By Shannon B. Hartsfield
The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have significant effects on providers, once finalized. CMS is soliciting comments from the public, which are due by Sept. 10, 2018. Much of the proposed rule focuses on revising the physician fee schedule, but there are also provisions dealing with a wide variety of other topics, including the Medicare Shared Savings Program, the Quality Payment Program, the Medicare and Medicaid Promoting Interoperability Program and the federal physician self-referral prohibitions, commonly known as the "Stark Law." A topic of particular interest that could be affected by the proposed rule relates to telemedicine.
Under Section 1834(m) of the Social Security Act, payment for telehealth services using "store-and-forward" technology, or asynchronous transmission of recorded images, is allowed only under federal demonstration programs conducted in Alaska and Hawaii. CMS is proposing to allow codes that would describe remote professional evaluation services using store-and-forward technology that would not be subject to the restrictions in 1834(m) of the Social Security Act. The services would likely be used to decide whether or not the patient needs to come to the office for an in-person visit. If the patient does come into the office after the remote consultation, the payment for the telehealth service would be bundled into the reimbursement for the office visit and would not be separately billable. Similarly, if a remote service relates to an in-office evaluation and management service provided within the prior seven days by the same physician or health professional, it also would not be separately billable.
If the telehealth service is not related to an office visit within the past seven days and does not result in a future evaluation and management office visit, CMS proposes a separate payment for the service, effective Jan. 1, 2019. CMS believes this would result in "increased access to services for Medicare beneficiaries." CMS is asking for comments regarding whether these services should be limited to established patients, or whether they would be appropriate for new patients in certain situations, such as new dermatology or ophthalmology patients.
In the proposed rule, CMS also would make separate payments for consultations between professionals performed via communications technology, such as telephone or internet, regarding a patient's treatment. CMS believes that paying for such consultations is "consistent with [its] ongoing efforts to recognize and reflect medical practice trends in primary care and patient-centered care management...." CMS believes that making payments for these consultations "will contribute to payment accuracy for primary care and care management services." CMS is seeking comment on how these services may be distinguished from consultation services that are primarily for the practitioner's benefit, such as consultations relating to continuing education or professional courtesy. CMS also is proposing to create a new modifier that would allow the identification of "acute stroke telehealth services." Under the proposed rule, a mobile stroke unit would be a permissible originating site for acute telehealth services relating to stroke.
Expanded Medicare reimbursement is likely to serve as a catalyst for telemedicine expansion. The proposed rules, if finalized, could result in further utilization and development of telemedicine technology.
Enforcement Former Employee Brings Qui Tam Action, Alleging Violations Under AKS and FCABy Kaitlyn Downs
In United States of Am. ex rel. Derrick v. Roche Diagnostics Corp., No. 1:14-cv-04601, 2018 WL 2735090 (N.D. Ill. June 7, 2018), the district court denied motions to dismiss filed by Roche Diagnostics (Roche) and Humana in a qui tam action. Roche contracted with Humana to make certain of Roche's products available on Humana's formularies; however, Humana later notified Roche that this contract would be terminated. Shortly thereafter, the relator, a Roche national accounts manager, discovered that Roche had overpaid rebates to Humana, which Roche's finance department valued at $45 million. After extensive negotiations, Roche and Humana agreed that Humana would pay Roche an amount not to exceed $11 million and Roche products would once again be available on Humana's formularies. Furthermore, the parties agreed that competing brand products would be excluded from Humana's formularies.
The relator, who was terminated by Roche, alleged that Roche and Humana engaged in a scheme that violated the Anti-Kickback Statute (AKS), that Roche and Humana violated the False Claims Act (FCA) and that Roche fired her in retaliation for her questioning the lawfulness of Roche and Humana's dealings. The court found unconvincing Humana and Roche's arguments that the relator's complaint failed to meet particularity and plausibility standards because the relator's allegations (1) supported an inference that Humana submitted claims resulting from an AKS violation, (2) provided evidence that Humana and Roche knew the arrangement was unlawful and (3) plausibly supported an inference that Roche's acceptance of an amount less than was owed by...
