Regulatory and Legislative Issues in Sleep Technology

1. Regulatory and Legislative Issues in Sleep Technology North East Sleep Society March 27, 2010 Presented by: Bruce Blehart, JD Director - Health Policy and Government Relations American Academy of Sleep Medicine

2. Legislative Status • Statutory requirements for sleep technologist recognition varies greatly from state to state. • Some states require licensure or certifi-cation for sleep technologists, while other states do not address education or training for sleep technologists at all in their statutes.

3. Legislative Status State statutory language for the practice for sleep technologists generally falls into five categories: • States which have a Polysomnography Practice Act. • States that contain general exemption language for sleep technologists in the Respiratory Care Act. • States that specifically define sleep technology and the scope of practice for sleep technologists in the Respiratory Care Act (Idaho and North Dakota). • States that do not address the practice of sleep technology at all in the Respiratory Care Act. • States that do not have either a Polysomnography or Respiratory Care Practice Act (Alaska and Hawaii).

4. Polysomnography Practice Acts Jurisdictions with a Polysomnography Practice Act providing sleep technologists a specific pathway for licensing/certification: California New Mexico Louisiana North Carolina Maryland Tennessee New Jersey Washington, DC

5. New Jersey Practice Act "Polysomnography" means the allied health specialty involving the treatment, management, diagnostic testing, research, control, edu-cation and care of patients with sleep and wake disorders under a qualified medical director and includes, but is not limited to, the process of analysis, monitoring and recording of physiologic data during sleep and wakefulness to assess, diagnose and assist in the treatment and research of disorders, syndromes and dysfunctions that either are sleep related, manifest during sleep or disrupt nor-mal sleep and wake cycles and activities. Polysomnography shall also include the therapeutic and diagnostic use of oxygen, the use of positive airway pressure including CPAP and bi-level modalities, cardiopulmonary resuscitation, maintenance of nasal and oral air-ways that do not extend in the trachea, transcription and imple-mentation of the written or verbal orders of a physician pertaining to the practice of polysomnography. Polysomnography shall not include a home-based unattended self-administered diagnostic test, provided that any test results shall only be read and analyzed by a licensed polysomnographic technologist or polysomnographic technician or a licensed physician. Polysomnography services shall be provided only when ordered by a physician who has medical responsibility for the patient.

6. Exemption Language • Thirty states contain general exemption language in their Respiratory Care Acts. • General exemption language allows sleep technologists to work within their scope of practice while under the direction of a licensed physician.

7. Exemption Language Thirty (30) States provide general exemption language: Alabama MassachusettsPennsylvania Arizona Michigan South Carolina Arkansas Minnesota South Dakota Colorado Mississippi Texas Georgia Missouri Utah Illinois Nebraska Vermont Indiana New Hampshire Virginia Iowa Nevada Washington Kansas Ohio West Virginia Maine Oklahoma Wyoming

8. Maine Licensed or credentialed persons. Any health care personnel licensed by this State or who currently hold a nationally recognized credential in a health care profession engaging in the delivery of respira-tory care services for which they have been formally trained. That training must include supervised preclinical didactic and laboratory activities and supervised clinical activities and must be approved by the board or an accrediting agency recognized by the board. It also must include an evaluation of competence through a standardized testing mechanism that is determined by the board to be both valid and reliable;

9. Massachusetts any person licensed in the commonwealth by any other statute or credentialed by an organization which is a member of the National Commission for Health Certifying Agencies from engaging in the profession for which he is licensed or credentialed,

10. New Hampshire "Registered polysomnographic technologist'' or "RPSGT'' means a person having successfully completed and achieved a passing score on the comprehensive registry examination for polysomno-graphic technologists administered by the Board of Registered Polysomnographic Technologists or its successor organization. Respiratory care performed as part of a limited scope of practice, as defined by the board, by certified pulmonary function technicians (CPFT), registered pulmonary function technologists (RPFT) or registered polysomnographic technologists (RPSGT) in a diagnostic laboratory or research setting.

11. Pennsylvania This section shall not prevent or restrict the practices, services or activities of a person executing or conveying medical orders pursuant to lawful delegation by a physician.

12. Vermont A polysomnographic technologist, technician, or trainee from performing activities within the scope of practice adopted by the association of polysomnographic technologists, while under the direction of a Vermont licensed physician who has training in sleep medicine.

13. No Language Nine (9) states have Respiratory Care Acts that do not address the practice of polysomnography. These states are: ConnecticutNew York Delaware Oregon Florida Rhode Island Kentucky Wisconsin Montana

14. Legislative Activity: 2008 - 2009 The following jurisdictions saw significant recent legislative activity: California New Mexico Georgia North Carolina Hawaii Oklahoma Maryland Tennessee Minnesota Washington D.C

15. California • Senate Bill 132, a bill to establish educational and training requirements for sleep technologists, was introduced February 9, 2009. • SB 132 is the same bill (SB 1526) Governor Schwarzenegger vetoed in 2008. • The Governor’s veto was completely unrelated to the merits of the bill, which had passed the legislature with a significant bipartisan majority.

