LCD Reference Article Response To Comments Article

Response to Comments: Chemotherapy Drugs and their Adjuncts (L37205)

A55641

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Source Article ID
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Article ID
A55641
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Chemotherapy Drugs and their Adjuncts (L37205)
Article Type
Response to Comments
Original Effective Date
08/01/2017
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Article Text

 

This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Chemotherapy Drugs and their Adjuncts, (DL37205).  Thank you for the comments.

 

Response To Comments

Number Comment Response
1

Why was the new policy written with the current chemotherapy policy in place?

 

This LCD is being brought forward to assist providers in chemotherapy coverage and guidance. With the numerous new chemotherapy drugs coming to market and new diagnosis codes frequently being added for a drugs appropriate usage, this policy will assist the provider in real time coverage for specific ICD-10 codes as listed in NCCN as Category 1 or 2A.

2

WPS received numerous concerns regarding the verbiage of coverage indications listed in the draft.

 

Thank you for the comments, suggestions and how you would like the draft paragraphs to read. The intent was to allow appropriate off label coverage for chemotherapy drugs. 

Per this LCD, chemotherapy agents may be covered if reasonable and medical necessity is met and the drug is FDA approved and listed in the current NCCN with the specific ICD-10 diagnosis for the drug/agent. The drug/agent must be listed as Category 1 or 2A in the NCCN and must utilize the NCCN recommended use of (order or combination) when applicable to the agent.

 

3

Does this mean that off-label uses supported by NCCN or any of the other compendia listed would not be covered unless listed in Group 1?

The final LCD is revised without any Groups or drugs listed. The non-oncological uses are now listed in their own Article to avoid any confusion.

4

How will providers be able to submit information for new FDA approvals, ICD-10 CM code updates, NCCN 1 or 2A updates? Is the reconsideration process the same?

This LCD decreases the provider’s burden of reconsiderations to add a chemotherapy agent and/or ICD-10 CM diagnosis codes since the process will now depend on the drug being on the market with FDA approval and the ICD-10 diagnosis listed in NCCN as Category 1 or 2A.

The process of a reconsideration of any LCD remains the same. However, there are not ICD-10 CM diagnosis codes or drugs listed within this LCD so a reconsideration would need to be based on other items.

 

5

If category 2B drugs are no longer routinely covered, this will result in delays, poorer care, and ultimately increased morbidity and mortality in my patient population of melanoma and skin cancer patients. This field is moving extremely rapidly, and patients who previously had a limited hope for extended remissions now have the realistic prospect of prolonged (i.e. many years) remissions and perhaps cures. The NCCN guidelines, while useful, will always be somewhat out of date.  Patients can ill afford to wait for infrequent updates to guidelines. Please do not change the current CMS guidelines.

The prior WPS GHA Chemotherapy Drugs and their Adjuncts LCD did not routinely cover Category 2B drugs. Previous reconsiderations submission for the prior LCD were usually related to either NCCN 1 or 2A, or peer reviewed literature. 

The contractor will also consider individual cases with provided published peer reviewed literature if the claim denies and the provider feels the treatment is medically necessary.

To find information about how and where to submit a claims Reconsideration (Appeal), please refer to: https://www.wpsgha.com/wps/portal/mac/site/appeals/

6

Update the Proposed LCD to ensure that the policy complies with LCD development and Medicare coverage requirements and adequately provides for the most appropriate coverage of cancer treatment through recognizing the full complement of compendia, modify the proposed LCD to include language about peer-reviewed medical literature in alignment with the Medicare Benefit Policy Manual, provide transparency to the specific criteria for inclusion or exclusion on the drug coding information list, include all of the CMS recognized compendia, requests WPS to implement a transparent process inclusive of clear, evidence-based justifications of policy changes.

This LCD was written according to the benefits as described in the Medicare Manual, the National Coverage Determinations, and the Social Security Acts. 

