1. What is telehealth?
   The Health Resources and Services Administration (HRSA) of the U.S.
   Department of Health and Human Services (HHS) defines telehealth as the use of electronic information and telecommunications technologies to support and promote long-distance clinical health care, patient and
   professional health-related education, and public health and health
   administration. Technologies include videoconferencing, the internet, storeand-forward imaging, streaming media, and landline and wireless
   communications. Telehealth services may be provided, for example, through audio, text messaging, or video communication technology, including videoconferencing software. For purposes of reimbursement, certain payors, including Medicare and Medicaid, may impose restrictions on the types of technologies that can be used.1 Those restrictions do not limit the scope of the HIPAA Notification
   of Enforcement Discretion regarding COVID-19 and remote telehealth
   communications.
2. What entities are included and excluded under the Notification of
   Enforcement Discretion regarding COVID-19 and remote telehealth
   communications?
   The Notification of Enforcement Discretion issued by the HHS Office for Civil Rights (OCR) applies to all health care providers that are covered by HIPAA and provide telehealth services during the emergency. A health insurance company that pays for telehealth services is not covered by the Notification of Enforcement Discretion. Under the Health Insurance Portability and Accountability Act (HIPAA), a “health care provider” is a provider of medical or health services and any other person or organization who furnishes, bills, or is paid for health care in
   the normal course of business. Health care providers include, for example, physicians, nurses, clinics, hospitals, home health aides, therapists, other mental health professionals, dentists, pharmacists, laboratories, and any other person or entity that provides health care. A “health care provider” is a covered entity under HIPAA if it transmits any health information in electronic form in connection with a transaction for which the Secretary has adopted a standard (e.g., billing insurance electronically). See 45 CFR 160.103 (definitions of health care provider, health care, and covered entity). By contrast, a health insurance company that merely pays for telehealth services would not be covered by the Notification of Enforcement Discretion because it is not engaged in the provision of health care.
3. What patients can a covered health care provider treat under the
   Notification of Enforcement Discretion regarding COVID-19 and
   remote telehealth communications and does it include Medicare and
   Medicaid patients?
   This Notification applies to all HIPAA-covered health care providers, with no limitation on the patients they serve with telehealth, including those patients that receive Medicare or Medicaid benefits, and those that do not. Information specifically about telehealth and Medicare is available at https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-healthcare-provider-fact-sheet and https://edit.cms.gov/files/document/medicaretelehealth-frequently-asked-questions-faqs-31720.pdf.
4. Which parts of the HIPAA Rules are included in the Notification of
   Enforcement Discretion regarding COVID-19 and remote telehealth
   communications?
   Covered health care providers will not be subject to penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This Notification does not affect the application of the HIPAA Rules to other areas of health care outside of telehealth during the emergency.
5. Does the Notification of Enforcement Discretion regarding COVID19 and remote telehealth communications apply to violations of 42
   CFR Part 2, the HHS regulation that protects the confidentiality of
   substance use disorder patient records?
   No, the Notification addresses the enforcement only of the HIPAA Rules. The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued similar guidance on COVID-19 and 42 CFR Part 2, which is available at: https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf.
6. When does the Notification of Enforcement Discretion regarding
   COVID-19 and remote telehealth communications expire?
   The Notification of Enforcement Discretion does not have an expiration date. OCR will issue a notice to the public when it is no longer exercising its enforcement discretion based upon the latest facts and circumstances.
7. Where can health care providers conduct telehealth?
   OCR expects health care providers will ordinarily conduct telehealth in
   private settings, such as a doctor in a clinic or office connecting to a patient who is at home or at another clinic. Providers should always use private locations and patients should not receive telehealth services in public or semi-public settings, absent patient consent or exigent circumstances. If telehealth cannot be provided in a private setting, covered health care providers should continue to implement reasonable HIPAA safeguards to limit incidental uses or disclosures of protected health information (PHI). Such reasonable precautions could include using lowered voices, not using speakerphone, or recommending that the patient move to a reasonable distance from others when discussing PHI.
8. What telehealth services are covered by the Notification of
   Enforcement Discretion regarding COVID-19 and remote telehealth
   communications?
   All services that a covered health care provider, in their professional
   judgement, believes can be provided through telehealth in the given
   circumstances of the current emergency are covered by this Notification.
