§ 1395cc. Agreements with providers of services; enrollment processes
(a)
Filing of agreements; eligibility for payment; charges with respect to items and services
(1)
Any provider of services (except a fund designated for purposes of section
1395f
(g) and section
1395n
(e) of this title) shall be qualified to participate under this subchapter and shall be eligible for payments under this subchapter if it files with the Secretary an agreement—
(A)
(i)
not to charge, except as provided in paragraph (2), any individual or any other person for items or services for which such individual is entitled to have payment made under this subchapter (or for which he would be so entitled if such provider of services had complied with the procedural and other requirements under or pursuant to this subchapter or for which such provider is paid pursuant to the provisions of section
1395f
(e) of this title), and
(B)
not to charge any individual or any other person for items or services for which such individual is not entitled to have payment made under this subchapter because payment for expenses incurred for such items or services may not be made by reason of the provisions of paragraph (1) or (9) of section
1395y
(a) of this title, but only if
(ii)
the Secretary’s determination that such payment may not be made for such items and services was made after the third year following the year in which notice of such payment was sent to such individual; except that the Secretary may reduce such three-year period to not less than one year if he finds such reduction is consistent with the objectives of this subchapter,
(C)
to make adequate provision for return (or other disposition, in accordance with regulations) of any moneys incorrectly collected from such individual or other person,
(D)
to promptly notify the Secretary of its employment of an individual who, at any time during the year preceding such employment, was employed in a managerial, accounting, auditing, or similar capacity (as determined by the Secretary by regulation) by an agency or organization which serves as a fiscal intermediary or carrier (for purposes of part A or part B, or both, of this subchapter) with respect to the provider,
(E)
to release data with respect to patients of such provider upon request to an organization having a contract with the Secretary under part B of subchapter XI of this chapter as may be necessary
(ii)
to allow such organization to carry out similar review functions under any contract the organization may have with a private or public agency paying for health care in the same area with respect to patients who authorize release of such data for such purposes,
(F)
(i)
in the case of hospitals which provide inpatient hospital services for which payment may be made under subsection (b), (c), or (d) of section
1395ww of this title, to maintain an agreement with a professional standards review organization (if there is such an organization in existence in the area in which the hospital is located) or with a utilization and quality control peer review organization which has a contract with the Secretary under part B of subchapter XI of this chapter for the area in which the hospital is located, under which the organization will perform functions under that part with respect to the review of the validity of diagnostic information provided by such hospital, the completeness, adequacy, and quality of care provided, the appropriateness of admissions and discharges, and the appropriateness of care provided for which additional payments are sought under section
1395ww
(d)(5) of this title, with respect to inpatient hospital services for which payment may be made under part A of this subchapter (and for purposes of payment under this subchapter, the cost of such agreement to the hospital shall be considered a cost incurred by such hospital in providing inpatient services under part A of this subchapter, and
(I)
shall be paid directly by the Secretary to such organization on behalf of such hospital in accordance with a rate per review established by the Secretary,
(II)
shall be transferred from the Federal Hospital Insurance Trust Fund, without regard to amounts appropriated in advance in appropriation Acts, in the same manner as transfers are made for payment for services provided directly to beneficiaries, and
(III)
shall not be less in the aggregate for a fiscal year than the aggregate amount expended in fiscal year 1988 for direct and administrative costs (adjusted for inflation and for any direct or administrative costs incurred as a result of review functions added with respect to a subsequent fiscal year) of such reviews),
(ii)
in the case of hospitals, critical access hospitals, skilled nursing facilities, and home health agencies, to maintain an agreement with a utilization and quality control peer review organization (which has a contract with the Secretary under part B of subchapter XI of this chapter for the area in which the hospital, facility, or agency is located) to perform the functions described in paragraph (3)(A),
(G)
in the case of hospitals which provide inpatient hospital services for which payment may be made under subsection (b) or (d) of section
1395ww of this title, not to charge any individual or any other person for inpatient hospital services for which such individual would be entitled to have payment made under part A of this subchapter but for a denial or reduction of payments under section
1395ww
(f)(2) of this title,
(H)
(i)
in the case of hospitals which provide services for which payment may be made under this subchapter and in the case of critical access hospitals which provide critical access hospital services, to have all items and services (other than physicians’ services as defined in regulations for purposes of section
1395y
(a)(14) of this title, and other than services described by section
1395x
(s)(2)(K) of this title, certified nurse-midwife services, qualified psychologist services, and services of a certified registered nurse anesthetist)
(II)
for which the individual is entitled to have payment made under this subchapter, furnished by the hospital or otherwise under arrangements (as defined in section
1395x
(w)(1) of this title) made by the hospital,
(ii)
in the case of skilled nursing facilities which provide covered skilled nursing facility services—
(I)
that are furnished to an individual who is a resident of the skilled nursing facility during a period in which the resident is provided covered post-hospital extended care services (or, for services described in section
1395x
(s)(2)(D) of this title, that are furnished to such an individual without regard to such period), and
to have items and services (other than services described in section
1395yy
(e)(2)(A)(ii) of this title) furnished by the skilled nursing facility or otherwise under arrangements (as defined in section
1395x
(w)(1) of this title) made by the skilled nursing facility,
(I)
in the case of a hospital or critical access hospital—
(i)
to adopt and enforce a policy to ensure compliance with the requirements of section
