On Thursday, July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the 2019 Physician Fee Schedule (PFS) Proposed Rule (the Proposed Rule). In it, CMS proposes a number of changes of note, including permitting Medicare reimbursement for certain communication technology-based and remote evaluation services that do not satisfy Medicare’s requirements for telehealth services, clarifying the requirements for written agreements and signatures under the Stark law, and revising the documentation requirements and payment levels for evaluation and management (E/M) visits. The Proposed Rule also solicits comments on a bundled episode of care for substance use disorder (SUD) treatment. We are following these and other proposed changes, and will be separately publishing articles on the changes for telehealth services and substance use disorder treatment services on our HLB Health Law & Policy Blog and in our monthly newsletter, HLB Perspectives. The Proposed Rule includes a number of proposed changes relevant to telehealth. First, CMS proposes distinguishing between Medicare telehealth services and “communication technology-based and remote evaluation services.” This distinction would permit Medicare reimbursement for three services that are colloquially referred to as types of telehealth services but that do not meet the statutory requirements for Medicare-reimbursable telehealth services. The particular types of communication technology-based and remote evaluation services that CMS proposes covering are discussed further below. Second, CMS proposes adding prolonged preventive services (HCPCS Codes G0513 and G0514) to the enumerated list of Medicare telehealth services that can be reimbursed when provided via telehealth and in compliance with CMS’ reimbursement requirements for telehealth services, including originating site restrictions and geographic requirements. Lastly, CMS proposes regulations implementing sections 40302 and 50325 of the Bipartisan Budget Act of 2018, which requires changes to the telehealth originating site and geographic requirements for home dialysis patients’ monthly clinical assessments and acute stroke services. Communication Technology-Based and Remote Evaluation Services. CMS proposes providing separate Medicare reimbursement for three types of communication technology-based and remote evaluation services as follows: These three communication technology-based and remote evaluation services do not satisfy the requirements for Medicare telehealth services as set forth in section 1834(m) of the Social Security Act, 42 U.S.C. § 1395m(m), but in the Proposed Rule, CMS takes the view that the Medicare telehealth standards do not apply to services that “inherently involve the use of communication technology.” In particular, CMS states: We have come to believe that section 1834(m) of the Act does not apply to all kinds of physicians’ services whereby a medical professional interacts with a patient via remote communication technology. Instead, we believe that section 1834(m) of the Act applies to a discrete set of physicians’ services …. For CY 2019, we are aiming to increase access for Medicare beneficiaries to physicians’ services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. CMS’ willingness to consider providing Medicare reimbursement for services that do not meet the statutory requirements for Medicare telehealth services but do involve the use of communication technology or remote evaluation appears to signal a general recognition of the value that these services can offer, including earlier and more cost-effective intervention. Although it is too early to draw large conclusions from this proposal, it may also signal the prioritization of regulatory flexibility and a more specific receptiveness to future proposals for other communication technology-based and remote evaluation services. The Proposed Rule envisions refining the Stark regulations to tighten and clarify (but not change) the existing law with respect to what qualifies as a written agreement and when a signature must be secured. Specifically, the proposed changes would add regulatory provisions specifying that (1) the writing requirement contained in various compensation arrangement exceptions can be satisfied by “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties” and (2) the signature requirement can be satisfied if the compensation arrangement meets all of the other requirements of the exception, and the required signatures are obtained within “90 consecutive calendar days immediately following the date” a signature was required but not yet secured. In the 2016 final PFS rule, CMS had explained its position on what qualifies as a written agreement, and indicated that it was merely clarifying what had been its longstanding interpretation. CMS explained this position in the preamble, but without