COVID-19 Legal Resources for Healthcare Providers and Suppliers

COVID-19 Legal Resources for Healthcare Providers and Suppliers - Part 2

Welcome to Wachler & Associates COVID-19 resource page.

CMS Enrollment Initiatives

The outbreak of COVID-19 has caused a sudden increase in demand for Medicare providers and a need to efficiently allocate a limited supply of providers. To address these issues, CMS has used Section 1135 waivers to take several actions to temporarily streamline provider enrollment in Medicare.

The first of these measures is a series of toll-free hotlines for physicians and non-physician providers to enroll in Medicare billing privileges. The hotlines are set up by CMS but operated by Medicare Administrative Contractors (MACs) to handle enrollment and field enrollment questions in each MAC’s particular jurisdiction. The hotline number associated with each MAC and the hours of operation of the hotline are:

CGS Administrators, LLC (CGS): 1-855-769-9920; 7:00 am – 4:00 pm CT
First Coast Service Options Inc. (FCSO): 1-855-247-8428; 8:30 AM – 4:00 PM EST
National Government Services (NGS): 1-888-802-3898; 8:00 am – 4:00 pm CT
National Supplier Clearinghouse (NSC): 1-866-238-9652; 9:00 AM – 5:00 PM ET
Novitas Solutions, Inc.: 1-855-247-8428; 8:30 AM – 4:00 PM EST
Noridian Healthcare Solutions: 1-866-575-4067; 8:00 am – 6:00 pm CT
Palmetto GBA: 1-833-820-6138; 8:30 am – 5:00 pm ET
Wisconsin Physician Services (WPS): 1-844-209-2567; 7:00 am – 4:00 pm CT

When calling a hotline to enroll, the physician or non-physician provider will be asked to provide their legal name, NPI number, Social Security number, a valid in-state or out-of-state license, and contact information. The MAC will attempt to screen the provider over the phone and reach an approval or rejection decision while the provider is on the line. Written confirmation of the approval or rejection decision will follow the call via email from the MAC. To allow screening over the phone, CMS has temporarily waived the requirements that physicians and non-physician providers submit to fingerprint-based criminal background checks and site visits.

Medicare billing privileges granted over the phone will be temporary. The earliest effective date for temporary enrollment is March 1, 2020. Temporary enrollment will last until the end of the declared public health emergency, at which time the MAC will send the provider a request for a complete CMS-855 application. Failure to submit the CMS-855 within 30 days will result in deactivation of the temporary billing privileges. The hotlines themselves will operate until the end of the public health emergency,

A physician or non-physician provider seeking to enroll in Medicare via the hotlines may also find increased flexibility in providing Medicare services across state lines. In addition to the blanket waivers above, CMS is also considering, on a case-by-case basis, waivers of the requirement that a physician or non-physician provider be licensed in the state in which she is practicing. This additional waiver is available only if four criteria a met:

The physician or non-physician practitioner must be enrolled as such in the Medicare program;
The physician or non-physician practitioner must possess a valid license to practice in the State of his or her Medicare enrollment;
The physician or non-physician practitioner is furnishing services in a State in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity. This can be in person or via telehealth; and
The physician or non-physician practitioner is not affirmatively excluded from practice in the State or any other State that is part of the Section 1135 emergency area. It is important to note that obtaining such a waiver from CMS does not waive any additional state or local licensure requirements.

Additionally, a physician or non-physician practitioner can provide Medicare services from home via telehealth by calling the applicable MAC hotline and updating their Medicare enrollment with their home address. The update is effective immediately in order to minimize disruption in services.

The hotlines currently are available only to physicians and non-physician providers. All other providers and suppliers, including DMEPOS suppliers, are still required to submit initial enrollments and changes of information through the CMS-855 application. However, CMS has directed MACs to expedite the processing of applications and has waived some of the screening requirements. Clean web applications submitted on or after March 18, 2020 will processed within 7 business days, and clean paper applications submitted on or after March 18, 2020 will be process within 14 business days. CMS is also temporarily waiving application fees, fingerprint-based criminal background checks, and site visits for these applications.

