1. MEDICARE POLICY FOR CARDIAC AND PULMONARY REHABILITATION- WHAT’S AHEAD
Karen Lui, RN, MS, FAACVPR
GRQ Consulting, LLC
OSCVPR
October 23, 2009

2. Today we will cover:
Legislative actions that led to regulatory changes for cardiac rehab (CR) and pulmonary rehab (PR)
Proposed Medicare regulations
AACVPR recommendations made to CMS on proposed regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

3. DEFINITIONS CMS-Centers for Medicare & Medicaid Services
NCD-National Coverage Determination
-Medicare coverage policy
LCD-Local Coverage Determination
-Local Medicare Contractor coverage policy
MAC-Medicare Administrative Contractor
-Formerly Fiscal Intermediaries & Carriers

4. DEFINITIONS APC Ambulatory Patient Classification
-Outpatient equivalent of DRGs for in- patients
-Grouping of services/procedures based on diagnosis
-APC 0095 includes both (all) cardiac rehabilitation codes and 93797

5. DEFINITIONS ICD-9-CM Code International Classification of Diseases
-Diagnosis and procedure codes
-Used to code and classify morbidity data from the inpatient, outpatient records, & physician offices
-ICD-10 to replace ICD-9 in US by
(currently used in Europe)

6. DEFINITIONS CPT Code Common Procedure Technology
-#s assigned to MD services
-Codes are owned by AMA
-Codes are determined by CPT Editorial Panel of AMA

7. DEFINITIONS HCPCS Codes Healthcare Common Procedure Coding System
-CMS creates procedures/professional services codes used by hospitals
-Not all CPT codes are available for hospitals to use

8. Today we will cover:
Legislative actions that led to regulatory changes for CR and PR
Proposed Medicare regulations for CR and PR
AACVPR recommendations made to CMS on proposed regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

9. LEGISLATIVE ACTIONS Purposes of Public Law 110-275 (MIPPA)
To create statutory coverage policies and payment categories for CR & PR
This was the recommendation of CMS
Examples of services covered by statutory regulations: OT/ PT, CORFs
To assure that both CR & PR remain “physician-supervised” programs

10. Today we will cover: Proposed Medicare regulations for CR and PR
AACVPR recommendations made to CMS on proposed regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

11. After passage of MIPPA (7-08)
REGULATORY ACTIONS
After passage of MIPPA (7-08)
11/08, 1/09: Face-to-face CR and PR meetings between professional societies and CMS policy writers to discuss interpretation of legislative language into clinically- appropriate policy
Follow-up written recommendations with evidence-based references were then submitted to CMS

12. REGULATORY ACTIONS Release of proposed regulations July, 2009
Physician Fee Schedule (PFS)-MDs
Outpatient Prospective Payment System (OPPS)-hospitals
Posted on AACVPR web site
Public comment period closed
Final regulations will be published November, 2009 with effective date

13. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
From MIPPA (Pulmonary and Cardiac Rehabilitation Act of 2008) legislative language: “A physician is immediately available and accessible for medical consultation and medical emergencies at all times items and services are being furnished under such a program in a hospital, such availability shall be presumed…”

14. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
Definition of hospital campus
“Campus means the physical area immediately adjacent to the provider’s main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual basis, by the CMS regional office, to be part of the provider’s campus.”
42 C.F.R

15. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
Medical Director required
“Physician who oversees or supervises …involved substantially in directing the progress of individuals in the program.”
Physician Supervision based on program location according to definition in OPPS proposed rule:
In hospital or in on-campus department:
MD “…must be present on the same campus, in the hospital or the on-campus PBD (provider-based department) of the hospital…” (pg 35361, OPPS)
No change from current rule

16. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
For programs located in an off-campus PBD (provider-based department):
MD “must be in the off-campus PBD and immediately…” (pg 35361, OPPS)
Current wording: “on the premises of the location” for off-campus programs may change

17. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
For on-campus and off-campus CR programs:
“It does not mean that the physician must be present in the room when the procedure is performed.”

18. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
On-campus CR/PR program that has access to a code team would meet “immediately available” requirement
For all programs, use of 911 does not meet Medicare requirement for physician “immediacy”
Calling 911 as back-up and for patient transport is appropriate, but doesn’t replace need for an MD who is assigned to be “immediately available”.

19. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
Larger issue of CMS’ current and proposed definition of direct physician supervision for hospital outpatient therapeutic services (examples include infusion therapy, partial hospitalization, wound care) is being challenged by professional societies.
CMS final decision on this issue, effective January 1, 2010, will be known in November.

20. PROPOSED CARDIAC & PULMONARY REHAB RULES-PHYSICIAN SUPERVISION
NPPs (NP, PA,CNS) may directly supervise all hospital outpatient therapeutic services…in accordance with State law and scope of practice and hospital-granted privileges EXCEPT FOR CR/ICR/PR
CR/ICR/PR must be furnished by a doctor of medicine or osteopathy

21. Today we will cover:
AACVPR recommendations made to CMS on proposed CR and PR MD regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

22. AACVPR RECOMMENDATIONS TO CMS
Physician Supervision
1. Clarify that definition in OPPS, not PFS, is rule for CR/PR
“…same campus, in the hospital or the on-campus department.”
NO CHANGE FROM CURRENT RULE
PFS rules are confusing as stated, “…for services provided in PBD of hospitals…must be on the premises of the location (meaning the PBD) and immediately…”

23. AACVPR RECOMMENDATIONS TO CMS
Physician Supervision
2. Allow CR/PR to use NPPs as other hospital outpatient services will be allowed as of
This does not replace the need for a physician to be immediately available.

24. Today we will cover: Proposed Medicare regulations for CR
AACVPR recommendations made to CMS on proposed regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

25. PROPOSED CARDIAC REHAB RULES WHAT’S THE SAME?
Same diagnoses qualify patient for early outpatient CR
Comparable reimbursement amounts
2010 = $ (co-pay=$13.86)
Reimbursement rate varies regionally
Physician supervision “immediately available”

26. PROPOSED CARDIAC REHAB RULES WHAT’S THE SAME?
Two appropriate settings: hospital outpatient or MD office
Maximum of 36 sessions within 18 weeks
Same two CPT (HCPCS) codes:
93798 and 93797

27. PROPOSED CARDIAC REHAB RULES WHAT’S NEW?
Each session must be minimum of 60 minutes
No CMS requirement re: minutes of exercise
36 one-hour sessions allowed within 18 weeks
Maximum of two sessions per day
Minimum of two sessions per week
Patient must exercise aerobically every day he/she receives rehab

28. PROPOSED CARDIAC REHAB RULES NEW REQUIRED COMPONENTS
Program must include:
Initial assessment by CR staff
Psychosocial assessment
Individualized Treatment Plan (ITP)
Frequency, intensity, modality, duration
Measurable and expected outcomes
Estimated timetables to achieve outcomes

29. PROPOSED CARDIAC REHAB RULES INDIVIDUALIZED TREATMENT PLAN
Established by a physician
Referring or “CR” (supervising) MD
CR MD must review and sign all plans prior to initiation of CR
From proposed regulation, “If the plan is developed by the referring physician who is not the CR physician, the CR physician must also review and sign the plan prior to initiation of CR.” (pg 33608, PFS)

30. PROPOSED CARDIAC REHAB RULES INDIVIDUALIZED TREATMENT PLAN
CR staff provides outcomes and psychosocial assessments and recommendations to supervising MD prior to 30-day deadline
Plan is reviewed and signed by “the” physician every 30 days (refers to Medical Director)
For CR, direct physician contact is not required to meet 30-day review standards (different for PR) unless patient needs such contact
Outcomes should be consistent with current clinical practice standards

31. PROPOSED CARDIAC REHAB RULES OUTCOMES ASSESSMENT
Part of treatment plan and not billed separately
Outcomes measured at beginning, prior to each 30-day review, and at end of patient’s CR program
Measures are determined by patient’s individual plan
“Alternate or additional measures may be appropriate.”
Measures should include:
BP, weight, BMI, medication dosages, QOL, exercise progress, behavioral measures (smoking, etc)

