Determining Self-Administration of Drug or Biological

50.2 - Determining Self-Administration of Drug or Biological (Rev. 157, Issued: 06-08-12, Effective: 07-01-12, Implementation: 07-02-12) The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self- administered by the patients who take them. Section 112 of the Benefits, Improvements & Protection Act of 2000 (BIPA) amended sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Act to redefine this exclusion. The prior statutory language referred to those drugs “which cannot be self-administered.” Implementation of the BIPA provision requires interpretation of the phrase “not usually self-administered by the patient”. A. Policy A/B MACs (A), (B), and (HHH), are instructed to follow the instructions below when applying the exclusion for drugs that are usually self-administered by the patient. Each individual A/B MAC (A), (B), or (HHH) must make its own individual determination on each drug. A/B MACs (A), (B), and (HHH) must continue to apply the policy that not only the drug is medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. That is, if a drug is available in both oral and injectable forms, the injectable form of the drug must be medically reasonable and necessary as compared to using the oral form. For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self- administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered. B. Administered The term “administered” refers only to the physical process by which the drug enters the patient’s body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the “incident to” benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient. C. Usually For the purposes of applying this exclusion, the term “usually” means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage and the A/B MAC (A), (B), or (HHH) may not make any Medicare payment for it. In arriving at a single determination as to whether a drug is usually self-administered, A/B MACs (A), (B), and (HHH) should make a separate determination for each indication for a drug as to whether that drug is usually self-administered. After determining whether a drug is usually self-administered for each indication, A/B MACs (A), (B), or (HHH) should determine the relative contribution of each indication to total use of the drug (i.e., weighted average) in order to make an overall determination as to whether the drug is usually self-administered. For example, if a drug has three indications, is not self-administered for the first indication, but is self administered for the second and third indications, and the first indication makes up 40 percent of total usage, the second indication makes up 30 percent of total usage, and the third indication makes up 30 percent of total usage, then the drug would be considered usually self-administered. Reliable statistical information on the extent of self-administration by the patient may not always be available. Consequently, CMS offers the following guidance for each A/B MAC (A)’s, (B)’s, or (HHH)’s consideration in making this determination in the absence of such data: 1. Absent evidence to the contrary, presume that drugs delivered intravenously are not usually self- administered by the patient. 2. Absent evidence to the contrary, presume that drugs delivered by intramuscular injection are not usually self-administered by the patient. (Avonex, for example, is delivered by intramuscular injection, not usually self-administered by the patient.) The A/B MAC (A), (B), or (HHH) may consider the depth and nature of the particular intramuscular injection in applying this presumption. In applying this presumption, A/B MACs (A), (B), and (HHH) should examine the use of the particular drug and consider the following factors: 3. Absent evidence to the contrary, presume that drugs delivered by subcutaneous injection are self- administered by the patient. However, A/B MACs (A), (B), and (HHH) should examine the use of the particular drug and consider the following factors: A. Acute Condition - Is the condition for which the drug is used an acute condition? If so, it is less likely that a patient would self-administer the drug. If the condition were longer term, it would be more likely that the patient would self-administer the drug. B. Frequency of Administration - How often is the injection given? For example, if the drug is administered once per month, it is less likely to be self-administered by the patient. However, if it is administered once or more per week, it is likely that the drug is self-administered by the patient. In some instances, A/B MACs (B) may have provided payment for one or perhaps several doses of a drug that would otherwise not be paid for because the drug is usually self-administered. A/B MACs (B) may have exercised this discretion for limited coverage, for example, during a brief time when the patient is being trained under the supervision of a physician in the proper technique for self-administration. Medicare will no longer pay for such doses. In addition, A/B MACs (A) may no longer pay for any drug when it is administered on an outpatient emergency basis, if the drug is excluded because it is usually self- administered by the patient. D. Definition of Acute Condition For the purposes of determining whether a drug is usually self-administered, an acute condition means a condition that begins over a short