The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services. The waivers apply only to financial relationships and referrals related to COVID. The circumstances and conditions under which the waivers apply are strictly and narrowly described. Moreover, the waivers have no impact in the presence of fraud or abuse. With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–
the federal requirement that the DHS be provided in the same building as the physician office is waived; and
the financial relationship limitations between the physician (or family member) and the DHS provider is waived.
The waiver also contains specific examples of waived interactions between providers and hospitals, including—
CMS has rolled out a telehealth/telemedicine tool kit to assist medical professionals with health care delivery during the current COVID-19 public health emergency.
The toolkit contains information and links concerning:
1135 Waivers – allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient health care services and items are available to meet the needs of individuals enrolled in Social Security Act programs during the emergency and that providers who provide services in good faith can be reimbursed and exempted from sanctions (provided there is no determination of fraud and abuse). 1135 waiver or modifications include:
Conditions of participation and other certification requirements;
Program participation and similar requirements;
State licensing requirements where services are rendered as long as the provider has equivalent licensing in another State (for Medicare, Medicaid, CHIP reimbursement only; State licensing still controls whether a non-Federal provider may provide services in a state he/she is not licensed in);
EMTALA sanctions for redirection for medical screening, as long as redirection is not the result of discrimination on the basis of a patient’s source of payment or ability to pay;
Stark self-referral sanctions;
Adjustment (not waiver) to performance deadlines and timetables;
Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.
The Medicare Access and CHIP Reauthorization Act was enacted to replace the flawed sustainable growth rate (SGR). MACRA contains performance measures for new payment models that will go in place in 2017. MACRA also established the Merit-Based Incentive Payment System (MIPS).
Physicians have to begin to learn about MACRA to improve performance and to avoid payment penalties.
We also have the Physician Quality Reporting System (PQRS), which penalizes providers for failing to report quality measures data on Part B services. To avoid a 2018 PQRS payment adjustment, for instance, providers have to report for a 12 month period.
There is also the Value Based Payment Modifier (VM) program that rewards groups for providing high quality, low cost care. It’s interesting to note that CMS proposes to publically report those providers who receive an upward adjustment. It’s being waived for Pioneer ACOs. It’s interesting to note that the measures used for the VM program are different than those used for ACOs; and this is causing a lot of confusion.
Bottom line: an increased use of benchmark establishment for quality and cost and financial incentive programs to achieve or surpass those benchmarks.
STARK LAW CHANGES
A new compensation arrangement exception is established for timeshare arrangements for the use of office space, equipment, personnel, items, supplies and other services. This sort of “overhead sharing” arrangement is done, but there hasn’t been a specific Stark provision for it till this year. It’s expected to be particularly useful in physician/hospital arrangements.
This exception amplifies the existing requirements that such arrangements must (1) be located where the physician or practice sees its patients, and (2) be used for designated health services that are incidental to what the doctor does, meaning E&M services and DHS that are provided at the time of such E&M services.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.