Source: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr;rgn=div6;view=text;node=42%3A4.0.1.1.10.1;idno=42;cc=ecfr
Timestamp: 2014-07-29 10:46:38
Document Index: 303091488

Matched Legal Cases: ['§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', '§441', 'art 440', '§441', '§440', '§441', '§435', '§483', '§441', 'art 486', '§441', '§440', '§489', '§441', '§440', 'arts 223', '§433', '§440', 'arts 223', '§431', '§431', '§441', '§440', '§405', '§482', '§491', '§405', '§405', '§441', '§440', '§431', '§431', '§441', '§441', '§441', '§440', '§440', '§441', '§440', '§440', '§440', '§441', '§441', '§435', '§441', '§441', 'art 440', '§482']

Subpart A—General ProvisionsContents§441.10 Basis.
§441.11 Continuation of FFP for institutional services.
§441.12 Inpatient hospital tests.
§441.13 Prohibitions on FFP: Institutionalized individuals.
§441.15 Home health services.
§441.16 Home health agency requirements for surety bonds; Prohibition on FFP.
§441.17 Laboratory services.
§441.18 Case management services.
§441.20 Family planning services.
§441.21 Nurse-midwife services.
§441.22 Nurse practitioner services.
§441.25 Prohibition on FFP for certain prescribed drugs.
§441.30 Optometric services.
§441.35 Organ transplants.
§441.40 End-stage renal disease.
§441.10 Basis.This subpart is based on the following sections of the Act which state requirements and limits on the services specified or provide Secretarial authority to prescribe regulations relating to services: (a) Section 1102 for end-stage renal disease (§441.40). (b) Section 1138(b) for organ procurement organization services (§441.13(c)). (c) Sections 1902(a)(10)(A) and 1905(a)(21) for nurse practitioner services (§441.22). (d) Sections 1902(a)(10)(D) and 1905(a)(7) for home health services (§441.15). (e) Section 1903(i)(1) for organ transplant procedures (§441.35). (f) Section 1903(i)(5) for certain prescribed drugs (§441.25). (g) Section 1903(i)(6) for prohibition (except in emergency situations) of FFP in expenditures for inpatient hospital tests that are not ordered by the attending physician or other licensed practitioner (§441.12). (h) Section 1903(i)(18) for the requirement that each home health agency provide the Medicaid agency with a surety bond (§441.16).(i) Section 1905(a)(4)(C) for family planning (§441.20). (j) Sections 1905 (a)(12) and (e) for optometric services (§441.30). (k) Section 1905(a)(17) for nurse-midwife services (§441.21). (l) Section 1905(a) (following (a)(24)) for prohibition of FFP in expenditures for certain services (§441.13). (m) Section 1905(a)(19) and 1915(g) of the Act for case management services as set forth in §441.18 and section 8435 of the Technical and Miscellaneous Revenue Act of 1988.
[60 FR 19862, Apr. 21, 1995, as amended at 63 FR 310, Jan. 5, 1998; 72 FR 68092, Dec. 4, 2007]
§441.11 Continuation of FFP for institutional services.(a) Basic conditions for continuation of FFP. FFP may be continued for up to 30 days after the effective date of termination or expiration of a provider agreement, if the following conditions are met: (1) The Medicaid payments are for beneficiaries admitted to the facility before the effective date of termination or expiration. (2) The State agency is making reasonable efforts to transfer those beneficiaries to other facilities or to alternate care. (b) When the 30-day period begins. The 30-day period begins on one of the following: (1) The effective date of termination of the facility's provider agreement by CMS; (2) The effective date of termination of the facility's Medicaid provider agreement by the Medicaid agency on its own volition; or (3) In the case of an ICF/IID, the later of—(i) The effective date of termination or nonrenewal of the facility's provider agreement by the Medicaid agency on its own volition; or (ii) The date of issuance of an administrative hearing decision that upholds the agency's termination or nonrenewal action. (c) Services for which FFP may be continued. FFP may be continued for any of the following services, as defined in subpart A of part 440 of this chapter: (1) Inpatient hospital services. (2) Inpatient hospital services for individuals age 65 or older in an institution for mental diseases. (3) Nursing facility services for individuals age 21 or older. (4) Nursing facility services for individuals age 65 or older in an institution for mental diseases. (5) Inpatient psychiatric services for individuals under age 21. (6) Nursing facility services for individuals under 21. (7) Intermediate care facility services for individuals with intellectual disabilities. [59 FR 56234, Nov. 10, 1994]
§441.12 Inpatient hospital tests.Except in an emergency situation (see §440.170(e)(1) of this chapter for definition), FFP is not available in expenditures for inpatient hospital tests unless the tests are specifically ordered by the attending physician or other licensed practitioner, acting within the scope of practice as defined under State law, who is responsible for the diagnosis or treatment of a particular patient's condition.
