(Medicare Benefit Policy Manual)

 The specific action that the requestor wishes CMS to take, for example to add or delete a specific compendium.   Detailed, specific documentation that the compendium that is the subject of the request does or does not comply with the conditions of this rule. Broad, nonspecific claims without supporting documentation cannot be efficiently reviewed; therefore, they wil l not be accepted.    A publicly transparent process for evaluating therapies, which includes the following: (1) internal or external request for listing of a therapy recommendation, including criteria used to evaluate the request (the complete application), (2) listing of all the evidentiary materials reviewed or considered for inclusion in the compendium (3) listing of all individuals who substantively participated in the review and development of the request, and (4) minutes and voting records of meetings for the review and d isposition of the request.  The information from an internal or external request for inclusion of a therapy in a compendium are available to the public for a period of not less than 5 years, which includes availability on the compendiums Web site for a pe riod of not less than 3 years, coincident with the compendiums publication.   A publicly transparent process for identifying potential conflicts of interests that provides: (1) direct or indirect financial relationships, and (2) ownership or investment interests that exist between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations, and the manufacturer or seller of the drug or biological being reviewed by the compendium.  This information shall be identified and made timely availab le in response to a public request for a period of not less than 5 years, which includes availability on the compendiums Web site for a period of not less than 3 years, coincident with the compendiums publication.  A request may have only a single compendium as its subject.  This will provide greater clarity to the scope of the Agencys review of a given request. A requestor may submit multiple requests, each requesting a different action.   E. Submission of Requests   Requests must be in writing and submitted in one of the following two ways (no duplicates please):   1. Electronic requests are encouraged to facilitate administrative efficiency. Each solicitation will include the electronic address for submissions.  2. Hard copy requests can be sent to: Centers for Medicare & Medicaid Services, Coverage and Analysis Group, Mailstop C10906, 7500 Security Boulevard, Baltimore, MD 21244.  Allow sufficient time for hard copies to be received prior to the close of the open request period.   F. Review of Requests   CMS will consider a compendiums attainment of the desirable characteristics specified in 50.4.5.1.B when reviewing requests.  CMS may consider additional, reasonable factors in making a determination.  For example, CMS may consider factors that are likely  to impact the compendiums suitability for this use, such as a change in the compendiums ownership or affiliation, and the standards applicable to the evidence considered by the compendium.  CMS may consider that broad accessibility by the general public  to the information contained in the compendium may assist beneficiaries, their treating physicians, or both, in choosing among treatment options.  CMS will also consider a compendiums grading of evidence used in making recommendations regarding off -label  uses, and the process by which the compendium grades the evidence. CMS may, at its discretion, combine and consider multiple requests that refer to the same compendium, even if those requests are for different actions.  This facilitates administrative eff iciency in the review of requests.   G. Publishing Review Results   CMS will publish decisions on the CMS Web site within 90 days after the close of the public comment period.  (This instruction was last reviewed by CMS in December 2009.)   50.4.6 - Less Than Effective Drug  (Rev. 1, 10- 01-03) B3-2049.4.C.5  This is a drug that has been determined by the Food and Drug Administration (FDA) to lack substantial evidence of effectiveness for all labeled indications.  Also, a drug that has been the subject of a Notice of an Opportunity for a Hearing (NOOH) publishe d in the Federal Register before being withdrawn from the market, and for which the Secretary has not determined there is a compelling justification for its medical need, is considered less than effective.  This includes any other drug product that is identical, similar, or related.  Payment may not be made for a less than effective drug.   Because the FDA has not yet completed its identification of drug products that are still on the market, existing FDA efficacy decisions must be applied to all similar products once they are identified.   50.4.7 - Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic Act  (Rev. 1, 10- 01-03) B3-2049.4.C.6  The Food and Drug Administration (FDA) has found that, from time to time, firms established as retail pharmacies engage in mass production of compounded drugs, beyond the normal scope of pharmaceutical practice, in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA).  By compounding drugs on a large scale, a company may be operating as a drug manufacturer within the meaning of the FFDCA, without complying with requirements of that law.  Such companies may be manufacturing drugs, which are subject to the new drug application (NDA) requirements of the FFDCA, but for which FDA has not approved an NDA or which are misbranded or adulterated.  If the FDA has not approved the manufacturing and processing procedures used by these facilities, the FDA has no assurance that the drugs these companies are producing are safe and effective.  The safety and effectiveness issues pertain to such factors as chemical stability, purity, strength, bioequivalency, and biovailability.  Section 1862(a)(1)(A) of the Act requires that drugs must be reasonable and necessary in order to by covered under Medicare.  This means, in the case of drugs, the FDA must approve them for marketing.  