42 C.F.R. Subpart H—Appeals Under the Medicare Part B Program
Title 42 - Public Health
Authority: Secs. 1102, 1842(b)(3)(C), 1869(b), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395u(b)(3)(C), 1395ff(b), and 1395hh).
Source: 32 FR 18028, Dec. 16, 1967, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977.
(a) The Medicare carrier makes an initial determination when a request for payment for Part B benefits is submitted. If an individual beneficiary is dissatisfied with the initial determination, he or she may request, and the carrier will perform, a review of the claim. Following the carrier's review determination, the beneficiary may obtain a carrier hearing if the amount remaining in controversy is at least $100. The beneficiary is also entitled to a carrier hearing without the benefit of a review determination when the initial request for payment is not being acted upon with reasonable promptness (as defined in §405.802). Following the carrier hearing, the beneficiary may obtain a hearing before an ALJ if the amount remaining in controversy is at least $500. If the beneficiary is dissatisfied with the decision of the ALJ, he or she may request the Departmental Appeals Board (DAB) to review the case. Following the action of the DAB, the beneficiary may file suit in Federal district court if the amount remaining in controversy is at least $1,000. (b) The rights of a beneficiary under paragraph (a) of this section to appeal the carrier's initial determination are granted also to— (1) A physician or supplier that furnishes services to a beneficiary and that accepts an assignment from the beneficiary, or (2) A physician who meets the conditions of section 1842(l)(1)(A) of the Act pertaining to refund requirements for nonparticipating physicians who have not taken assignment on the claim(s) at issue. (c) Procedures governing the determinations by SSA as to whether an individual has met basic Part B entitlement requirements are covered in subpart G of this part and 20 CFR part 404, subpart J. Subparts J and R of 20 CFR part 404 are also applicable to ALJ, DAB, and judicial review conducted under subpart H, except to the extent that specific provisions are contained in this subpart. [62 FR 25853, May 12, 1997] As used in subpart H of this part, the term— After receipt of the notice means 5 days after the date on the notice, unless it is shown that the notice was received earlier or later. Appellant designates the beneficiary, assignee or other person or entity that has filed an appeal concerning a particular determination of benefits under Medicare part B. Designation as an appellant does not in itself convey standing to appeal the determination in question. Assignee means a physician or supplier who furnishes services to a beneficiary under Medicare part B and who has accepted a valid assignment executed by the beneficiary. Assignment means the transfer by the assignor of his or her claim for payment to the assignee in return for the latter's promise not to charge more for his or her services than the carrier finds to be the reasonable charge or other approved amount. Assignor means a beneficiary under Medicare part B whose physician or supplier has taken assignment of a claim. Carrier means an organization which has entered into a contract with the Secretary pursuant to section 1842 of the Act and which is authorized to make determinations with respect to part B of title XVIII of the Act. For purposes of this subpart, the term carrier also refers to an intermediary that has entered into a contract with the Secretary under section 1816 of the Act and is authorized to make determinations with respect to part B provider services, as specified in §421.5(c) of this chapter. Common issues of law and fact, with respect to the aggregation of claims by two or more appellants to meet the minimum amount in controversy needed for an ALJ hearing, occurs when the claims sought to be aggregated are denied or reduced for similar reasons and arise from a similar fact pattern material to the reason the claims are denied. Delivery of similar or related services, with respect to the aggregation of claims by two or more physician/supplier appellants to meet the minimum amount in controversy needed for an ALJ hearing, means like or coordinated services or items provided to the same beneficiary by the appellants. Representative means an individual meeting the conditions described in §§405.870 through 405.871. With reasonable promptness means within a period of 60 consecutive days after the receipt by the carrier of a request for payment. [59 FR 12182, Mar. 16, 1994, as amended at 62 FR 25853, May 12, 1997] (a) Carriers make initial determinations regarding claims for benefits under Medicare Part B. (b) An initial determination for purposes of this subpart includes determinations such as the following: (1) Whether services furnished are covered. (2) Whether the deductible has been met. (3) Whether the receipted bill or other evidence of payment is acceptable. (4) Whether the