Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma

June 5, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo for Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma (CAG-00181R3)

Dear Dr. Jacques:

The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to comment on the Center for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma (CAG-00181R3) (the "Proposed Decision"). As the leading trade association representing medical imaging and radiotherapy technology manufacturers, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA supports the recent proposed decision and looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, related image acquisitions, diagnostic ultrasound, and nuclear medical imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI). Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures. In addition, medical imaging equipment often is used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions. MITA's members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

In the Proposed Decision, CMS announces that it will remove "the current absolute restriction" on coverage of FDG PET scans for beneficiaries with solid tumors. Under the current policy, Medicare covers "only one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary's treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor."

CMS concludes that this absolute restriction "is not supported by the available evidence and therefore proposes to amend 220.6.17 of the National Coverage Determinations Manual" to make the following changes:

1. The NCD will be changed to remove the current absolute restriction of coverage to "only one" FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above;
2. CMS will continue to nationally cover one FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy as described above; and
3. Local Medicare administrative contractors will have discretion to cover (or not cover) within their jurisdictions any additional FDG PET scan for the therapeutic purposes related to the initial treatment strategy as described above.

CMS concludes that the usefulness of any additional FDG PET scan for initial treatment planning for a particular beneficiary might be affected by "the beneficiary's specific medical problem, the availability of results of other diagnostic tests and the expertise of the interpreting physician." CMS also concludes that local administrative contractors, who may more readily obtain better case-specific information on the needs of the beneficiary, can make better individual determinations about any additional FDG PET scan for initial treatment planning within their jurisdictions.

MITA is pleased that CMS proposes to expand access to FDG PET by giving local contractors discretion to cover additional scans for individual beneficiaries. We believe that each Medicare beneficiary should receive the imaging services determined by his or her physician to be best suited for the beneficiary's unique clinical circumstances, and we hope that Medicare's contractors will use their discretion to support these clinical decisions.

The Proposed Decision also states that CMS does not believe that a national coverage determination (NCD) is the most appropriate way to address coverage for any additional FDG PET scans for the therapeutic purposes related to the initial treatment strategy at this time. We agree that the Proposed Decision is supported by the available clinical evidence, and MITA would be pleased to work with CMS on gathering relevant clinical data should the agency determine that an NCD would be appropriate in the future.

We appreciate this opportunity to submit these comments and applaud CMS for this Proposed Decision to expand Medicare beneficiaries' access to clinically effective care. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.

Respectfully submitted,

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June 4, 2010

Louis B Jacques, MD,
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid
7500 Security Blvd, Mail Stop C1-09-06
Baltimore, MD 21244

Re: Public Comment on (CAG 00181R-3) (Proposed Decision Memorandum for Positron Emission Tomography (PET) for Initial Treatment Strategy in Solid Tumors and Myeloma)

Dear Director Jacques:

GE Healthcare (GEHC) appreciates this opportunity to comment on the Proposed Decision Memorandum CAG-00181R3, of the Centers for Medicare& Medicaid Services’ (CMS), to eliminate the current absolute limit of permitting only one FDG-PET scan related to the initial treatment strategy for cancer patients based on existing published clinical evidence along with current medical practice.

GEHC, a $17 billion unit of General Electric Company with headquarters in the United Kingdom, has expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceuticals manufacturing technologies. GEHC’s broad range of products and services enables healthcare providers to offer patients’ earlier and better diagnosis and treatment of cancer, heart disease, neurological diseases, and other conditions to improve the quality and length of life. Worldwide, GEHC employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GEHC fully supports the collaborative response submitted jointly by the Academy of Molecular Imaging (AMI), the American College of Radiology (ACR), the American Society for Therapeutic Radiology and Oncology (ASTRO),) the American College of Nuclear Medicine, and the Society of Nuclear Medicine (SNM). Collectively, clinicians, academicians, researchers and nuclear medicine providers coordinated their feedback and we would like to acknowledge their efforts to unify responses from the various stakeholders for optimal oncology patient care.