[46 FR 48554, Oct. 1, 1981]
§441.13 Prohibitions on FFP: Institutionalized individuals.(a) FFP is not available in expenditures for services for—(1) Any individual who is in a public institution, as defined in §435.1010 of this chapter; or (2) Any individual who is under age 65 and is in an institution for mental diseases, except an individual who is under age 22 and receiving inpatient psychiatric services under subpart D of this part. (b) With the exception of active treatment services (as defined in §483.440(a) of this chapter for residents of ICFs/IID and in §441.154 for individuals under age 21 receiving inpatient psychiatric services), payments to institutions for Individuals with Intellectual Disabilities or persons with related conditions and to psychiatric facilities or programs providing inpatient psychiatric services to individuals under age 21 may not include reimbursement for formal educational services or for vocational services. Formal educational services relate to training in traditional academic subjects. Subject matter rather than setting, time of day, or class size determines whether a service is educational. Traditional academic subjects include, but are not limited to, science, history, literature, foreign languages, and mathematics. Vocational services relate to organized programs that are directly related to the preparation of individuals for paid or unpaid employment. An example of vocational services is time-limited vocational training provided as a part of a regularly scheduled class available to the general public.(c) FFP is not available in expenditures for services furnished by an organ procurement organization on or after April 1, 1988, that does not meet the requirements of part 486 subpart G of this chapter. [43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17, 1986; 53 FR 6549, Mar. 1, 1988; 57 FR 54709, Nov. 20, 1992; 71 FR 31046, May 31, 2006; 71 FR 39229, July 12, 2006]
§441.15 Home health services.With respect to the services defined in §440.70 of this subchapter, a State plan must provide that— (a) Home health services include, as a minimum—(1) Nursing services; (2) Home health aide services; and (3) Medical supplies, equipment, and appliances. (b) The agency provides home health services to—(1) Categorically needy beneficiaries age 21 or over; (2) Categorically needy beneficiaries under age 21, if the plan provides skilled nursing facility services for them; individuals; and (3) Medically needy beneficiaries to whom skilled nursing facility services are provided under the plan. (c) The eligibility of a beneficiary to receive home health services does not depend on his need for or discharge from institutional care. (d) The agency providing home health services meets the capitalization requirements included in §489.28 of this chapter.
[43 FR 45229, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11, 1980; 63 FR 310, Jan. 5, 1998]
§441.16 Home health agency requirements for surety bonds; Prohibition on FFP.(a) Definitions. As used in this section, unless the context indicates otherwise—Assets includes but is not limited to any listing that identifies Medicaid beneficiaries to whom home health services were furnished by a participating or formerly participating HHA.Participating home health agency means a “home health agency” (HHA) as that term is defined at §440.70(d) of this subchapter.Surety bond means one or more bonds issued by one or more surety companies under 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225, provided the bond otherwise meets the requirements of this section.Uncollected overpayment means an “overpayment,” as that term is defined under §433.304 of this subchapter, plus accrued interest, for which the HHA is responsible, that has not been recouped by the Medicaid agency within a time period determined by the Medicaid agency.(b) Prohibition. FFP is not available in expenditures for home health services under §440.70 of this subchapter unless the home health agency furnishing these services meets the surety bond requirements of paragraphs (c) through (l) of this section.(c) Basic requirement. Except as provided in paragraph (d) of this section, each HHA that is a Medicaid participating HHA or that seeks to become a Medicaid participating HHA must—(1) Obtain a surety bond that meets the requirements of this section and instructions issued by the Medicaid agency; and(2) Furnish a copy of the surety bond to the Medicaid agency.(d) Requirement waived for Government-operated HHAs. An HHA operated by a Federal, State, local, or tribal government agency is deemed to have provided the Medicaid agency with a comparable surety bond under State law, and is therefore exempt from the requirements of this section if, during the preceding 5 years, the HHA has not had any uncollected overpayments.(e) Parties to the bond. The surety bond must name the HHA as Principal, the Medicaid agency as Obligee, and the surety company (and its heirs, executors, administrators, successors and assignees, jointly and severally) as Surety.(f) Authorized Surety and exclusion of surety companies. An HHA may obtain a surety bond required under this section only from an authorized Surety.(1) An authorized Surety is a surety company that—(i) Has been issued a Certificate of Authority by the U.S. Department of the Treasury in accordance with 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225 as an acceptable surety on Federal bonds and the Certificate has neither expired nor been revoked;(ii) Has not been determined by the Medicaid agency to be an unauthorized Surety for the purpose of an HHA obtaining a surety bond under this section; and(iii) Meets other conditions, as specified by the Medicaid agency.