CMS Proposes Rule Regarding the Exchange of Electronic Health Information Which Impacts Hospitals, Clinicians and Government Payors – On February 11, 2019, CMS issued a proposed rule, to improve access to electronic health information (the Proposed Rule). The Proposed Rule results from the 21st Century Cures Act (the Cures Act), in which CMS and the Office of the National Coordinator for Health Information Technology (ONC) were directed to develop policies to improve interoperability through data sharing and patient access to health information. The Proposed Rule is scheduled to be published in the Federal Register on March 4, 2019, but is available in an unpublished version here.

The Proposed Rule first seeks to require Medicare Advantage organizations, Children’s Health Insurance Program (CHIP) managed care entities, state Medicaid and CHIP Fee-For-Service (FFS) programs and Qualified Health Plans (QHP) (Covered Entities), to make patient claim and encounter data available in a standardized format through an Application Programming Interface (API). In 2018, CMS introduced Blue Button 2.0, an API that enabled Medicare beneficiaries to access their health claims information through an application of their choosing. CMS proposes that the Covered Entities similarly implement openly published APIs in which patient claim and other health information will be made available to patients through third-party applications. This data includes: adjudicated claims, encounters with capitated providers, and provider remittances, enrollee cost-sharing, and clinical data, including laboratory results. CMS proposes requiring compliance by January 1, 2020, and July 1, 2020, for Medicare Advantage plans and QHP issuers in FFEs, and Medicaid FFS, Medicaid managed care plans and CHIP managed care entities, respectively.

Second, CMS is proposing to require hospitals, (including short-term acute care hospitals, psychiatric hospitals, children’s hospitals, long-term care hospitals, cancer hospitals and rehabilitation hospitals, and Critical Access Hospitals), to send electronic notifications when a patient is admitted, discharged or transferred to other health care facilities or community providers. CMS proposes to limit this requirement to Medicare- and-Medicaid participating hospitals that that have adopted electronic health records systems. CMS seeks to require that hospitals convey the patient’s basic personal or demographic information, as well as the name of the sending institution, and, (if not prohibited by other applicable law), diagnosis.

Third, CMS stressed that Section 4003 of the Cures Act recognized the importance of making provider digital contact information available through a common directory. The Proposed Rule would additionally make publicly available the names and National Provider Identifiers of those providers who have not added digital contact information to their entries in the National Plan and Provider Enumeration System beginning in the second half of 2020.

Fourth, states and CMS additionally routinely exchange data to support the administration of benefits to Medicare-Medicaid dually eligible beneficiaries. The Proposed Rule also seeks to update the regularity with which states are required to exchange “buy-in” and “MMA” data on dually eligible beneficiaries, from a monthly exchange to a daily exchange.

Finally, CMS stressed the need to deter the practice of information blocking—when a vendor unreasonably interferes with or prevents access to electronic health information. CMS seeks to make publicly available a list of clinicians, hospitals and CAHs that have submitted a "no" response to any of the attestation statements regarding the prevention of information blocking in the Quality Payment Program or the Medicare FFS Promoting Interoperability Program.

CMS additionally issued requests for information as part of the Proposed Rule. CMS is seeking public comment regarding: (1) how CMS can utilize its program authority to improve patient identification and safety, and enable better care coordination and interoperability; and (2) how CMS can more broadly incentivize the adoption of interoperable health IT systems and use of interoperable data across settings such as facilities, and those settings serving individuals who are dually eligible for Medicare and Medicaid and/or receiving home and community-based services; and (3) ways in which the CMS Innovation Center may promote interoperability among model participants and other health care providers as part of the design and testing of innovative payment and service delivery models.

Comments on the proposed rule are due by 5 p.m., 60 days after its publication in the Federal Register. All submissions received must refer to file code “CMS-9115-P,” and may be submitted electronically, or by regular or express or overnight mail.

