42 C.F.R. Subpart G—Reconsiderations and Appeals Under Medicare Part A
Title 42 - Public Health
Authority: Secs. 1102, 1155, 1869(b), 1871, 1872, and 1879 of the Social Security Act (42 U.S.C. 1302, 1320c–4, 1395ff(b), 1395hh, 1395ii, and 1395pp).
Source: 37 FR 5814, Mar. 22, 1972, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977.
(a) This subpart implements section 1869 of the Social Security Act. Section 1869(a) provides that the Secretary will make determinations about the following matters, and section 1869(b) provides for a hearing for an individual who is dissatisfied with the Secretary's determination as to: (1) Whether the individual is entitled to hospital insurance (part A) or supplementary medical insurance (part B) under title XVIII of the Act; or (2) The amount payable under hospital insurance. (b) This subpart establishes the procedures governing initial determinations, reconsidered determinations, hearings, and final agency review, and the reopening of determinations and decisions that are applicable to matters arising under paragraph (a) of this section. (c) Subparts J and R of 20 CFR part 404 (dealing with determinations, the administrative review process and representation of parties) are also applicable to matters arising under paragraph (a) of this section, except to the extent that specific provisions are contained in this subpart. (d) Definitions. As used in subpart G of this part, the term— Appellant designates the beneficiary, provider or other person or entity that has filed an appeal concerning a particular determination of benefits under Medicare part A. Designation as an appellant does not in itself convey standing to appeal the determination in question. 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 a 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 provider appellants to meet the minimum amount in controversy needed for a hearing, means like or coordinated services or items provided to the same beneficiary by the appellants. [55 FR 11020, Mar. 26, 1990, as amended at 59 FR 12181, Mar. 16, 1994] After a request for payment under part A of title XVIII of the Act is filed with the intermediary by or on behalf of the individual who received inpatient hospital services, extended care services, or home health services, and the intermediary has ascertained whether the items and services furnished are covered under part A of title XVIII, and where appropriate, ascertained and made payment of amounts due or has ascertained that no payments were due, the individual will be notified in writing of the initial determination in his case. In addition, if the items or services furnished such individual are not covered under part A of title XVIII by reason of §411.15(g) or §411.15(k) and payment may not be made for such items or services under §411.400 only because the requirements of §411.400(a)(2) are not met, the provider of services which furnished such items or services will be notified in writing of the initial determination in such individual's case. These notices shall be mailed to the individual and the provider of services at their last known addresses and shall state in detail the basis for the determination. Such written notices shall also inform the individual and the provider of services of their right to reconsideration of the determination if they are dissatisfied with the determination. [55 FR 11020, Mar. 26, 1990] (a) Applications and entitlement of individuals. An initial determination with respect to an individual includes the following— (1) A determination with respect to entitlement to hospital insurance or supplementary medical insurance; (2) A disallowance of an individual's application for entitlement to hospital or supplementary medical insurance, if the individual fails to submit evidence requested by SSA to support the application. (SSA will specify in the initial determination the conditions of entitlement that the applicant failed to establish by not submitting the requested evidence); (3) A denial of a request for withdrawal of an application for hospital or supplementary medical insurance; (4) A denial of a request for cancellation of a “request for withdrawal”; and (5) A determination as to whether an individual, previously determined to be entitled to hospital or supplementary medical insurance, is no longer entitled to such benefits, including a determination based on nonpayment of premiums. (b) Requests for payment by or on behalf of individuals. An initial determination with respect to an individual includes any determination made on the basis of a request for payment by or on behalf of the individual under part A of Medicare, including a determination with respect to: (1) The coverage of items and services furnished; (2) The amount of an applicable deductible; (3) The application of the coinsurance feature; (4) The number of days of inpatient hospital benefits utilized during a spell of illness or for purposes of the inpatient psychiatric hospital 190-day lifetime maximum; (5) The number of days of the 60-day lifetime reserve utilized for inpatient hospital coverage; (6) The number of days of posthospital extended care benefits utilized; (7) The number of home health visits utilized; (8) The physician certification requirement; (9) The request for payment requirement; (10) The beginning and ending of a spell of illness, including a determination made under the presumptions established under §409.60(c)(2) of this chapter, as specified in §409.60(c)(4) of this chapter. (11) The medical necessity