time period, is likely to be of short duration and/or the expected course of treatment is for a short, finite interval. A course of treatment consisting of scheduled injections lasting less than 2 weeks, regardless of frequency or route of administration, is considered acute. Evidence to support this may include Food and Drug Administration (FDA) approval language, package inserts, drug compendia, and other information. E. By the Patient The term “by the patient” means Medicare beneficiaries as a collective whole. The A/B MAC (B) includes only the patients themselves and not other individuals (that is, spouses, friends, or other care-givers are not considered the patient). The determination is based on whether the drug is self-administered by the patient a majority of the time that the drug is used on an outpatient basis by Medicare beneficiaries for medically necessary indications. The A/B MAC (B) ignores all instances when the drug is administered on an inpatient basis. The A/B MAC (B) makes this determination on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis. In evaluating whether beneficiaries as a collective whole self-administer, individual beneficiaries who do not have the capacity to self-administer any drug due to a condition other than the condition for which they are taking the drug in question are not considered. For example, an individual afflicted with paraplegia or advanced dementia would not have the capacity to self-administer any injectable drug, so such individuals would not be included in the population upon which the determination for self-administration by the patient was based. Note that some individuals afflicted with a less severe stage of an otherwise debilitating condition would be included in the population upon which the determination for “self-administered by the patient” was based; for example, an early onset of dementia. F. Evidentiary Criteria A/B MACs (A), (B), and (HHH), and DME MACs are only required to consider the following types of evidence: peer reviewed medical literature, standards of medical practice, evidence-based practice guidelines, FDA approved label, and package inserts. A/B MACs (A), (B), and (HHH), and DME MACs may also consider other evidence submitted by interested individuals or groups subject to their judgment. A/B MACs (A), (B), and (HHH), and DME MACs should also use these evidentiary criteria when reviewing requests for making a determination as to whether a drug is usually self-administered, and requests for reconsideration of a pending or published determination. Note that prior to August 1, 2002, one of the principal factors used to determine whether a drug was subject to the self-administered exclusion was whether the FDA label contained instructions for self-administration. However, CMS notes that under the new standard, the fact that the FDA label includes instructions for self- administration is not, by itself, a determining factor that a drug is subject to this exclusion. G. Provider Notice of Noncovered Drugs A/B MACs (A), (B), and (HHH), and DME MACs must describe on their Web site the process they will use to determine whether a drug is usually self-administered and thus does not meet the “incident to” benefit category. A/B MACs (A), (B), and (HHH), and DME MACs must publish a list of the injectable drugs that are subject to the self-administered exclusion on their Web site, including the data and rationale that led to the determination. A/B MACs (A), (B), and (HHH), and DME MACs will report the workload associated with developing new coverage statements in CAFM 21208. A/B MACs (A), (B), and (HHH), and DME MACs must provide notice 45 days prior to the date that these drugs will not be covered. During the 45-day time period, A/B MACs (A), (B), and (HHH), and DME MACs will maintain existing medical review and payment procedures. After the 45-day notice, A/B MACs (A), (B), and (HHH), and DME MACs may deny payment for the drugs subject to the notice. A/B MACs (A), (B), and (HHH), and DME MACs must not develop local coverage determinations (LCDs) for this purpose because further elaboration to describe drugs that do not meet the ‘incident to’ and the ‘not usually self-administered’ provisions of the statute are unnecessary. Current LCDs based solely on these provisions must be withdrawn. LCDs that address the self-administered exclusion and other information may be reissued absent the self-administered drug exclusion material. A/B MACs (A), (B), and (HHH), and DME MACs will report this workload in CAFM 21206. However, A/B MACs (A), (B), and (HHH), and DME MACs may continue to use and write LCDs to describe reasonable and necessary uses of drugs that are not usually self-administered. H. Conferences Between A/B MACs (A), (B), and (HHH), and DME MACs Contractors’ Medical Directors (CMDs) may meet and discuss whether a drug is usually self-administered without reaching a formal consensus. Each A/B MAC (A), (B), or (HHH), or DME MAC uses its discretion as to whether or not it will participate in such discussions. Each A/B MAC (A), (B, or (HHH) or DME MAC) must make its own individual determinations, except that A/B MACs (A) or (HHH) may, at their discretion, follow the determinations of the A/B MAC (B) with respect to the self-administered exclusion. I. Beneficiary Appeals If a beneficiary’s claim for a particular drug is denied because the