(2) The Medicaid agency may determine that a surety company is an unauthorized Surety under this section—(i) If, upon request by the Medicaid agency, the surety company fails to furnish timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a surety bond that an HHA presents to the Medicaid agency that shows the surety company as Surety on the bond;(ii) If, upon presentation by the Medicaid agency to the surety company of a request for payment on a surety bond and of sufficient evidence to establish the surety company's liability on the bond, the surety company fails to timely pay the Medicaid agency in full the amount requested up to the face amount of the bond; or(iii) For other good cause.(3) The Medicaid agency must specify the manner by which public notification of a determination under paragraph (f)(2) of this section is given and the effective date of the determination.(4) A determination by the Medicaid agency that a surety company is an unauthorized Surety under paragraph (f)(2) of this section—(i) Has effect only within the State; and(ii) Is not a debarment, suspension, or exclusion for the purposes of Executive Order No. 12549 (3 CFR 1986 Comp., p. 189).(g) Amount of the bond—(1) Basic rule. The amount of the surety bond must be $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services furnished under this subchapter for which FFP is available, whichever is greater.(2) Computation of the 15 percent: Participating HHA. The 15 percent is computed by the Medicaid agency on the basis of Medicaid payments made to the HHA for the most recent annual period for which information is available as specified by the Medicaid agency.(3) Computation of 15 percent: An HHA that seeks to become a participating HHA by obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA by purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent is computed on the basis of Medicaid payments made by the Medicaid agency to the participating or formerly participating HHA for the most recent annual period as specified by the Medicaid agency.(4) Computation of 15 percent: Change of ownership. For an HHA that undergoes a change of ownership (as “change of ownership” is defined by the State Medicaid agency) the 15 percent is computed on the basis of Medicaid payments made by the Medicaid agency to the HHA for the most recent annual period as specified by the Medicaid agency.(5) An HHA that seeks to become a participating HHA without obtaining assets or ownership interest. For an HHA that seeks to become a participating HHA without purchasing the assets or the ownership interest of a participating or formerly participating HHA, the 15 percent computation does not apply.(6) Exception to the basic rule. If an HHA's overpayment in the most recent annual period exceeds 15 percent, the State Medicaid agency may require the HHA to secure a bond in an amount up to or equal to the amount of the overpayment, provided the amount of the bond is not less than $50,000.(7) Expiration of the 15 percent provision. For an annual surety bond, or for a rider on a continuous surety bond, that is required to be submitted on or after June 1, 2005, notwithstanding any reference in this section to 15 percent as a basis for determining the amount of the bond, the amount of the bond or rider, as applicable, must be $50,000 or such amount as the Medicaid agency specifies in accordance with paragraph (g)(6) of this section, whichever amount is greater.(h) Additional requirements of the surety bond. The surety bond that an HHA obtains under this section must meet the following additional requirements:(1) The bond must guarantee that, upon written demand by the Medicaid agency to the Surety for payment under the bond and the Medicaid agency furnishing to the Surety sufficient evidence to establish the Surety's liability under the bond, the Surety will timely pay the Medicaid agency the amount so demanded, up to the stated amount of the bond.(2) The bond must provide that the Surety is liable for uncollected overpayments, as defined in paragraph (a), provided such uncollected overpayments are determined during the term of the bond and regardless of when the overpayments took place. Further, the bond must provide that the Surety remains liable if the HHA fails to furnish a subsequent annual bond that meets the requirements of this subpart or fails to furnish a rider for a year for which a rider is required to be submitted, or if the HHA's provider agreement terminates and that the Surety's liability shall be based on the last bond or rider in effect for the HHA, which shall then remain in effect for an additional 2-year period.(3) The bond must provide that the Surety's liability to the Medicaid agency is not extinguished by any of the following:(i) Any action by the HHA or the Surety to terminate or limit the scope or term of the bond. The Surety's liability may be extinguished, however, when—(A) The Surety furnishes the Medicaid agency with notice of such action not later than 10 days after receiving notice from the HHA of action by the HHA to terminate or limit the scope of the bond, or not later than 60 days before the effective date of such action by the Surety; or(B) The HHA furnishes the Medicaid agency with a new bond that meets the requirements of both this section and the Medicaid agency.(ii) The Surety's failure to continue to meet the requirements of paragraph (f)(1) of this section or the Medicaid agency's determination that the surety company is an unauthorized surety under paragraph (f)(2) of this section.(iii) Termination of the HHA's provider agreement described under §431.107 of this subchapter.