evekhm/cms_iom_500 huggingface dataset:
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of the Act, the Medicare contractor may pay for medically necessary services of the furnishing entity, provided the furnishing entity is not also a physician or practitioner that has opted out of the Medicare program.    40.33 - Mandatory Claims Submission  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  Section 1848(g)(4) of the Act, Physician/Practitioner Submission of Claims, regarding mandatory claims submission, does not apply once a physician or practitioner signs and submits an affidavit to the Medicare contractor opting out of the Medicare program, for the duration of the physicians or practitioners opt-out period, unless the physician or practitioner knowingly and willfully violates a term of the affidavit.  40.34 - Cancellation of Opt -Out (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  A physician or practitioner may cancel opt-out by submitting a written notice to each MAC to which he or she would file claims absent the opt-out, not later than 30 days before the end of the current 2-year opt-out period, indicating that the physician or practitioner does not want to extend the application of the opt-out affidavit for a subsequent 2- year period.   40.35 - Early Termination of Opt -Out (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  If a physician or practitioner changes his or her mind after the Medicare contractor has approved the affidavit, the opt-out may be terminated within 90 days of the effective date of the affidavit.  To properly terminate an opt -out, a physician or practiti oner must:    Not have previously opted out of Medicare;   Notify all Medicare contractors, with which the physician or practitioner filed an affidavit, of the termination of the opt- out no later than 90 days after the effective date of the initial 2 -year period;   Refund to each beneficiary with whom the physician or practitioner has privately contracted all payment collected in excess of:
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 Refund to each beneficiary with whom the physician or practitioner has privately contracted all payment collected in excess of:    The Medicare limiting charge (in the case of physicians or practitioners); or  The deductible and coinsurance (in the case of practitioners).   Notify all beneficiaries with whom the physician or practitioner entered into private contracts of the physicians or practitioners decision to terminate opt-out and of the beneficiaries rights to have claims filed on their behalf with Medicare for ser vices furnished during the period between the effective date of the opt -out and the effective date of the termination of the opt-out period.  When the physician or practitioner properly terminates opt-out in accordance with the second bullet above, the physician or practitioner (who was previously enrolled in Medicare) will be reinstated in Medicare as if there had been no opt-out, and the provision of 40.3 must not apply unless the physician or practitioner subsequently properly opts-out.  40.36 - Appeals  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  A determination by CMS that a physician or practitioner has failed to properly opt- out, failed to maintain opt-out, failed to timely renew opt-out, failed to privately contract,  failed to properly terminate opt-out, or failed to properly cancel opt-out is an initial determination for purposes of 42 CFR 498.3(b).  A determination by CMS that no payment can be made to a beneficiary for the services of a physician who has opted out is an initial determination for purposes of 42 CFR 405.924.  See the Medicare Claims Processing Manual, Chapter 29, Appeals of Claims Decisions, for additional information on appeals.  40.37 - Application to the Medicare Advantage Program  (Rev. 160, Issued: 10-26-12, Effective: 01-28-13, Implementation: 01-28-13)  The Medicare Managed Care Manual contains instructions for Medicare Advantage plans about the impact on managed care.   The manual provides in general that Medicare Advantage plans:    Must acquire and maintain information from Medicare contractors on physicians and practitioners who have opted out of Medicare.
(Medicare Benefit Policy Manual)
 Must acquire and maintain information from Medicare contractors on physicians and practitioners who have opted out of Medicare.   Must make no payment directly or indirectly for Medicare covered services furnished to a Medicare beneficiary by a physician or practitioner who has opted out of Medicare, except for emergency or urgent care services furnished to a beneficiary who has not previously entered into a private contract with the physician or practitioner, in accordance with 40.28.  The Medicare contractor must maintain mutually agreeable means of advising Medicare Advantage plans of who has opted out.  Disputes with Medicare Advantage plans about the provision of opt out information should be referred to the regional office staff for resolution.  40.38 - Claims Denial Notices to Opt -Out Physicians and Practitioners  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  To ensure that the notice denying payment to the opt-out physician or practitioner indicates the proper reason for denial of payment, the Medicare contractor must include language in the notice appropriate to particular circumstances as follows:    When the claim is submitted inadvertently  by the opt-out physician/practitioner, the Medicare contractor must use claim adjustment reason code 27 (expenses incurred after coverage terminated) at the claim level with group code PR (patient responsibility) and the remark code MA47:  Our records show that you have opted out of Medicare, agreeing with the patient not to bill Medicare for services/tests/supplies furnished.  As a result, we cannot pay this claim.  The patient is responsible for payment.   The Medicare contractor uses the following message when the claim is submitted knowingly and willfully  by the opt-out physician/practitioner.  It must use claim adjustment reason code 27 (expenses incurred after coverage terminated) at the claim level with group code PR (patient responsibility) and the remittance advice remark code MA47 N771 :
(Medicare Benefit Policy Manual)
