Medicare Coverage When There Are No NCDs, LCDs, or Related Articles

Scenario 
Physicians, qualified health professionals, and those working in hospital-owned outpatient wound management provider-based departments seem to be confused about selecting medical options when Medicare has not released an NCD or their MACs have not written or have retired their LCDs/articles. Recently, this author conducted numerous teleconsultations with concerned stakeholders because: 1) they thought they could not provide a medical option if their MAC had not published an LCD/article about it and/or 2) they thought they could do whatever they wanted if their MAC  had not published or had retired their LCD/article about a medical option. The first concern caused them to unnecessarily lose patients to competitors who legitimately provided the medical options that the patients needed. The second concern resulted in repayments for medical options that their MAC found not medically necessary based upon reviews of their patients’ medical records.  

Facts to Consider 

• Medicare does not cover medically unreasonable and unnecessary medical options to diagnose and treat a beneficiary’s condition. 

• Medical options must meet specific medical-necessity requirements in the statute, regulations, and manuals, as well as the specific medical necessity criteria defined in NCDs and LCDs/articles (if they exist).

• Medicare does not write NCDs and MACs do not write LCDs and/or articles about every medical option they cover and reimburse.

• For every medical option that wound management stakeholders bill to Medicare, the medical record must: 1) indicate the specific sign, symptom, or beneficiary complaint that makes the medical option reasonable and necessary and 2) document why that medical option is appropriate for that patient. 

• Wound management stakeholders must give written notice to a fee-for-service Medicare beneficiary before furnishing medical options that Medicare usually covers but the stakeholders do not expect Medicare to cover in a specific instance for certain reasons, such as lack of medical necessity. This notice is called an advance beneficiary notice (ABN) of non-coverage. 

Consultation 
Each of the aforementioned teleconsultations began by discussing and assessing the exact scenario(s) that stimulated the request for assistance. A myriad of misinformation, misinterpretations, misunderstandings, rumors, company politics, and personal dynamics were typically intertwined. Once all the issues were clearly understood, a discussion on the potpourri of related items that payers consider when determining if a medical option should be covered for patients was conducted. Topics included:  

• Patient’s medical condition, results of diagnostic tests, diagnosis, etc. 

• Previous care provided for the same condition.

• Pertinent published clinical practice guidelines.

• Medical options, including each option’s indications and contraindications, published evidence (diagnoses that were included in the study/trial, standard of care required before performance of service/procedure or use of product, etc.), and instructions for use.

• Statute, regulations, manuals, and specific medical necessity criteria defined by NCDs and LCDs/articles (if they exist). NOTE: The fact that MACs retire LCDs/articles does not mean they have not forgotten the research conducted about the medical option and the coverage guidelines that were in the retired LCD/article. Absent of the LCDs/articles, the MACs place the onus on providers and professionals to follow all the regulations, guidelines, and published evidence; to impeccably “paint the picture” about the patient’s condition; and to document the reason that medical option was selected for that patient. 

• If the patient’s condition and selected medical option do not align with published clinical practice guidelines, statues, regulations, manuals, specific medical necessity criteria, published evidence, instructions for use, etc., Medicare may not cover the medical option for that patient even though the medical option is covered by Medicare. In that case, the wound management providers and professionals should inform the patient: 1) that Medicare does cover the medical option, but may not cover it for that patient and 2) about their cost if the medical option is not covered by Medicare. The patient should be given an appropriately completed ABN. After the patient decides if he/she wishes to proceed with that medical option and to accept financial responsibility for it, the patient should mark his/her choice on the ABN, sign it, and keep a copy. 

During these teleconsultations, the wound management providers and professionals often declared that they had not carefully conformed with all of the items mentioned within this article. Many of these individuals also said they proceeded with the medical option and, if the claim was paid, they kept providing the option. When an LCD did not exist, the claims were often paid because the claims-processing software allowed the claim through the system. Unfortunately, when their MACs conducted post-payment reviews, the stakeholders experienced repayments and could not charge the patient because they did not provide the patients with ABNs. In addition, the selection of the medical option did not always align with the items listed within this article and the medical record documentation was inadequate to file and win an appeal.

Summary
Medicare covers many medical options that are not the subject of NCDs, LCDs, and/or articles. However, in those instances, the wound management providers and professionals own the responsibility of verifying that: 1) their selected medical options can be justified by published clinical practice guidelines and clinical trials, 2) they meet all payer regulations, and 3) they clearly “paint the picture” of the patient’s condition as well as the who/what/where/why the medical option is appropriate for that patient (at that time and at that frequency). In the past, this author worried about wound management stakeholders getting paid. Now, the concern is more about them having the appropriate documentation and clinical evidence to prevent a repayment and to win appeals. 

Kathleen D. Schaum oversees her own consulting business and is a founding member of the Today’s Wound Clinic editorial advisory board. She can be reached for consultation and questions at kathleendschaum@bellsouth.net