Medicare Physician Fee Schedule for 2022. The proposed rule follows much of contours of the original billing rule, but makes some changes to accommodate the 2021 changes to the E/M rules. Specifically, rather than a focus on medical decision-making (MDM), the proposed rule focuses more on time spent by providers on the visit, allowing the physician and NPP to total their distinct time (although time spent in discussion with each other is only counted once). The proposed regulation will define “substantive portion” to mean more than half of the time spent in the encounter, with a goal to prevent the physician from merely “poking their head” into the room.

Among the designated health services (DHS) which are the subject of the Stark law restrictions are outpatient prescription drugs.  When the Stark statute was enacted, Part D of Medicare didn't even exist; so, while it was obvious that drugs paid for under Part B, (many of which are provided in physician offices in infusions and otherwise) were covered, the answer was not so clear for drugs paid for by Part D, which may come from pharmacies, including physician owned pharmacies in some places. In fact, there is a specific regulation which sweeps Part D drugs into the ambit of Stark DHS. Physician groups which own pharmacies need to take this into account in their compensation and profit-sharing formulas.