charges for services furnished are reasonable. (5) If the services furnished to a beneficiary by a physician or a supplier pursuant to an assignment under §424.55 of this chapter are not covered because they are determined to be not reasonable and necessary under §411.15(k) of this chapter, whether the beneficiary, physician or supplier, or a physician who meets the requirements of §411.408, knew or could reasonably have been expected to know at the time the services were furnished that the services were not covered. (c) The following are not initial determinations for purposes of this subpart: (1) Any issue or factor for which SSA or CMS has sole responsibility, for example, whether an independent laboratory meets the conditions for coverage of services; whether a Medicare overpayment claim should be compromised, or collection action terminated or suspended. (2) Any issue or factor which relates to hospital insurance benefits under Medicare Part A. [62 FR 25853, May 12, 1997] After a carrier has made an initial determination on a request for payment written notice of this determination shall be mailed to each party to the determination at his last known address. The notice of the determination shall inform each party to the determination of his right to have such determination reviewed. The parties to the initial determination (see §405.803) may be any party described in §405.802. [64 FR 52670, Sept. 30, 1999] The initial determination is binding upon all parties to the claim for benefits unless the determination is— (a) Reviewed in accordance with §§405.810 through 405.812; or (b) Revised as a result of a reopening in accordance with §405.841. [62 FR 25853, May 12, 1997] (a) General. A party to an initial determination by a carrier, that is dissatisfied with the initial determination and wants to appeal the matter, may request that the carrier review the determination. The request for review by the party to an initial determination must clearly indicate that he or she is dissatisfied with the initial determination and wants to appeal the matter. The request for review does not constitute a waiver of the party's right to a hearing (under §405.815) after the review. (b) Place and method of filing a request. A request by a party for a carrier to review the initial determination may be made in one of the following ways: (1) In writing and filed at an office of the carrier, SSA, or CMS. (2) By telephone to the telephone number designated by the carrier as the appropriate number for the receipt of requests for review. (c) Time of filing request. (1) The carrier must provide a period of 6 months after the date of the notice of the initial determination within which the party to the initial determination may request a review. (2) The carrier may, upon request by the party, extend the period for requesting the review of the initial determination. [64 FR 52670, Sept. 30, 1999] The parties to the review (as provided for in §405.807(a)) shall be the persons who were parties to the carrier's initial determination as described in §405.805, and any other party whose rights with respect to the particular claim being reviewed may be affected by such review. [39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977] The parties to the review (as provided for in §405.807(a)) shall have a reasonable opportunity to submit written evidence and contentions as to fact or law relative to the claim at issue. [39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977] Subject to the provisions of §§405.807 through 405.809, the carrier shall review the claim in dispute and, upon the basis of the evidence of record, shall make a separate determination affirming or revising in whole or in part the findings and determination in question. [39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977] Written notice of the review determination is mailed to a party at his or her last known address. The review determination states the basis of the determination and advises the party of his or her right to a carrier hearing when the amount in controversy is $100 or more as determined in accordance with §405.817. The notice states the place and manner of requesting a carrier hearing as well as the time limit under which a hearing must be requested (see §405.821). [59 FR 12182, Mar. 16, 1994] The review determination is binding upon all parties to the review unless a carrier hearing decision is issued pursuant to a request for hearing made in accordance with §405.821 or is revised as a result of reopening in accordance with §405.841. [59 FR 12182, Mar. 16, 1994, as amended at 62 FR 25855, May 12, 1997] Any party designated in §405.822 is entitled to a carrier hearing after a review determination has been made by the carrier if the amount remaining in controversy is $100 or more and the party meets the requirements of §405.821 of this subpart. To be entitled to a hearing before an ALJ following the carrier hearing, the amount remaining in controversy must be $500 or more, and for judicial review following