Our records show that you have opted out of Medicare, agreeing with the patient not to bill Medicare for services/tests/supplies furnished.  As a result, we cannot pay this claim.  The patient is responsible for payment.  Alert: Under Federal law you cannot charge more than the limiting charge amount.  40.39 - Claims Denial Notices to Beneficiaries  (Rev. 160, Issued: 10-26-12, Effective: 01-28-13, Implementation: 01-28-13)  To ensure that the notice to the beneficiary indicates the proper reason for denial of payment, the Medicare contractor must include language in the notice appropriate to particular circumstances as follows:   It must use the following MSN message when the claim is submitted inadvertently  by the opt-out physician/practitioner:  MSN # 21.20 - The provider decided to drop out of Medicare.  No payment can be made for this service.  You are responsible for this charge.   It must use the following message when the claim is submitted knowingly and willfully  by the opt-out physician/practitioner:  MSN # 21.19 - The provider decided to drop out of Medicare.  No payment can be made for this service.  You are responsible for this charge.  Under Federal law your doctor cannot charge you more than the limiting charge amount.   It must use the following message when the claim is submitted by the beneficiary for a service furnished by an opt-out physician/practitioner:  MSN # 21.20 - The provider decided to drop out of Medicare.  No payment can be made for this service.  You are responsible for this charge.   50 - Drugs and Biologicals  (Rev. 1, 10-01-03) B3-2049, A3-3112.4.B, HO-230.4.B  The Medicare program provides limited benefits for outpatient drugs.  The program covers drugs that are furnished incident to a physicians service provided that the drugs are not usually self-administered by the patients who take them.  Generally, drugs and biologicals are covered only if all of the following requirements are met:   They meet the definition of drugs or biologicals (see 50.1 );   They are of the type that are not usually self- administered. (see 50.2 );
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 They are of the type that are not usually self- administered. (see 50.2 );   They meet all the general requirements for coverage of items as incident to a physicians services (see 50.1 and 50.3);   They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice (see 50.4);   They are not excluded as noncovered immunizations (see 50.4.4.2 ); and    They have not been determined by the FDA to be less than effective.  (See 50.4.4 ).  Medicare Part B does generally not cover drugs that can be self-administered, such as those in pill form, or are used for self -injection.  However, the statute provides for the coverage of some self-administered drugs.  Examples of self -administered drugs that are covered include blood-clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, osteoporosis drugs for certain homebound patients, and certain oral cancer drugs. (See 110.3 for coverage of drugs, which are necessary to the effective use of Durable Medical Equipment (DME) or prosthetic devices.)  50.1 - Definition of Drug or Biological  (Rev. 1, 10-01-03) B3-2049.1
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50.1 - Definition of Drug or Biological  (Rev. 1, 10-01-03) B3-2049.1  Drugs and biologicals must be determined to meet the statutory definition.  Under the statute 1861(t)(1), payment may be made for a drug or biological only where it is included, or approved for inclusion, in the latest official edition of the United States Pharmacopoeia National Formulary (USP -NF), the United States Pharmacopoeia -Drug Information (USD- DI), o r the American Dental Association (AOA) Guide to Dental Therapeutics, except for those drugs and biologicals unfavorably evaluated in the ADA Guide to Dental Therapeutics.  The inclusion of an item in the USP DI does not necessarily mean that the item is a drug or biological.  The USP DI is a database of drug information developed by the U.S. Pharmacopoeia but maintained by Micromedex, which contains medically accepted uses for generic and brand name drug products.  Inclusion in such reference (or approval by a hospital committee) is a necessary condition for a product to be considered a drug or biological under the Medicare program, however, it is not enough.  Rather, the product must also meet all other program requirements to be determined to be a drug or biological .  Combination drugs are also included in the definition of drugs if the combination itself or all of the therapeutic ingredients of the combination are included, or approved for inclusion, in any of the above drug compendia.   Drugs and biologicals are considered approved for inclusion in a compendium if approved under the established procedure by the professional organization responsible for revision of the compendium.  50.2 - Determining Self -Administration of Drug or Biological  (Rev.  157, Issued: 06- 08-12, Effective: 07 -01-12, Implementation: 07- 02-12)
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The Medicare program provides limited benefits for outpatient prescription drugs.  The program covers drugs that are furnished incident to a physicians service provided that the drugs are not usually self -administered by the patients who take them.  Sec tion 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.  Imple mentation 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 medicall y 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 reas onable 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
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B.  Administered   The term administered refers only to the physical process by which the drug enters the patients 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, topica l 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 i s 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 determinatio n 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 indi cations, 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 a bsence of such data:
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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.)  T he 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 t he 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
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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 interva l.  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, pac kage 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 determinat ion 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 injectabl e 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
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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 MAC s (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 determina tion.  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
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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 -administe red 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 proc edures.  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 sta tute 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 (H HH), 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.
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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 beneficiarys 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, a n 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