of services (See parts 466 and 473 of this chapter for provisions pertaining to initial and reconsidered determinations made by a QIO); (12) When services are excluded from coverage as custodial care (§411.15(g)) or as not reasonable and necessary (§411.15(k)), whether the individual or the provider of services who furnished the services, or both, knew or could reasonably have been expected to know that the services were excluded from coverage (see §411.402); (13) Any other issues having a present or potential effect on the amount of benefits to be paid under part A of Medicare, including a determination as to whether there has been an overpayment or underpayment of benefits paid under part A, and if so, the amount thereof; and (14) Whether a waiver of adjustment or recovery under sections 1870 (b) and (c) of the Act is appropriate when an overpayment of hospital insurance benefits or supplementary medical insurance benefits (including a payment under section 1814(e) of the Act) has been made with respect to an individual. (c) Initial determination with respect to a provider of services. An initial determination with respect to a provider of services shall be a determination made on the basis of a request for payment filed by the provider under part A of Medicare on behalf of an individual who was furnished items or services by the provider, but only if the determination involves the following: (1) A finding by the intermediary that such items or services are not covered by reason of §411.15(g) or §411.15(k); and (2) A finding by the intermediary that either such individual or such provider of services, or both, knew or could reasonably have been expected to know that such items or services were excluded from coverage under the program. [55 FR 11020, Mar. 26, 1990] An initial determination under Part A of Medicare does not include determinations relating to: (a) The reasonable cost of items or services furnished under Part A of Medicare; (b) Whether an institution or agency meets the conditions for participation in the program; (c) Whether an individual is qualified for use of the expedited appeals process as provided in §405.718; (d) An action regarding compromise of a claim arising under the Medicare program, or termination or suspension of collection action on such a claim under the Federal Claims Collection Act of 1966 (31 U.S.C. 3711). See 20 CFR 404.515 for overpayment claims against an individual, §405.376 for overpayment claims against a provider, physician or other supplier, and §408.110 for claims concerning unpaid Medicare premiums; (e) The transfer or discharge of residents of skilled nursing facilities in accordance with §483.12 of this chapter; or (f) The preadmission screening and annual resident review processes required by part 483 subparts C and E of this chapter. [45 FR 73932, Nov. 7, 1980; 46 FR 24565, May 1, 1981, as amended at 52 FR 22454, June 12, 1987; 52 FR 48123, Dec. 18, 1987; 57 FR 56504, Nov. 30, 1992; 61 FR 63749, Dec. 2, 1996] (a) General rule. A decision of a utilization review committee is a medical determination by a staff committee of the provider or a group similarly composed and does not constitute a determination by the Secretary within the meaning of section 1869 of the Act. The decision of a utilization review committee may be considered by CMS along with other pertinent medical evidence in determining whether or not an individual has the right to have payment made under Part A of title XVIII. (b) Applicability under the prospective payment system. CMS may consider utilization review committee decisions related to inpatient hospital services paid for under the prospective payment system (see part 412 of this chapter) only as those decisions concern: (1) The appropriateness of admissions resulting in payments under subparts D, E and G of part 412 of this chapter. (2) The covered days of care involved in determinations of outlier payments under §412.80(a)(1)(i) of this chapter; and (3) The necessity of professional services furnished in high cost outliers under §412.80(a)(1)(ii) of this chapter. [48 FR 39831, Sept. 1, 1983] (a) The initial determination under §405.704 (a) or (b) shall be binding upon the individual on whose behalf payment under part A has been requested or, if such individual is deceased, upon the representative of such individual's estate, unless it is reconsidered in accordance with §§405.710 through 405.717 or revised in accordance with §405.750. Such individual (or the representative of such individual's estate if the individual is deceased) shall be the party to such initial determination. (b) The initial determination under §405.704(c) shall be binding upon the provider of services unless it is reconsidered in accordance with §§405.710 through 405.717 or revised in accordance with §405.750. Such provider of services shall be the party to such initial determination. [55 FR 11021, Mar. 26, 1990, as amended at 62 FR 25855, May 12, 1997] (a) An individual who is a party to an initial determination, as specified in §405.704 (a) and (b), (or if such individual is deceased, the representative of such individual's estate) and who is dissatisfied with the initial determination may request a reconsideration of such determination in accordance with §405.711 regardless of the amount in controversy. (b) A provider of services who is a party to an initial determination (as specified in §405.704(c)) and who is dissatisfied with such initial determination may request a reconsideration of such determination in