the ALJ hearing and Departmental Appeals Board Review, the amount remaining in controversy must be $1000 or more. [59 FR 12182, Mar. 16, 1994, as amended at 61 FR 32348, June 24, 1996] (a) Individual appellants. For the purpose of determining whether an individual appellant meets the minimum amount in controversy needed for a carrier hearing ($100) or ALJ hearing ($500), the following rules apply: (1) The amount in controversy is computed as the actual amount charged the individual for the items and services in question, less any amount for which payment has been made by the carrier and less any deductible and coinsurance amounts applicable in the particular case. (2) A single beneficiary may aggregate claims from two or more physicians/suppliers to meet the $100 or $500 thresholds. A single physician/supplier may aggregate claims from two or more beneficiaries to meet the $100 or $500 threshold levels of appeal. (3) In either of the circumstances specified in paragraph (a)(2) of this section, two or more claims may be aggregated by an individual appellant to meet the amount in controversy for a carrier hearing only if the claims have previously been reviewed and a request for hearing has been made within six months after the date of the review determination(s). (4) In either of the circumstances specified in paragraph (a)(2) of this section, two or more claims may be aggregated by an individual appellant to meet the amount in controversy for an ALJ hearing only if the claims have previously been decided by a carrier hearing officer and a request for an ALJ hearing has been made within 60 days after receipt of the carrier hearing officer decision(s). (5) When requesting a carrier hearing or an ALJ hearing, the appellant must specify in his or her appeal request the specific claims to be aggregated. (b) Two or more appellants. As specified in this paragraph, under section 1869(b)(2) of the Act, two or more appellants may aggregate their claims together to meet the minimum amount in controversy needed for an ALJ hearing ($500). The right to aggregate under this statutory provision applies to claims for items and services furnished on or after January 1, 1987. (1) The aggregate amount in controversy is computed as the actual amount charged the individual(s) for the items and services in question, less any amount for which payment has been made by the carrier and less any deductible and coinsurance amounts applicable in the particular case. (2) In determining the amount in controversy, two or more appellants may aggregate their claims together under the following circumstances: (i) Two or more beneficiaries may combine claims representing services from the same or different physician(s) or supplier(s) if the claims involve common issues of law and fact; (ii) Two or more physicians/suppliers may combine their claims if the claims involve the delivery of similar or related services to the same beneficiary; (iii) Two or more physicians/suppliers may combine their claims if the claims involve common issues of law and fact with respect to services furnished to two or more beneficiaries. (iv) In any of the circumstances specified in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, the claims may be aggregated only if the claims have previously been decided by a carrier hearing officer(s) and a request for ALJ hearing has been made within 60 days after receipt of the carrier hearing officer decision(s). Moreover, in a request for ALJ hearing, the appellants must specify the claims that they seek to aggregate. (c) The determination as to whether the amount in controversy is $100 or more is made by the carrier hearing officer. The determination as to whether the amount in controversy is $500 or more is made by the ALJ. (d) In determining the amount in controversy under paragraph (b) of this section, the ALJ will also make the determination as to what constitutes “similar or related services” or “common issues of law and fact.” (e) When a civil action is filed by either an individual appellant or two or more appellants, the Secretary may assert that the aggregation principles contained in this subpart may be applied to determine the amount in controversy for judicial review ($1000). (f) Notwithstanding the provisions of paragraphs (a)(1) and (b)(1) of this section, when payment is made for certain excluded services under §411.400 of this chapter or the liability of the beneficiary for those services is limited under §411.402 of this chapter, the amount in controversy is computed as the amount that would have been charged the beneficiary for the items or services in question, less any deductible and coinsurance amounts applicable in the particular case, had such expenses not been paid under §411.400 of this chapter or had such liability not been limited under §411.402 of this chapter. (g) Under this subpart, an appellant may not combine part A and part B claims together to meet the requisite amount in controversy for a carrier hearing or ALJ hearing. HMO, CMP and HCPP