MAC Jurisdiction-12 Contractor Advisory Committee CAC Meetings February 11-13, 2009

2. Highmark Medicare Services MAC Jurisdiction-12 Contractor Advisory Committee (CAC) Meetings February 11-13, 2009

3. Highmark Medicare Services AGENDA Welcome and Introductions J-12 Contractor Update Medical Affairs Review Contractor Advisory Committee Roles, Composition, Survey, Schedule Discussion of Draft LCDs Old Business / New Business Q & A

4. Highmark Medicare Services Andrew Bloschichak, MD, MBA VP Clinical Affairs 717-302-4198 (office) 717-302-4165 (fax)andrew.bloschichak@ highmarkmedicareservices.com

5. Highmark Medicare Services Paula Bonino, MD, MPE Contractor Medical Director 412-544-1931 (office) 412-544-1971 (fax) paula.bonino@ highmarkmedicareservices.com

6. Highmark Medicare Services Eileen M. Moynihan, M.D., FACR, FACP Contractor Medical Director 856-857-5257 (office) 717-302-4165 (fax) eileen.moynihan@ highmarkmedicareservices.com

7. Highmark Medicare Services Highmark Medicare Services J-12 Contractor Update

8. Highmark Medicare Services Transition Update All transitions completed as of 12-12-08 Largest Jurisdiction in country Approximately 4.2 M Medicare beneficiaries 137,350 physicians and healthcare professionals 433 Hospitals 131 Million claims per year (11% of Nat�l volume) $31.5 Billion/year in healthcare payments Current Operational Metrics:

9. Highmark Medicare Services Claims Processing � Part A

10. Highmark Medicare Services Claims Processing � Part B

11. Highmark Medicare Services Provider Contact Center � Part A

12. Highmark Medicare Services Provider Contact Center � Part B

13. Highmark Medicare Services Provider Contact Center � Part A

14. Highmark Medicare Services Provider Contact Center � Part B

15. Highmark Medicare Services Redeterminations

16. Highmark Medicare Services Enrollment � Part A (January 2009)

17. Highmark Medicare Services Enrollment � Part B (January 2009)

18. Highmark Medicare Services Highmark Medicare Services J-12 Medical Affairs Update

19. Highmark Medicare Services Local Coverage Decisions Local Coverage Decisions implement the SSA 1862(a)(1)(A) requirement of Reasonable and Necessary through: Analysis of scientific evidence Refinement and input from a diverse body of clinicians (CAC) Use of �Community Standard of Practice� via clinicians and data Application to individual claim determinations

20. Highmark Medicare Services LCD Development Process LCDs will be developed, in keeping with CMS directives: A validated widespread problem; a significant risk to the Medicare trust fund (high dollar and/or high volume services); Assuring beneficiary access to care; Frequent denials issued or anticipated; Multi-state contractor creating uniform LCDs across its jurisdiction; CERT findings

21. Highmark Medicare Services Local Coverage Decisions LCDs set coverage for ALL Medicare programs in the state PLUS Medicare used as template by many other payors All LCDs (and drafts) on contractor Web Site Can comment on web, via CAC, to CMDs directly, at �Open session�

22. Highmark Medicare Services Local Coverage Decisions (LCDs) Draft LCDs sent out to CAC and posted on website to allow 45 days for comment Interested parties can comment directly, through website, at �Open Session�. After final policy published, allow 45 days notification until implementation Draft policy comments and responses posted on website All then posted on CMS national LCD database (www.cms.hhs.gov/coverage)

23. Highmark Medicare Services C0ntractor Advisory Committee One CAC per state Meets 3-4 times per year, no more than 4 months apart Purpose: Formal mechanism for participation in development of ALL LCDs in advisory capacity Mechanism to discuss administrative policies Forum for information exchange

24. Highmark Medicare Services C A C CAC is not a forum for peer review, discussion of individual cases, or individual providers Not a forum for specific billing issues or individual interests Reviews and comments on ALL drafts, but final implementation rests with CMD

25. Highmark Medicare Services MAC LCDs and CAC Local Coverage Determinations (Medical Policies) 57 Policies for MAC start Had full comment period prior to finalization LCDs, Comments & Responses Posted on our Website Date of Service Sensitive by Segment Cutover Date In the absence of an NCD/LCD services must be �R&N� per SSA National Coverage Determinations Coding Articles - PET Scans; BMM; Immunizations Jurisdiction Advisory Committee / Contractor Advisory Committee Statewide Membership; A/B Combined; 3/year Survey recently sent to members of record Updated rosters and contact information