accordance with §405.711, regardless of the amount in controversy, but only if the individual on whose behalf the request for payment was made has indicated in writing that he does not intend to request reconsideration of the intermediary's initial determination on such request for payment, or if the intermediary has made a finding (see §405.704(c)) that such individual did not know or could not reasonably have been expected to know that the expenses incurred for the items or services for which such request for payment was made were not reimbursable by reason of §411.15(g) or §411.15(k). [55 FR 11021, Mar. 26, 1990] The request for reconsideration shall be made in writing and filed at an office of the SSA or the CMS or, in the case of a qualified railroad retirement beneficiary (see 20 CFR 404.368) filed at an office of the Railroad Retirement Board, within 60 days after the date of receipt of notice of initial determination, unless such time is extended as provided in §405.712. A request for reconsideration which is filed with the intermediary which received the request for payment submitted on behalf of the individual is considered to have been filed with the CMS as of the date it is filed with the intermediary. For purposes of this section, the date of receipt of notice of the initial determination shall be presumed to be 5 days after the date of such notice, unless there is a reasonable showing to the contrary. [41 FR 47917, Nov. 1, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] If a party to an initial determination desires to file a request for reconsideration after the time for filing such request in accordance with §405.711 has passed, such party may file a petition with the SSA or the CMS or, in the case of a qualified railroad retirement beneficiary, with the Railroad Retirement Board, for an extension of time for the filing of such request. Such petition shall be in writing and shall state the reasons why the request for reconsideration was not filed within the required time. For good cause shown, the CMS may extend the time for filing the request for reconsideration. [37 FR 5814, Mar. 22, 1972. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] A request for reconsideration may be withdrawn by the party to the initial determination who filed the request or by his representative provided that the withdrawal is made in writing and filed at an office of the SSA or the CMS or, in the case of a qualified railroad retirement beneficiary, with the Railroad Retirement Board prior to the date of the mailing of the notice of reconsidered determination. A withdrawal filed with the intermediary which received the request for payment submitted on behalf of the individual is considered to have been filed with the CMS as of the date it is filed with the intermediary. [40 FR 1025, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] (a) In reconsidering an initial determination, the CMS shall review such initial determination, the evidence and findings upon which such determination was based, and any additional evidence submitted to the SSA or the CMS or otherwise obtained by the intermediary or the CMS; and shall make a determination affirming or revising, in whole or in part, such initial determination. (b) If the request for reconsideration is filed by an individual with respect to an initial determination specified in §405.704(b)(12), the provider of services who furnished the items or services shall, prior to the making of the reconsidered determination, be made a party thereto. If pursuant to §405.710(b) a request for reconsideration is filed by a provider of services with respect to an individual determination under §405.704(c), the individual who was furnished the items or services shall, prior to the making of the reconsidered determination, be made a party thereto. [55 FR 11021, Mar. 26, 1990, as amended at 62 FR 25855, May 12, 1997] Written notice of the reconsidered determination shall be mailed by the CMS to the parties and their representatives at their last known addresses. Such notice shall state the specific reasons for the reconsidered determination and shall advise the parties of their right to a hearing if the amount in controversy is $100 or more, or, if appropriate, advise them of the requirements for use of the expedited appeals process (see §405.718). [40 FR 53387, Nov. 18, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] The reconsidered determination is binding upon all parties unless— (a) A request for a hearing is filed with SSA or CMS within 60 days after the date of receipt of notice of the reconsidered determination by the parties (for purposes of this section, the date of receipt of notice of the reconsidered determination is presumed to be 5 days after the date of the notice, unless it is shown that the notice was received earlier or later); or (b) The reconsidered determination is revised in accordance with §405.750; or (c) The expedited appeals process is used in accordance with §405.718. [62 FR 25852, May 12, 1997] (a) Conditions for use of expedited appeals process (EAP). A party may use the EAP to request court review in place of an administrative law judge (ALJ) hearing or Departmental Appeals Board (DAB) review if the following conditions are met: (1) CMS has made a reconsideration determination; 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). (3) The party has filed a request for an ALJ hearing in accordance with §405.722, 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 reconsideration determination