appellants under part 417 of this chapter may combine part A and part B claims together to meet the requisite amount in controversy for a hearing. [59 FR 12182, Mar. 16, 1994] (a) A request for a carrier hearing is any clear expression in writing by a claimant asking for a hearing to adjudicate a claim when not acted upon with reasonable promptness or by a party to a review determination who states, in effect, that he or she is dissatisfied with the carrier's review determination and wants further opportunity to appeal the matter to the carrier. (b) The hearing request must be filed at an office of the carrier or at an office of SSA or CMS. (c) Except when a carrier hearing is held because the carrier did not act upon a claim with reasonable promptness, a party to the review determination may request a carrier hearing within six months after the date of the notice of the review determination. The carrier may, upon request by the party affected, extend the period for filing the request for hearing. [59 FR 12183, Mar. 16, 1994, as amended at 62 FR 25855, May 12, 1997] The parties to a hearing shall be the persons who were parties to the carrier's review determination (§405.808) which is in question. Any other person may be made a party if that person's rights with respect to supplementary medical insurance benefits may be prejudiced by the decision. [39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994] Any hearing provided for in this subpart shall be conducted by a hearing officer designated by the appropriate official of the carrier. [39 FR 12097, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, and amended at 59 FR 12183, Mar. 16, 1994] A hearing officer shall not conduct a hearing in any case in which he is prejudiced or partial with respect to any party, or if he has any interest in the matter before him. Notice of any objection with respect to the hearing officer who will conduct the hearing shall be made by the objecting party at his earliest opportunity. The hearing officer shall consider such objection and shall, at his discretion, withdraw. If the hearing officer withdraws, the appropriate official of the carrier shall designate another hearing officer to conduct the hearing. If the hearing officer does not withdraw, the objecting party may present his objections to the carrier for consideration at any time prior to the issuance of a decision. The carrier shall review the request and take appropriate action. The fact that a hearing officer is an employee of the carrier may not serve as prima facie cause for disqualification. [32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994] (a) Time and place. The hearing officer shall fix a time and place for the hearing reasonably convenient to the requesting party and not inconsistent with the public interest. (b) Adjournment or postponement. The hearing officer may, for a good and sufficient reason, fix a new time and/or place for the hearing; he may change the time and place for the hearing or adjourn the hearing on his own motion upon reasonable notification to the parties. [32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994] The notice of hearing is to include notice of the time and place of the hearing; information as to the specific issues to be determined; and the matters on which findings will be made and conclusions will be reached. The notice is to contain sufficient information about the hearing procedure (including the party's right to representation) for effective preparation for the hearing. [32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994] (a) General. Hearings shall be open to the parties and to such other persons as the hearing officer deems necessary and proper for the orderly and efficient conduct of the hearing. The hearing officer shall inquire fully into the matters at issue and shall receive in evidence the testimony of witnesses and any documents which are relevant and material to such matters. The parties shall be provided an opportunity to enter any objection to the inclusion of any document. The order in which evidence and allegations shall be presented and the procedure at the hearing, except as this subpart otherwise expressly provides, shall be at the discretion of the hearing officer and of such nature as to afford the parties a proper hearing. (b) Evidence. Evidence may be received at the hearing even though inadmissible under rules of evidence applicable to court procedures. (c) Witnesses. The hearing officer may examine the witnesses and shall allow the parties or their representatives to do so. If the hearing officer conducts the examination of a witness, he may allow the parties to suggest matters upon which they desire the witness to be questioned, and the hearing officer shall question the witness with respect to such matters if they are relevant and material to any issue pending for decision before him. (d) Oral argument and written allegations. The parties, upon their request shall be allowed a reasonable time for the presentation of oral