   This includes diagnosis or treatment of COVID-19 related conditions, such as taking a patient’s temperature or other vitals remotely, and diagnosis or treatment of non-COVID-19 related conditions, such as review of physical therapy practices, mental health counseling, or adjustment of prescriptions, among many others.
9. What may constitute bad faith in the provision of telehealth by a
   covered health care provider, which would not be covered by the
   Notification of Enforcement Discretion regarding COVID-19 and
   remote telehealth communications?
   OCR would consider all facts and circumstances when determining whether a health care provider’s use of telehealth services is provided in good faith and thereby covered by the Notice. Some examples of what OCR may consider a bad faith provision of telehealth services that is not covered by this Notice include:
    Conduct or furtherance of a criminal act, such as fraud, identity theft,
   and intentional invasion of privacy;
    Further uses or disclosures of patient data transmitted during a
   telehealth communication that are prohibited by the HIPAA Privacy
   Rule (e.g., sale of the data, or use of the data for marketing without
   authorization);
    Violations of state licensing laws or professional ethical standards that
   result in disciplinary actions related to the treatment offered or
   provided via telehealth (i.e., based on documented findings of a health
   care licensing or professional ethics board); or
    Use of public-facing remote communication products, such as TikTok,
   Facebook Live, Twitch, or a public chat room, which OCR has identified
   in the Notification as unacceptable forms of remote communication for
   telehealth because they are designed to be open to the public or allow
   wide or indiscriminate access to the communication.
10. What is a “non-public facing” remote communication product?
    A “non-public facing” remote communication product is one that, as a
    default, allows only the intended parties to participate in the communication. Non-public facing remote communication products would include, for example, platforms such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Whatsapp video chat, Zoom, or Skype. Such products also would include commonly used texting applications such as Signal, Jabber, Facebook Messenger, Google Hangouts, Whatsapp, or iMessage. Typically, these platforms employ end-to-end encryption, which allows only an individual and the person with whom the individual is communicating to see what is transmitted. The platforms also support individual user accounts, logins, and passcodes to help limit access and verify participants. In addition, participants are able to assert some degree of control over particular capabilities, such as choosing to record or not record the communication or to mute or turn off the video or audio signal at any point. In contrast, public-facing products such as TikTok, Facebook Live, Twitch, or a public chat room are not acceptable forms of remote communication for telehealth because they are designed to be open to the public or allow wide
    or indiscriminate access to the communication. For example, a provider
    that uses Facebook Live, Twitch, or a public chat room are not acceptable forms of remote communication for telehealth because they are designed to be open to the public or allow wide or indiscriminate access to the communication. For example, a provide that uses Facebook Live to stream a presentation made available to all its patients about the risks of COVID-19 would not be considered reasonably private provision of telehealth services. A provider that chooses to host such a public-facing presentation would not be covered by the Notification and should not identify patients or offer individualized patient advice in such a livestream.
11. If a covered health care provider uses telehealth services during
    the COVID-19 outbreak and electronic protected health information
    is intercepted during transmission, will OCR impose a penalty on the
    provider for violating the HIPAA Security Rule?
    No. OCR will exercise its enforcement discretion and will not pursue
    otherwise applicable penalties for breaches that result from the good faith provision of telehealth services during the COVID-19 nationwide public health emergency. OCR would consider all facts and circumstances when determining what constitutes a good faith provision of telehealth services. For example, if a provider follows the terms of the Notification and any applicable OCR guidance (such as this and other FAQs on COVID-19 and HIPAA), it will not face HIPAA penalties if it experiences a hack that exposes protected health information from a telehealth session. OCR believes that many current and commonly available remote electronic communication products include security features to protect ePHI transmitted between health care providers and patients. In addition, video communication vendors familiar with the requirements of the Security Rule often include stronger security capabilities to prevent data interception and provide assurances they will protect ePHI by signing a HIPAA business associate agreement (BAA). Providers seeking to use video communication products are encouraged to use such vendors, but will not be penalized for using less secure products in their effort to provide the most timely and accessible care possible to patients during the Public Health Emergency. Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable
    all available encryption and privacy modes when using such applications. OCR does not endorse the use of or the security capabilities of any particular communications product.