or hearing decision, each party concurs, in writing, with the request for the EAP. (b) Content of the request for EAP. The request for the 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. (c) Place and time for requesting an EAP—(1) Place for filing request. The person must file a written request— (i) At an office of SSA or CMS; or (ii) If the person is in the Philippines, at the Veterans Administration Regional Office or with an ALJ; or (iii) If the person is a qualified railroad retirement beneficiary, at an office of the Railroad Retirement Board. (2) Time of filing request. The party may file a request for the EAP— (i) If the party has requested a hearing, at any time prior to receipt of the notice of the ALJ's decision; (ii) Within 60 days after the date of receipt of notice of the ALJ's decision or dismissal, unless the time is extended in accordance with the standards set out in 20 CFR 404.925(c). For purposes of this section, the date of receipt of the notice is presumed to be 5 days after the date on the notice, unless it is shown that the notice was received later; or (iii) If the party has requested DAB review, at any time prior to receipt of notice of the Board's decision. (d) Parties to the EAP. The parties to the EAP are the persons who were parties to the reconsideration determination and, if appropriate, to the hearing. (e) Determination on request for EAP. (1) For EAP requests initiated at the ALJ level, an ALJ determines whether all conditions of paragraphs (a) and (b) of this section are met. (2) If a hearing decision has been issued, the DAB determines whether all conditions of paragraphs (a) and (b) of this section are met. (f) ALJ or DAB certification for the EAP. If the party meets the requirements for the EAP, the ALJ or the DAB, as appropriate, certifies the case in writing stating that: (1) The facts involved in the claim are not in dispute; (2) Except as indicated in paragraph (f)(3) of this section, CMS's interpretation of the law is not in dispute; (3) The sole issue(s) in dispute is the constitutionality of a statutory provision or the validity of a regulation, CMS Ruling, or national coverage decision based on section 1862(a)(1) of the Act. (4) Except for the provision challenged, the right(s) of the party is established; and (5) The determination or decision made by the ALJ or DAB is final for purposes of seeking judicial review. (g) Effect of ALJ or DAB certification. (1) Following the issuance of the certification described in paragraph (f) of this section, the party waives completion of the remaining steps of the administrative appeals process. (2) The 60-day period for filing a civil suit in a Federal district court begins on the date of receipt of the ALJ or DAB certification. (h) Effect of a request for EAP that does not result in certification. If a request for the EAP does not meet all the conditions for use of the process, the ALJ or DAB so advises the party and treats the request as a request for hearing or DAB review, as appropriate. [62 FR 25852, May 12, 1997] A person has a right to a hearing regarding any initial determination made under §405.704 if: (a) Such initial determination has been reconsidered by the CMS; (b) Such person was a party to the reconsidered determination; (c) Such person or his representative has filed a written request for a hearing in accordance with the procedure described in §405.722; and (d) The amount in controversy is $100 or more. [40 FR 1025, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] The request for a hearing shall be made in writing and filed at an office of the SSA or the CMS or with a ALJ, or, in the case of a qualified railroad retirement beneficiary, at an office of the Railroad Retirement Board. Such request must be filed within 60 days after the date of receipt of notice of the reconsidered determination by such individual, except where the time is extended as provided in 20 CFR 404.933(c). For purposes of this section, the date of receipt of notice of the reconsidered determination shall be presumed to be 5 days after the date of such notice, unless there is a reasonable showing to the contrary. [45 FR 73933, Nov. 7, 1980, as amended at 62 FR 25855, May 12, 1997] Regulations beginning at 20 CFR 404.967 regarding SSA Appeals Council Review are also applicable to DAB review of matters addressed by this subpart. [62 FR 25852, May 12, 1997] (a) To the extent authorized by sections 1869, 1876(c)(5)(B), and 1879(d) of the Act, a party to a Departmental Appeals Board (DAB) decision or an ALJ decision if the DAB does not review the ALJ 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 at 20 CFR 422.210. (b) A party to a reconsidered determination or an ALJ hearing decision may obtain a court review if the amount in controversy is $1,000 or more, and he or she requests and meets the conditions for the expedited appeals process set forth in §405.718. [62 FR 25852, 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 has been 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 has been 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 63715, Nov. 7, 2003] (a) Individual appellants. For the purpose of determining whether an individual appellant meets the minimum amount in controversy needed for a hearing ($100), 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 intermediary and less any deductible and coinsurance amounts applicable in the particular case. (2) A single beneficiary may aggregate claims from two or more providers to meet the $100 hearing threshold and a single provider may aggregate claims for services provided to one or more beneficiaries to meet the $100 hearing threshold. (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 only if the claims have previously been reconsidered and a request for hearing has been made within 60 days after receipt of the reconsideration determination(s). (4) When requesting a hearing, the appellant must specify in his or her appeal request the specific claims to be aggregated. (b) Two or more appellants. As specified below, 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 a hearing ($100). 