argument or for the filing of briefs or other written statements or allegations of facts or law. (e) Consolidated issues. When one or more new issues are raised at any time after a request for hearing has been made, but before the mailing of notice of the decision, the hearing officer may, at his discretion, consider the issues along with the other issues pending before him on the same request for hearing. [32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994] If all parties waive their right to appear before the hearing officer and present evidence and contentions personally or by representative, it shall not be necessary for the hearing officer to give notice of or conduct a formal hearing as provided in §§405.825 through 405.830. A waiver of the right to appear is to be in writing and filed with the hearing officer or the carrier. Such waiver may be withdrawn by a party at any time prior to the mailing of notice of the decision in the case. Even though all of the parties have filed a waiver of the right to appear and present evidence and contentions at a hearing before the hearing officer, the hearing officer may, nevertheless, give notice of a time and place and conduct a hearing as provided in §§405.825 through 405.830, if he believes that the personal appearance and testimony of the party or parties would assist him to ascertain the facts at issue in the case. For purposes of this section, failure of the parties to appear shall not be cause for a finding of abandonment and the hearing officer shall make his decision on the basis of all evidence adduced. [32 FR 18028, Dec. 16, 1967. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] (a) By application of party. With the approval of the hearing officer, a request for a hearing may be withdrawn or dismissed at any time prior to the mailing of notice of the decision upon the application of the party or parties filing the request for such hearing. A party may request a dismissal by filing a written notice of such request with the carrier, the hearing officer or orally stating such request at the hearing. The dismissal of a request for hearing shall be binding unless vacated (see paragraph (d) of this section). (b) Dismissal by abandonment of party. A hearing officer may dismiss a request for hearing upon abandonment by the party or parties who filed the request. A party shall be deemed to have abandoned a request for hearing, other than where personal appearance is waived in accordance with §405.831, if neither the party nor his representative appears at the time and place fixed for the hearing and within 10 days after the mailing of a notice to him by the hearing officer to show cause, such party does not show good and sufficient cause for such failure to appear and failure to notify the hearing officer prior to the time fixed for hearing that he cannot appear. (c) Dismissal for cause. The hearing officer may, on his own motion, dismiss a hearing request, either entirely or as to any stated issue, under either of the following circumstances: (1) Where the party requesting a hearing is not a proper party under §405.822 or does not otherwise have a right to a hearing under section 1842(b)(3)(C) of the Act; or (2) Where the party who filed the hearing request dies and there is no information before the hearing officer showing that an individual who is not a party may be prejudiced by the carrier's determination. (d) Dismissal without prejudice. The hearing officer may on his own motion dismiss without prejudice a hearing request where the amount in controversy is less than $100. (e) Vacation of dismissal. A hearing officer may, on request of a party and for good and sufficient cause shown, vacate any dismissal of a request for hearing at any time within 6 months from the date of mailing notice of the dismissal to the party requesting the hearing at his last known address. [32 FR 18028, Dec. 16, 1967, as amended at 39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994; 62 FR 25855, May 12, 1997] A complete record of the proceedings at the carrier hearing is made. The testimony is transcribed and copies of other documentary evidence are reproduced in any case when directed by the hearing officer, the carrier, or CMS. The record will also be transcribed and reproduced at the request of any party to the hearing provided the requesting party bears the cost. [62 FR 25853, May 12, 1997] (a) As soon as practicable after the close of a carrier hearing, the carrier hearing officer issues a decision in the case based upon the evidence presented at the hearing or otherwise included in the hearing record. The decision is issued as a written notice to the parties and contains— (1) Findings of fact, (2) A statement of reasons, and (3) Notification to the parties of their right to an ALJ hearing when the amount remaining in controversy is at least $500. (b) A copy of the decision is mailed to the parties to the hearing at their last known addresses. [62 FR 25854, May 12, 1997] The carrier hearing officer's decision