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On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a number of clarifications and proposals on remote patient monitoring (RPM) services reimbursed under the Medicare program. The changes, part of the advance copy of CMS’ proposed 2021 Physician Fee Schedule, are intended to clarify CMS’ position on how it reads and interprets the requirements for RPM services.  The comments build on prior RPM guidance for Medicare reimbursement, CMS’ creation of new RPM codes in 2019 and 2020, and regulatory changes allowing RPM to be delivered under general supervision for purposes of incident to billing. 

The ten FAQs below are drafted based on CMS’ clarification statements and proposals in the 2021 proposed rule (2021 Proposed Rule).

1.  What is remote patient monitoring?

RPM involves the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition. The five primary Medicare RPM codes are CPT codes 99091, 99453, 99454, 99457, and 99458.  

2. Must the patient have a chronic condition to qualify for RPM?

Although CMS initially described RPM services in the 2019 PFS final rule as services furnished to patients with chronic conditions, CMS clarified in the 2021 Proposed Rule that practitioners may furnish RPM services to remotely collect and analyze physiologic data from patients with acute conditions, as well as from patients with chronic conditions.

3.  Can RPM be used with new and established patients, alike?

In the 2021 Proposed Rule, CMS clarified that RPM services are limited to “established patients.”  In support of this position, CMS asserts that a physician who has an established relationship with a patient would likely have had an opportunity to provide a new patient E/M service.  During that new patient E/M service, the physician would have collected relevant patient history and conducted a physical exam, as appropriate. As a result, the physician would possess information needed to understand the current medical status and needs of the patient prior to ordering RPM services to collect and analyze the patient’s physiologic data and to develop a treatment plan. However, CMS waived this restriction during the Public Health Emergency (PHE), but stated that when the PHE ends, CMS will require that RPM services must be furnished only to established patients. CMS’ waiver suggests that during the PHE, practitioners may render RPM services without first conducting a new patient E/M service.

To date, CMS has not published guidance on physicians using telehealth (i.e., real-time interactive audio-video technology) to conduct a new patient E/M service via telehealth in connection with enrolling a beneficiary in an RPM program.  However, we do know that, for Medicare telehealth services, CMS allows the use of real-time interactive audio-video technology to satisfy the face-to-face element of an E/M service.  And we do know that “new patient E/M service” codes (e.g., CPT Codes 99201-99205) are listed among the Medicare-covered telehealth services.  Moreover, CMS generally defers to state laws on professional practice requirements, clinical standards of care, and valid doctor-patient relationships.  Nowadays, state laws allow doctors to use telehealth to create a valid doctor-patient relationship for new patients.  

4.  Who can order and bill for RPM services?

RPM codes are considered Evaluation and Management (E/M) services. CMS stated they can be ordered and billed only by physicians or nonphysician practitioners who are eligible to bill Medicare for E/M services.

5.  Who can furnish RPM services and obtain consent?

While CPT code 99091 can only be furnished by a physician or other qualified healthcare professional, CPT codes 99457 and 99458 can be furnished by a physician or other qualified healthcare professional, or by clinical staff under the general supervision of the physician. 

A physician or other qualified healthcare professional is defined in the CPT Codebook as “an individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within his/her scope of practice and independently reports that professional service.”  When referring to a particular service described by a CPT code for Medicare purposes, a “physician or other qualified healthcare professional” is an individual whose scope of practice and Medicare benefit category includes the service and who is authorized to independently bill Medicare for the service.

A clinical staff member is defined in the CPT Codebook as “a person who works under the supervision of a physician or other qualified healthcare professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service.” 