CMS’ decision to amend the current PET coverage policy for initial treatment planning is applauded by GEHC. We would, however ask that CMS encourage local contractors to develop policies that support the intent of this proposed decision memorandum to ensure that beneficiaries with cancer will indeed be able to obtain additional PET scans for radiation treatment planning when clinically appropriate.

We appreciate the opportunity to comment on this proposed decision memorandum, and look forward to providing CMS with any additional information that would be of value in this regard.

Sincerely,

Hugh Zettel
GE Healthcare, Strategic Reimbursement Executive

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June 2, 2010

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244

Re: Public Comment on CAG-00181R3 (Proposed Decision Memorandum for Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma)

Dear Director Jacques:

The Society of Nuclear Medicine (SNM) submits this comment in support of the Proposed Decision Memorandum of the Centers for Medicare & Medicaid Services (CMS) in regard to CAG-00181R3, and as a supplement to the joint comment submitted in support of the Proposed Decision Memorandum by AMI, ACNM, ACR, ASTRO, and SNM on May 28, 2010. As articulated in the joint comment letter, SNM believes that CMS has proposed a flexible approach to the use of FDG-PET scans for initial treatment strategy, which reflects both the existing clinical literature and medically appropriate clinical practice.

SNM writes separately here to highlight the practical importance of ensuring that local contractors receive clear written direction from CMS regarding implementation of this policy, in the event that the Proposed Decision Memorandum is finalized. We believe that such clear direction will help to minimize the local-level confusion we have observed on similar previous occasions, where ambiguity in CMS direction regarding the exercise of local contractor discretion has unnecessarily complicated efforts to ensure consistent policy implementation.

SNM is an international scientific and professional organization founded in 1954 to promote the science, technology and practical application of nuclear medicine. Its 16,000 members are physicians, technologists and scientists specializing in the research and practice of nuclear medicine. In addition to publishing journals, newsletters and books, the Society also sponsors international meetings and workshops designed to increase the competencies of nuclear medicine practitioners and to promote new advances in the science of nuclear medicine.

Should CMS decide to finalize the proposal, we respectfully request that CMS provide clear written directions to the local contractors regarding this change in policy. We request that statements in contractor transmittals specify that the prior one-time limit for use of FDG-PET for initial treatment strategies is now being released to local contractor discretion for all such scans beyond the first scan, which remains nationally covered. We also request that CMS require the contractors to communicate the national policy change, and to explain how this change will be implemented on the local level. We believe that published local policies or local educational news items—whichever the local contractor prefers — are the most effective methods for doing so, but we are open to other written options.

We make this request because we are deeply concerned that the ambiguity of some past CMS instructions has led to confusion among local Medicare contractors, resulting in widely differing interpretations of transmittals. For example, SNM members continue to report problems with a number of local Medicare contractors who believe that they can no longer pay for FDG-PET scans for indications where medical necessity is not supported by a cancer diagnosis (ICD-9 code). This misunderstanding appears to be a direct result of varying interpretations of Transmittal 1833 (October 16, 2009) Change Request 6632. This Transmittal was rescinded several times, and even six months later we continue to be told by Medicare contractors that the Transmittal did not authorize them to pay for any diagnosis codes other than those for malignant neoplasms. This is despite the fact that the admittedly uncommon use of FDG-PET for cancer diagnosis is now covered as an element of Initial Treatment Strategy evaluation for essentially all cancers (except cervical cancer). Claims for FDG-PET studies performed for cancer diagnosis cannot be submitted with a cancer ICD-9 code, precisely because a cancer diagnosis has not yet been established. Additionally, FDG-PET is covered (either outright or under coverage with evidence development) for suspected recurrence of a previously treated cancer as an element of Subsequent Treatment Strategy evaluation; in such situations, prevailing coding rules often require use of a V10.xx ICD-9 code, rather than a cancer ICD-9 code. Nevertheless, many contractors erroneously believe they cannot pay for clams submitted with such a code.