is binding upon all parties to the hearing unless— (a) A request for an ALJ hearing is filed in accordance with §405.855, or (b) The decision is revised in accordance with §405.841. [62 FR 25854, May 12, 1997] The carrier hearing officer, in adjudicating Medicare Part B claims, complies with all of the provisions of, and regulations issued under, title XVIII of the Act, as well as with CMS Rulings, national coverage decisions, and other policy statements, instructions, and guides issued by CMS. [62 FR 25854, May 12, 1997] An initial or review determination of a carrier or a decision of a hearing officer may be reopened by such carrier or hearing officer: (a) Within 12 months from the date of the notice of such initial or review determination or decision to the party to such determination or decision; or (b) After such 12-month period, but within 4 years from the date of the notice of the initial determination to the party to such determination, upon establishment of good cause for reopening such determination or decision (see 20 CFR 404.988(b) and 404.989); or (c) At any time, when: (1) Such initial or review determination or decision was procured by fraud or similar fault of the beneficiary or some other person, or (2) Such initial or review determination or decision is unfavorable, in whole or in part, to the party thereto, but only for the purpose of correcting a clerical error or error on the face of the evidence on which such determination or decision was based. [39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 59 FR 12183, Mar. 16, 1994; 62 FR 25855, May 12, 1997] (a) Notice. When any determination or decision is reopened as provided in §405.841, notice of such reopening shall be mailed to the parties to such determination or decision at their last known addresses. A notice of revision following a reopening of a decision, shall be mailed to the parties and shall state the basis for the revised determination or decision. (b) Effect of revised determination. The revision of a determination (see §405.841) shall be binding upon all parties thereto unless a party files a written request for a hearing with respect to a revised determination when the amount in controversy is $100 or more. [32 FR 18028, Dec. 16, 1967, as amended at 39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977; 62 FR 25855, May 12, 1997] Change of a legal interpretation or administrative ruling upon which a determination or decision was made shall not be considered as good and sufficient reason for reopening the determination or decision. (a) Conditions for use of expedited appeals process (EAP). A party may use the EAP set forth in §405.718 of this chapter to request court review in place of the ALJ hearing or Departmental Appeals Board (DAB) review if the following conditions are met: (1) The carrier hearing officer has made a decision; an ALJ has made a hearing decision; or DAB review has been requested, but a final decision has not been issued. (2) The filing entity is a party referred to in §405.718(d) of this chapter. (3) The party has filed a request for an ALJ hearing in accordance with §405.855, or DAB review in accordance with 20 CFR 404.968. (4) The amount remaining in controversy is $1,000 or more. (5) If there is more than one party to the hearing decision, each party concurs, in writing, with the request for an EAP. (b) Content of the request for EAP. The request for an EAP: (1) Alleges that there are no material issues of fact in dispute; and (2) Asserts that the only factor precluding a decision favorable to the party is a statutory provision that is unconstitutional or a regulation, national coverage decision under section 1862(a)(1) of the Act, or CMS Ruling that is invalid. [62 FR 25854, May 12, 1997] (a) Right to hearing. A party to the carrier hearing has a right to a hearing before an ALJ if— (1) The party files a written request for an ALJ hearing within 60 days after receipt of the notice of the carrier hearing decision; and (2) The amount remaining in controversy is $500 or more. (b) Place of filing hearing request. The request for an ALJ hearing must be made in writing and filed with the carrier that issued the decision, a Social Security office, or, in the case of a qualified railroad retirement beneficiary, an office of the Railroad Retirement Board. (c) Effect of ALJ hearing decision. (1) An ALJ's decision is binding on all parties to the hearing unless— (i) The DAB reviews the ALJ decision; (ii) The DAB does not review the ALJ decision, and the party requests judicial review; (iii) The decision is revised by the DAB or an ALJ in accordance with the provisions of §405.750 of this chapter; or (iv) The expedited appeals process is used. [62 FR 25854, May 12, 1997] Regulations beginning at 20 CFR 404.967 regarding SSA Appeals Council Review are applicable to DAB review of matters addressed by this subpart. [62 FR 25854, May 12, 1997] (a) General rule. To the extent authorized by sections 1869, 1876(c)(5)(B), and 1879(d) of the Act, a party to a DAB