WPS GHA adheres to the IOM 100-08 Medicare Program Integrity Manual Chapter 13-Local Coverage Determinations and in accordance with Section 1862(a)(1)(A) of the Social Security Act. Draft Policies are discussed at the Open meetings and the Contractor Advisory Committee (CAC) meetings in each jurisdiction to provide transparency and participation to all interested parties in the development of a LCD. The contractor considers all comments and revises the LCD as needed and will provide a minimum notice period for 45 days on the final LCD. The Summary of Evidence, Analysis of Evidence and Bibliography are included in the Policy. 

The LCD does not preclude the use of the other Medicare approved compendia. The drug must be used according to the indication and protocol listed in one of the Medicare approved compendia which are listed in the LCD. The compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium. A medically accepted use is identified by a compendium if the indication is a Category 1 or 2A in NCCN, or Class I, Class IIa or Class IIb in DrugDex; or is listed in Lexi-Drugs as “Use: Off-Label” and rated as “evidence level A” and the narrative text in AHFS-DI or Clinical Pharmacology is supportive. 

WPS GHA finds that NCCN is more commonly cited by oncology practitioners and providers who seek coverage for chemotherapy. With that in mind, off label uses of chemotherapy are covered, as noted in the Coverage Guidance section of the LCD. This is to assist the provider in real-time coverage that is in accordance with a compendium. If the drug is not listed in NCCN as Category 1 or 2A and the provider feels the treatment is medically necessary, but the claim denies, this contractor may consider this on an individual patient basis.

7

Comments were received requesting clarification for non-oncology applications of certain drugs or agents.

Medicare has defined benefits which WPS GHA adheres to. Please see A55639 Chemotherapy Agents for Non-Oncological Conditions which has been developed to address chemotherapy administration codes which apply to parenteral administration of anti-neoplastic agents provided for treatment of noncancer diagnoses.

 

8

The proposed LCD does not provide any evidentiary basis for its determinations, nor does it consider the body of evidence weighing against it. Without providing the public with the “strongest evidence available” regarding the determination, stakeholders cannot evaluate whether a proposed LCD is based on sound scientific evidence. Therefore, WPS should withdraw the proposed LCD. Because the proposed LCD is not compliant with the Medicare Statue and the Medicare Benefit Policy Manual, it would inappropriately create geographic access disparities for Medicare beneficiaries. Medicare beneficiaries in the J5 & J8 jurisdictions would be subject to a different set of restrictions than beneficiaries in other MAC jurisdictions where policies are compliant with the statue and manual.

The LCD was based on Medicare Regulations and the Benefit Policy Manual, and lists the evidentiary basis for its determinations. Local Coverage Determinations (LCDs) are local and therefore there may be variations between Medicare Administrator Contractors and their jurisdictions. WPS GHA believes the final LCD coverage will allow providers real time answers to on and off label chemotherapy coverage for their patients.

9

How were the edits or audits going to keep up and remain consistent with the NCCN database? How will the system identify the nonclassified chemotherapy medications? When will the NOC Article be published as referenced in the draft L37025?

Edits or audits may be on or off and are proprietary. High dollar claim review would still apply. Please refer to the associated A55639 for Chemotherapy Agents for Non-Oncologic Conditions and A55640 Not Otherwise Classified Chemotherapy Agents (NOC): both will become effective 09/16/2017 with the LCD L37205 Chemotherapy Drugs and their Adjuncts.

10

Regarding claim processes: how will a provider know that their claims will be processed in a timely fashion? Will it be processed as a clean claim? The LCD isn’t specific how we get our information into the system promptly so we can have a reasonable turnaround time.

This LCD addresses the coverage for chemotherapy agents based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition, medical necessity and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition. The LCD does not address the claims process.

Information about claim submission and denials, Electronic Data Interchange (EDI) modifiers, claim corrections and more is located on the WPS GHA website: https://www.wpsgha.com/wps/portal/mac/site/claims/home/home/

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Updated On Effective Dates Status
07/18/2017 08/01/2017 - N/A Currently in Effect You are here

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