Finally, CMS is temporarily halting revalidation efforts for all Medicare providers and suppliers. Revalidation will resume after the end of the public health crisis. CMS is also postponing DMEPOS accreditation and reaccreditation deadlines. Suppliers should still comply with accreditation requirements, however, because CMS will continue to monitor billing activity and may take further action at a later date.

CMS Updates on Medicare Audits During COVID-19 Pandemic

The Center for Medicare & Medicaid Services (CMS) has published multiple updates on its website regarding how it is responding to COVID-19. With audits that have already been initiated specifically in mind, CMS has indicated it will be taking the following steps for Medicare appeals involving Fee for Service, MA, and Part D:

Providing extensions to file an appeal;
Waiving timeliness for requests for additional information to adjudicate the appeal;
Processing the appeal even with incomplete Appointment of Representative forms (AORs), but communicating only to the beneficiary;
Processing requests for appeals that don’t meet the required elements, but using information that is available;
Utilizing all flexibilities available in the appeal process as if good cause is satisfied.

Additionally. CMS is suspending most Medicare Fee-For-Service medical review during this Public Health Emergency. No additional documentation requests will be issued for the duration of the Public Health Emergency, and any ongoing Targeted Probe and Educate review will be suspended, and claims will be released from review. Current post-payment reviews will also be suspended and released from review at this time. However, CMS retains the right to conduct reviews during or after the Public Health Emergency if there is an indication of potential fraud.

In response to the growing use of telemedicine as a resource for treating COVID-19, CMS has updated its guidelines for billing telemedicine services. According to CMS’ Telemedicine Provider Fact Sheet, HHS will not conduct audits to track whether there was a prior-patient physician relationship for claims submitted during this public health emergency.

For commercial insurance plans, such as Blue Cross Blue Shield, Cigna, and more, each payor will be handling audits differently during this time. However, it is our firms experience in the last few weeks that most, if not all, pending deadlines for ongoing audits will be generously relaxed upon request of the provider or its attorneys. If a provider has any concern about sufficiently complying with a private payor’s audit requests during this time, having its attorney openly communicate these concerns can be key to ensure the provider has the best chance at defending against an audit.

DEA Relaxes Procedures for Prescribing Controlled Substances During COVID-19 Pandemic

Following the declaration of a public health emergency, the Drug Enforcement Agency (DEA) has issued updated guidance that relaxes some of the procedural hurdles required to prescribe substances in schedules II through V. These measures enable social distancing by decreasing the need for face-to-face contact between patients, practitioners, and pharmacists.

First, DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances via telemedicine. This change temporarily eliminates the need for an in-person medical evaluation, if the practitioner meets three conditions: (1) the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; (2) the telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and (3) the practitioner is acting in accordance with applicable Federal and State laws. This change applies to all areas of the United States and is effective for the duration of the public health emergency.

Second, once a practitioner has evaluated a patient by telemedicine, if the practitioner prescribes a schedule II controlled substance, he/she now has the option to “call-in” an emergency schedule II prescriptions to the pharmacy by telephone. The DEA has made this option available for this emergency. The practitioner may “call-in” the emergency schedule II prescription and the pharmacy may dispense it without the original prescription if several requirements are met:

The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order.
The prescription order must be immediately reduced to writing by the pharmacist and must contain all information, except for the prescribing practitioner's signature.
If the prescribing individual practitioner is not known to the pharmacist, he/she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, such as calling back the practitioner at their publicly listed number or other good faith efforts to ensure his or her identity.
The prescribing practitioner must provide a written and signed prescription to the pharmacy within seven days of issuing the emergency telephone prescription. The prescription must have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist must attach this written prescription to the oral emergency prescription which had earlier been reduced to writing by the pharmacist. The pharmacist must notify the local DEA field office if the prescriber does not provide a written prescription within seven days.