26. Highmark Medicare Services CAC Surveys 231 Responses received ! Prefer 3 meetings/year; Feb � June � Oct cycle for all locales Maintain state specific membership and meetings (but almost 2/3 in favor of at least 1 CAC/yr as combined) Meeting times: PA Weekday mornings NJ Weekday morning (afternoon close 2nd) Del Weekday evening MD Weekday evening DCMA Weekday morning (evening close 2nd)

27. Highmark Medicare Services CAC Surveys Prefer option to attend any CAC of choice if schedule demands In favor of CAC meetings via teleconference: YES 58% NO 41% Many comments in favor of one teleconference/year, however not all CACs via teleconference as find face-to-face meetings important

28. Highmark Medicare Services Upcoming CAC Meetings Second Thursday of Feb-June-Oct as anchor Separate Meetings for each Locale Week of June 10-12 Planning for combined meeting for all J-12 October 9/10 

29. Highmark Medicare Services COMPREHENSIVE ERROR RATE TESTING (CERT) PROGRAM

30. Highmark Medicare Services Comprehensive Error Rate Testing (CERT) Program GPRA established in mid 90�s Managed by CMS with outside contractor, Advance Med Data obtained by specialty, procedures, locale Major driver of Medical Review LCD Development Physician/Provider Outreach and Education

31. Highmark Medicare Services Comprehensive Error Rate Testing (CERT) Program CERT Documentation Office requests records from billing provider of record AdvanceMed performs complex medical review using NCDs, CMS coding policies, each contractor�s LCDs and articles Contractors must recover �overpayments� and pay �underpayments� on claims with errors determined by AdvanceMed Physicians / providers can appeal such findings Contractors are tasked with implementing various interventions to reduce the Error rate Highmark Medicare Services and CMS website quite extensive in CERT information (www.cms.hhs.gov/cert)

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33. Error Rates by Specialty

34. Error Rates by Specialty (cont.)

35. Highmark Medicare Services CMS May �07 CERT Report Part B

36. Highmark Medicare Services J-12 Part B CERT

37. Highmark Medicare Services J-12 Part A CERT

47. Highmark Medicare Services Part B CERT Drivers Our Informatics and CERT Team is able to determine CERT Drivers (within statistically significant groupings) for our Jurisdiction by County Specialty / Provider Type Procedure Codes and Betos Groups This information is utilized to focus our interventions and monitor effectiveness

48. Highmark Medicare Services Part B CERT Drivers Evaluation and Management Services Consultations (esp. inpatient Level IV/V) Subsequent Office Visits (esp. 99214) Hospital Visits , including Discharge (time separates 99238-99239) Therapies PT / OT Chiropractic Services Diagnostic Studies (-26) need �Interpretation and Report� New Issue - Date of Service and Physician Orders!

49. Highmark Medicare Services MEDICAL REVIEW Medical Review / Progressive Corrective Action (PCA) is DATA DRIVEN (but not data determined) Data includes CERT, Medicare utilization in many statistical analyses Notice of Medical Review: Provider notified via �ADR� Additional Documentation Request If based on comparative data, data is provided Reviews can be provider-specific or service-specific (procedure code driven) Most common provider-specific reviews of recent years are �Pre-pay Probes� which consists of 20-30 claim sample reviewed BEFORE payment made

50. Highmark Medicare Services MEDICAL REVIEW Documentation is not only required, but is essential for fair and accurate review Providers have 30 days to respond Service denied as not �R&N� if no doc after 45 days Unfortunately in many PCA efforts we do not receive any documentation 30 +% of the time!! Contractors have 60 days from receipt of records to complete review Depending on outcome of Probe and $ at risk, can lead to full Pre-Pay review

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54. Highmark Medicare Services E&Ms Based on E&M Documentation Guidelines per AMA and CMS (1995/1997) E&M Scoresheet and dedicated webpage on web Computer-based modules with CME credit on website HMS POE staff very able and willing to conduct learning workshops

