Editor’s intro: Home Sleep Apnea testing (HSAT) is an evolving area of health care, and the regulations continue to change and expand. Read this article by Jayme R. Matchinski, Esq., and see how dentists can utilize HSAT in their practices and work with DME companies and sleep physicians for the provision of HSAT.
by Jayme R. Matchinski, Esq.
As the provision of Dental Sleep Medicine continues to evolve and expand, dentists are faced with the challenge of how to incorporate home sleep apnea testing (HSAT) into the care and treatment of their patients who may have obstructive sleep apnea (OSA) and require Oral Appliance Therapy (OAT). HSAT has changed the provision of Polysomnography from the traditional setting of providing an in-lab attended sleep study at a sleep disorder center to the utilization of HSAT, as a portable device which is a sleep study tool that can be provided to a patient in their home, and is an unattended sleep study that tracks a patient’s breathing, oxygen levels, and breathing effort while wearing the HSAT device.
I am often asked by dentists how they can utilize HSAT in their practices and how they can work with DME companies and sleep physicians for the provision of HSAT. There has been a lot of discussion and questions regarding whether dentists can order HSATs and provide HSATs free of charge to their patients. Dentists have also sought to contract with companies which provide HSAT. Dentists should not seek to circumvent the involvement of a sleep physician in the examination, referral, diagnosis, and treatment of a patient with OSA or other sleep disorder. Dentists and sleep physicians should seek to work together to develop protocols for the usage of HSAT and provision of OAT.
Licensure and Regulatory Compliance
Dentists should check their state licensure and third party payor agreements regarding whether they can prescribe HSAT. While sleep testing companies are encouraging dentists to provide HSATs to their patients for the screening and diagnosis of OSA, this may be outside a dentist’s scope of practice depending upon state licensure.
Additionally, certain third party payors, including the Center for Medicare & Medicaid (CMS), require a licensed sleep physician to prescribe an HSAT and interpret the results from the HSAT. Dentists should consider setting up protocols and agreements with referring physician, including sleep physicians, in order to identify each doctor’s responsibilities for the sleep testing, diagnosis and treatment of a patient with OSA. Dentists should be careful not practice outside their scope of practice and state licensure.
CMS will not pay any DME supplier, including dentists and sleep physicians, for the provision of CPAP if that DME supplier or its affiliate, is the provider of the sleep test, either directly or indirectly, and the sleep test is used to diagnose the Medicare patient or any patient who has coverage pursuant to a federal or state program, unless the sleep test is provided in an attended facility-based polysomnogram. “No Medicare payment will be made to the supplier of a CPAP device if that supplier, or its affiliate, is directly or indirectly the provider of the sleep test used to diagnose the beneficiary with obstructive sleep apnea. This prohibition does not apply if the sleep test is an attended facility-based polysomnogram.” (42 CFR §424.57(f)). For purposes of this regulation, “affiliate” means “a person or organization that is related to another person or organization through a compensation arrangement or ownership.” (42 CFR §424.57 (a)). “Attended facility-based polysomnogram” means “a comprehensive diagnostic sleep test including at least electroencephalography, electrooculography, electromyography, heart rate or electrocardiography, airflow, breathing effort, and arterial oxygen saturation furnished in a sleep laboratory facility in which a technologist supervises the recording during sleep time and has the ability to intervene if needed.” (42 CFR §424.57 (a)). If a provider combines functions of a sleep lab and DME services and the provider has Medicare provider and supplier numbers for the sleep lab and DME supplier, under 42 CFR §424.57(f), the DME supplier will not receive Medicare, Medicaid, CHAMPUS, TriCare, or any other government program reimbursement for the CPAP unless the sleep test is an attended facility-based polysomnogram which includes Level 1 sleep testing.