In the 2021 Proposed Rule, CMS proposed to allow auxiliary personnel, in addition to clinical staff, to furnish services described by CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner. Auxiliary personnel include other individuals who are not clinical staff but are employees, or leased or contracted employees.  As noted in the 2021 Proposed Rule, CMS supported its proposal under the idea that “the CPT code descriptors do not specify that clinical staff must perform RPM services.” 

CMS also stated that RPM services are not considered to be diagnostic tests; they cannot be furnished and billed by an Independent Diagnostic Testing Facility on the order of a physician.

CMS proposed that consent to RPM can be obtained at the time RPM services are furnished. The consent can be obtained by individuals under contract with the billing physician or qualified healthcare professional.  CMS did not propose or address a permanent waiver of RPM co-payments.

6. What does it mean to have an ‘interactive communication’ with a patient?

CMS stated that “interactive communication” for purposes of CPT codes 99457 and 99458 involves, at a minimum, a real-time synchronous, two-way audio interaction that is capable of being enhanced with video or other kinds of data transmission.  CMS stated the interactive communication must total at least 20 minutes of interactive time with the patient over the course of a calendar month for CPT code 99457 to be reported.  CMS stated that each additional 20 minutes of interactive communication between the patient and the physician/nonphysician practitioner/clinical staff is reported using CPT code 99458. In support of this position, CMS indicated the CPT Codebook states that unless there are code- or code-range specific instructions, parenthetical instructions, or code descriptors to the contrary, time is considered to be the “face-to-face” time with the patient or patient’s caregiver/medical decision-maker. Because RPM is a service not typically furnished in person with the patient, CMS stated it interprets time in the 99457 and 99458 code descriptor to mean the time spent in direct, real-time interactive communication with the patient.  

This is the first time CMS has addressed, in published guidance, the interactive communication requirement in the context of RPM.  Until now, there has been no formal guidance published by CMS as to the scope of this element in CPT codes 99457 and 99458.  CMS’ new clarification posits that there must be at least 20 minutes of interactive communication with the patient, as opposed to the interactive communication being a component of the overall 20 minutes of RPM service.  This position renders RPM an outlier compared to the other similar designated care management services such as chronic care management services (CCM), for which CMS has been clear that the time-based requirements consist of a combination of patient interactive communication, monitoring, and management of the patient’s care plan. Moreover, the very nature of the RPM code descriptors themselves – which include “monitoring and management” as part of the service – suggests the inclusion of time spent other than purely communication with the patient.  It is unclear why CMS, in its most recent proposed policy clarification, has taken a different approach with respect to RPM than it has with CCM and other similar services.  

This is clearly an issue ripe for stakeholder input during the 60-day public comment period.  It may be helpful for the AMA and its digital health council (the group of experts who created the RPM codes in the first place) to offer clarification on whether it actually intended the RPM codes to require a practitioner to spend at least 20 minutes per month of time communicating via audio or video with the patient.  A more reasonable reading of the code descriptor and intent is that the interactive communication with the patient is part of the 20 minute minimum, but the practitioner can also include time spent reviewing and analyzing the patient’s RPM data and determining how to change the care management accordingly.  

7.  What type of RPM devices qualify for Medicare purposes?

The RPM device must meet the FDA’s definition of a medical device as described in section 201(h) of the Federal, Food, Drug and Cosmetic Act. CMS found no language in the CPT Codebook indicating the RPM device must be FDA-cleared, although such clearance may be appropriate. Nor did CMS find information that the RPM device must be prescribed by a physician, although this could be possible depending upon the medical device. CMS stated the RPM device should digitally (that is, automatically) upload patient physiologic data (that is, data cannot be self-recorded and/or self-reported by the patient). As with any service provided to a Medicare beneficiary, use of a RPM device to digitally collect and transmit a patient’s physiologic data must be reasonable and necessary for the diagnosis or treatment of the patient’s illness or injury or to improve the functioning of a malformed body member. Further, the RPM device must be used to collect and transmit reliable and valid physiologic data that allow understanding of the patient’s health status to develop and manage a plan of treatment.

