Physicians & Other Qualified Healthcare Professionals Are Questioning Medicare Contractors’ Coverage of CTPs

Some wound care physicians and other qualified healthcare professionals (QHPs) are old enough to remember when only three or four cellular and/or tissue-based products (CTPs) for skin wounds were available. Still, many younger individuals are aware of the more than 70 CTPs on the market today. NOTE: Until recently, CTPs were inaccurately called “skin substitutes.” Not a week goes by that this author does not answer many questions from physicians and QHPs about CTP coverage. All questions pertain to Medicare coverage of these CTPs. Therefore, in this edition of Business Briefs we will share some of the coverage-related questions (as well as the answers) with our readers. 

BACKGROUND OF CTP COVERAGE 

To set the stage, let’s review the background of CTP Medicare coverage. When the first several CTPs received Healthcare Common Procedure Coding System (HCPCS) codes for the product and Current Procedural Terminology (CPT^®) codes for the application procedure, they still needed to achieve coverage from Medicare’s fiscal intermediaries (FIs) and carriers (nearly one for every state). At first, the FIs and carriers considered all CTPs “experimental and investigational.” Most FIs and carriers told wound care manufacturers and professionals they would consider covering the CTPs after randomized, controlled trials (RCTs) were conducted and their results were published. Once the manufacturers conducted RCTs and published the results, most FIs and carriers honored their word and began covering the products one by one. Shortly after the FIs and carriers began covering the CTPs, utilization rapidly escalated. Unfortunately, some wound care professionals used CTPs for diagnoses that were not listed on each product’s package insert/instructions for use. In addition, many wound care professionals’ documentation did not adequately justify the medical necessity for the procedure/product and did not fully describe the application procedures, the fixation of the product, and the dressing/offloading, etc. To make matters worse, many wound care professionals debrided the CTPs away the week after they were applied. Therefore, to control overutilization and appropriate use, the FIs and carriers began releasing Local Medical Review Policies (LMRPs) that identified the brand(s) of CTPs they would cover, how they would determine if the CTPs were medically necessary, the covered indications for use of each brand, the expected frequency of use, the number of covered applications, the HCPCS and CPT codes relevant for each brand, the required documentation, and the resources that were reviewed to determine the coverage. When new draft LMRPs were released or when coverage in existing LMRPs was changed, FIs and carriers conducted open LMRP meetings where physicians and QHPs, scientists, manufacturers, patients, and other interested stakeholders could educate the medical director(s) about the specific CTP brand, its clinical evidence, and actual clinical experiences. During these open comment periods, stakeholders could also submit written comments about the draft LMRP. After the comment periods closed, the medical director(s) reviewed all the information presented at the open LMRP meetings and all the written comments they received. They used that information to create the final LMRPs, released the final LMRPs with a 45-day notice, and implemented the LMRPs 45 days later. At one time or another, nearly every FI/carrier had an LMRP that pertained to CTPs. If a final LMRP contained language that the wound care stakeholders did not believe aligned with the most current published clinical evidence, the stakeholders could use the LMRP reconsideration process to present the new information to the FI and/or carrier medical director(s). If the medical director found the new evidence compelling, he/she revised the published LMRP. In fact, this is the process that was followed to gain coverage for the early CTPs. Today, FIs/carriers have been replaced by Medicare Administrative Contractors (MACs) that process both Medicare Part A and Part B claims in one of 10 jurisdictions throughout the country. See the Table on page 8 for a list of the eight MACs that currently process physicians’/QHPs’ claims and write medical policies that pertain to their jurisdiction. NOTE: Although the Centers for Medicare & Medicaid Services (CMS) created 10 jurisdictions, the Table only lists eight MACs because several MACs won the contract to manage more than one jurisdiction. The MAC medical policies are no longer known as LMRPs. Instead, they are known as local coverage determinations (LCDs). The process of releasing draft LCDs, open LCD meetings, open comment periods, and the LCD reconsideration process are still the same as the LMRP process. At one time or another, every MAC has had an LCD that pertains/pertained to CTPs.  