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 intermediary 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 provider(s) if the claims involve common issues of law and fact; (ii) Two or more providers may combine their claims if the claims involve the delivery of similar or related services to the same beneficiary; or (iii) Two or more providers 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 reconsidered and a request for hearing has been made within 60 days after receipt of the reconsideration determination(s). Moreover, in the request for 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 administrative law judge (ALJ). (d) In determining the amount in controversy under paragraph (b) of this section, the ALJ also makes 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 pursuant to §411.400 of this chapter or had such liability not been limited pursuant to §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 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 amounts in controversy for a hearing. [59 FR 12181, Mar. 16, 1994] For the purpose of determining whether a party to a reconsidered determination is entitled to a hearing, the amount in controversey after the reconsideration action rather than the amount in controversy initially at issue shall be controlling. [40 FR 1026, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977] The ALJ shall, without holding a hearing, dismiss the request for hearing if the request for hearing plainly shows that less than $100 is in controversy. If a hearing is held and the ALJ finds that the amount in controversy is less than $100, the ALJ shall dismiss the request for hearing and will not rule on the substantive issues involved in the appeal. [37 FR 5814, Mar. 23, 1972. Redesignated at 42 FR 52826, Sept. 30, 1977, as amended at 62 FR 25855, May 12, 1997] (a) Reopenings concerning applications and entitlement. A determination, or decision, or revised determination or decision made by the SSA concerning any matter under §405.704(a), may be reopened and revised under 20 CFR 404.988 (Conditions for reopening). (b) Reopenings concerning a request for payment. An initial, revised, or reconsidered determination of CMS, or a decision or revised decision of an ALJ or of the DAB, with respect to an individual's right concerning a request for payment under Medicare Part A, which is otherwise binding under 20 CFR 404.955 or 404.981 and §§405.708 or 405.717 of this subpart may be reopened: (1) Within 12 months from the date of the notice of the initial or reconsidered determination to the party to such determination; (2) After such 12-month period, but within 4 years after the date of the notice of the initial determination to the individual, upon establishment of good cause for reopening such determination or decision (see 20 CFR 404.988(b) and 404.989); or (3) At any time, when: (i) Such initial, revised, or reconsidered determination or such decision or revised decision is unfavorable, in whole or in part, to the party thereto, but only for the purpose of correcting clerical error or error on the face of the evidence on which such determination or decision was based; or (ii) Such initial, revised, or reconsidered determination or such decision or revised decision was procured by fraud or similar fault of the beneficiary or some other person. [45 FR 73933, Nov. 7, 1980, as amended at 61 FR 32348, June 24, 1996; 62 FR 25853, 25855, May 12, 1997] (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 G—Reconsiderations and Appeals Under Medicare Part A
§ 405.701 Basis, purpose and definitions.
§ 405.702 Notice of initial determination.
§ 405.704 Actions which are initial determinations.
§ 405.705 Actions which are not initial determinations.
§ 405.706 Decisions of utilization review committees.
§ 405.708 Effect of initial determination.
§ 405.710 Right to reconsideration.
§ 405.711 Time and place of filing request for reconsideration.
§ 405.712 Extension of time to request reconsideration.
§ 405.714 Withdrawal of request for reconsideration.
§ 405.715 Reconsidered determination.
§ 405.716 Notice of reconsidered determination.
§ 405.717 Effect of a reconsidered determination.
§ 405.718 Expedited appeals process.
§ 405.720 Hearing; right to hearing.
§ 405.722 Time and place of filing request for a hearing.
§ 405.724 Departmental Appeals Board (DAB) review.
§ 405.730 Court review.
§ 405.732 Review of a national coverage determination (NCD).
§ 405.740 Principles for determining the amount in controversy.
§ 405.745 Amount in controversy ascertained after reconsideration.
§ 405.747 Dismissal of request for hearing; amount in controversy less than $100.
§ 405.750 Time period for reopening initial, revised, or reconsidered determinations and decisions or revised decisions of an ALJ or the Departmental Appeals Board (DAB); binding effect of determination and decisions.
§ 405.753 Appeal of a categorization of a device.