55. Highmark Medicare Services Consultations Effective January 1, 2006, per AMA CPT: 99251 � 99255 Initial inpatient consultation for new or established patient 99241 � 99245 Office (or other Outpatient) consultation for new or established patient Can use TIME if documentation meets time requirements Need: Request � Reason - Report LCD requirements (Expertise and/or specific patient knowledge) Appropriate documentation for level of care Requires all 3 components of History, Exam, and Medical Decision Making Effective January 1, 2006 I want to make you aware of some important CPT changes. Follow-up inpatient consultation codes 99261-99263 have been deleted. Confirmatory consultation codes 99271-99275 are deleted. Effective January 1, 2006, in the hospital setting, the consulting physician or qualified NPP must use the appropriate Initial Inpatient Consultation codes 99251-99255 for the initial consultation service and thereafter use the Subsequent Hospital Care codes 99231-99233 for additional follow-up visits. In the nursing facility setting, the consulting physician or qualified NPP must use the appropriate Initial Inpatient Consultation codes 99251-99255 for the initial consultation service and thereafter use the Subsequent Nursing Facility Care codes 99307-99310 for additional follow-up visits. Effective January 1, 2006, CPT codes 99311-99313 were deleted and are not valid for subsequent nursing facility visits. Shared/split E/M payment policy does not apply to consultation services. The Initial Inpatient Consultation may be reported only once per consultant per patient per facility admission. For additional information on consultations as well as the documentation requirements for consultations, please refer to HGSA�s LCD on Consultation Services, C-2 and/or Change Request 4217/Transmittal 788. I have listed both of the direct links to these documents on the slide for your convenience. Also, FAQ 120 � verbal requests may come up and should be talked about here. Effective January 1, 2006 I want to make you aware of some important CPT changes. Follow-up inpatient consultation codes 99261-99263 have been deleted. Confirmatory consultation codes 99271-99275 are deleted. Effective January 1, 2006, in the hospital setting, the consulting physician or qualified NPP must use the appropriate Initial Inpatient Consultation codes 99251-99255 for the initial consultation service and thereafter use the Subsequent Hospital Care codes 99231-99233 for additional follow-up visits. In the nursing facility setting, the consulting physician or qualified NPP must use the appropriate Initial Inpatient Consultation codes 99251-99255 for the initial consultation service and thereafter use the Subsequent Nursing Facility Care codes 99307-99310 for additional follow-up visits. Effective January 1, 2006, CPT codes 99311-99313 were deleted and are not valid for subsequent nursing facility visits. Shared/split E/M payment policy does not apply to consultation services. The Initial Inpatient Consultation may be reported only once per consultant per patient per facility admission. For additional information on consultations as well as the documentation requirements for consultations, please refer to HGSA�s LCD on Consultation Services, C-2 and/or Change Request 4217/Transmittal 788. I have listed both of the direct links to these documents on the slide for your convenience. Also, FAQ 120 � verbal requests may come up and should be talked about here.

56. Highmark Medicare Services CONSULTATIONS Need History; Exam; AND Medical Decision-Making (or Time reporting requirements) NPPs may Request or Perform Consults ( within scope of practice, expertise) Split-Sharing of Consults is NOT allowed as of 1-1-2006 per CMS instruction �Standing� consults are not covered by Medicare For ongoing management, report as subsequent visits The three key components when selecting the appropriate level for any E/M service are history, examination and medical decision making. All three key components must be met or exceeded in order to select the appropriate level of consultation service. We will discuss these components in more detail when we walk through the E/M scoresheet. The three key components when selecting the appropriate level for any E/M service are history, examination and medical decision making. All three key components must be met or exceeded in order to select the appropriate level of consultation service. We will discuss these components in more detail when we walk through the E/M scoresheet.

57. Highmark Medicare Services Prevention Gap A study released by the Government Accountability Office (GAO) in September 2004 found that most Medicare beneficiaries receive some but not all recommended preventive services. As you can see from the chart listed on this slide, patients are not using many valuable benefits. We hope that you will help increase the health and wellness of the Medicare population. A study released by the Government Accountability Office (GAO) in September 2004 found that most Medicare beneficiaries receive some but not all recommended preventive services. As you can see from the chart listed on this slide, patients are not using many valuable benefits. We hope that you will help increase the health and wellness of the Medicare population.

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59. Highmark Medicare Services Medicare Part B Preventative Services

60. Highmark Medicare Services Medicare Part B Preventative Services

61. Highmark Medicare Services Medicare Part B Preventative Services

62. Highmark Medicare Services Medicare Part B Preventative Services

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64. Highmark Medicare Services REVIEW OF DRAFT LCDs

65. Highmark Medicare Services Conflict of Interest The opportunity to influence a policy and/or decision, either directly or indirectly, through one�s membership on the Committee, which allows for personal gain.