(iv) Any action by the Medicaid agency to suspend, offset, or otherwise recover payments to the HHA.(v) Any action by the HHA to—(A) Cease operation;(B) Sell or transfer any assets or ownership interest;(C) File for bankruptcy; or(D) Fail to pay the Surety.(vi) Any fraud, misrepresentation, or negligence by the HHA in obtaining the surety bond or by the Surety (or by the Surety's agent, if any) in issuing the surety bond, except that any fraud, misrepresentation, or negligence by the HHA in identifying to the Surety (or to the Surety's agent) the amount of Medicaid payments upon which the amount of the surety bond is determined shall not cause the Surety's liability to the Medicaid agency to exceed the amount of the bond.(vii) The HHA's failure to exercise available appeal rights under Medicaid or to assign such rights to the Surety (provided the Medicaid agency permits such rights to be assigned).(4) The bond must provide that actions under the bond may be brought by the Medicaid agency or by an agent that the Medicaid agency designates.(i) Term and type of bond—(1) Initial term: Each participating HHA that is not exempted by paragraph (d) of this section must submit to the State Medicaid agency a surety bond for a term beginning January 1, 1998. If an annual bond is submitted for the initial term it must be effective for an annual period specified by the State Medicaid agency.(2) Type of bond. The type of bond required to be submitted by an HHA, under this section, may be either—(i) An annual bond (that is, a bond that specifies an effective annual period that corresponds to an annual period specified by the Medicaid agency); or(ii) A continuous bond (that is, a bond that remains in full force and effect from term to term unless it is terminated or canceled as provided for in the bond or as otherwise provided by law) that is updated by the Surety for a particular period, via the issuance of a “rider,” when the bond amount changes. For the purposes of this section, “Rider” means a notice issued by a Surety that a change to a bond has occurred or will occur. If the HHA has submitted a continuous bond and there is no increase or decrease in the bond amount, no action is necessary by the HHA to submit a rider as long as the continuous bond remains in full force and effect.(3) HHA that seeks to become a participating HHA. (i) An HHA that seeks to become a participating HHA must submit a surety bond before a provider agreement described under §431.107 of this subchapter can be entered into.(ii) An HHA that seeks to become a participating HHA through the purchase or transfer of assets or ownership interest of a participating or formerly participating HHA must also ensure that the surety bond is effective from the date of such purchase or transfer.(4) Change of ownership. An HHA that undergoes a change of ownership (as “change of ownership” is defined by the State Medicaid agency) must submit the surety bond to the State Medicaid agency by such time and for such term as is specified in the instructions of the State Medicaid agency.(5) Government-operated HHA that loses its waiver. A government-operated HHA that, as of January 1, 1998, meets the criteria for waiver of the requirements of this section but thereafter is determined by the Medicaid agency to not meet such criteria, must submit a surety bond to the Medicaid agency within 60 days after it receives notice from the Medicaid agency that it does not meet the criteria for waiver.(6) Change of Surety. An HHA that obtains a replacement surety bond from a different Surety to cover the remaining term of a previously obtained bond must submit the new surety bond to the Medicaid agency within 60 days (or such earlier date as the Medicaid agency may specify) of obtaining the bond from the new Surety for a term specified by the Medicaid agency.(j) Effect of failure to obtain, maintain, and timely file a surety bond. (1) The Medicaid agency must terminate the HHA's provider agreement if the HHA fails to obtain, file timely, and maintain a surety bond in accordance with this section and the Medicaid agency's instructions.(2) The Medicaid agency must refuse to enter into a provider agreement with an HHA if an HHA seeking to become a participating HHA fails to obtain and file timely a surety bond in accordance with this section and instructions issued by the State Medicaid agency.(k) Evidence of compliance. (1) The Medicaid agency may at any time require an HHA to make a specific showing of being in compliance with the requirements of this section and may require the HHA to submit such additional evidence as the Medicaid agency considers sufficient to demonstrate the HHA's compliance.(2) The Medicaid agency may terminate the HHA's provider agreement or refuse to enter into a provider agreement if an HHA fails to timely furnish sufficient evidence at the Medicaid agency's request to demonstrate compliance with the requirements of this section.(l) Surety's standing to appeal Medicaid determinations. The Medicaid agency must establish procedures for granting appeal rights to Sureties.(m) Effect of conditions of payment. If a Surety has paid the Medicaid agency an amount on the basis of liability incurred under a bond obtained by an HHA under this section, and the Medicaid agency subsequently collects from the HHA, in whole or in part, on such overpayment that was the basis for the Surety's liability, the Medicaid agency must reimburse the Surety such amount as the Medicaid agency collected from the HHA, up to the amount paid by the Surety to the Medicaid agency, provided the Surety has no other liability under the bond.