8.  How many days must the RPM device monitor per month?

The CPT language indicates that monitoring must occur over at least 16 days of a 30-day period in order for CPT codes 99453 and 99454 to be billed.  CMS stated that these two codes are not to be reported for a patient more than once during a 30-day period.  CMS stated the CPT language suggests that even when multiple medical devices are provided to a patient, the services associated with all the medical devices can be billed only once per patient per 30-day period and only when at least 16 days of data have been collected. CMS also noted that CPT 99453 can be billed only once per episode of care where an episode of care is defined as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals.”

9. What are the RPM practice expense codes?

There are two practice expense only codes (99453 and 99454), valued to cover clinical staff time, supplies, and equipment, including the medical device for the typical case of remote monitoring.  CPT code 99453 is valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices. CPT code 99454 is valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring.  CMS stated that the medical device or devices that are supplied to the patient and used to collect physiologic data are considered equipment and as such are direct practice expense inputs for the code.  Providers should always consult with their certified billing and coding professionals for proper Medicare device billing. 

10.  What are the RPM monitoring and management codes?

This is another example of first time guidance provided by CMS in which they lay out the “order of events” for an RPM program.  CMS stated that after analyzing and interpreting a patient’s remotely collected physiologic data, the next step in RPM is the development of a treatment plan informed by the analysis and interpretation of the patient’s data. At this point, the physician develops a treatment plan with the patient and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care. CPT code 99457 and its add-on code, CPT code 99458, describe the treatment and management services associated with RPM.  This suggests that Codes 99457 and 99458 cannot be billed until after the initial 30 day period of monitoring, as opposed to being billed simultaneously during the same time period.  However, CMS does not provide this level of detail, nor does it address whether any of the RPM codes are co-dependent on each other such, for example, whether 99457 or 9458 can be billed even if the requisite elements of 99453 or 99454 are not met, (e.g., if only 15 days of monitoring occurred).

What to Do Next?

Providers, technology companies, and virtual care entrepreneurs interested in RPM should consider providing comments to the proposed rule.  Comments need not only relate to CMS’ proposals or clarifications but can also request responses on issues CMS did not address.  CMS is soliciting comments on the proposed rule until 5:00 p.m. through the end of September, 2020. Anyone may submit comments – anonymously or otherwise – via electronic submission at this link. Alternatively, commenters may submit comments by mail to:

• Regular Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1734-P, P.O. Box 8016, Baltimore, MD 21244-8016.
• Express Overnight Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1734-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850 (for express overnight mail). 

If submitting via mail, please be sure to allow time for comments to be received before the closing date.

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CMS recently announced provider reimbursement for self-isolation and other coronavirus counseling and updated FAQs on COVID-19 billing for remote services and coronavirus testing.

August 03, 2020 – Provider reimbursement is now available to physicians who tell their patients to self-isolate at the time of COVID-19 testing, according to CMS.

An announcement released late last week in collaboration with the Centers for Disease Control and Prevention (CDC) said CMS will leverage existing evaluation and management (E/M) payment codes to reimburse eligible providers for the coronavirus counseling services, including telling patients about self-isolation and the benefits of wearing a mask at all times if they test positive for the novel coronavirus.

The reimbursement will be available to physicians in a variety of settings, CMS added, including doctor’s offices, urgent care clinics, hospitals, and community drive-thru or pharmacy testing sites, as long as counseling is provided at the time of testing.

By making reimbursement available to providers, CMS and CDC hope to stop the spread of COVID-19.

“The Centers for Disease Control and Prevention (CDC) models show that when individuals who are tested for the virus are separated from others and placed in quarantine, there can be up to an 86 percent reduction in the transmission of the virus compared to a 40 percent decrease in viral transmission if the person isolates after symptoms arise,” CMS stated.

With the number of COVID-19 cases continuing to rise, the reimbursement will incent providers to encourage their patients seeking testing for the virus to separate from others and wear a mask if their results come back positive.

“Provider counseling to patients, at the time of their COVID-19 testing, will include the discussion of immediate need for isolation, even before results are available, the importance to inform their immediate household that they too should be tested for COVID-19, and the review of signs and symptoms and services available to them to aid in isolating at home,” CMS explained.