The options to transmit a schedule II prescription to the pharmacy by facsimile or by electronic prescription and the option to call-in a schedule III-V remain available, if their normal requirements are met.

It should be noted that DEA guidance does not eliminate state or local requirements for prescribing controlled substances.

COVID-19 Long Term Care (LTC) Waivers and Practical Guidance

The Novel Coronavirus (COVID-19) pandemic has caused lots of regulatory changes for every area of the medical profession. Many waivers have been applied across the various fields. Long Term Care (“LTC”) facilities – consisting of Skilled Nursing Facilities (“SNF”) and/or Nursing Facilities (“NF”)—have many waivers they must be aware of:

Physical Environment: Historically, 42 CFR § 483.90 would prevent SNFs from operating in non-SNF buildings. However, the Centers for Medicare and Medicaid Services (“CMS”) has waived this requirement to allow for a non-SNF building to be temporarily certified as available for use by an SNF in the event that isolation is necessary for COVID-19 patients and the existing SNF would not allow for the requisite isolation. Additionally, CMS will waive certain conditions of participation if a NF needs to be opened quickly to be used as a temporary isolation and treatment location. Furthermore, rooms in SNFs that are not typically patient rooms, such as activity rooms, meeting rooms, and conference rooms, may be used to accommodate beds and residents to help with the increased surge of patients. All of these measures aim at reducing the spread of COVID-19 and should be strictly followed by LTC facility administrators.

Guidance from CMS indicates SNFs should use any new facilities in a way that physically separates COVID-19 positive patients, negative patients, and those whose status is unknown. CMS also encourages consistent staffing of all SNF residents, regardless of COVID-19 status. That is, staff should work consistently with the same group of residents, to the exclusion of others. Specifically, staff working with COVID-19 positive patients or those whose status is unknown should not also work with patients who are COVID-19 negative.

Transferring COVID-19 Patients: By waiving certain requirements in 42 CFR §§ 483.10, .15, & .21, LTC facilities may now temporarily move residents within a facility or transfer them to another LTC in order to separate residents who test positive for COVID-19 from other residents. Previously, there was a long process that facility administrators had to go through before moving any patient anywhere, but because of the rapid spread of COVID-19, there is simply no time to go through that process.

CMS is encouraging state and local authorities to designate certain facilities to handle COVID-19 positive patients. CMS advises that designated facilities receive adequate supplies and PPE and isolate any patient therein whose COVID-19 status is unknown in their room for 14 days. Some designated facilities will likely need the capacity, staffing, and infrastructure to manage higher intensity patients, including ventilator management.

3-Day Prior Hospitalization: CMS has waived the requirement for a 3-day prior hospitalization that is usually required to receive coverage of a SNF stay. Eliminating the qualifying hospital protects those people who have experienced SNF dislocations or have otherwise been impacted by the COVID-19 pandemic. This waiver also permits those SNF beneficiaries who have exhausted their benefits to renew SNF coverage without having to begin a new benefit period. This measure keeps patients out of hospitals so that more beds are available to COVID-19 patients and reduces the risk of SNF residents/future residents from contracting COVID-19.

Waive Pre-Admission Screening and Annual Resident Review (“PASRR”): New residents are always required to have a PASRR before admission into nursing homes. CMS has waived the PASRR requirement for new residents for 30 days, and after 30 days, patients specifically with a mental illness or intellectual disability should receive a PASRR. CMS has indicated, however, that every resident should be assessed for COVID-19 symptoms and have their temperature checked every day.

Resident Groups: 42 CFR § 483.10(f)(5) has been waived such that LTC facilities may restrict having in-person meetings during the national emergency in order to maintain CDC recommended social distancing guidelines. Where a staffer enters the room of a patient, CMS recommends the resident cover their nose and mouth with a tissue or cloths, if they display COVID-19 symptoms, or a medical facemask, if they are COVID-19 positive. CMS encourages staff to wear facemasks at all time within the facilities and full PPE when interacting with a COVID-19 positive patient.