PHYSICIAN & QHP QUESTIONS ABOUT MEDICARE COVERAGE OF CTPs

Now let’s review the most common CTP coverage questions that physicians and other QHPs have asked: 

Q: How can I learn if the MAC that processes my claims will cover a particular brand of CTP for a particular diagnosis?

A: Physicians and QHPs should research the Medicare coverage database (visit www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx) to determine if their MAC has a published LCD pertaining to CTPs. If an LCD exists, they should download it, print it, and download and print any articles attached to the bottom of the LCD. Then, physicians and QHPs should carefully read the LCD and attached article, if one exists, to determine the standard wound care that must be tried before applying CTPs, the specific brand(s) of covered CTPs, the covered indications, the limitations to coverage, the appropriate codes, the utilization guidelines, the documentation guidelines, and the resources used to create the LCD. 

Q: My MAC recently released a draft LCD pertaining to CTPs that specifies guidelines that do not align with published clinical evidence about a certain CTP.  The draft states that comments may be submitted. Is it worth my effort to submit comments? Will the MAC medical director seriously consider comments, or is this just a formality?

A: The comment period is an important opportunity for all stakeholders (especially physicians and QHPs) to educate the MAC medical director(s) about published clinical evidence (that was not considered in the resources listed near the end of the draft LCD resources) and about real-life use of the CTPs. Interested stakeholders actually have two comment opportunities:

1. Submit written comments before the close of the comment period. This is an educational opportunity that physicians and QHPs should not miss. Thoughtfully present any agreement/disagreement with the draft LCD by attaching pertinent published evidence and relevant, compelling, real-life case studies, etc. Then, be sure to specifically tell the medical director which language/codes/resources, etc. are being recommended. Also, consider listing the draft LCD language that is incorrect and then list the recommended language based on the evidence supplied. Do not assume the medical director will interpret comments in the manner expected — tell them and show them!
2. Register, attend, and present at the open LCD meeting. This is an awesome opportunity to meet MAC medical director(s) and their medical policy staff. They usually share the LCD process, often share the background of the draft LCD, listen carefully to all presentations, and usually stay after the meeting ends to answer one-on-one questions for attendees. Physicians and QHPs should do their best to self-fund their participation in the open LCD meeting rather than accept funding from a manufacturer, even if the comments are about a particular brand of CTP. This prevents the appearance of manufacturers influencing important presentations. Physicians and QHPs should be happy to know that the medical directors are required to review and consider all oral presentations and all written comments after the comment period closes. The medical directors will use compelling evidence-based recommendations to refine draft LCDs. The highest priority is given to recommendations made by physicians and QHPs in their jurisdiction. Therefore, comments do matter! Do not miss any opportunity to educate medical director(s) at these meetings!

Q: Once a draft LCD comment period ends, when is the final LCD released?

A: The answer to this question always surprises physicians and QHPs. The MAC medical directors do not have any time requirements after a draft LCD comment period ends. In fact, the medical director may decide to drop the draft LCD. In that case, the physicians and QHPs won’t see a final LCD. However, if the medical director reviews and considers the comments and decides to proceed with a refined final LCD, the medical director must post the “future effective LCD” on the Medicare coverage database a minimum of 45 days before the LCD becomes active. That gives all physicians and QHPs time to educate themselves and their staffs about the new coverage guidelines. When the 45-day notice period is over, the “future effective LCD” becomes an “active LCD.”  

Q: If I believe the guidelines in an active LCD don’t align with current published medical evidence, as well as my actual clinical experience, is it possible to request a revision to the CTP LCD?

