As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories. In the past two weeks, CMS has issued disease-specific coverage and billing guidance, developed new HCPCS billing codes for COVID-19 laboratory tests, outlined screening, treatment, and transfer protocols for hospitals with emergency departments, and suspended certain state survey activities to prioritize focus on infection control.
CMS Fact Sheet: Coverage and Payment Related to COVID-19 – Medicare
On March 5, 2020, CMS issued a fact sheet with guidance for healthcare providers and patients that describes various benefits in the Medicare program. The fact sheet is part of a broader effort by CMS and the White House Coronavirus Task Force to educate the public about benefits that can be used to contain the disease. The fact sheet is organized into two main sections, the first covering Original Medicare and the second covering Medicare Parts C and D. CMS continued to supplement the fact sheet throughout last week with additional information covering new benefit categories. The fact sheet currently includes brief sections addressing: diagnostic tests; vaccines; inpatient hospital services; inpatient hospital quarantines; ambulatory services; telehealth and other communication-based technology services; requests for prescription refills; emergency ambulance transportation; Medicare Advantage coverage and cost sharing; and Part D coverage, as well as other topics.
The fact sheet is available here.
Two New HCPCS Billing Codes for Coronavirus Diagnostic Tests
CMS developed two, new Healthcare Common Procedure Coding System (HCPCS) codes that laboratories can use to bill for certain COVID-19 diagnostic tests. The first HCPCS code (U0001) can be used to bill for CDC testing laboratories to test patients for COVID-19. The second HCPCS billing code (U0002) allows providers to bill for non-CDC laboratory tests. Last month, the FDA issued guidance for laboratories to develop their own tests. The use of coronavirus-specific HCPCS billing codes will permit CMS to encourage more testing and to enhance pandemic tracking efforts. The Medicare claims processing system will begin to accept the HCPCS billing codes on April 1, 2020 for dates of service after February 4, 2020. CMS has tasked the regional MACs with developing reimbursement rates for these new codes until a national payment rate is established.
More information on the new HCPCS billing codes is available here.
Guidance to Hospitals with Emergency Departments on Patient Screening, Treatment and Transfer Requirements
On March 9, 2020, CMS published a memorandum to State Survey Agency Directors providing guidance to hospitals with emergency departments (EDs) on patient screening, treatment and transfer requirements to prevent the spread of infectious disease and illness, including COVID-19. The memorandum, “Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19),” advises that hospitals should continue to follow both CDC guidance for infection control and EMTALA requirements. In the memorandum, CMS emphasizes that every hospital and critical access hospital (CAH) with an ED is required to conduct an appropriate medical screening examination (MSE) of all individuals who come to the ED, including those who are suspected of having COVID-19. Every hospital with an ED is expected to have the capability to apply appropriate COVID-19 screening criteria, to immediately identify and isolate individuals who meet COVID-19 screening criteria, and to contact their state or local public health officials to determine next steps.
Consistent with the obligations imposed by EMTALA, hospitals with capacity and the specialized capabilities needed for stabilizing treatment are required to accept appropriate transfers from hospitals without the necessary capabilities. The memorandum advises that, in assessing whether a hospital had the requisite capabilities and capacity for COVID-19 treatment, CMS would take into account the CDC’s recommendations at the time of the event in question. The CDC’s most current infection prevention and control recommendations for hospital patients with suspected or known COVID-19 are available here.
The memorandum also describes three options available to hospitals for managing extraordinary ED surges under existing EMTALA requirements. First, hospitals may set up alternative screening sites on campus, outside the ED. Individuals may be redirected to these sites after being logged in, and this process can even take place outside the ED’s entrance. Second, hospitals may set up screening at off-campus, hospital-controlled sites. Hospitals and community officials may encourage the public to go to these sites instead of the hospital for screening for influenza-like illness (ILI). However, a hospital may not tell individuals who have already come to its ED to go to the off-site location for the MSE. EMTALA requirements do not apply to such off-campus sites, unless the off-campus site is already a dedicated ED of the hospital. Third, communities may set up screening clinics at sites not under the hospital’s control, and hospitals and community officials may encourage the public to go to such sites for ILI screening. Such sites are not subject to EMTALA’s requirements.
The memorandum is available here.
Guidance to Medicare Advantage and Part D Plans
On March 10, 2020, CMS issued a memorandum that outlines the flexibilities that Medicare Advantage Organizations (MAOs) and Part D sponsors have to waive certain requirements to help prevent the spread of COVID-19. Most significantly, the memorandum advises that MAOs may waive or reduce enrollee cost-sharing for beneficiaries enrolled in their MA plans. For example, MAOs may waive or reduce cost-sharing for COVID-19 laboratory tests, telehealth benefits or other services to address the outbreak, provided cost-sharing is waived or reduced for all similarly situated plan enrollees on a uniform basis. The OIG has advised that should a MAO choose to voluntarily waive or reduce enrollee cost-sharing, such waivers or reductions would satisfy the safe harbor to the federal Anti-Kickback Statute for increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans, set forth at 42 C.F.R. § 1001.952(l).
The memorandum also advises that MAOs may provide enrollees access to Part B services through telehealth in any geographic area and from a variety of places, including beneficiaries’ homes. To combat the COVID-19 outbreak, MAOs may expand coverage of telehealth services for similarly situated enrollees beyond those approved by CMS in the plan’s benefit package, until CMS determines such expansion is no longer necessary in conjunction with the outbreak. OIG has advised that such an expansion of coverage by a MAO would also qualify for the safe harbor at 42 C.F.R. § 1001.952(l).
The memorandum describes several options available to Part D sponsors. Sponsors may relax their “refill-too-soon” edits if circumstances are reasonably expected to result in a disruption in access to drugs. Sponsors may also permit affected enrollees to obtain the maximum extended day supply available under their plan, if requested and available. Further, to ensure enrollees have adequate access to covered drugs when those enrollees cannot reasonably be expected to obtain such drugs from network pharmacies, sponsors may reimburse enrollees for prescriptions obtained from out-of-network pharmacies. Finally, where it would be difficult or impossible for an enrollee to access a retail pharmacy (due to a disaster, emergency, or quarantine situation), sponsors may voluntarily relax any plan-imposed policies that discourage certain methods of delivery (e.g., mail or home delivery).
The memorandum is available here.
CMS Suspends Certain Survey Activities to Focus on Infection Control
On March 4, 2020, CMS issued a memorandum to State Survey Agency Directors that suspended non-emergency inspections across the country and prioritized a focus on infection control deficiencies. In the memorandum, CMS limited survey activity to the following priorities: (i) immediate jeopardy complaints and allegations of abuse and neglect; (ii) complaints with allegations of infectious disease control concerns; (iii) recertification surveys that are statutorily required for nursing homes, home health, hospice, and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID facilities); (iv) re-visits needed to resolve enforcement actions; (v) initial certifications; (vi) surveys of facilities with a history of infectious disease control issues at the immediate jeopardy level within the past three years; and (vii) surveys of facilities with a history of infectious disease control deficiencies at lower levels than immediate jeopardy.
The memorandum is available here.