32. PROPOSED CARDIAC REHAB RULES INTENSIVE CARDIAC REHABILITATION
ICR
New model of CR formerly known as a “lifestyle modification” program
Must apply annually to CMS to receive ICR designation demonstrating that program has:
Positively affected progression of CHD
Reduced need for CABG
Reduced need for PCI

33. PROPOSED CARDIAC REHAB RULES INTENSIVE CARDIAC REHABILITATION
ICR Program Criteria
“Each program must submit peer- reviewed published research specific to the actual program applying for approval.”
All designated programs must demonstrate continued compliance with MIPPA standards every year to maintain qualified status.

34. PROPOSED CARDIAC REHAB RULES INTENSIVE CARDIAC REHABILITATION
ICR Program Criteria (cont.)
Must demonstrate statistically significant reduction (pre vs. post) in at least 5 of the following:
LDLs
Trigs
BMI
Systolic BP
Diastolic BP
Need for cholesterol, BP, and DM meds

35. PROPOSED CARDIAC REHAB RULES INTENSIVE CARDIAC REHABILITATION
ICR Program Criteria (cont.)
Must submit specific outcomes assessment information for all patients who initiated and completed the full ICR program during the initial year-long CMS designation
Must submit average beginning and ending levels of at least 5 of those measures for the program as a whole
CMS will determine whether program continues to meet payment standards
Further details about the designation process will be published with final regulation.

36. PROPOSED CARDIAC REHAB RULES INTENSIVE CARDIAC REHABILITATION
ICR Program Criteria (cont.)
Program Delivery
Patients receive 72 one-hour sessions within 18 weeks
Up to 6 sessions per day
Patient must exercise aerobically every day he/she receives rehab
Equivalent reimbursement per session to “general” CR

37. PROPOSED CARDIAC REHAB RULES
What about expanded CR coverage for heart failure diagnosis?
HF-ACTION trial: initial findings published fall, 2008
Await publication of secondary data analysis
spring 2009 through fall, 2009
Addition of diagnosis coverage is at HHS Secretary’s discretion

38. Today we will cover:
AACVPR recommendations made to CMS on proposed CR regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

39. AACVPR RECOMMENDATIONS TO CMS
Correct the flawed payment calculation software that determines payment for CR so that accurate payment data can begin to be collected in 2010
Support CMS proposed Medical Director qualifications:
Training and proficiency in CV disease management and exercise training of heart patients
This is in agreement with AACVPR Position Statement on Medical Direction for CR Progrmas

40. AACVPR RECOMMENDATIONS TO CMS
CR staff qualifications should follow AACVPR Core Competencies regardless of specific academic discipline or legal credentials=multi-disciplinary service
CR programs should have the flexibility to deliver services based on individual patient need
No minimum on sessions/wk
36 week window should be allowed for maximum of 36 sessions

41. Today we will cover: Proposed Medicare regulations for PR
AACVPR recommendations made to CMS on proposed regulations
AACVPR recent and future actions regarding proposed CR rule changes
Recommended next steps for your program

42. PROPOSED PULMONARY REHAB RULES PAYMENT
Current billing codes
Three G Codes (G0237, 0238, 0239) for education and exercise (PT/OT codes )
CPT codes for inhalation therapy, 6MWT, nebulizer instruction
PFT codes
Current payment amounts
$18/15 minute increments for G Codes
6MWT=$ 55.00, etc.; billable as separate services
$70/four “G Code services” in a day

43. PROPOSED PULMONARY REHAB RULES PAYMENT
New G code replaces G
Code bundled, precluding billing for services (6MWT), (MDI, IPPB,neb), (vibration)
New payment rate=$ hour limit /day

44. PROPOSED PULMONARY REHAB RULES PAYMENT
This would be a 78% payment reduction
Where did CMS go wrong?
Program costs miscalculated
Staffing assumptions not valid
Standard of care=up to 72 hours
LVRS mandates hours in 2-hr sessions
Assumed MD work comparable to CR CPT 93797

