Cardiac Rehabilitation Programs

12-23-09

Proposed Decision Memo for Cardiac Rehabilitation Programs (CAG-000089R2)

The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) is in support of the CMS proposal to withdraw section 20.10 from the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03).

Public Law 110-275, Section 144 (a) provides coverage of cardiac rehabilitation under Medicare part B, effective January 1, 2010. The specific requirements in this statute render the current NCD obsolete. Removal of 20.10 is appropriate with the publication of section 410.49: Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage in the Public Health Code of Federal Regulations (42 C.F.R.).

Respectfully submitted,AACVPR

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Letter to CMS re: Direct Supervision for Cardiac Rehab

On Nov 25, 2009, CMS issued a Proposed Coverage Decision Memorandum for Cardiac Rehabilitation Programs (CAG-00089R2), in which CMS proposed repealing Section 20.10 of the Medicare National Coverage Determination Manual (CMS Pub. 100-03) ("NCD Manual") effective January 1, 2010 in order to ensure consistency between the statute and new regulations governing these services that also become effective January 1, 2010. We urge CMS not to repeal Section 20.10 of the NCD Manual but to instead revise this Section to exercise CMS'' authority to specify that Cardiac Rehabilitation services may be provided in Critical Access Hospitals ("CAHs"). In addition, we urge CMS to further specify that CAHs may provide such services with direct supervision by appropriate mid-level providers, as is allowed for CAH inpatient and outpatient services under the CAH conditions of participation and coverage rules.

Importantly, it is not clear under Section 144(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Public Law 110-275) ("MIPPA") whether CAHs are an appropriate setting for the provision of Cardiac Rehabilitation services. Instead, this section states that Cardiac Rehabilitation programs can be delivered: "(i) in a physician''s office; (ii) in a hospital on an outpatient basis; or (iii) in other settings determined appropriate by the Secretary." As defined in Section 1861(e) of the Social Security Act ("SSA"), the term "hospital" does not include a CAH unless the context otherwise so requires. There is no other indication in Section 144(a) of MIPPA whether Cardiac Rehabilitation services can be provided in a CAH. We therefore urge CMS not to repeal Section 20.10 of the NCD Manual, but instead to specify in this Section that CAHs are an appropriate setting for these services.

We also urge CMS to clarify in Section 20.10 of the NCD Manual that Cardiac Rehabilitation programs in CAHs need not be under the direct supervision of a physician. As specified in Section 1820(c)(2)(B)(iv) of the SSA and the implementing regulations at 42 C.F.R. § 485.631, CAHs are not required to have physicians on-site at the CAH, even when providing inpatient services to CAH patients. As such, physician assistants, nurse practitioners or certified nurse specialists should be allowed to provide direct supervision of Cardiac Rehabilitation services in the CAH setting subject to the general oversight of the physician. We note that Cardiac Rehabilitation patients residing in CAH service areas that experience or develop emergent symptoms would go to the CAH Emergency Room where they could be appropriately treated by a mid-level provider staffing the Emergency Room. Thus, allowing these mid-level providers also to directly supervise Cardiac Rehabilitation services would provide the same level and standard of care that the patient would otherwise receive from the CAH under other circumstances.

Requiring physician supervision of Cardiac Rehabilitation services in CAHs is inconsistent with Section 1820 of the SSA and its implementing regulations and would place undue burdens (both operationally and financially) on CAHs to arrange for physician presence and supervision when it is not otherwise required for any other service in the CAH. This may force many CAHs to cease providing Cardiac Rehabilitation services, which will impact the availability of these services in rural areas, forcing Medicare beneficiaries to either go without these services or to drive significant distances in order to obtain these services elsewhere.

We note that Mr. Marc Hartstein of CMS, in a recent email to the American Hospital Association, confirmed that diagnostic services provided in CAHs are not subject to the physician supervision standards otherwise required for diagnostic services provided in hospitals paid under the Outpatient Prospective Payment System. We believe a similar exception should apply to Cardiac Rehabilitation services provided in CAH facilities.

We stress that CAHs serve a vital role in our rural communities by providing care to elderly patients in need of medical and other health services, including Cardiac Rehabilitation services. We urge CMS to revise Section 20.10 of the NCD Manual as specified above to ensure that CAHs are able to continue providing these much needed services to the elderly patients in our communities.

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Letter to CMS re: Direct Supervision for Cardiac Rehab

On Nov 25, 2009, CMS issued a Proposed Coverage Decision Memorandum for Cardiac Rehabilitation Programs (CAG-00089R2), in which CMS proposed repealing Section 20.10 of the Medicare National Coverage Determination Manual (CMS Pub. 100-03) ("NCD Manual") effective January 1, 2010 in order to ensure consistency between the statute and new regulations governing these services that also become effective January 1, 2010. We urge CMS not to repeal Section 20.10 of the NCD Manual but to instead revise this Section to exercise CMS'' authority to specify that Cardiac Rehabilitation services may be provided in Critical Access Hospitals ("CAHs"). In addition, we urge CMS to further specify that CAHs may provide such services with direct supervision by appropriate mid-level providers, as is allowed for CAH inpatient and outpatient services under the CAH conditions of participation and coverage rules.

