Provision of Oral Appliances and Regulatory Compliance: Why Your Practice Should Have a Compliance Plan

Editor’s intro: What are regulatory compliance plans, and are they needed by dental sleep medicine professionals? Jayme R. Matchinski, Esq., discusses the elements of an effective compliance program to accommodate applicable regulations and requirements.

by Jayme R. Matchinski, Esq.

In recent years, there have been an increasing number of government and commercial insurance company audits and investigations related to durable medical equipment (DME) companies, dentists, and physicians providing Oral Appliances to patients who have been diagnosed with Obstructive Sleep Apnea (OSA). Most sleep disorder centers and DME companies have historically billed the Medicare and Medicaid programs and other third-party payors, including commercial insurance companies, for the provision of patient care, Oral Appliances, and related services and supplies. However, due to the rapid growth of Dental Sleep Medicine across the nation, collaboration between dentists and sleep physicians for the provision of Oral Appliances, and the related increased payment by third-party payors, including reimbursement by the Medicare program, Dental Sleep Medicine providers and suppliers are now on the radar of government agencies and third-party payors for regulatory compliance issues and related enforcement efforts. Additionally, the utilization of telemedicine by Dental Sleep Medicine providers and suppliers with multiple locations in different jurisdictions, and the availability of Oral Appliances for purchase on the Internet by individuals without a prescription or documented Polysomnography (sleep study) and diagnosis of OSA, has given rise to additional regulatory concerns and compliance issues.

Regulatory Environment and Compliance Issues
The current regulatory environment impacts how health care providers and suppliers provide Dental Sleep Medicine. Specifically, dentists, DME companies, sleep physicians, and sleep disorder centers have all been impacted by complex regulations in connection with the provision of Dental Sleep Medicine and Oral Appliances. An increasing number of audits and investigations are being conducted by government agencies and third-party payors, which have caused dentists, DME companies, sleep physicians, and sleep disorder centers, to revisit their regulatory compliance efforts and compliance programs. The national growth and expansion of Dental Sleep Medicine aligns with new and advancing technology and the evolving regulations and enforcement efforts.

Compliance programs have become an effective tool to demonstrate regulatory compliance in the event of an audit, investigation or other enforcement activity.

Dentists who provide Dental Sleep Medicine to their patients in conjunction with other health care providers and suppliers, including sleep disorder centers, sleep physicians, and DME companies should consider implementing a compliance program to demonstrate regulatory compliance, and as a preventative measure for risk management in the event of an audit or investigation. A compliance program is a system to ensure continuous compliance with all applicable laws, regulations, industry standards, organizational standards, governance principles, and community and ethical standards.

Dental Sleep Medicine and a Compliance Program
Corporate compliance is a term that is used in the health care industry to indicate that a provider or supplier runs a clean operation and does not commit fraud, waste or abuse of health care funds. Compliance programs increase staff awareness, demonstrate commitment to regulatory compliance, and may be a mitigating factor during an audit or investigation. Compliance programs for Dental Sleep Medicine should be designed, implemented, and enforced so that the program is effective in preventing and detecting fraud, and abuse and criminal conduct.

Compliance plans may be required by law or contract. Third-party payor agreements may include a provision that the provider or supplier has to have a compliance program. The Office of Inspector General (OIG) has developed a series of compliance program guidance documents directed at various segments of the health care industry, including: hospitals, nursing homes, physician practices, hospices, home health agencies, clinical laboratories, third-party billers, and DME suppliers. These OIG model compliance programs encourage the development and use of internal controls to monitor adherence to applicable regulations, and program requirements. It should be noted that the OIG developed and published the compliance guidance in an effort to promote ethical and lawful conduct throughout the entire health care industry, and currently the OIG compliance guidance are not required by law.

The OIG published the Compliance Program Guidance for the Durable Medical Equipment, Prosthetics, Orthotics and Supply Industry in the Federal Register, Volume 64, No. 128 (July 6, 1999). The OIG identified seven (7) fundamental elements applicable to an effective compliance program. These elements are:

  • Implementing written policies, procedures and standards of conduct;
  • Designating a compliance officer and compliance committee;
  • Conducting effective training and education;
  • Developing effective lines of communication;
  • Enforcing standards through well publicized disciplinary guidelines;
  • Conducting internal monitoring and auditing; and
  • Responding promptly to detected offenses and developing corrective action. (64 FR 36368)

Using these seven (7) identified elements for an effective compliance program, the OIG has identified specific areas of the durable medical equipment, prosthetic, orthotics and supply (DMEPOS) industry operations, which includes Oral Appliances, that may prove to be vulnerable to fraud and abuse. Like previously issued OIG compliance guidance for other health care providers and suppliers, the adoption of the Compliance Program Guidance for the DMEPOS industry is voluntary, and not mandated by federal regulation. The OIG’s compliance program guidance is intended to assist suppliers of DME, including Oral Appliances, and their agents and subcontractors with the development of effective internal controls that promote adherence to applicable state and federal regulations, and the program requirements of state, federal, and private health plans.