16. California On Oct. 23, 2009, SB 132 was signed into law by Governor Schwarzenegger. The California Medical Board is now charged to develop regulations to establish which educational and training programs will be accepted by the Board. The AASM will continue to work with the California Sleep Society (CSS) and the California Medical Board on the development of regulations.

17. Georgia The Georgia Composite State Board of Medical Examiners issued a statement in their November 2008 Newsletter which could have expanded the respiratory care practice act in a manner that could have defined sleep technologists as illegally providing respiratory care. Following action from the AASM and AAST to stop this action, the Georgia Association of Sleep Professionals (GASP) worked with state legislators and the Governor’s office to protect the sleep technologist profession. House Bill 509, which provides an exemption for sleep technologists, was signed by Governor Sonny Perdue on May 11, 2009. On March 23, the Georgia Composite Medical Board issued proposed regulations. Comments may be provided through the end of April and a hearing has been set for May 6, 2010.

18. Minnesota • On February 16, 2009, Senate Bill 685 (SF 685) was introduced into the Minnesota Legislature. • The bill would have amended the Respiratory Care Practice Act by changing the status for respiratory therapists from “registered” to “licensed.” • However, the legislation also included language which could have negatively changed the exemption language for sleep technologists. • SF 685 could have also precluded sleep technologists employed by a DME or home medical equipment from performing “assessment, education, or evaluation of the patient” on respiratory care equipment.

19. Minnesota • AASM worked with our Minnesota members in developing letters to state legislators requesting that the exemption language revert back to its original form and that the DME language allow sleep technologists to instruct the patient on the use of, and/or maintaining respiratory care equipment. • Senate Bill 1447 (SF 1447), an omnibus health care bill, was amended to include acceptable exemption language for sleep technologists. • House Bill 1276 (HF 1276), a bill addressing numerous health issues, was amended to include DME language stating that an individual employed by a DME or home medical equipment provider may “deliver, set up, and instruct the patient on the use of, or maintaining respiratory care equipment.” • Both bills were signed by Governor Tim Pawlenty on May 22, 2009.

20. Tennessee Senate Bill 726, which had the backing of the American Association for Respiratory Care (AARC), was introduced on February 11, 2009. The bill would negatively amend the newly established Polysomnographic Practice Act: • Require that licensed sleep technologists and technicians work under the direct supervision of licensed physicians. • Eliminate all Accredited Sleep Technologist Programs (A-STEP) in the state; or • Delete the BRPT examination for respiratory therapists.

21. Tennessee • The bill was significantly amended where the proposed negative provisions were deleted. • The final version stated that respiratory therapists may provide polysomnographic care if they are credentialed by the: • BRPT; • NBRC (SDS); or • Tennessee Board of Respiratory Care based on documentation provided through a standardized, uniform mechanism that has been reviewed through consultation with the Medical Board. • The measure was signed by Governor Bredesen on June 11, 2009.

22. Washington, DC • On March 3, 2009, the Washington, DC City Council unanimously approved Bill 18-33, titled “Practice of Polysomnography Amendment Act of 2009.” • The bill would provide for the regulation of polysom-nography under the Board of Medicine, and created an Advisory Committee on Polysomnography. • The bill was sent to the Mayor’s office on April 13th for his signature. The Mayor approved the legislation on April 28, 2009.

23. Legislative Activity: 2010 Legislative activity that we currently track is occurring in the following states: Florida Hawaii New York Oklahoma Virginia

24. Legislative Activity: 2010 - Florida SB 1144 and H 221 are identical bills that: • designates Drowsy Driving Prevention Week; • encourages the public and the law enforcement community to be better educated about the relationship between fatigue and drivingperformance; and • restricts use of mobile telecommunications devices by school bus drivers.

25. Legislative Activity: 2010 - Hawaii On January 28, 2009, nine bills were introduced in the Hawaii State Legislature to establish a Respiratory Care Practice Act. Hawaii is one of two (Alaska) states that do not have a sleep or respiratory care practice act. Senate Bill 1332, which had the most traction, would have precluded sleep technologists from practicing. The AASM and AAST worked closely with the Hawaii Sleep Society on this issue. None of the bills, including SB 1332, were passed out of committee.