King & Spalding Client Alert: EPA Issues New Waste Rules for Hospitals, Medical Clinics and Pharmacies – On February 22, 2019, the U.S. Environmental Protection Agency (EPA) published new regulations for managing pharmaceutical waste under the Resource Conservation and Recovery Act (RCRA). The rules specify new requirements for hazardous waste management for healthcare facilities that generate pharmaceutical waste. In issuing these rules, EPA aimed to achieve two objectives: reduce the presence of pharmaceutical compounds in wastewater and balance the support for appropriate recycling or reuse with proper management of waste pharmaceuticals. These changes will impact a broad range of healthcare facilities, defined under the regulations to include hospitals, medical clinics, and retail pharmacies. They also apply to pharmaceutical manufacturers who act as reverse distributors. The new rules will take effect on August 21, 2019, six months from the date of publication in the Federal Register; however, certain requirements will require adoption by the states. For more information about the new pharmaceutical waste rule and how it may impact your organization please see the King & Spalding Client Alert, available here.

CMS Announces Innovative Payment Model for Emergency Ambulance Services – Coined the Emergency Triage, Treat, and Transport (ET3) model, CMS published details of its latest innovative payment model focused on emergency ambulance services. Currently, Medicare regulations limit payment for emergency ground ambulance services to certain facilities, which oftentimes results in Medicare beneficiaries being transported directly to a hospital’s emergency department (ED) even when a lower-acuity destination is more appropriate. ET3 is a voluntary, five-year payment model tested by the Center for Medicare and Medicaid Innovation (CMMI) within CMS. ET3 aims to provide incentives and payments for not only transports to EDs but also alternative destinations, or treatment on the scene by a qualified practitioner or via telehealth. CMMI is providing an overview webinar of ET3, timeline for release of the Request for Applications (RFA) and notice of funding opportunity on Wednesday, February 27, at 1:00 p.m. ET. Interested stakeholders can expect an RFA from CMMI in the summer of 2019, but CMMI suggests that up to three additional rounds for RFAs could occur. The first year of the five-year ET3 model is planned to begin January 2020.

CMMI aims to “improve quality and lower costs by reducing avoidable transports to the ED and unnecessary hospitalization following those transports.” CMMI cited to a study indicating that $560 million per year could be saved by transporting individuals to doctors’ offices rather than an ED. Therefore, CMMI identified ET3 as an opportunity to provide a continuum of care for those patients where a lower-acuity destination may more appropriately meet that patient’s needs.

With the above in mind, ET3 will pay participating ambulance suppliers and providers to: (1) transport an individual to an ED or other destination covered under current Medicare regulations, (2) transport to an alternative destination, or (3) provide treatment in place with a qualified healthcare practitioner, either on the scene or connected using telehealth. CMMI specifies that an alternative destination includes a primary care doctor’s office or an urgent care clinic.

CMMI describes the ET3 model as starting with a 911 call, where either an ambulance is dispatched, or a health care professional discusses with the individual his or her health concerns via a “medical triage line,” which is a “new service under the ET3 model.” When an ambulance is dispatched, CMMI outlines two options: (1) the ambulance can transport the individual to receive additional care, or (2) a qualified health care practitioner (either on site or via telehealth) provides treatment in place.

CMMI clearly contemplates a broader role for emergency ground ambulance services and envisions that Medicare-enrolled ambulance suppliers and hospital-owned ambulance providers will participate. Additionally, CMMI indicates that local governments or other entities that have authority for ambulance services could be selected for “cooperative agreement funding.”

For further information on ET3, CMS published a Fact Sheet and a Press Release.

Heading Off Health Plan Payment Reduction Tactics – King & Spalding is seeing a revival in many markets of the age-old health plan practice of denying line items and downgrading levels of care pre-payment. Health plans reduce payment to hospital providers with line item charge denials, assertions of improper bundling and unbundling of charges, as well as downgrades of levels of care. Watch King & Spalding’s Healthcare Partner Leslie Murphy discuss the challenges and share strategies that hospital providers can use to address these payment reduction tactics. These issues are discussed in greater detail in the Roundtable available here.