66. Highmark Medicare Services Conflict of Interest CAC acknowledges that members represent their specific specialties and clinical practice, and will be speaking on behalf of that specialty/practice. To that extent, any inherent benefit as such is not considered a �conflict of interest.�

67. Highmark Medicare Services Conflict of Interest CAC members are asked to divulge any �significant financial interest�, as defined as ownership interest of 5 % or more in companies (other than their clinical practice), which stand to benefit from Medicare policy decisions, prior to providing comments regarding specific policies.

68. Highmark Medicare Services Draft Local Coverage  Determinations (LCDs) DL 27499Intraoperative Neurophysiological Testing DL 27530Sleep Disorders Testing DL 29544Posterior Tibial Nerve Stimulation DL 29547EMG and Nerve Conduction Studies

69. Highmark Medicare Services DL 27530 Sleep Disorders Testing Updated LCD to address: Repeat testing criteria for PSG Coverage criteria for Home Sleep Testing Clarify specific covered indications for PSG, HST for OSA and CPAP HST emerging with CMS mandate for coverage of CPAP based on Dx of OSA by HST

70. Highmark Medicare Services DL 27530 Sleep Disorders Testing LCD updated in keeping with: CMS HST instructions DMERC CPAP coverage Guidelines American Academy of Sleep Medicine Clinical Guidelines for Use of Unattended Portable Monitors in Dx of OSA (specifically physician performing PC) Other contractor LCDs

71. Highmark Medicare Services DL 27530 Sleep Disorders Testing No change to documentation guidelines Significant updates to ICD-9 covered indications to include: Expansion of coverage for 95807-95810 Allowing limited coverage for 95806 and G0398-G0400 CAC Comments�.. *

72. Highmark Medicare Services Updated policy for emerging/expanding service; initially distributed 04/01/08 Data often showed monitoring of ten or more cases at a time Many diagnoses did not seem to support medical necessity Many inquiries about who could perform LCD DL27499 IntraoperativeNeurophysiological Testing

73. Highmark Medicare Services LCD DL27499 IntraoperativeNeurophysiological Testing Many inquiries and issues about location of the performing provider Many inquiries about type of equipment to be used Needed to add ICD 9 CM codes to match the narrative diagnoses for ease of processing CAC comments *

74. Highmark Medicare Services LCD DL29547 Electromyography (EMG) and Nerve Conduction Studies Components of testing in segregated policies in the past. Difficult to pull all components together in one policy without JAC comments Clarify what constitutes valid studies under the CPT codes of the policy. Specify guidance for performance and billing of nerve conduction studies due to previously high utilization

75. Highmark Medicare Services LCD DL29547 Electromyography (EMG) and Nerve Conduction Studies Followed AAEM guidelines regarding number of studies CAC Comments�.

76. Highmark Medicare Services DL29544 Posterior Tibial Nerve Stimulation (PTNS) This procedure involves percutaneous (or transcutaneous) peripheral stimulation of the posterior tibial nerve. It has been under study for the treatment of pelvic floor dysfunction manifesting in a variety of clinical problems such as: urinary frequency, urgency, incontinence or retention; bowel dysfunction; and/or pelvic pain. This procedure came to our attention through a provider inquiry about proper coding; and through CMS Contractor Medical Director Workgroup discussions.

77. Highmark Medicare Services Posterior Tibial Nerve Stimulation Procedure / Methods While studies vary in the protocols used, generally a 34 gauge needle is placed percutaneously above the medial malleolus, into the tibial nerve, with a surface electrode on the foot. A stimulator delivers a low voltage electrical impulse. Most papers report sessions of 30 minutes of treatment weekly for 10 to 12 weeks. Continuation beyond the initial treatment is highly variable, and little published experience is available. What is available shows a rapid loss of improvement when treatment is stopped. Most use �for the duration�, every 3 to 4 weeks. One small study demonstrated about a 3 month window before loss of effect.

78. Highmark Medicare Services Posterior Tibial Nerve Stimulation: Hypotheses The mechanism of action is not known, but some of the hypothetical bases are as follows: The posterior tibial nerve is a mixed sensory-motor nerve whose fibers originate from spinal roots L4 through S3. PTNS inhibits bladder activity by depolarizing somatic sacral and lumbar afferent fibers. Afferent stimulation provides central inhibition of the preganglionic bladder motor neurons. Stimulation of the large somatic fibers could modulate / inhibit the thinner afferent A-delta or C fibres, decreasing the perception of urgency. Neurochemical changes and changes to blood flow have been hypothesized.