Section 50.4.1  instructs A/B MACs (A) and (B)to deny coverage for drugs that have not received final marketing approval by the FDA, unless instructed otherwise by CMS.  The Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 180, instructs A/B MACs (B) to deny coverage of services related to the use of noncovered drugs as well.  Hence, if DME or a prosthetic device is used to administer a noncovered drug, coverage is denied for both the nonapproved drug and the DME or prosthetic device.   In those cases in which the FDA has determined that a company is producing compounded drugs in violation of the FFDCA, Medicare does not pay for the drugs because they do not meet the FDA approval requirements of the Medicare program.  In addition, Medicare does not pay for the DME or prosthetic device used to administer such a drug if FDA determines that a required NDA has not been approved or that the drug is misbranded or adulterated.  The CMS will notify the A/B MAC (B) when the FDA has determined that compounded drugs are being produced in violation of the FFDCA.  The A/B MAC (B) does not stop Medicare payment for such a drug unless it is notified that it is appropriate to do so through a subsequent instruction.  In addition, if the A/B MAC (B) or Regional Offices (ROs) become aware that other companies are possibly operating in violation of the FFDCA, the A/B MAC (B) or RO notifies:  Centers for Medicare & Medicaid Services  Center for Medicare Management  7500 Security Blvd. Baltimore, MD 21244-1850  50.4.8 - Process for Amending the List of Compendia for Determination of Medically -Accepted  Indications for Off -Label Uses of Drugs and Biologicals in an Anti- Cancer Chemotherapeutic Regimen   50.5 - Self-Administered Drugs and Biologicals (Rev. 1, 10-01-03) B3-2049.5  Medicare Part B does not cover drugs that are usually self -administered by the patient unless the statute provides for such coverage.  The statute explicitly provides coverage, for blood clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, certain oral anti- cancer d rugs and anti-emetics used in certain situations.   50.5.1 - Immunosuppressive Drugs  (Rev.11764, Issued: 12-22-2022; Effective: 01- 01-2023; Implementation: 01-01-2023)  Until January 1, 1995, immunosuppressive drugs were covered under Part B for a period of one year following discharge from a hospital for a Medicare covered organ transplant.  The CMS interpreted the 1-year period after the date of the transplant procedure  to mean 365 days from the day on which an inpatient is discharged from the hospital.  Beneficiaries are eligible to receive additional Part B coverage within  18 months after the discharge date for drugs furnished in 1995; within  24 months for drugs furnis hed in 1996; within  30 months for drugs furnished in 1997; and within  36 months for drugs furnished after 1997.   For immunosuppressive drugs furnished on or after December 21, 2000, this time limit for coverage is eliminated.   The Consolidated Appropriations Act of 2021 amended section 1836(b) of the Social Security Act to add a new form of coverage that provides solely for coverage of immunosuppressive drugs beginning January 1, 2023, for eligible individuals whose entitlement to Medicare based on End -Stage Renal Disease (ESRD) ends the 36th month after the month in which the individuals receive a successful kidney transplant. T his new benefit is referred to as the Part B immunosuppressive drug benefit or Part B -ID. Refer to P ub. 100-01, Chapter 2, Section 40.9 for more information on Part B -ID. Covered drugs include those immunosuppressive drugs that have been specifically labeled as such and approved for marketing by the FDA.  (This is an exception to the standing drug policy which permits coverage of FDA approved drugs for nonlabeled uses, where such uses are found to be reasonable and necessary in an individual case.)   Covered drugs also include those prescription drugs, such as prednisone, that are used in conjunction with immunosuppressive drugs as part of a therapeutic regimen reflected in FDA approved labeling for immunosuppressive drugs.  Therefore, antibiotics, hypertensives, and other drugs that are not directly related to rejection are not covered.  The FDA has identified and approved for marketing the following specifically labeled immunosuppressive drugs.  They are:   Sandimmune (cyclosporine), Sandoz Pharmaceutical;  Imuran (azathioprine), Burroughs Wellcome;  Atgam (antithymocyte globulin), Upjohn;  Orthoclone OKT3 (Muromonab- CD3), Ortho Pharmaceutical;  Prograf (tacrolimus), Fujisawa USA, Inc;  Celicept (mycophenolate mefetil, Roche Laboratories;  Daclizumab (Zenapax);  Cyclophosphamide (Cytoxan);  Prednisone; and  Prednosolone.  The CMS expects contractors to keep informed of FDA additions to the list of the immunosuppressive drugs.  50.5.2 - Erythropoietin (EPO)  (Rev. 1, 10- 01-03) A3-3112.4.B.4, HO -230.4.B.4  The statute provides that EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis.  Coverage is available regardless of whether the drug is administered by the patient or the patients caregiver.  EPO is a bio logically engineered protein which stimulates the bone marrow to make new red blood cells.  NOTE:   Non -ESRD patients who are receiving EPO to treat anemia induced by other conditions such as chemotherapy or the drug zidovudine (commonly called AZT) must meet the coverage requirements in 50 .  EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis when:   It is administered in the renal dialysis facility; or    It is self -administered in the home by any dialysis patient (or patient caregiver) who is determined competent to use the drug and meets the other conditions detailed below.  NOTE:   Payment may not be made for EPO under the incident to provision when EPO is administered in the renal dialysis facility.   Also, in the office setting, reimbursement will be made for the administration charge only for non- ESRD patients receiving EPO.  50.5.2.1 - Requirements for Medicare Coverage for EPO  (Rev. 1, 10-01-03) B3-2049.5