In addition to the above waivers, CMS has also put out a memorandum with additional guidance regarding infection control and disease protection for visitation at LTC facilities. This guidance includes screenings of every individual who enters an LTC, including residents, staff, visitors, outside healthcare workers, and vendors. CMS also recommends that facilities limit the number of available entrances and have a screening station at each entrance. Certainly, all of the measures being taken by CMS consider the fact that most, if not all, residents in a LTC facility are higher risk patients. As such, LTC facilities and providers should be extra cautious to reduce any exposure of COVID-19 to these patients and follow all waivers that CMS has promulgated to combat this pandemic.

COVID-19 Waivers for DME

In response to the public health emergency, CMS is empowered to take proactive steps to expand the government’s efforts against COVID-10 by providing many blanket waivers for certain requirements. The Center for Medicare & Medicaid Services (CMS) has provided updated temporary guidelines regarding the handling and use of Durable Medical Equipment (DME) during the COVID-19 public health emergency.

Generally, certain replacement standards are required where Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) are lost, destroyed, irreparably damaged, or otherwise rendered unusable. However, during the current pandemic, contractors are given the flexibility to waive certain replacement requirements. With regards to replacing DMEOPOS, the following requirements are subject to these blanket waivers:

The requirement that the provider meet with the patient on a face-to-face basis;
The requirement that the provider must issue a new order for the item; and
The requirement that the provider must document the new medical necessity for the replacement.

Providers will still, however, be required to include a narrative description on the claim explaining the reason why the equipment must be replaced. CMS is reminding providers to maintain documentation to indicate that the DMEPOS was lost, destroyed, irreparably damaged, or otherwise rendered unusable or unavailable as a result of the emergency. CMS hopes that these waivers will help Medicare patients obtain replacement DMEPOS more quickly without further contact that may expose them or otherwise contribute to the spread of COVID-19.

Impact of COVID-19 Stimulus Legislation on Home Health Providers

On March 27, 2020, Congress passed the Novel Coronavirus (“COVID-19”) stimulus bill and President Trump signed it into law. In order to more efficiently protect the public from COVID-19, the stimulus legislation sought to streamline many of the processes occurring within the industry. One of the areas of healthcare that the stimulus legislation makes necessary changes to is home health care.

In the past, physician assistants (“PAs”), nurse practitioners (“NPs”), and clinical nurse specialists (“CNS”) were permitted to order durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) and other home health services for only Medicare beneficiaries. The stimulus legislation is now allowing these non-physicians to order DMEPOS and home health services to Medicaid beneficiaries as well. This process is known as “non-physician certification.” Notably, this change is not temporary. This expansion of non-physician certification will remain in effect permanently. The stimulus legislation requires that the U.S. Department of Health and Human Services develop regulatory guidance to enable these provisions to take effect within six months of the legislation being enacted.

This legislation is crucial during the COVID-19 pandemic, because there are millions of Medicare and Medicaid beneficiaries who are homebound or require significant home health care, with the number expecting to significantly climb with the spread of COVID-19. The legislation now makes it easier for homebound Medicaid beneficiaries to obtain life sustaining DMEPOS and other home health services. Additionally, this gives non-physicians the ability to order home health services in order to free up hospital beds for more serious COVID-19 patients and decrease the spread of the virus. Uninfected patients may stay in their home and away from doctors’ offices and hospitals where the virus may be prevalent, while still obtaining proper care and treatment.

The legislation also permits home health providers to temporarily receive Medicare reimbursement sooner. Since 2013, a process known as “sequestration” reduces payments to all fee-for-service Medicare providers by 2%—but the new legislation creates an 8 month break from the sequestration process. This means that all home health and other Medicare providers would receive a 2% increase in Medicare reimbursement for the next 8 months. The 2% increase in Medicare reimbursement will help home healthcare providers who may have lost some reimbursement due to more elective treatments and services being postponed during the COVID-19 pandemic.

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