45. PROPOSED PULMONARY REHAB RULES DIAGNOSES
Will cover only:
Moderate COPD (GOLD classification II)
Severe COPD (GOLD classification III)
Any other conditions will be considered through NCD process with evidence that supports significantly improved outcomes

46. PROPOSED PULMONARY REHAB RULES DIAGNOSES
This eliminates 2/3rds of currently covered patients in PR under local Medicare policies.
Where did CMS go wrong?
Misread the GOLD Guidelines
Should include very severe COPD classification
Didn’t look at numerous local Medicare policies that include non-COPD dx

47. PROPOSED PULMONARY REHAB RULES REQUIRED COMPONENTS
Physician
Physician-prescribed exercise
Individualized Treatment Plan (ITP)
Outcomes Assessment
Psychosocial Assessment
Education and training

48. PROPOSED PULMONARY REHAB RULES PHYSICIAN REQUIREMENTS
Program must have a Medical Director
Substantial involvement in monitoring and direction of individuals’ progress
Physician qualifications
Doctor of medicine or osteopathy
Must have training and proficiency in:
Chronic respiratory disease management
Exercise training of chronic respiratory disease patients

49. PROPOSED PULMONARY REHAB RULES PHYSICIAN REQUIREMENTS
A physician must be immediately available and accessible for medical consultation and medical emergencies at all times when PR service is being provided=“Supervising Physician”
Daily Supervising MD does not have to be the Medical Director or the same physician every day
Physician-prescribed exercise
Physical activity, including aerobic exercise, prescribed and supervised by a physician that improves or maintains an individual’s pulmonary functional level

50. PROPOSED PULMONARY REHAB RULES INDIVIDUALIZED TREATMENT PLAN
ITP
Written treatment plan to describe pt’s dx, F.I.T.T., specific educational & training needs, goals set with patient
Medical Director must sign ITP prior to program entry, every 30 days, and at program completion
PR staff provides outcome and psychosocial assessments to Medical Director, but MD is responsible for reviewing, modifying, and signing plan

51. PROPOSED PULMONARY REHAB RULES INDIVIDUALIZED TREATMENT PLAN
Individualized plan should specify mix of services necessary for that individual patient
CMS expects at least one direct MD contact with individual in each 30-day period
This is NOT a requirement for CR programs
Even if referring MD develops and signs initial ITP, Medical Director must review and sign plan prior to initiation of PR

52. PROPOSED PULMONARY REHAB RULES OUTCOMES ASSESSMENT
A physician’s evaluation of the patient’s progress as it relates to his/her rehab
This term NOT used in CR rules
Includes:
Pre & post assessments, based on patient- centered outcomes, conducted by the physician
Objective clinical measures of exercise performance, dyspnea, & behavior

53. PROPOSED PULMONARY REHAB RULES OUTCOMES ASSESSMENT
Assessments are part of ITP (plan of care)
Considered part of PR program and may not be billed separately
Measures should include clinical measures such as:
6MWT
Exercise performance
Weight
QOL
Self-reported dyspnea
Behavioral measures

54. PROPOSED PULMONARY REHAB RULES PSYCHOSOCIAL ASSESSMENT
Written assessment and intervention plan by program staff
Part of 30-day review for ITP
All the usual:
Family & home situation (support group?)
Depression & anxiety (referral for tx?)
Smoking cessation
No changes to NCD for “Smoking & tobacco use cessation counseling”, i.e., separately billable service

55. PROPOSED PULMONARY REHAB RULES EDUCATION & TRAINING
Physician should evaluate and include only education & training that addresses particular needs of patient
Primary objective is understanding and self- management of chronic respiratory disease
All the usual educational components of PR

56. PROPOSED PULMONARY REHAB RULES EDUCATION & TRAINING
CMS examples
Respiratory techniques for physical energy conservation, work simplification and relaxation techniques
Skills training and education that encourage behavioral changes by the patient which lead to improved health and long term adherence
Brief smoking cessation
Proper use of medications, nutrition counseling

57. PROPOSED PULMONARY REHAB RULES PROGRAM DELIVERY
Max sessions=36
Limit 1 session (hour) per day
Patient must have some aerobic exercise each day he/she attends rehab
Suggested minimum 2x/wk for combination of endurance and strength tx
“Patients should generally receive 2-3 sessions per week which are a minimum of 60 minutes each.”
That means a 60-minute session-not 60 minutes of exercise

58. PROPOSED PULMONARY REHAB RULES PROGRAM DELIVERY
Settings: MD office or hospital outpatient
CORFs (Comprehensive Outpatient Rehabilitation Facility) will not be held to these rules because they have their own statutory language
“Respiratory therapy services performed in a CORF are part of a CORF and not part of a PR program.”

