Federal Authorities Adjusting Regulatory Requirements ahead of 2021

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Original story posted on: December 7, 2020

CMS has finalized a new requirement that the nation's 6,200 hospitals report information about their inventory of therapeutics to treat COVID-19.

There has been a recent flurry of activity at the Centers for Medicare & Medicaid Services (CMS), with the federal agency publishing final rules for 2021 payments, giving providers more COVID-19 flexibility, and offering more administrative relief. These actions include the following:

In the Physician Fee Schedule Final Rule for 2021 payments there are changes to evaluation and management (E&M) services and codes, including increasing the relative value of several services, such as maternity care bundles and end-stage renal disease capitated payment bundles. Quoting CMS Administrator Seema Verma, "the finalized policy marks the most significant updates to E&M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients' care. In the past, the system has rewarded interventions and procedures over time spent with patients — time taken preventing disease and managing chronic illnesses."

Regarding telehealth, the final rule adds more than 60 services to Medicare's telehealth list, ensuring that they're covered beyond the end of the COVID-19 public health emergency (PHE). CMS stated that  "these additions allow beneficiaries in rural areas who are in a medical facility … to continue to have access to telehealth services, such as certain types of emergency department visits, therapy services, and critical care services." The agency also continues to look at telehealth expansion.  

Also, under this final rule, direct supervision can be provided using real-time, interactive audio/video technology through Dec. 31, 2021. And certain nonphysician practitioners, such as physician assistants and nurse practitioners, can supervise diagnostic testing if state law allows.

In the Outpatient Prospective Payment System (OPPS) Final Rule, CMS is eliminating the Inpatient-Only List over the course of three years. About 300 mostly musculoskeletal-related services will be removed first, followed by the rest of the list by 2024. An exemption has been granted from site-of-service claims denials under Medicare Part A for these procedures. "This exemption will last until we have Medicare claims data indicating that the procedure is more commonly performed in the outpatient setting than the inpatient setting," CMS said.

And beginning July 1, 2021, CMS is implementing a prior authorization process for the following categories of hospital outpatient department services: cervical fusion with disc removal and implanted spinal neurostimulators.

CMS has also finalized a new requirement that the nation's 6,200 hospitals report information about their inventory of therapeutics to treat COVID-19, providing the information needed to track and accurately allocate therapeutics to the hospitals that need additional inventory to care for patients and meet surge needs. 

CMS has noted the need to expand hospital capacities during the PHE. Medicare will provide payments under the Acute Hospital Care at Home program, providing eligible hospitals with unprecedented regulatory flexibilities to treat eligible patients in their homes. Efforts to provide at-home hospital care throughout the country have produced success by several leading hospital institutions and networks.

CMS and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) also recently issued coordinated rules, with HHS making Stark Law and Anti-Kickback Statute reforms to support coordinated value-based care. These new rules give providers more flexibility in making arrangements to coordinate care. They include giving exceptions to prohibitions for value-based program arrangements, reducing burdens for identifying exceptions, and protecting beneficial arrangements. Some examples of these newly allowed arrangements are the following:

  • A hospital may provide physician offices with care coordinators that furnish individually tailored case management services for patients requiring post-acute care, improving patient transitions from one care delivery point to the next;
  • A hospital may provide support and reward institutional post-acute providers for achieving outcome measures that effectively and efficiently coordinate care across care settings and reduce hospital readmissions;
  • A primary care physician or other provider may furnish a smart tablet capable of two-way, real-time interactive communication between the patient and his or her physician; patient access to a smart tablet could facilitate communication through telehealth and the provision of in-home services; and
  • A health system may furnish cybersecurity technology to physician practices to reduce harm from cyber threats to all their systems.

CMS is also providing additional regulatory flexibility to allow Ambulatory Surgery Centers (ASCs) to be temporarily certified as hospitals and provide inpatient care for longer periods than normally allowed, with the appropriate staffing in place.

Programming Note: Listen to Stanley Nachimson report this story live today during his popular RegWatch segment on Talk Ten Tuesdays, 10 a.m. EST.

Stanley Nachimson, MS

Stanley Nachimson, MS is principal of Nachimson Advisors, a health IT consulting firm dedicated to finding innovative uses for health information technology and encouraging its adoption.   The firm serves a number of clients, including WEDI, EHNAC, the Cooperative Exchange, the Association of American Medical Colleges, and No World Borders.  Stanley is focusing on assisting health care providers and plans with their ICD-10 implementation and is the director of the NCHICA-WEDI Timeline Initiative.  He serves on the Board of Advisors for QualEDIx Corporation.

Stanley served for over 30 years in the US Department of Health and Human Services in a variety of statistical, management, and health technology positions.  His last ten years prior to his 2007 retirement were spent in developing HIPAA policy, regulations, and implementation planning and monitoring, beginning CMS’s work on Personal Health Records and serving as the CMS liaison with several industry organizations, including WEDI and HITSP.  He brings a wealth of experience and information regarding the use of standards and technology in the health care industry.

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