“In addition, they will be counseled that if they test positive, to wear a mask at all times and they will be contacted by public health authorities and asked to provide information for contact tracing and to tell their immediate household and recent contacts in case it is appropriate for these individuals to be tested for the virus and to self-isolate as well,” the agency stated.

CMS also provided a checklist for providers on proper coronavirus counseling. It did not say how much providers will get paid for the services.

Additionally, CMS also recently announced the creation of new hospital procedure codes for the use of COVID-19 therapeutics.

The agency said over the weekend that it has developed and implemented new procedures codes for the use of remdesivir and convalescent plasma for treating hospitalized COVID-19 patients. The ICD-10-PCS codes went into effect on August 1st and can be reported to Medicare and other insurers to identify the use of the treatments by hospital providers.

In addition to the announcements, CMS also answered COVID-19 billing and coding questions last week, including questions on hospital billing for remote services and outpatient therapy during the pandemic.

A new question in CMS’ COVID-19 FAQs clarified that hospitals and other institutional providers cannot bill for telehealth services.

“A hospital may serve as the originating site, and can bill for an originating site facility fee for a registered hospital outpatient who is receiving a telehealth service,” CMS stated. “Billing for telehealth services is distinct from billing for hospital services and other institutional services, and in most circumstances occurs using professional claims, not institutional claims that would be submitted by the hospital or other institutional provider.”

Updated FAQs on hospital billing of remote services also addressed how hospitals can ensure when a beneficiary’s home qualifies as a provider-based department of a hospital, a condition necessary for Medicare fee-for-service payment for the remote service; when a hospital can bill for the originating site facility fee for remote hospital outpatient clinic visits; and whether hospitals can furnish services remotely without a Medicare-enrolled professional billing.

CMS also clarified how hospitals should bill for outpatient therapy services furnished via telehealth during the COVID-19 public health emergency, as well as how hospitals can bill Medicare for outpatient therapy services furnished by employed or contracted therapists using telecommunications technology.

Utilization of remote services has skyrocketed since the start of the pandemic when healthcare organizations stopped elective procedures to stop the spread of COVID-19.

While many communities are opening back up, hospitals and other providers are still leveraging telehealth and remote patient monitoring to keep COVID-19 rates down and accommodate social distancing recommendations.

There are also new sections in the document on whether hospitals can bill for and get a separate payment for COVID-19 testing services rendered in the outpatient department before an inpatient admission; the application of cost-sharing modifiers to pre-survey testing services that include COVID-19 testing; and the identification of episodes of care for use of adjusting Medicare Shared Savings Program calculations.

To view all the new COVID-19 billing answers, click here.

Questions added last week are in sections “B. Diagnostic Laboratory Services,” “P. Medicare Telehealth,” “U. Medicare Shared Savings Program – Accountable Care Organizations (ACO),” “LL. Hospital Billing for Remote Services,” and “MM. Outpatient Therapy Services.

The post CMS Pays for Coronavirus Counseling, Other COVID-19 Billing Updates appeared first on mTelehealth.

On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act (FFCRA), which became law on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020. Both laws addressed Coronavirus (COVID-19) testing and prevention coverage, as well as expansion of telehealth service availability. This is the second set of FAQs issued by the joint agencies addressing compliance with the FFCRA and the CARES Act. For more information, see our previous articles on the prior FAQ, the provisions of the FFCRA and the provisions of the CARES Act.

COVID-19 Testing Applies to Self-Insured/Self-Funded Plans

Effective March 18, 2020, the FFCRA generally requires group health plans to provide benefits for certain items and services related to diagnostic testing to detect or diagnose COVID-19 without cost sharing (including deductibles, copayments and coinsurance), prior authorization or any other medical management requirement. Per the FAQs, multiple diagnostic tests must be covered if the attending healthcare provider determines such tests are medically appropriate. If a facility fee (e.g., a fee for using facilities or equipment that an individual’s provider does not own, or that are owned by a hospital) is charged for a visit that results in an order for, or administration of, a COVID-19 diagnostic test, a plan must cover that facility fee to the extent the fee relates to furnishing or administering a COVID-19 test, or to evaluating an individual to determine her need for testing. The new FAQs also provide that plans must cover at-home testing if the physician or other provider has determined that the test is medically appropriate for the individual, including tests where the individual performs self-collection of a specimen at home. There is no limit on the number of tests a plan must cover relating to a specific individual. Any number of tests must be covered as long as the tests are diagnostic and medically appropriate for the individual, as determined by an attending healthcare provider in accordance with current accepted standards of medical practice.

