In re LCD Complaint: Immunosuppressive Drugs (LCD No. L33824), DAB CR5286 (2019)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

I dismiss the complaint filed against Local Coverage Determination (LCD) No. L33824 as unacceptable because the Aggrieved Party submitted a statement in which she said that she was not challenging the reasonableness of the LCD’s provision related to the limitation on the supply of the medication she needs, but instead wants proper consideration of her request for an exception to the limitation based on her personal circumstances.  The process to challenge the reasonableness of an LCD is not the proper process for considering the Aggrieved Party’s request for an exception permitted by a policy of the Centers for Medicare & Medicaid Services (CMS).  The Aggrieved Party should seek a determination from Noridian Healthcare Solutions (Noridian) on her request for a greater supply of medication and, if necessary, appeal an adverse decision through the claims appeal process.  The Noridian representative assigned to this case should assist the Aggrieved Party in locating the correct office within Noridian to file her request.

I.  Background

The Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services, received correspondence dated December 12, 2018, from a Medicare beneficiary (i.e., the Aggrieved Party) that identified LCD No.  L33824 and expressed that she needed greater than a 30-day supply of

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immunosuppressive drugs in order to travel outside the United States.  CRD docketed this as an LCD complaint case and assigned it to me for hearing and decision.

After conducting a review of the submission under 42 C.F.R. § 426.410(b), I concluded that it did not constitute an acceptable complaint under 42 C.F.R. § 426.400(c).  As a result, I ordered the Aggrieved Party to amend the unacceptable complaint.  42 C.F.R. § 426.410(c).  That order specified the following requirements that had to be met in order to perfect her complaint:

• LCD-identifying information:  The Aggrieved Party must submit, in addition to the name of the contractor using the LCD and the title of the LCD being challenged, the specific provision of the LCD adversely affecting her.
• Aggrieved Party statement:  A statement from the Aggrieved Party explaining she thinks that the provisions(s) of the LCD is (are) not valid under the reasonableness standard.
• Clinical or scientific evidence:  Copies of clinical or scientific evidence that support the complaint and an explanation for why the Aggrieved Party thinks that this evidence shows that the LCD is not reasonable.

In an effort to understand the Aggrieved Party’s complaint, I also added the following information so that I could learn which provision of the LCD the Aggrieved Party was challenging:

Although the Aggrieved Party provided the name of the contractor using the LCD and the title of the LCD being challenged, she did not provide the specific provision or provisions of the LCD adversely affecting her.  However, a review of the LCD discloses the following provision that may relate to the Complaint:

The quantity of immunosuppressive drugs dispensed is limited to a 30-day supply. Quantities of immunosuppressive drugs dispensed in excess of a 30-day supply will be denied as not medically necessary.  If a drug is denied as not medically necessary, the related supply fee (Q0510, Q0511 and Q0512) will be denied as not medically necessary (bp102c15, §50.4.3 and CMS Claims Processing Manual, Internet-Only Manual, CMS Pub. 100-04, Chapter 17, Section 80.3 [hereinafter clm104c17, §80.3]).

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This LCD provision cites CMS’s Medicare Claims Processing Manual, Chapter 17, § 80.3.  National Coverage Determination (NCD) 260.1 Liver Transplant also cites that manual provision under the title “Immunosuppressive Drugs.  That manual provision provides: 

Contractors are expected to keep informed of FDA additions to the list of the immunosuppressive drugs and notify providers. Prescriptions for immunosuppressive drugs generally should be non-refillable and limited to a 30-day supply.  The 30-day guideline is necessary because dosage frequently diminishes over a period of time, and further, it is not uncommon for the physician to change the prescription from one drug to another.  Also, these drugs are expensive and the coinsurance liability on unused drugs could be a financial burden to the beneficiary.  Unless there are special circumstances, contractors will not consider a supply of drugs in excess of 30 days to be reasonable and necessary and should deny payment accordingly.

In response, the Aggrieved Party submitted emails and uploaded two letters.  I have reviewed all of those written communications and all have been uploaded to the DAB E‑file system.  The Aggrieved Party’s letters include all of the material information provided in the emails.  In her March 23, 2019 letter response, the Aggrieved Party stated that she needed to obtain a supply of her immunosuppressive drug that exceeded 30 days in duration because the Aggrieved Party wants to travel to Asia to see her son who is living there.  She mentioned that the countries she plans to visit will not accept an American prescription for the drug, and she would need to carry a supply for 60 days to ensure that she had enough.  She also mentioned that the anti-rejection drug she is on due to a liver transplant, Tacrolimus, has been successful for her from the beginning and that she has been very stable on that drug for two years.  The Aggrieved Party stated that she received clearance from her physicians for foreign travel, but that she must take her medication every day or risk a serious health situation that would require her to return to the United States immediately.