This ongoing issue is particularly problematic for the patients with Solitary Pulmonary Nodules (SPN), where the typical diagnosis code would be 518.89 or 793.1. Providers in states such as Florida continue to receive denials even after medical review of the claims coded with 518.89 or 793.1. Additionally, the Medicare Florida contractor not only continues to decline to publish a list of acceptable ICD-9 codes by CPT code, but also fails to provide any educational news publications regarding how providers should report SPN cases. Of most serious concern is a recent communication with this contractor on this issue, in which the contractor cites CMS Transmittal CR 6861 and concludes that “currently, however, we are bound by the language in the CRs and both of them say that a cancer diagnosis must be included on the claim.” While SNM has attempted to provide accurate guidance to its members with regard to SPN coding (see Appendix A), the ambiguity of the transmittal—and the resulting inconsistency with which the policy is being implemented at the local level—makes doing so exceptionally and unnecessarily difficult.

We respect and encourage the principle of local discretion for Medicare contractors, as we believe this is an important aspect of the Medicare coverage process. However, we strongly urge CMS both to correct past ambiguous communications in future transmittals, and to ensure that future communications concerning NCD policies pertaining to contractor discretion—including CAG-00181R3, if finalized—correctly and clearly relay to local contractors both the parameters of such discretion and the information required to ensure that such discretion is exercised consistently nationwide. Our goal, as surely is yours, is smooth implementation of finalized national Medicare coverage policies without incident, and without patients being inappropriately denied access to covered, medically necessary services. Thank you for your attention to our comments and concerns. Please contact Denise Merlino, SNM coding staff at dmerlino@snm.org or phone 978-283-0940 if SNM can provide CMS with any additional information that you may find valuable as CMS finalizes its decision in this matter.

Sincerely,
Gary L. Dillehay, MD, FACR, FACNM
Chair, SNM Coding & Reimbursement Committee

APPENDIX A

SNM Coding Corner

http://interactive.snm.org/index.cfm?PageID=8734

SPN and MPN PET Medicare Coverage

Created: June 22, 2009
Revised: January 25, 2010

Question

We are confused about the Medicare PET coverage for lung masses, solitary pulmonary nodules and multiple pulmonary nodules. Can you please clarify? In the past we were billing with diagnosis codes 518.89 or 793.1 prior to biopsy when a biopsy was not available or medically feasible. Can you tell us which ICD 9 indications the Medicare contractors will accept as payable?

Answer

Deciding whether or not to do a PET scan and whether or not it is covered requires medical judgment, as well as compliance judgment. Where PET fits into the continuum in the evaluation of patients with lung nodules depends on many factors including the full clinical history, risk factors for lung cancer, history of prior cancers, the CT appearance of nodule(s), etc. Thus, the answer rests on the specific clinical question being posed by the referring MD. Moreover, the question should be well thought out before ordering an expensive diagnostic test.

To address the questions, we will give a few examples, but these are by no means all of the possibilities. Each of these examples are included under the current Medicare coverage for "initial treatment strategy".

As a general rule, it is usually preferable to get a tissue diagnosis before launching a complex imaging evaluation of a suspected cancer anywhere in the body. This is not always possible, however, and not always the best first step.

In the case of a single nodule or mass thought highly likely to be a primary lung cancer, PET is often ordered before biopsy, less as a test to diagnose cancer, but rather to stage the cancer. If PET demonstrates other lesions (e.g., supraclavicular or mediastinal nodes), it may be far easier to biopsy these than the index lesion in the lung.

In the case of an indeterminate solitary pulmonary nodule, PET is done for "diagnosis" (to determine whether the lesion is more likely benign or malignant). If PET is negative, the patient typically does not undergo biopsy. In other words, PET helps in this situation to avoid an invasive diagnostic procedure. The situation is similar with an indeterminate biopsy; if PET is negative; the patient is typically followed and avoids an even more invasive diagnostic procedure (resection by VATS or thoracotomy).