A: Yes, CMS requires MACs to have an LCD reconsideration process and to post directions on their websites. The reconsideration process request must be in writing and must identify the language that the requestor wants added to or deleted from the LCD. Requests should include a justification supported by new evidence, which may materially affect the LCD’s content or basis.  Within 30 days of the day the request is received, the MAC determines whether the request is valid or invalid and notifies the requestor of that determination. If the request is invalid, the MAC explains the reason(s) it was invalid. If the request is valid, within 90 days of the day the request is received, the MAC makes a reconsideration decision and notifies the requestor of the decision and the rationale for the decision. Decision options include:

• no revision,
• revision to a less restrictive policy,
• considering revision to a more restrictive LCD, and
• retiring the LCD.

If the decision is to revise to a less restrictive LCD, the revised LCD is published on the Medicare coverage database. The effective date is specified in the revised LCD. If the decision is to consider revision to a more restrictive LCD, the MAC subjects the proposed revision to the formal LCD development process, including a formal advice-and-comment period. If the decision is to retire the LCD, notice is published on the MAC’s website. The termination date of the LCD is specified in the retired LCD. NOTE: The reconsideration process cannot be used to challenge other documents such as:

• national coverage determinations;
• coverage provisions in CMS interpretive manuals;
• draft LCDs;
• template LCDs, unless or until they are adopted by the contractor;
• retired LCDs;
• individual claim determinations;
• bulletins, articles, training materials; and
• any instance in which no LCD exists.

Q: My MAC removed the covered diagnoses from the LCD pertaining to CTPs. Does that mean that wound care professionals can use the CTPs for patients with all diagnoses?

A: No, it means the MAC expects physicians and other QHPs to use the covered CTPs based upon the package insert/instructions for use. It also means the MAC expects the physicians and other QHPs to use specific ICD-10-CM codes to describe the major reasons they are applying particular CTPs. 

Q: For many years, my MAC had a specific LCD that gave positive coverage to brand-specific CTPs once they had completed RCTs and published trial results. In fact, the LCD had a separate attached article for each covered CTP. The brand-specific articles listed covered diagnoses and coverage guidelines. Then, my MAC, like several others, retired the LCD and attached articles. Does that mean my MAC now covers all CTPs on the market, even those that don’t have published clinical evidence?

A: No, the lack of an LCD does not imply coverage. Instead, it reflects that the MAC is silent on coverage. The MAC continues to retain the option of reviewing claims to determine whether services and products meet the standard of “reasonable and necessary” as mandated in Section 1862(a)(1)(A) of the Social Security Act. For example, when one of the MACs — National Government Services — retired its LCD, CTP stakeholders were encouraged to establish uniform guidelines for assessing and comparing products for efficacy and long-term results (outcome-based results). They warned CTP stakeholders that the lack of these uniform guidelines may lead to unfavorable coverage. They also stated that they would be reaching out to wound care departments and clinicians with experience in this area to enlist their help in establishing parameters for appropriate use based on demonstrated clinical effectiveness. 

Q: Now that CMS packages wound care hospital-based outpatient department (HOPD) payment for the CTP products into the payment for the application procedure, why can’t physicians and other QHPs who apply CTPs in HOPDs use any product they want?

A: Physicians and QHPs should remember that reimbursement is composed of three parts: coding, payment, and coverage. The existence of a code for a product does not guarantee payment or coverage. The existence of a code and a payment rate does not guarantee coverage. The MACs still have the right to determine if a product is reasonable and necessary and to release LCDs. Keep in mind that Medicare is still paying the HOPD for the CTP via the packaged “low cost” and “high cost” CTP application codes. Therefore, if a MAC writes an LCD, physicians and other QHPs have the choice to either use covered or noncovered CTPs. If they choose to apply a noncovered CTP, physicians and other QHPs should provide the patient with an advanced beneficiary notice of noncoverage before they order and apply the CTP. If the MAC does not have a pertinent LCD, physicians and other QHPs must clearly document the medical necessity for that particular CTP, and its use should align with published clinical evidence.

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Kathleen D. Schaum, MS, is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth,FL; and director, medical products, reimbursement, at Smith & Nephew, Fort Worth, TX.