MEDICARE POLICY FOR CARDIAC AND PULMONARY REHABILITATION- WHAT’S AHEAD Karen Lui, RN, MS, FAACVPR GRQ Consulting, LLC karen@GRQConsulting.com 770-531-9298 OSCVPR October 23, 2009

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

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

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 93798 and 93797

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 10-1-2013 (currently used in Europe)

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

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

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

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

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

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

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 8-31-09 Final regulations will be published November, 2009 with effective date 1-1- 2010.

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…”

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. 413.65

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

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

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.”

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”.

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.

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

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

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…”

AACVPR RECOMMENDATIONS TO CMS Physician Supervision 2. Allow CR/PR to use NPPs as other hospital outpatient services will be allowed as of 1-1- 2010 This does not replace the need for a physician to be immediately available.

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

PROPOSED CARDIAC REHAB RULES WHAT’S THE SAME? Same diagnoses qualify patient for early outpatient CR Comparable reimbursement amounts 2010 = $ 38.40 (co-pay=$13.86) Reimbursement rate varies regionally Physician supervision “immediately available”

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

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

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

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)

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

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)

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

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.

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

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.

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

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

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

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

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

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

PROPOSED PULMONARY REHAB RULES PAYMENT Current billing codes Three G Codes (G0237, 0238, 0239) for education and exercise (PT/OT codes 97001- 97004) 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

PROPOSED PULMONARY REHAB RULES PAYMENT New G code replaces G0237-39 Code bundled, precluding billing for services 94620 (6MWT), 94664 (MDI, IPPB,neb), 94667 (vibration) New payment rate=$ 15/hour@one hour limit /day

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 44-66 hours in 2-hr sessions Assumed MD work comparable to CR CPT 93797

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

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

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

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

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

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

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

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

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

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 210.4 for “Smoking & tobacco use cessation counseling”, i.e., separately billable service

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

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

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

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.”

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

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

PROPOSED PULMONARY REHAB RULES PAYMENT AACVPR recommendations Continue current G codes (0237-39) 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

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

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

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

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 110-275 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)

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

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)

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

Today we will cover: Recommended next steps for your program

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.

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!