26. Legislative Activity: 2010 - Hawaii SB 2600 - Respiratory Therapist Licensure As introduced, the bill has the following exemption language: Exemptions.  This chapter shall not apply to:     (1)  A person working within the scope of practice or duties of another licensed profession that overlaps with the practice of respiratory care… (2)  A person enrolled as a student in an accredited respiratory therapy program… (3)  A person rendering services in the case of an emergency… or   (4)  A person employed by a federal, state, or county government agency in a respiratory therapist position…

27. Legislative Activity: 2010 - Hawaii SB 2600 - Respiratory Therapist Licensure As amended, with an effective date of 2050, the legislation is moving with two different versions of exemption language: Senate – 1) A person working as a sleep technologist whose scope of work may include, but is not limited to, and who has passed an examination for, set-up, titration, and monitoring of continuous positive airway pressure or bi-level positive airway pressure for diagnostic purposes; 2) A person employed by a DME provider who engages in the delivery, assembly, …provided that no person providing such services shall be authorized to assess patients, develop care plans, instruct patients in taking treatment, or discuss the hazards, administration, or side effects of medication with patients; House - This chapter is not intended to restrict the practice of other licensed or credentialed healthcare practitioners practicing within their own recognized scopes of practice and shall not apply to a person: (2) Working as, in training to become, or studying to become a sleep technologist or sleep technician as defined by the American Association of Sleep Technologists;

28. Legislative Activity: 2010 New York: AB 9546 - Polysomnographic Technology Practice Relates to licensing the practice of polysomno-graphic technology; establishes requirements and procedures for professional licensure and registra-tion; allows limited permits to be issued to eligible applicants; establishes mandatory continuing education for licensed polysomnographic technologists.

29. Legislative Activity: 2010 – Oklahoma On February 2, 2009 the “Oklahoma Sleep Diagnostic Testing Regulation Act” was introduced. The bill would: Require that the interpreting physician is board-certified in sleep medicine by the American Board of Sleep Medicine (ABSM) or American Board of Medical Specialties (ABMS); Require that the supervising physician is board-certified in sleep medicine by the American Board of Sleep Medicine (ABSM) or American Board of Medical Specialties (ABMS); Require sleep diagnostic testing facilities to be fully or provisionally certified or accredited by the: American Academy of Sleep Medicine; Joint Commission; or Accreditation Commission for Healthcare. • SB 810 was signed by Governor Brad Henry on May 27, 2009.

30. Legislative Activity: 2010 - Oklahoma e Legislation (SB 1985) to amend the Oklahoma Sleep Diagnostic Testing Regulation Act passed the Senate on March 11 on a 40 to 7 vote. It amends the Act as follows: “Interpreting physician” means a physician who provides professional interpretation of data generated by sleep diagnostic tests. An interpreting physician shall be board-certified in sleep medicine by the American Board of Sleep Medicine (ABSM) or the American Board of Medical Specialties or must have completed a one-year sleep medicine fellowship accredited by the Accreditation Council for Graduate Medical Education (ACGME)a specialty approved by the State Board of Medical Licensure and Supervision or the State Board of Osteopathic Examiners;

31. Legislative Activity: 2010 Virginia: HB 725 – Licensure of Polysomnographic Technologists Summary/Purpose: Provides that no person shall practice as a polysomnographic technologist or to assume the title “licensed polysomnographic technologist,” “polysomno-graphic technologist,” or “licensed sleep tech” unless such person is licensed by the Board of Medicine. This bill also creates the Advisory Board on Polysomnographic Technol-ogy to assist the Board in establishing the qualifications, examination, and other requirements for the regulation of licensed polysomnographic technologists. 02/08/10  House: VOTE: --- PASSAGE (93-Y 3-N) 03/01/10  Senate: Passed Senate (40-Y 0-N)

32. Moving Legislation Mobilize • The first step in introducing legislation is mobilizing every sleep physician and technologist in the state. • While this seems simple enough it requires a great deal of coordination.

33. Moving Legislation Draft Legislation/Hire Lobbyist • Draft a bill that all can agree on – AASM/AAST staff can assist in drafting language. • Consider hiring a lobbyist – A lobbyist generally is essential when introducing legislation. • The State Medical or Hospital Society might be able to recommend a lobbyist.

34. Moving Legislation Connecticut – The Connecticut Sleep Society is developing legislation to establish licensure for sleep technologists. They are working with the local respiratory care society on issues relating to education and supervision.

35. Moving Legislation Identifying a State Legislator to Sponsor Your Bill • One of the most effective ways of identifying a sponsor for your legislation is to first find out who you know. • More times than not, you will discover that one of your members has some type of relationship or association with a sate representative. A state legislator might be a member’s next door neighbor, his or her patient, a sailing buddy, or a friend of a friend. • Schedule a meeting to discuss and identify which member has a relationship with a state representative and ORGANIZEYOUR MESSAGE.

36. Moving Legislation Coalition with other Organizations • Solicit the support of the State Medical Society and the State Hospital Society. • As a general rule health related legislation must get the approval of these groups. • If you know someone who has a connection to either organization it can be very beneficial towards your legislative efforts.