The adoption and implementation of voluntary compliance programs by dentists for the provision of Dental Sleep Medicine may prevent fraud, abuse, and waste in the health care plans while providing quality patient care, the Oral Appliance, and related services. Compliance efforts should be designed to establish a culture within the Dental Sleep Medicine Program that promotes prevention, detection, and resolution of instances of conduct that does not conform with applicable state and federal regulations. The compliance program should effectively articulate and demonstrate the ethical and business policies of the dentist, DME company, sleep physician, sleep disorder center, and any other health care providers or suppliers involved in the provision of Dental Sleep Medicine. Benchmarks should be established by the dentists, and other Dental Sleep Medicine health care providers and suppliers, which demonstrate that implementation and achievements are essential for an effective compliance program.

The compliance program is critical as an internal quality assurance control in the reimbursement and payment areas where claims and billing operations are often the source of fraud and abuse, and have been the focus of government regulation, and government and commercial insurance scrutiny, enforcement, and sanctions. Every compliance program implemented by dentists should require the development and distribution of written compliance policies, standards, and practices that identify specific areas of risk to the health care provider or supplier. These policies and procedures should be developed and drafted under the direction and supervision of the appointed compliance officer. Dentists and their staff, independent contractors, agents, representatives, designees, and any other individual who may impact billing decisions, should be required to review the compliance program and attest and acknowledge that they understand and agree to comply with the compliance program. Dentists and dental practices should require new hires to review their compliance program during orientation and sign an acknowledgement form that they agree to fully comply with the compliance program and the applicable state and federal regulations.

The OIG has identified certain areas of concern for DMEPOS suppliers including, but not limited to:

  • Billing for items or services not provided;
  • Billing for services that the DMEPOS supplier believes may be denied;
  • Billing patients for denied charges without a signed written notice;
  • Duplicate billing which occurs when more than one claim for payment is submitted for the same patient for the same service, for the same date of service;
  • Billing for items or services not ordered;
  • Upcoding, which involves selecting a code to maximize reimbursement when such code is not the most appropriate descriptor of the service;
  • Unbundling items or supplies, which involves billing for individual components when a specific HCFA Common Procedure Coding System (HCPCS) code provides for the components to be billed as a unit;
  • Billing for new equipment and providing used equipment;
  • Resubmission of denied claims with different information in an attempt to be improperly reimbursed;
  • Refusing to submit a claim to the Center for Medicare & Medicaid Services (CMS) for which payment is made on a reasonable charge or fee schedule basis;
  • Providing or billing for substantially excessive amounts of DMEPOS items or supplies;
  • Failure to monitor medical necessity on an ongoing basis;
  • Delivering or billing for certain items or supplies prior to receiving a physician’s order and/or appropriate Certificate of Medical Necessity (CMN); and
  • Falsifying information on the claim form, CMN, and/or accompanying documentation. (64 FR 36373).

These areas of concern identified by the OIG are a good roadmap for dentists to utilize when considering their collaboration with sleep physicians, documentation and provision of Dental Sleep Medicine, and billing and reimbursement for Oral Appliances. It is imperative that dentists, and other health care providers and suppliers providing Dental Sleep Medicine, conduct their own risk assessment to determine areas of concern and vulnerabilities specific to their operations and provision of patient care and Oral Appliances. Often, improper billing results from a lack of communication between different health care professionals who are providing services to the patient and improper coding and claims submission.