The situation with multiple pulmonary nodules also involves several scenarios.

If one or more of the nodules appear spiculated and the patient is a smoker, such that multifocal adenocarcinoma of the lung is the most likely diagnosis, we would view this as an instance of "Lung Cancer: Diagnosis", which is definitely a Medicare-covered indication. Depending on which ICD-9 codes your carrier accepts for a case like this as indicating medical necessity, you may need to be prepared to appeal for payment. Thus, extra care in documentation of medical necessity in the PET report is advised.

If the multiple nodules appear round and smooth and there is significant clinical concern for metastatic disease to the lungs from an unknown primary tumor, PET previously would have had to be performed under NOPR as "Diagnosis: Unknown Primary". This is now a Medicare-covered indication. The same proviso as above regarding ICD-9 codes to document medical necessity applies. We repeat, extra care to document medical necessity in the PET report is advised.

If the patient has a previously treated cancer and now has new pulmonary nodules, PET may be appropriate to evaluate for suspected recurrence of that cancer. This "subsequent treatment strategy" use of PET may be covered or may have to be done under NOPR depending on the type of cancer for which the patient was previously treated.Each Medicare Administrative Contractor (MAC) develops its own list of covered ICD-9 codes based on the current National Coverage Determination (NCD) for PET. Most Medicare contractors have developed these lists of ICD-9 codes and frequency limits to support medical necessity based on their interpretation of the current NCD. There is considerable, continuing dialog between providers, medical specialties and contractors regarding some LCDs in which the diagnosis codes 518.89 or 793 were not included as covered ICD 9 codes. The SNM does not believe that absence of these codes is a guaranteed final decision of denial by the local Medicare Administrative Contractor. We believe that providers should continue to code appropriately following ICD 9 coding guidelines and if you are in one of those States that have omitted these ICD 9 codes you should expect an initial denial of the claim. The provider should be prepared to submit an appeal to the Medicare contractor with appropriate supporting documentation. As with any denial, providers may always appeal initial MAC decisions. Should the appeal be denied and you continue to believe it was denied without merit you should ask for a review of the claim and the situation with the MAC Medical Director.

Please visit here to see the final CMS PET NCD.

Disclaimer
The opinions referenced are those of the members of the SNM Coding and Reimbursement Committee and their consultants based on their coding experience. They are based on the commonly used codes in Nuclear Medicine, which are not all inclusive. Always check with your local insurance carriers as policies vary by region. The final decision for the coding of a procedure must be made by the physician considering regulations of insurance carriers and any local, state or federal laws that apply to the physicians practice. The SNM and its representatives disclaim any liability arising from the use of these opinions.

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We are writing in support of the Proposed Decision Memorandum of the Centers for Medicare & Medicaid Services (CMS) in regard to CAG-00181R3, which would amend the current absolute limit of permitting only one FDG-PET scan related to the initial treatment strategy for cancer patients, regardless of the clinical circumstances of their disease management and treatment planning. CMS has proposed a prudent and flexible approach that we believe reflects both the existing clinical literature and medically appropriate clinical practice.

This letter is submitted jointly on behalf of the Academy of Molecular Imaging (AMI), the American College of Nuclear Medicine (ACNM), the American College of Radiology (ACR), the American Society for Radiation Oncology (ASTRO), and the Society of Nuclear Medicine (SNM). Our groups collectively encompass clinicians, academicians, researchers and nuclear medicine providers who utilize molecular imaging technologies, including integrated positron emission tomography/computed tomography (PET/CT). Our five associations represent tens of thousands of physicians, providers, and patients with regard to this technology, and have worked closely with CMS over the past several years to provide clinically appropriate use of PET/CT through the development of the National Oncologic PET Registry (NOPR).