[63 FR 310, Jan. 5, 1998, as amended at 63 FR 10731, Mar. 4, 1998; 63 FR 29654, June 1, 1998; 63 FR 41170, July 31, 1998]
§441.17 Laboratory services.(a) The plan must provide for payment of laboratory services as defined in §440.30 of this subchapter if provided by—(1) An independent laboratory that meets the requirements for participation in the Medicare program found in §405.1316 of this chapter;(2) A hospital-based laboratory that meets the requirements for participation in the Medicare program found in §482.27 of this chapter;(3) A rural health clinic, as defined in §491.9 of this chapter; or (4) A skilled nursing facility—based clinical laboratory, as defined in §405.1128(a) of this chapter.(b) Except as provided under paragraph (c), if a laboratory or other entity is requesting payment under Medicaid for testing for the presence of the human immunodeficiency virus (HIV) antibody or for the isolation and identification of the HIV causative agent as described in §405.1316(f) (2) and (3) of this chapter, the laboratory records must contain the name and other identification of the person from whom the specimen was taken.(c) An agency may choose to approve the use of alternative identifiers, in place of the requirement for patient's name, in paragraph (b) of this section for HIV antibody or causative agent testing of Medicaid beneficiaries.
[54 FR 48647, Dec. 2, 1988. Redesignated at 63 FR 310, Jan. 5, 1998.]
§441.18 Case management services.(a) If a State plan provides for case management services (including targeted case management services), as defined in §440.169 of this chapter, the State must meet the following requirements:(1) Allow individuals the free choice of any qualified Medicaid provider within the specified geographic area identified in the plan when obtaining case management services, in accordance with §431.51 of this chapter, except as specified in paragraph (b) of this section.(2) Not use case management (including targeted case management) services to restrict an individual's access to other services under the plan.(3) Not compel an individual to receive case management services, condition receipt of case management (or targeted case management) services on the receipt of other Medicaid services, or condition receipt of other Medicaid services on receipt of case management (or targeted case management) services.(4) Indicate in the plan that case management services provided in accordance with section 1915(g) of the Act will not duplicate payments made to public agencies or private entities under the State plan and other program authorities;(5) [Reserved](6) Prohibit providers of case management services from exercising the agency's authority to authorize or deny the provision of other services under the plan.(7) Require providers to maintain case records that document for all individuals receiving case management as follows:(i) The name of the individual.(ii) The dates of the case management services.(iii) The name of the provider agency (if relevant) and the person providing the case management service.(iv) The nature, content, units of the case management services received and whether goals specified in the care plan have been achieved.(v) Whether the individual has declined services in the care plan.(vi) The need for, and occurrences of, coordination with other case managers.(vii) A timeline for obtaining needed services.(viii) A timeline for reevaluation of the plan.(8) Include a separate plan amendment for each group receiving case management services that includes the following:(i) Defines the group (and any subgroups within the group) eligible to receive the case management services.(ii) Identifies the geographic area to be served.(iii) Describes the case management services furnished, including the types of monitoring.(iv) Specifies the frequency of assessments and monitoring and provides a justification for those frequencies.(v) Specifies provider qualifications that are reasonably related to the population being served and the case management services furnished.(vi) [Reserved](vii) Specifies if case management services are being provided to Medicaid-eligible individuals who are in institutions (except individuals between ages 22 and 64 who are served in IMDs or individuals who are inmates of public institutions).(9) Include a separate plan amendment for each subgroup within a group if any of the following differs among the subgroups:(i) The case management services to be furnished;(ii) The qualifications of case management providers; or(iii) The methodology under which case management providers will be paid.(b) If the State limits qualified providers of case management services for target groups of individuals with developmental disability or chronic mental illness, in accordance with §431.51(a)(4) of this chapter, the plan must identify any limitations to be imposed on the providers and specify how these limitations enable providers to ensure that individuals within the target groups receive needed services.(c) Case management does not include, and FFP is not available in expenditures for, services defined in §441.169 of this chapter when the case management activities constitute the direct delivery of underlying medical, educational, social, or other services to which an eligible individual has been referred, including for foster care programs, services such as, but not limited to, the following:(1) Research gathering and completion of documentation required by the foster care program.(2) Assessing adoption placements.(3) Recruiting or interviewing potential foster care parents.(4) Serving legal papers.(5) Home investigations.(6) Providing transportation.(7) Administering foster care subsidies.(8) Making placement arrangements.(d) After the State assesses whether the activities are within the scope of the case management benefit (applying the limitations described above), in determining the allowable costs for case management (or targeted case management) services that are also furnished by another federally-funded program, the State must use cost allocation methodologies, consistent with OMB Circular A-87, CMS policies, or any subsequent guidance and reflected in an approved cost allocation plan.