drug is subject to the “self-administered drug” exclusion, the beneficiary may appeal the denial. Because it is a “benefit category” denial and not a denial based on medical necessity, an Advance Beneficiary Notice (ABN) is not required. A “benefit category” denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability (under §1879 of the Act). Therefore, physicians or providers may charge the beneficiary for an excluded drug. J. Provider and Physician Appeals A physician accepting assignment may appeal a denial under the provisions found in Pub. 100-04, Medicare Claims Processing Manual, chapter 29. K. Reasonable and Necessary A/B MACs (A) and (B) will make the determination of reasonable and necessary with respect to the medical appropriateness of a drug to treat the patient’s condition. MACs will continue to make the determination of whether the intravenous or injection form of a drug is appropriate as opposed to the oral form. MACs will also continue to make the determination as to whether a physician’s office visit was reasonable and necessary. However, MACs should not make a determination of whether it was reasonable and necessary for the patient to choose to have his or her drug administered in the physician’s office or outpatient hospital setting. That is, while a physician’s office visit may not be reasonable and necessary in a specific situation, in such a case an injection service would be payable. L. Reporting Requirements Each A/B MAC (A), (B), or (HHH), or DME MACs must report to CMS its complete list of injectable drugs that the A/B MACs (A), (B), or (HHH), or DME MACs has determined are excluded when furnished incident to a physician’s service on the basis that the drug is usually self-administered. The CMS expects that A/B MACs (A), (B), and (HHH), and DME MACs will review injectable drugs on a rolling basis and update their list of excluded drugs as it is developed and no less frequently than annually. For example, A/B MACs (A), (B), and (HHH), and DME MACs should not wait to publish this list until every drug has been reviewed. A/B MACs (A), (B), and (HHH), and DME MACs must enter their self-administered drug exclusion list to the Medicare Coverage Database (MCD). This database can be accessed at www.cms.hhs.gov/mcd. See Pub.100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3, “Policies and Guidelines Applied During Review”, for instructions on submitting these lists to the MCD. M. Drugs Treated as Hospital Outpatient Supplies In certain circumstances, Medicare pays for drugs that may be considered usually self-administered by the patient when such drugs function as supplies. This is the case when the drugs provided are an integral component of a procedure or are directly related to it, i.e., when they facilitate the performance of or recovery from a particular procedure. Except for the applicable copayment, hospitals may not bill beneficiaries for these types of drugs because their costs, as supplies, are packaged into the payment for the procedure with which they are used. Listed below are examples of when drugs are treated as supplies and hospitals should bill Medicare for the drug as a supply and should not separately bill the beneficiary. • Sedatives administered to a patient while he or she is in the preoperative area being prepared for a procedure. • Mydriatic drops instilled into the eye to dilate the pupils, anti-inflammatory drops, antibiotic drops/ointments, and ocular hypotensives that are administered to a patient immediately before, during, or immediately following an ophthalmic procedure. This does not refer to the patient’s eye drops that the patient uses pre-and postoperatively. • Barium or low osmolar contrast media provided integral to a diagnostic imaging procedure. • Topical solution used with photodynamic therapy furnished at the hospital to treat nonhyperkeratotic actinic keratosis lesions of the face or scalp. • Antibiotic ointments such as bacitracin, placed on a wound or surgical incision at the completion of a procedure. The following are examples of when a drug is not directly related or integral to a procedure, and does not facilitate the performance of or recovery from a procedure. Therefore the drug is not considered a packaged supply. In many of these cases the drug itself is the treatment instead of being integral or directly related to the procedure, or facilitating the performance of or recovery from a particular procedure. • Drugs given to a patient for his or her continued use at home after leaving the hospital. • Oral pain medication given to an outpatient who develops a headache while receiving chemotherapy administration treatment. • Daily routine insulin or hypertension medication given preoperatively to a patient. • A fentanyl patch or oral pain medication such as hydrocodone, given to an outpatient presenting with pain. • A laxative suppository for constipation while the patient waits to receive an unrelated X-ray. These two lists of examples may serve to guide hospitals in deciding which drugs are supplies packaged as a part of a procedure, and thus may be billed under Part B. Hospitals should follow CMS’ guidance for billing drugs that are packaged and paid as supplies, reporting coded and uncoded drugs with their charges under the revenue code associated with the cost center under which the hospital accumulates the costs for the drugs.