37. Moving Legislation Timeline • Expect the process to take at least two years. Most bills do not pass in the first year. • Review your legislative calendar before making any definitive judgment on a time line. • Stay united!

38. State Sleep Societies • The AASM and AAST launched this initiative in March, 2008. • Reasons AASM/AAST wanted to establish state sleep societies was to: • Strengthen the sleep care community in the state; • Establish a unified voice for the profession; • Provide a forum that will serve to educate members, and; • Advance the profession in addressing any issues that may affect the ability to provide high quality care. • At the start of this initiative there were 18 state sleep societies. Currently, there are 38 state sleep societies, and we are in the process of working with AASM and AAST members in additional states.

39. State Sleep Societies • Established State Sleep Societies: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Georgia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina Tennessee, Texas, Virginia, West Virginia, Washington, Wisconsin, & Washington D.C. • In the Process of Being Established: Arkansas, Maine, Minnesota, New Hampshire, Oklahoma, and Utah

40. AARC Communications On April 15, 2009 the AARC sent a letter to its members stating: “We write to you today to emphasize a situation that we have warned you about before, but now we must collectively and proactively take a stand. Our profession is under attack. We are at the precipice of a situation where state by state the profession of respiratory therapy stands to legally have part of its scope of practice rescinded and taken away from you. There have been attempts both successful and unsuccessful at changing a state’s respiratory therapist legal scope of practice.”

41. AARC Communications • “It is our firm conviction that any requirement for further testing, credentialing or licensing of the respiratory therapist in the services deemed “polysomnography” is not warranted. We support state regulation of appropriately educated, competency-tested and credentialed polysomnographic personnel so long as it does not in any way adversely impact the scope of practice and/or licensure status of the respiratory therapist.” • In May, 2009, the AASM and the AAST sent an open letter to the AARC in response to their April 15th communication.

42. AARC Communications - Response • One of the main points in the letter emphasized that the AASM and AAST do not have an agenda that in any way will restrict the practice of respiratory care. • The letter further stated that the AASM and AAST agree with the statement: “We support state regulation of appropriately educated, competency tested and credentialed polysomnographic personnel so long as it does not in any way adversely impact the scope of practice and/or licensure status of the respiratory therapist.” • AASM/AAST are currently working with AARC on a framework for state recognition of the Sleep Technol-ogist profession in a manner that will help ensure that our patients receive care from professionals who are appropriately educated, competency-tested and credentialed.

43. Regulations Independent Diagnostic Testing Facility (IDTF) 42 CFR 410.33(c) - Nonphysician personnel. Any nonphysician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body. The IDTF must maintain documentation available for review that these requirements are met.

44. Regulations IDTF Credentialing Matrix National Government Services, Inc. (Medicare Contractor for New York) LCD # L28135   LCD Title - Independent Diagnostic Testing Facility (IDTF)  Credentialing Matrix - Credentialed by BRPT: RPSGT or ABRET: R. EEG T. (Polysomnography)

45. Regulations FY 2010 Office of Inspector General Work Plan Enrollment Standards for Independent Diagnostic Testing Facilities - We will review IDTFs enrolled in Medicare to determine whether they meet Medicare’s enrollment standards. Pursuant to Federal regulations at 42 CFR § 410.33, IDTFs, which received payments of approximately $1 billion in 2007, are required to certify on their enrollment applications that they comply with 14 standards. Such standards include, among others, requirements that IDTFs be in compliance with all applicable Federal and State licensure and regulatory requirements for the health and safety of patients, provide complete and accurate information on their enrollment applications, and have technical staff on duty with the appropriate credentials to perform tests. (OEI; 00-00-00000; expected issue date: FY 2010; new start)

46. Regulations FY 2010 Office of Inspector General Work Plan Appropriateness of Medicare Payments for Polysomnog-raphy - We will examine the appropriateness of Medicare payments for sleep studies. Sleep studies are reimbursable for patients with symptoms consistent with sleep apnea, narcolepsy, impotence, or parasomnia in accordance with the CMS “Medicare Benefit Policy Manual,” Pub. No. 102, ch. 15, § 70. Medicare payments for polysomnography increased from $62 million in 2001 to $215 million in 2005. We will also examine the factors contributing to the rise in Medicare payments for sleep studies and assess provider compliance with Federal program requirements. (OEI; 00-00-00000; expected issue date: FY 2011; new start)

47. Regulations 3 x 12 x 6 x 11,000 = 2,376,000 Claims Months Look-Back $$$$$

48. Regulation

49. Patient Protection and Affordable Care Act; PL 111-xxx SEC. 1128J. MEDICARE AND MEDICAID PROGRAM INTEGRITY PROVISIONS. (i) Increased Funding To Fight Fraud and Abuse- In addition to the funds otherwise appropriated… there are hereby appropriated an additional $10,000,000… for each of fiscal years 2011 through 2020.

50. Questions??