codifying this in the regulations themselves. That final rule also allowed parties 90 days to secure a signature, but limited it to once every three years with the same physician. However, in 2018, Congress amended the statute itself to provide that a collection of documents can qualify as a writing and to give parties 90 days to secure a signature, and notably did not limit parties who are tardy in gathering signatures to once every three years with the same physician. Thus, these proposed changes would effectively codify, in regulation, what is already the law, pursuant to the statute. In the Proposed Rule, CMS reiterated its commitment to make combatting the opioid epidemic a top priority for the agency and to align its efforts with the Department of Health and Human Services’ (HHS) opioid initiative. In support of that commitment, CMS is considering, and seeking comment on, the creation of a bundled episode of care for SUD treatment that would include components of Medication Assisted Treatment (MAT) such as management and counseling treatment, treatment planning, and medication management or observing drug dosing for treatment of SUDs. CMS has expressed hope that such bundling could expand access to treatment for SUDs, and thus, be effective in preventing the need for more acute services, such as hospitalization. Further opportunities also exist to leverage communication technology, such as CMS’ proposal to provide separate payment for certain “virtual check-ins” (discussed above) provided for particular components of MAT. Finally, in addition to bundling, CMS also requested comments on whether the counseling portion or other MAT components could be provided by qualified practitioners “incident to” services of the billing physician. CMS has also proposed adding two new Promoting Interoperability measures to the e-Prescribing objective for clinicians eligible for Merit-Based Incentive Payment System (MIPS): (1) Query of Prescription Drug Monitoring Programs (PDMPs); and (2) Verify Opioid Treatment Agreement. These measures are intended to support HHS opioid initiatives by helping health care providers avoid inappropriate prescriptions, improving coordination of prescribing amongst health care providers and focusing on the advanced use of EHR technology. CMS also proposed corresponding changes to the measures for eligible hospitals in the FY 2019 Inpatient Prospective Payment System (IPPS) Proposed Rule. We will explore CMS’s proposals related to opioid use disorders in more detail in a future article on our HLB Health Law & Policy Blog and in our monthly newsletter, HLB Perspectives. The Proposed Rule offers a number of significant changes for physicians and other practitioners paid under the Medicare PFS for E/M services. Stakeholders have long maintained that the 1995 and 1997 E/M Documentation Guidelines that practitioners rely on are administratively burdensome, outdated, and ought to be revised and revalued. The Proposed Rule includes a number of changes related to E/M documentation and payment, including proposals to: Past proposed changes to E/M guidelines and payment rules have faced difficulties due to the lack of consensus among stakeholders. Because the anticipated impact of the foregoing proposals will vary widely by specialty and other practice factors, we expect that stakeholder comments will sharply diverge, particularly with regard to the proposed single-PFS rate with add-on payment and ratesetting adjustments. The foregoing is a sampling of key highlights found among the more than 1,400 pages of the Proposed Rule. Comments on CMS’ proposals are due on September 10, 2018. The Proposed Rule will be published in the Federal Register on July 27, 2018 at https://federalregister.gov/d/2018-14985. In the interim, the unpublished version is available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-14985.pdf. For more information on the PFS, Telemedicine, Stark, Opioid Use Disorder Treatment, and E/M Guidelines and Payment, please contact: Amy Joseph or Jeremy Sherer in Boston at 617.532.2700; Katrina Pagonis in San Francisco at 415.875.8515; Charles Oppenheim, Alicia Macklin, or Paul Garcia in Los Angeles at 310.551.8111; Martin Corry, Keith Fontenot, or David Vernon in Washington, D.C. at 202.580.770; or your regular Hooper, Lundy & Bookman contact.CMS Proposes Changes to Telehealth Reimbursement, Stark, Substance Use Disorder Treatment Reimbursement, and Evaluation & Management Reimbursement in the CY 2019 Physician Fee Schedule Proposed Rule
Proposed Telehealth Reimbursement Changes
Proposed Clarifications to Stark Written Agreement and Signature Requirements
Opiod Use Disorder Treatment and Other Substance Use Disorder (SUD) Treatment
Evaluation and Management (E/M) Documentation and Payment
Other Issues of Note
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