This federal regulation prohibits Medicare reimbursement for CPAP to a DME supplier if the sleep test is HSAT and the HSAT is provided by an affiliate of the DME supplier; however, there has been discussion regarding the expansion of this regulation to include OAT as the prohibited DME if the DME supplier or its affiliate is the provider of the sleep study. To date, these federal regulations specifically identify CPAP as the DME that will not be reimbursed if the DME supplier or its affiliate is the provider of the sleep test, and this federal regulation has not been revised to include OAT. Dentists, sleep physicians, DME suppliers need to continue to monitor this federal regulation in the event that it is revised in the future to include OAT as the DME. CMS promulgated this federal regulation to monitor the utilization of HSAT and to discourage referrals between affiliated sleep labs and DME suppliers which have a compensation arrangement or ownership. Based upon this regulation, DME suppliers will not receive reimbursement for the DME, specifically CPAP, that is prescribed based upon a diagnosis of OSA if the sleep test was an HSAT or not provided in an attended facility-based by an affiliate of the DME supplier.
Provision of HSAT
There have been a lot of questions posed by dentists regarding who can refer a patient for a sleep study, including a HSAT. In general, a “referral” is a sleep physician’s request for, ordering of (or certifying or recertifying the need for), any diagnostic testing or services for Medicare patients, including a consultation request and tests or procedures ordered, performed or supervised by the consulting physician or the physician’s request or establishment of a plan of care involving Medicare designated health services pursuant to the Stark Law regulations. In addition, a physician who directs or controls referrals by others is deemed to be a “referring physician”. For Medicare patients, a physician is required to write an order for a sleep study. Many commercial insurance companies have adopted the Medicare regulations and coverage guidelines for HSAT and provision of DME. Dentists should carefully review their third party payor agreements with commercial insurance companies to determine the qualifications and licensure that are required by the payor agreement for the provision of sleep studies and OAT.
HSAT Agreements and Regulatory Compliance
I am often asked how dentists can work with HSAT companies which provide the equipment, scoring, and billing related to the provision of HSAT to patients. Dentists should have a written agreement with the HSAT company and/or the sleep physicians who are prescribing, diagnosing, and interpreting the results of the HSAT. Dentists should consider including provisions in agreements for HSAT which specifically state which services will be provided, including the equipment, scoring, and billing related to the provision of HSAT. There should also be a provision in the HSAT agreement which identifies who is responsible for the documentation of the provision of the HSAT and retention of such documentation. There are state and federal regulations regarding what information is required to be included in a patient’s medical record and how long such medical records must be retained by the provider.
Some DME companies and providers, including dentists, have sought to provide HSAT free of charge to patients in order to facilitate the provision of OAT. This practice may be in violation of the applicable state and federal anti-kickback regulation. Each state has anti-kickback regulations which generally prohibit payment or an arrangement between providers which would induce patient referrals which are prohibited by state law. There is a federal Anti-Kickback Statute which applies to any arrangement for the provision of services to Medicare patients or other government beneficiaries. 42 U.S.C. § 1320a-7B, commonly known as the Medicare Anti-Kickback Statute, states that is a felony for a person or entity to knowingly or willfully offer or pay any remuneration to induce a person to refer a person for the furnishing or arranging for the furnishing of any item for which payment may be made under a federal health care program, including the Medicare and Medicaid programs, or the purchase or lease or the recommendation of the purchase or lease of any item for which payment may be made under a federal health care program, including HSAT and OAT. Health care providers and suppliers cannot offer or pay any remuneration to induce referrals between providers and other entities, including any arrangements that directly or indirectly base compensation upon volume or value of such patient referrals.
There have been cases and Advisory Opinions by the Office of Inspector General (OIG) which have indicated that offering rental space, equipment, staff, and ambulance services and related supplies without charge to providers and patients is a violation of the federal Medicare Anti-Kickback Statute because it is an inducement for patient referrals by and between health care providers and entities. Any compensation arrangements, including payment for services, by and between dentists, sleep physicians, DME companies, and sleep labs cannot be based upon any volume or value of patient referrals between the parties.
Additionally, dentists and sleep physicians must consider the impact of the Stark Law on any arrangements for the provision of HSAT and OAT if Medicare or any other government patients are involved. 2 U.S.C. § 1395nn, known as the Stark Law (Ethics in Patient Referral Act), prohibits physicians from referring Medicare patients for “designated health services” (“DHS”) to any facility or other entity with which the referring physician (or any of his or her immediate family members) has any financial relationship, unless an exception in the Stark Law or related regulations is satisfied. Furthermore, the entity providing the DHS would be prohibited from billing Medicare for the services.