Sleep disorder centers and DME companies have received denials for claims submission and reimbursement when medical necessity is not established and documented by the ordering physician or other health care providers who are authorized to order items or services which be paid by the Medicare or Medicaid programs. Dentists, DME companies, sleep physicians, and sleep disorder centers should take all steps to ensure that they are not submitting claims for services that are not covered, reasonable and necessary. DME companies should keep the treating physician’s or other authorized person’s signed and dated order or CMN on file for all DMEPOS items and services, including Oral Appliances. Upon a third-party payors request, the DME company should be able to provide documentation, such as physician orders, completed original CMNs, proof of delivery of the DME, written confirmation of verbal orders, and any other documentation to support the medical necessity of an item or service the DME company has provided and billed to a federal health care program or commercial insurance company.

Potential Pitfalls and the False Claims Act
Health care providers and suppliers have a legal duty to ensure that there is no submission of false or inaccurate claims to government and private payors, including the Medicare and Medicaid programs, and commercial insurance companies. Health care fraud cases under the False Claims Act, 31 U.S.C. §3729 (FCA) have significantly increased in recent years. The FCA is the government’s primary civil remedy to redress false claims for federal money or property, including incorrectly billing for the provision of health care services. Most actions are filed under the FCA’s whistleblower, or qui tam provisions. Qui tam lawsuits are civil lawsuits brought by whistleblowers, also known as the relators, under the FCA. The FCA rewards whistleblowers if their qui tam cases recover funds for the government. Given the increasing number of qui tam lawsuits that are being filed, dentists, sleep physicians, DME companies, and sleep disorder centers need to ensure that their coding and billing practices and claims submissions are in compliance with the CMS regulations, coverage guidelines, and applicable National Coverage Decision and Local Coverage Decision guidelines for their Medicare Administrative Contractors (MACs) jurisdiction. Each state is assigned to a specific MAC jurisdiction and MAC. For example, Illinois is assigned to MAC 6 with National Government Services, Inc. designated as the MAC for this state.

Benefits of Implementing a Compliance Program
By voluntarily implementing a compliance program, dentist and other providers and suppliers involved in the provision of Dental Sleep Medicine, may realize the following benefits:

  • The formation of effective internal controls to ensure compliance with state and federal statues, rules, and regulations, and state, federal, and third-party payor health care program requirements and internal guidelines;
  • Improvement of the quality, efficiency, and consistency of providing services;
  • An increased likelihood of identification and prevention of criminal and unethical conduct;
  • The ability to obtain an assessment of employee and contractor behavior relating to fraud and abuse;
  • A centralized source for distributing information on health care statutes, regulations, policies, and other program directives regarding fraud and abuse and related issues;
  • Procedures that require the prompt, thorough investigation of alleged misconduct by corporate officers, managers, representatives, employees, and independent contractors, consultant, clinicians, and other health care professionals;
  • Early detection and reporting, which may minimize the loss to the government from false claims, and thereby reducing the dentist’s and other Dental Sleep Medical provider and suppliers’ exposure to civil damages and penalties, criminal sanctions, and administrative remedies, such as program exclusion;
  • Initiation of immediate and deliberate corrective action; and
  • Enhancement of the structure of the Dental Sleep Medicine Program’s operations and consistency between any related entities and service locations.

While the implementation of a compliance program will not completely eliminate the potential for fraud and abuse, the development of a compliance program by dentists and other health care providers and suppliers involved in the provision of Dental Sleep Medicine, will demonstrate compliance with the applicable state and federal statutes, rules, and regulations and state, federal, and private payor health care program requirements, and will significantly reduce the risk of unlawful or improper conduct by the health care provider or supplier and reduce the risk of a potential audit, investigation, or other enforcement activity, including a qui tam action.

A compliance program can be the foundation which enables a dentist and dental practice to build and develop the process necessary for an effective Dental Sleep Medicine Program that demonstrates compliance with the applicable regulations and requirements. An effective and well developed compliance program should incorporate the OIG’s identified seven (7) fundamental elements into a compliance program, and dentists and dental practices should strive to provide the highest level of patient care in the provision of Oral Appliances while reducing fraud, abuse, and waste to state, federal, and private health program.

Besides regulatory compliance plans, knowledge of Medicare regulations for durable medical equipment such as oral appliance therapy can make billing less difficult and time consuming. Read “Medicare: Reasonable and useful lifetime (RUL). What is that?” here.

Jayme R. Matchinski is a health care attorney and Officer in the Chicago office of the law firm Greensfelder, Hemker & Gale, P.C. Jayme focuses her practice in health and corporate law, including helping health care providers and suppliers handle the complex regulatory and operation issues unique to the industry. She has significant experience in the area of Dental Sleep Medicine. She can be reached at

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