59. PROPOSED PULMONARY REHAB RULES
Four primary areas of concern:
Payment
Qualifying Diagnoses
Program Delivery Restrictions
Physician Supervision

60. Today we will cover:
AACVPR recommendations made to CMS on proposed PR regulations
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

61. PROPOSED PULMONARY REHAB RULES PAYMENT
AACVPR recommendations
Continue current G codes ( )
Continue use of component billing for related services (94620, 94664, 94667)
Permit MD to submit Evaluation and Management code (“E & M”) when medically necessary
Re-calculate staffing assumptions based on more accurate staffing mix (part of payment calculation)
Re-calculate equipment assumptions to be more inclusive of real costs

62. PROPOSED PULMONARY REHAB RULES DIAGNOSES
AACVPR recommendations
Appropriate diagnoses for PR based on evidence & current LCDs:
Very severe COPD (GOLD IV)
Cystic Fibrosis
Interstitial Lung Disease (ILD)
Restrictive Chest Wall Disease
Pulmonary Hypertension
Lung Ca
Neuromuscular Disease

63. PROPOSED PULMONARY REHAB RULES PROGRAM REQUIREMENTS
AACVPR Recommendations
Allow 72 hours maximum for PR program, based on current standard of care and science behind that standard
Allow and pay for 2-3 hours per day, the typical duration for PR paradigm

64. Today we will cover:
AACVPR recent and future actions regarding proposed rule changes
Recommended next steps for your program

65. AACVPR ACTIONS Pulmonary
Collaboration with ATS, ACCP, AARC, NAMDRC, ALA, NECA, NHOPA
Fly-in of leaders for three face-to-face meetings with CMS policy and payment staff between Oct, 2008 and present
Letter sent to Congressional staff alerting of implications of these rules in contrast to intent of Public Law
Written request to meet with Secretary or Deputy Secretary of HHS (Bill Core) asap
27 page document of comments to CMS (including 101 scientific references)

66. AACVPR ACTIONS Cardiac
Collaboration with ACC, AHA, AHospA, PCNA, CEPA on issues of concern
AACVPR recommendations submitted to CMS on proposed CR rules

67. AACVPR FUTURE ACTIONS
AACVPR Webinar November 10th (10 am PST) to present CMS 2010 final rules
AACVPR will develop ITP for its members that is a collaborative effort of:
Reimbursement Committee (Medicare compliant)
Outcomes Committee (which outcomes and which tools)
Program Certification and Re-certification Committees (will include future criteria)
Guidelines Committee (will include future program recommendations)

68. AACVPR FUTURE ACTIONS
Work with state affiliates for clinically- appropriate interpretation of CMS rules by local Medicare contractors
15 regional AACVPR MAC committees
This will happen through your AACVPR MAC Committee working collaboratively with your MAC for Jurisdiction 2 - “J-2”
Susan P (AACVPR Reim Comm), Aaron H, Angie G, Chris W

70. Today we will cover:
Recommended next steps for your program

71. NEXT STEPS Wait for final CMS regulations to be published in November.
Get ready to help with advocacy efforts if CMS doesn’t “do the right thing” for programs and patients, particularly for pulmonary rehab.
Stay informed through AACVPR, your local affiliate, and your MAC Committee.
Check out the “What’s New” section of AACVPR web site.

72. NEXT STEPS Prepare for implementation of new rules on 1- 1-2010.
Seek answers to your questions first from your MAC committee.
Share what you know with your billing department, compliance department, and administration.
YOU are the expert on CR/PR services!