79. Highmark Medicare Services Posterior Tibial Nerve Stimulation: Hypotheses Activation of endorphin pathways within the spinal cord could affect detrusor behavior Most of the discussion has focused on the role of neuromodulation of the sacral nervous outflow tract Neuromodulation helps restore the balance between inhibitory and excitatory impulses that govern bladder function The �minimally invasive� method for neuromodulation may address drawbacks of implantation of sacral neurostimulator, including the need for re-operation (up to 30%); migration of neural leads, etc.

80. Highmark Medicare Services Posterior Tibial Nerve Stimulation: Clinical Considerations for Medicare Patients, Esp. Elderly Urinary incontinence is a common and disabling problem associated with isolation, embarrassment, other illnesses (e.g., infection, decubiti), and loss of independent living � need more and better prevention and treatment options Often multifactorial � drugs, drug interactions Consider practical realities of treatment delivery Diabetes and other peripheral neuropathy Peripheral edema, CHF Cardiovascular disease � patient on anticoagulation Visual impairment Arthritis � hands, hips, etc. � positioning and performing, mobility Cognitive impairment, dementia BPH, prostate CA

81. Highmark Medicare Services Posterior Tibial Nerve Stimulation: Regulatory Considerations Related NCDs: 160.2 Treatment of Motor Function Disorders with Electric Nerve Stimulation: Not covered, with some exceptions 160.7 Electrical Nerve Stimulators: Peripheral and Central, for chronic intractable pain; criteria for coverage discussed 160.7.1 Assessing Patients Suitability for Electrical Nerve Stimulation Therapy: for pain; TENS and PENS discussed 230.8 Non-Implantable Pelvic Floor Electrical Stimulator: covered for stress and/or urge urinary incontinence with specific criteria (usually delivered by vaginal or anal probes, external pulse generator)

82. Highmark Medicare Services Posterior Tibial Nerve Stimulation: Regulatory Considerations, Data 230.15 Electrical Continence Aid: Not covered (device placed in anal canal, portable generator stimulates anal musculature) 230.16 Bladder Stimulators (Pacemakers): Not covered (implanted electrodes, current causes contractions) 230.18 Sacral Nerve Stimulation for Urinary Incontinence: Covered for urinary urge incontinence, urgency-frequency syndrome, and urinary retention. Test stimulation, then permanent implantation. Specific inclusion and exclusion criteria discussed. Data on next slide � NOC code � claims review showed almost all of the services were not PTNS, but rather neurosurgical services: very little current use in J12 region per claims

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84. Highmark Medicare Services Posterior Tibial Nerve StimulationPublished Research Findings Small numbers; various etiologies and problems; mixed prior history of treatment and length / type of symptoms; No control groups, unable to assess placebo effect; methods vary in amount of current applied, frequency and length of treatments (not directly comparable); Almost all do not reflect the Medicare population, except perhaps the disabled; No randomized controlled studies or studies of sufficient sample size and power; Some investigators receive support from the study sponsor

85. Highmark Medicare Services Posterior Tibial Nerve StimulationPublished Research Findings Misattributed effects of urodynamic testing itself as evidence of success of procedure Some report an �intention-to-treat� analysis, others do not evaluate dropouts. Definitions of success or improvement also vary � not directly comparable Modest statistical findings � clinical relevance? Other Medicare Contractors who have LCDs: Non-coverage at this time

86. Highmark Medicare Services Posterior Tibial Nerve Stimulation Alternatives are available, all with pros and cons: meds, surgical, behavioral, multiple interventions for multifactorial problem �On the horizon�: implanted electrode in posterior tibial nerve, externally placed radiofrequency generator � self-administered. �Promising work�, currently experimental / investigational for the Medicare population, therefore not reasonable and necessary (non-covered). Discussion

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88. Highmark Medicare Services Upcoming CAC Meetings Second Thursday of Feb-June-Oct as anchor Separate Meetings for each Locale Week of June 10-12 Planning for combined meeting for all J-12 October 9/10 

89. Highmark Medicare Services CAC DISCUSSION OLD BUSINESS� NEW BUSINESS�

90. Highmark Medicare Services �The Future Ain�t What It Used To Be� Yogi