Importantly, it is not clear under Section 144(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Public Law 110-275) ("MIPPA") whether CAHs are an appropriate setting for the provision of Cardiac Rehabilitation services. Instead, this section states that Cardiac Rehabilitation programs can be delivered: "(i) in a physician''s office; (ii) in a hospital on an outpatient basis; or (iii) in other settings determined appropriate by the Secretary." As defined in Section 1861(e) of the Social Security Act ("SSA"), the term "hospital" does not include a CAH unless the context otherwise so requires. There is no other indication in Section 144(a) of MIPPA whether Cardiac Rehabilitation services can be provided in a CAH. We therefore urge CMS not to repeal Section 20.10 of the NCD Manual, but instead to specify in this Section that CAHs are an appropriate setting for these services.

We also urge CMS to clarify in Section 20.10 of the NCD Manual that Cardiac Rehabilitation programs in CAHs need not be under the direct supervision of a physician. As specified in Section 1820(c)(2)(B)(iv) of the SSA and the implementing regulations at 42 C.F.R. § 485.631, CAHs are not required to have physicians on-site at the CAH, even when providing inpatient services to CAH patients. As such, physician assistants, nurse practitioners or certified nurse specialists should be allowed to provide direct supervision of Cardiac Rehabilitation services in the CAH setting subject to the general oversight of the physician. We note that Cardiac Rehabilitation patients residing in CAH service areas that experience or develop emergent symptoms would go to the CAH Emergency Room where they could be appropriately treated by a mid-level provider staffing the Emergency Room. Thus, allowing these mid-level providers also to directly supervise Cardiac Rehabilitation services would provide the same level and standard of care that the patient would otherwise receive from the CAH under other circumstances.

Requiring physician supervision of Cardiac Rehabilitation services in CAHs is inconsistent with Section 1820 of the SSA and its implementing regulations and would place undue burdens (both operationally and financially) on CAHs to arrange for physician presence and supervision when it is not otherwise required for any other service in the CAH. This may force many CAHs to cease providing Cardiac Rehabilitation services, which will impact the availability of these services in rural areas, forcing Medicare beneficiaries to either go without these services or to drive significant distances in order to obtain these services elsewhere.

We note that Mr. Marc Hartstein of CMS, in a recent email to the American Hospital Association, confirmed that diagnostic services provided in CAHs are not subject to the physician supervision standards otherwise required for diagnostic services provided in hospitals paid under the Outpatient Prospective Payment System. We believe a similar exception should apply to Cardiac Rehabilitation services provided in CAH facilities.

We stress that CAHs serve a vital role in our rural communities by providing care to elderly patients in need of medical and other health services, including Cardiac Rehabilitation services. We urge CMS to revise Section 20.10 of the NCD Manual as specified above to ensure that CAHs are able to continue providing these much needed services to the elderly patients in our communities.

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December 14, 2009

Louis B. Jacques, MD
Director
Coverage and Analysis Group
Center for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed NCD on cardiac rehabilitation programs (CAG-00089R2)

Dear Dr. Jacques:

The American College of Cardiology (ACC) is pleased to submit comments on the proposed national coverage determination on Medicare’s coverage of cardiac rehabilitation. The ACC is a professional medical society and teaching institution made up of 37,000 cardiovascular professionals from around the world – including 90 percent of practicing cardiologists in the United States and a growing number of registered nurses, clinical nurse specialists, nurse practitioners, physician assistants and clinical pharmacists. We appreciate the opportunity to provide input on this important issue.

The ACC is supportive of Medicare coverage for services designed to stabilize, slow or even reverse the progression of cardiovascular disease, thereby reducing the risk of heart disease, another cardiac event or death. Because of this, the College supports coverage for cardiac rehabilitation programs.

The Centers for Medicare & Medicaid Services (CMS) has proposed eliminating the National Coverage Determination (NCD) for cardiac rehabilitation. The Medicare Improvements for Patients and Providers Act of 2007 (MIPPA) requires CMS to cover cardiac rehabilitation programs. CMS issued the relevant regulations as part of the 2010 Medicare physician fee schedule, thus making the NCD redundant. Because regulations are given more legal weight than an NCD, CMS has decided to rescind the NCD.

It is the ACC’s understanding that the rescission of the NCD has no practical effect on the coverage of cardiac rehabilitation programs. The new regulations essentially codify the information contained within the NCD. The ACC agrees with CMS’ concerns that confusion might ensue if two documents purported to be the authority on Medicare coverage for cardiac rehabilitation programs. Additionally, it is the ACC’s understanding that CMS intends to ensure that errors do not ensue from attempting to maintain two sets of authority with respect to cardiac rehabilitation.

Given these understandings, the ACC supports the proposed rescission of the NCD on Medicare coverage for cardiac rehabilitation programs. We look forward to working with CMS on future coverage issues. Please direct any questions or concerns to Lisa P. Goldstein at (202) 375-6527 or lgoldstein@acc.org.

Sincerely,

CC: Jack Lewin, MD – CEO, ACC

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I feel that it should be up to my Doctor to decide if I need cardiac rehab and for what time period. My feelings are that Medicare should pay for this because it really helps patients, mentally and physically. After any type of heart problem, patients feel vunerable and afraid. Rehab helps with the guidance (mental as well as physical, how the patient is reacting to medication and give guidance as to what the can and cannot do, self assurance etc. etc. Financially with all areas of life costing more money most people that are retired and living only on Social Security (because their savings in the stock market are gone), cannot afford to pay for these services.

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