decision, or an ALJ decision if the DAB does not review the ALJ's decision, may obtain a court review if the amount remaining in controversy is $1,000 or more. A party may obtain court review by filing a civil action in a district court of the United States in accordance with the provisions of section 205(g) of the Act. The filing procedure is set forth in 20 CFR 422.210. (b) Prohibition against court review of certain Part B regulations or instructions. Under section 1869(b)(4) of the Act, a court may not review a regulation or instruction that relates to a method of payment under Part B if the regulation was promulgated, or the instruction issued, before January 1, 1981. [62 FR 25854, May 12, 1997] (a) General rule. (1) An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under title XVIII of the Act. (2) An NCD does not include a determination of what code, if any, is assigned to a particular item or service covered under title XVIII or a determination for the amount of payment made for a particular item or service. (3) NCDs are made under section 1862(a)(1) of the Act or other applicable provisions of the Act. (4) An NCD is binding on all Medicare carriers, fiscal intermediaries, QIOs, HMOs, CMPs, HCPPs, the Medicare Appeals Council, and ALJs. (b) Review by ALJ. (1) An ALJ may not disregard, set aside, or otherwise review an NCD. (2) An ALJ may review the facts of a particular case to determine whether an NCD applies to a specific claim for benefits and, if so, whether the NCD is applied correctly to the claim. (c) Review by Court. For initial determinations and NCD challenges under section 1862(a)(1) of the Act, arising before October 1, 2002, a court's review of an NCD is limited to whether the record is incomplete or otherwise lacks adequate information to support the validity of the decision, unless the case is remanded to the Secretary to supplement the record regarding the NCD. In these cases, the court may not invalidate an NCD except upon review of the supplemental record. [68 FR 63716, Nov. 7, 2003] A party to an initial determination, informal review or hearing as provided in §§405.803 through 405.934, may appoint as his representative in any such proceeding any person qualified under §405.871. Where the representative is an attorney, in the absence of information to the contrary, his representation that he has such authority shall be accepted as evidence of the attorney's authority to represent a party. Any individual may be appointed to act as representative in accordance with §405.870, unless he is disqualified or suspended from acting as a representative in proceedings before the SSA or the CMS or unless otherwise prohibited by law. [39 FR 12098, Apr. 3, 1974. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] A representative, appointed and qualified as provided in §§405.870 and 405.871, may make or give, on behalf of the party he represents, any request or notice relative to any proceeding before the carrier including review and hearing. A representative shall be entitled to present evidence and allegations as to facts and law in any proceeding affecting the party he represents and to obtain information with respect to the claim of such party to the same extent as such party. Notice to any party or any action, determination, or decision, or request to any party for the production of evidence, shall be sent to the representative of such party. (a) An entity serving as a National Supplier Clearinghouse must act promptly to determine if any entity submitting a request for a billing number as a Medicare supplier of part B items meets the standards set forth in part 424. Effective July 1, 1993, the National Supplier Clearinghouse must accept, reject or request additional information within 15 days of the receipt of an enrollment application. (b) If the National Supplier Clearinghouse disallows an entity's request for a billing number or revokes, with the concurrence of CMS, an entity's billing number, the National Supplier Clearinghouse notifies the entity by certified mail. Revocation is effective 15 days after the National Supplier Clearinghouse mails notice of its determination. The carrier disallows payment for items furnished by the supplier beginning with that effective date. The notice must inform the entity of the reason for the rejection or revocation, its right to appeal, the date by which it must file that appeal (90 days after the postmark of the notice) and the address to which the appeal must be sent in writing. (c) A fair hearing officer not involved in the original determination to disallow an entity's request for a billing number, or to revoke an entity's billing number, must schedule a hearing to be held within one week of receipt of an appeal, or later at the request of the entity. Both the entity and carrier may offer evidence. The hearing officer issues notice of his/her decision within 2 weeks of the hearing. The notice is sent by certified letter to CMS, the carrier, and the appealing entity. This notice must include information