The Aggrieved Party included a March 22, 2019 letter from her physician who stated that:  the Aggrieved Party is stable on her current dose of Tacrolimus; he did not anticipate any change to her dose for the next 12 months; and a 30-day supply of the drug

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was not reasonable because the Aggrieved Party often travels and would be at great risk for rejection of her transplanted liver graft if she missed doses.

The Aggrieved Party submitted a supplemental response dated March 26, 2019, which was still within the time permitted for her to amend the complaint.  In this statement, she said:  “I am not really ‘challenging’ the validity of  LCD regulation of 30-day supply on immunosuppressives (in my case Tacrolimus), but to ask for a special circumstance to allow a 60 day supply period, for this coming year.”  The Aggrieved Party reiterated her desire to see her son in Asia and the difficulties and dangers of attempting the trip while only carrying a 30-day supply of the drug.  Further, the Aggrieved Party indicated that there was no clinical or scientific evidence that would relate to the dose quantity to be provided.

II.  Analysis

An LCD is “a determination by a fiscal intermediary or a carrier under part A of this subchapter or part B of this subchapter, as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis under such parts.”  42 U.S.C. § 1395ff(f)(2)(B).  When a fiscal intermediary or carrier issues an initial determination denying coverage of an item or service based on an LCD, the determination must state that the LCD was used in making that determination.  42 U.S.C. § 1395ff(a)(4)(A)(i).  If a qualified independent contractor considers a claim on reconsideration, the LCD “shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration” but “the qualified independent contractor shall consider the local coverage determination in making such decision.”  42 U.S.C. § 1395ff(c)(3)(B)(ii)(II).  If a case is further appealed to an administrative law judge (ALJ) at the Office of Medicare Hearings and Appeals, the ALJ is not bound by the LCD, but must give the reasons for not following an LCD.  42 C.F.R. § 405.1062.

Outside of the Medicare claims appeal process, a beneficiary entitled to Medicare Parts A and/or B may seek review of an LCD by an ALJ, who will only defer to reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law.  42 U.S.C. § 1395ff(f)(2)(A)(i)(III); see also 42 C.F.R. § 426.431.  The ALJ may uphold or invalidate the challenged LCD provision.  42 C.F.R. § 426.460.  The LCD review process is distinct from the claims appeal process.  42 C.F.R. § 426.310.

In the present case, the Aggrieved Party needed to provide specific information in order for her complaint to be valid.  During the process to supplement the original complaint, the Aggrieved Party acknowledged that she was not actually challenging the LCD, but wanted an opportunity to show that she has a special circumstance that would permit her to obtain reimbursement for a 60-day supply of her immunosuppressant drug, rather than just a 30-day supply.  The LCD provision at issue does not permit approval of a claim for more than a 30-day supply of immunosuppressant drugs.  However, the CMS manual

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provision on which the LCD provision is based permits an exception to that rule when there are special circumstances in an individual case.  It is significant that NCD 260.1, regarding liver transplants, expressly cross-references the CMS manual provision as the operative policy for immunosuppressant drugs.  The LCD provision appears to conflict with the CMS manual provision, which both the LCD and NCD cross-reference.  As noted above, the Aggrieved Party can obtain review through the claims appeal process by adjudicators who are not bound by LCDs and can apply the CMS manual provision that is endorsed by the NCD.

In regard to the requirements for a valid LCD complaint, the Aggrieved Party has not submitted a statement explaining why the LCD provision is not reasonable.  42 C.F.R. § 426.400(b)(5).  On the contrary, she stated in her last supplement to her complaint that she is not challenging the LCD provision.  Further, the Aggrieved Party did not submit any clinical and scientific evidence related to the provision.  42 C.F.R. § 426.400(b)(6).  I agree with the Aggrieved Party that it is unlikely that there is scientific or clinical evidence concerning how often a beneficiary should refill an order for immunosuppressant drugs.

The Aggrieved Party’s concern relates to the application of CMS’s manual provision that permits coverage for supplies of immunosuppressant drugs that exceed 30 days when special circumstances are present.  This is a legal issue related to the facts specific to the Aggrieved Party and not a generalized issue of an LCD provision as to whether a health care item or service is covered.

III.  Conclusion

Therefore, for the reasons explained above, the Aggrieved Party’s complaint remains unacceptable under 42 C.F.R. § 426.410(b).  I am required to dismiss the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  Accordingly, I order that the complaint be dismissed.