The original Stark Law (Stark I) applied only to Medicare referrals for clinical laboratory services. Stark II, enacted in August 1993, expanded the prohibition to apply to an additional list of DHS and to referrals to Medicaid as well as Medicare patients. While the actual sleep study, including HSAT, is not considered a DHS for purposes of the Stark Law, DME, including OAT, is a DHS and dentists and sleep physicians must consider the impact of the Stark Law on the provision of OAT to Medicare and Medicaid patients or any other government beneficiaries. Under Stark I and Stark II, prohibited financial relationships include: ownership or investment interests through equity, debt or other means and include indirect ownership interests through other entities, as well as compensation arrangements including virtually any form of remuneration. Possible sanctions for violation of the Stark Law include: civil monetary penalties, exclusion from the federal health care programs (including Medicare and Medicaid) and forfeiture of all improperly collected amounts.
The Medicare regulations define DME as:
§414.202 Definitions. Durable medical equipment means equipment, furnished by a supplier or a home health agency that meets the following conditions: (1) Can withstand repeated use. (2) Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years. (3) Is primarily and customarily used to serve a medical purpose. (4) Generally is not useful to an individual in the absence of an illness or injury. (5) Is appropriate for use in the home. (42 CFR § 414.202.)
OAT meets the definition of DME for purposes of Medicare coverage, and Medicare will reimburse eighty percent (80%) of the expenses for the OAT if the OAT meets the following criteria:
- The item is “durable medical equipment”. An item is covered only if it meets the statutory definition of durable medical equipment which is cited above;
- The item is necessary and reasonable. DME, including OAT, is covered only if it is necessary and reasonable for the treatment of an illness or injury, or to improve the functioning of a malformed body member. Equipment is necessary when it can be expected to make a reasonable contribution to the patient’s In most cases, a physician’s prescription for the equipment, along with other medical information available to the carrier, will establish medical necessity. However, it is important to note that even if an item serves a useful medical purpose, it will be covered only to the extent that it would be reasonable for the Medicare program to pay for the item prescribed; and
- The item is appropriate for use in the The DMEPOS benefit is available only for items used in the beneficiary’s home, which can be a beneficiary’s own dwelling, an apartment, a relative’s home, a home for the aged, or some other type of institution. However, an institution cannot be considered a beneficiary’s home if it meets the basic definition of a hospital or skilled nursing facility.
The provision of HSAT and OAT across state lines triggers state regulations, including scope of practice, in the states where the patient is purchasing the OAT. Each state has its own practice acts, including Dental Practice Acts, and scope of practice requirements. Given the changing regulatory landscape, dentists and sleep physicians need to carefully consider how they are providing professional services, diagnostic testing, including HSAT, and related OAT for the treatment of patients and their OSA.
In summary, given the enforcement efforts by CMS and state licensing boards regarding compliance with the Anti-Kickback Statute, Stark Law, and the applicable state Dental Practice Act, dentists must structure their proposed arrangements with other providers, including sleep medicine physicians and physician group practices, for the provision of HSAT and OAT, in full compliance with the applicable regulations so as not to jeopardize the dentist’s licensure and enrollment with third party payors. Dentists should consider the following steps to ensure regulatory compliance for the provision of HSAT and OAT:
- Comply with all applicable state and federal regulations for the provision of HSAT and OAT;
- Consider requiring the utilization of a patient acknowledgment form that the patient will need to review and sign prior to receiving OAT. This patient acknowledgment form will require the patient to sign off that they have been given a choice as to where they receive their OAT and have decided to receive the OAT from the designated dentist. Dentists should retain this signed patient acknowledgment form in the patient record; and
- Continue to monitor new regulations and CMS and State Licensing Board’s enforcement efforts, investigations, and audits regarding the provision of HSAT and DME, including OAT, as Dental Sleep Medicine is an evolving area of health care and the regulations continue to change and expand.
Find out more about home sleep apnea testing from the article, “Insider’s Guide to Home Sleep Testing For the Dentist.”