about the supplier's further right to appeal, the carrier's right to appeal, the date by which the appeal must be filed (90 days after the postmark of the notice) and the address to which the appeals must be sent in writing. Either the carrier or entity may appeal the hearings officer's decision to CMS. (d) A CMS official, designated by the Administrator of CMS, must make an appeal decision based on the evidence presented to the fair hearing officer and his or her decision. The CMS official requests any additional information he or she deems necessary from either the carrier or the entity within two weeks of receipt by the CMS of the appeal. Notice of the CMS official's decision— (1) Is issued within two weeks of when the last information is received is received by the CMS official, or four weeks of when the information is requested, whichever is shorter, unless the party appealing the fair hearing decision requests a delay; (2) Is sent by the CMS official by certified mail to both the carrier and the entity; and (3) Contains information on any further appeals the entity and carrier may have. (e) A billing number is not issued, or remains revoked, and payment is not made, for items or services furnished by any entity which a carrier determines does not qualify for a billing number, until the carrier (upon reapplication of the entity), a fair hearing officer, or a CMS official designated to hear such appeals, determines that the entity qualifies for a billing number. Any claims for items or services furnished after revocation of the supplier's billing number and submitted by the entity during the appeals period are held and not processed, i.e., are neither approved, denied or developed, until all administrative appeals have been exhausted. If an entity is determined not to have qualified for a billing number in one period but to have qualified in another, the carrier pays for claims for items sold or rented to beneficiaries during the period the entity qualified as a supplier. If there is evidence of an overpayment, see subpart C of part 405 of this Chapter. (f) A billing number may be reinstated after revocation when an entity completes a corrective action plan, to which CMS has agreed, and provided sufficient assurance of its intent to comply fully with the supplier standards. [57 FR 27305, June 18, 1992] (a) CMS's acceptance of the FDA categorization of a device as an experimental/investigational (Category A) device under §405.203 is a national coverage decision under section 1862(a)(1) of the Act. (b) CMS's acceptance of the FDA categorization of a device as an experimental/investigational (Category A) device under §405.203 is an aspect of an initial determination that, under section 1862 of the Act, payment may not be made. (c) In accordance with section 1869(b)(3)(A) of the Act, CMS's acceptance of the FDA categorization of a device as an experimental/investigational (Category A) device under §405.203 may not be reviewed by an administrative law judge. [60 FR 48424, Sept. 19, 1995]
Title 42: Public Health
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart H—Appeals Under the Medicare Part B Program
§ 405.801 Part B appeals—general description.
§ 405.802 Definitions.
§ 405.803 Initial determination.
§ 405.804 Notice of initial determination.
§ 405.805 Parties to the initial determination.
§ 405.806 Effect of Initial Determination.
§ 405.807 Request for review of initial determination.
§ 405.808 Parties to the review.
§ 405.809 Opportunity to submit evidence.
§ 405.810 Review determination.
§ 405.811 Notice of review determination.
§ 405.812 Effect of review determination.
§ 405.815 Amount in controversy for carrier hearing, ALJ hearing and judicial review.
§ 405.817 Principles for determining amount in controversy.
§ 405.821 Request for carrier hearing.
§ 405.822 Parties to a carrier hearing.
§ 405.823 Carrier hearing officer.
§ 405.824 Disqualification of carrier hearing officer.
§ 405.825 Location of carrier hearing.
§ 405.826 Notice of carrier hearing.
§ 405.830 Conduct of the carrier hearing.
§ 405.831 Waiver of right to appear at carrier hearing and present evidence.
§ 405.832 Dismissal of request for carrier hearing.
§ 405.833 Record of carrier hearing.
§ 405.834 Carrier hearing officer's decision.
§ 405.835 Effect of carrier hearing officer's decision.
§ 405.836 Authority of the carrier hearing officer.
§ 405.841 Reopening initial or review determination of the carrier, and decision of a carrier hearing officer.
§ 405.842 Notice of reopening and revision.
§ 405.850 Change of ruling or legal precedent.
§ 405.853 Expedited appeals process.
§ 405.855 ALJ hearing.
§ 405.856 Departmental Appeals Board (DAB) review.
§ 405.857 Court review.
§ 405.860 Review of a national coverage determination (NCD).
§ 405.870 Appointment of representative.
§ 405.871 Qualifications of representatives.
§ 405.872 Authority of representatives.
§ 405.874 Appeals of carrier decisions that supplier standards are not met.
§ 405.877 Appeal of a categorization of a device.