We agree with the conclusion of CMS in the Proposed Decision Memorandum that “the current absolute restriction is not supported by the available evidence,” which reflects the position the joint societies articulated in detail in both our October 14, 2009 reconsideration request and December 9, 2009 public comment. In particular, we applaud the carefully crafted framework proposed in the Proposed Decision Memorandum, under which CMS would *continue* to nationally cover one FDG-PET scan for purposes related to initial treatment strategy, while allowing local Medicare Administrative Contractors the discretion to cover *additional* FDG-PET scans for initial treatment strategy purposes. We believe that this approach strikes an appropriate and reasoned balance, removes an arbitrary limitation lacking in clinical support, and establishes appropriate safeguards to protect against inappropriate use of diagnostic imaging.

The need for an initial treatment strategy FDG-PET study will not be common. When the need does occur, we estimate that the majority of additional FDG-PET scans will arise in the context of radiation therapy treatment planning (and the need for FDG-PET to be obtained in precisely the same position as planned radiation therapy), as was discussed in the draft policy analysis and our previous comment letters. The other clinical circumstances where a repeat initial treatment strategy FDG-PET study might be needed to obtain accurate staging information are expected to be much less common. These scenarios include a patient with an initially false-negative PET who is later documented to have cancer and a patient where initiation of treatment is delayed substantially, such that the original PET may no longer reflect the extent of the disease accurately.

The joint societies are prepared to pool their collective expertise to develop a model local coverage policy for additional scans to be used for radiation treatment planning, which could then be adopted by local Medicare Administrative Contractors. The joint societies have worked closely with local Medicare Administrative Contractors on numerous previous occasions to develop other model local coverage policies, and we would welcome the opportunity to do so again in the radiation therapy context. Working together, our societies are well-positioned to assist local contractors in identifying clinically relevant scenarios and associating them with appropriate CPT and ICD-9 code combinations.

More rarely, patients may require a second FDG-PET scan due to their particular or unusual clinical circumstances. Such requests can probably be adequately resolved on a case-by-case basis via the existing established procedures for medical necessity appeals. Finally, the joint societies will continue to provide education and training programs for local Medicare Administrative Contractors to ensure a seamless transition between the existing NCD and the proposed revised NCD.

In conclusion, we encourage CMS to adopt the Proposed Decision Memorandum and authorize NCD-based coverage for one scan for initial treatment strategy purposes, plus local coverage discretion for clinically necessary additional FDG-PET scans. We believe that adoption of the Proposed Decision Memorandum will help to harmonize the omnibus PET coverage policy with the existing clinical evidence on the value of certain “second initial treatment strategy evaluation” scans, and will provide the flexibility necessary to ensure that patients can continue to be treated in accordance with good clinical practice.

We look forward to working closely with CMS and the local Medicare Administrative Contractor Medical Directors to establish appropriate local policies for the coverage of additional FDG-PET scans in necessary circumstances. Please let us know if we can provide any additional information that CMS would find of use in finalizing its Proposed Decision Memorandum.

Sincerely,

/s/
Timothy J. McCarthy, PhD
President, AMI

/s/
Jay A. Harolds, MD, FACNP
President, ACNM

/s/
Harvey L. Neiman, MD, FACR
Executive Director, ACR

/s/
Laura I. Thevenot, CAE
Chief Executive Officer, ASTRO

/s/
Michael M. Graham, PhD, MD
President, SNM

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I agree with the decision to allow more than one PET/CT exam in the initial ant-tumor planning phase.

However, if the CMS is going to task the Local Medicare Contractor with determining if another exam is appropriate, than CMS should also provide a framework for this function. In most cases physicians need to diagnose and stage patients rapidly, so that therapy can be started quickly. If there is not a rapid system in place to evaluate these cases, patients who need these exams may go without them so that therapy can start in a timely fashion.

Without a clear timeline and framework for this process patients will not be able to wait for the paperwork to be reviewed by the local contractor. In some cases the doctor will be forced to proceed without the PET/CT data. So, I believe it is critical that CMS place CLEAR standards that govern this process.

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