[72 FR 68092, Dec. 4, 2007, as amended at 74 FR 31196, June 30, 2009]
§441.20 Family planning services.For beneficiaries eligible under the plan for family planning services, the plan must provide that each beneficiary is free from coercion or mental pressure and free to choose the method of family planning to be used. Back to Top
§441.21 Nurse-midwife services.If a State plan, under §440.210 or 440.220 of this subchapter, provides for nurse-midwife services, as defined in §440.165, the plan must provide that the nurse-midwife may enter into an independent provider agreement, without regard to whether the nurse-midwife is under the supervision of, or associated with, a physician or other health care provider.
[47 FR 21051, May 17, 1982]
§441.22 Nurse practitioner services.With respect to nurse practitioner services that meet the definition of §440.166(a) and the requirements of either §440.166(b) or §440.166(c), the State plan must meet the following requirements: (a) Provide that nurse practitioner services are furnished to the categorically needy. (b) Specify whether those services are furnished to the medically needy. (c) Provide that services furnished by a nurse practitioner, regardless of whether the nurse practitioner is under the supervision of, or associated with, a physician or other health care provider, may—(1) Be reimbursed by the State Medicaid agency through an independent provider agreement between the State and the nurse practitioner; or (2) Be paid through the employing provider.
[60 FR 19862, Apr. 21, 1995]
§441.25 Prohibition on FFP for certain prescribed drugs.(a) FFP is not available in expenditures for the purchase or administration of any drug product that meets all of the following conditions:(1) The drug product was approved by the Food and Drug Administration (FDA) before October 10, 1962.(2) The drug product is available only through prescription.(3) The drug product is the subject of a notice of opportunity for hearing issued under section 505(e) of the Federal Food, Drug, and Cosmetic Act and published in the Federal Register on a proposed order of FDA to withdraw its approval for the drug product because it has determined that the product is less than effective for all its labeled indications.(4) The drug product is presently not subject to a determination by FDA, made under its efficacy review program (see 21 CFR 310.6 for an explanation of this program), that there is a compelling justification of the drug product's medical need.(b) FFP is not available in expenditures for the purchase or administration of any drug product that is identical, related, or similar, as defined in 21 CFR 310.6, to a drug product that meets the conditions of paragraph (a) of this section.
[46 FR 48554, Oct. 1, 1981] Back to Top
§441.30 Optometric services.The plan must provide for payment of optometric services as physician services, whether furnished by an optometrist or a physician, if—(a) The plan does not provide for payment for services provided by an optometrist, except for eligibility determinations under §§435.531 and 436.531 of this subchapter, but did provide for those services at an earlier period; and (b) The plan specifically provides that physicians' services include services an optometrist is legally authorized to perform. Back to Top
§441.35 Organ transplants.(a) FFP is available in expenditures for services furnished in connection with organ transplant procedures only if the State plan includes written standards for the coverage of those procedures, and those standards provide that—(1) Similarly situated individuals are treated alike; and(2) Any restriction on the practitioners or facilities that may provide organ transplant procedures is consistent with the accessibility of high quality care to individuals eligible for the procedures under the plan.(b) Nothing in paragraph (a) permits a State to provide, under its plan, services that are not reasonable in amount, duration, and scope to achieve their purpose.
§441.40 End-stage renal disease.FFP in expenditures for services described in subpart A of part 440 is available for facility treatment of end-stage renal disease only if the facility has been approved by the Secretary to furnish those services under Medicare. This requirement for approval of the facility does not apply under emergency conditions permitted under Medicare (see §482.2 of this chapter). [43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17, 1986] Back to Top