The new FAQ confirms that FFCRA’s health plan provisions apply to self-insured/self-funded group health plans, which include private employment-based group health plans (plans governed by the Employee Retirement Income Security Act of 1974), non-federal governmental plans (such as plans sponsored by states and local governments) and church plans. Plans that do not cover at least two current employees, such as retiree-only plans, are not required to comply.

Types of Tests Required

The new FAQs clarify that all in vitro diagnostic tests for COVID-19 that have received an emergency use authorization from the US Food and Drug Administration (FDA) must be covered. A list of such test can be found here.

The FAQs also clarify that for purposes of covering an in vitro diagnostic test for which the developer has requested or intends to request emergency use authorization, a clinical laboratory or commercial manufacturer that is listed on FDA’s website as having provided notification under the FDA guidance can reasonably be assumed to have requested, or as intending to request, an emergency use authorization (except for laboratory-developed serology tests). Therefore, coverage must be provided for in vitro diagnostic tests for COVID-19 that are included on the FDA list.

Lastly, for purposes of covering an in vitro diagnostic test that is developed in and authorized by a state that has provided proper notification, a list of states and territories that have provided notification can be found here.

Return-to-Work Testing Need Not Be Covered

The agencies note that COVID-19 testing for surveillance or employment purposes is not required to be covered under the FFCRA. Testing conducted to screen for general workplace health and safety (such as employee return-to-work programs), for public health surveillance for COVID-19, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope of the FFCRA.

Balance Billing Issues

The new FAQs provide that the agencies interpret the FFCRA and the CARES Act (as well as related guidance) as intended to protect participants from being balance billed for an applicable COVID-19 test. Under the CARES Act, a plan will reimburse a COVID-19 testing provider either a negotiated rate or an amount that equals the cash price for such service that is listed by the provider on a public website. If the provider fails to post the cash price, the parties may have to negotiate the price, and the provider may be subject to penalties for failure to comply with the CARES Act. In either case, the amount the plan or issuer reimburses the provider constitutes payment in full for the test, with no cost-sharing to the individual or other balance due. Individuals may still be subject to balance billing for items and services furnished during a visit that are not covered by the CARES Act.

Notice Requirements

The expanded coverage for COVID-19 testing continues until a “outbreak” period ends. If an employer wants to align COVID-19 testing with its other benefits upon the end of the national emergency period and impose cost sharing, prior notice to participants is required unless the notice eliminating cost sharing included information about the temporary nature of the relief.

Telehealth

The FAQs confirm that employers may offer a telehealth-only plan (including other remote care service arrangements) to employees and dependents who are not otherwise eligible for the employer’s group health plan—at least during the pandemic, with the stipulation that the telehealth-only plan cannot have pre-existing condition exclusions, cannot discriminate based on health status, cannot conduct rescissions of coverage, and is still subject to mental health parity.

Conclusion

Many of the changes required or permitted by the FFCRA and the CARES Act as highlighted in these FAQs will require amendments to plan documents and updates to summary plan descriptions. Plan sponsors should work with third-party administrators, insurers and legal counsel to ensure that these changes are implemented correctly and to review any other legal requirements that might be implicated.

Specifically, plan sponsors should work with their insurers and third-party administrators to ensure that cost sharing has been eliminated for COVID-19 testing and diagnostics. Plan sponsors also may wish to work with insurers and third-party administrators to ascertain pricing from out-of-network facilities, in light of the prohibition on balance billing. Participant communications also should be revised to reflect plan changes.

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