1395dd of this title and to meet the requirements of such section,
(J)
in the case of hospitals which provide inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care under any health plan contracted for under section
1079 or
1086 of title
10, or under section
1713 [1] of title
38, in accordance with admission practices, payment methodology, and amounts as prescribed under joint regulations issued by the Secretary and by the Secretaries of Defense and Transportation, in implementation of sections
1079 and
1086 of title
10,
(K)
not to charge any individual or any other person for items or services for which payment under this subchapter is denied under section
1320c–3
(a)(2) of this title by reason of a determination under section
1320c–3
(a)(1)(B) of this title,
(L)
in the case of hospitals which provide inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care under section
1703 of title
38, in accordance with such admission practices, and such payment methodology and amounts, as are prescribed under joint regulations issued by the Secretary and by the Secretary of Veterans Affairs in implementation of such section,
(M)
in the case of hospitals, to provide to each individual who is entitled to benefits under part A of this subchapter (or to a person acting on the individual’s behalf), at or about the time of the individual’s admission as an inpatient to the hospital, a written statement (containing such language as the Secretary prescribes consistent with this paragraph) which explains—
(i)
the individual’s rights to benefits for inpatient hospital services and for post-hospital services under this subchapter,
(ii)
the circumstances under which such an individual will and will not be liable for charges for continued stay in the hospital,
(iii)
the individual’s right to appeal denials of benefits for continued inpatient hospital services, including the practical steps to initiate such an appeal, and
(iv)
the individual’s liability for payment for services if such a denial of benefits is upheld on appeal,
and which provides such additional information as the Secretary may specify,
(N)
in the case of hospitals and critical access hospitals—
(i)
to make available to its patients the directory or directories of participating physicians (published under section
1395u
(h)(4) of this title) for the area served by the hospital or critical access hospital,
(ii)
if hospital personnel (including staff of any emergency or outpatient department) refer a patient to a nonparticipating physician for further medical care on an outpatient basis, the personnel must inform the patient that the physician is a nonparticipating physician and, whenever practicable, must identify at least one qualified participating physician who is listed in such a directory and from whom the patient may receive the necessary services,
(iii)
to post conspicuously in any emergency department a sign (in a form specified by the Secretary) specifying rights of individuals under section
1395dd of this title with respect to examination and treatment for emergency medical conditions and women in labor, and
(O)
to accept as payment in full for services that are covered under this subchapter and are furnished to any individual enrolled with a Medicare+Choice organization under part C of this subchapter, with a PACE provider under section
1395eee or
1396u–4 of this title, or with an eligible organization with a risk-sharing contract under section
1395mm of this title, under section
1395mm
(i)(2)(A) of this title (as in effect before February 1, 1985), under section
1395b–1
(a) of this title, or under section 222(a) of the Social Security Amendments of 1972, which does not have a contract (or, in the case of a PACE provider, contract or other agreement) establishing payment amounts for services furnished to members of the organization or PACE program eligible individuals enrolled with the PACE provider, the amounts that would be made as a payment in full under this subchapter (less any payments under sections
1395ww
(d)(11) and
1395ww
(h)(3)(D) of this title) if the individuals were not so enrolled,
(P)
in the case of home health agencies which provide home health services to individuals entitled to benefits under this subchapter who require catheters, catheter supplies, ostomy bags, and supplies related to ostomy care (described in section
1395x
(m)(5) of this title), to offer to furnish such supplies to such an individual as part of their furnishing of home health services,
(Q)
in the case of hospitals, skilled nursing facilities, home health agencies, and hospice programs, to comply with the requirement of subsection (f) of this section (relating to maintaining written policies and procedures respecting advance directives),
(R)
to contract only with a health care clearinghouse (as defined in section
1320d of this title) that meets each standard and implementation specification adopted or established under part C of subchapter XI of this chapter on or after the date on which the health care clearinghouse is required to comply with the standard or specification,
(S)
in the case of a hospital that has a financial interest (as specified by the Secretary in regulations) in an entity to which individuals are referred as described in section
1395x
(ee)(2)(H)(ii) of this title, or in which such an entity has such a financial interest, or in which another entity has such a financial interest (directly or indirectly) with such hospital and such an entity, to maintain and disclose to the Secretary (in a form and manner specified by the Secretary) information on—
(T)
in the case of hospitals and critical access hospitals, to furnish to the Secretary such data as the Secretary determines appropriate pursuant to subparagraph (E) of section
1395ww
(d)(12) of this title to carry out such section,
(U)
in the case of hospitals which furnish inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care both—
(i)
under the contract health services program funded by the Indian Health Service and operated by the Indian Health Service, an Indian tribe, or tribal organization (as those terms are defined in section
1603 of title
25), with respect to items and services that are covered under such program and furnished to an individual eligible for such items and services under such program; and
(ii)
under any program funded by the Indian Health Service and operated by an urban Indian organization with respect to the purchase of items and services for an eligible urban Indian (as those terms are defined in such section
1603),
in accordance with regulations promulgated by the Secretary regarding admission practices, payment methodology, and rates of payment (including the acceptance of no more than such payment rate as payment in full for such items and services,[2] and
(V)
in the case of hospitals that are not otherwise subject to the Occupational Safety and Health Act of 1970 [29 U.S.C. 651 et seq.] (or a State occupational safety and health plan that is approved under 18(b) [3] of such Act [29 U.S.C. 667
(b)]), to comply with the Bloodborne Pathogens standard under section
1910.1030 of title 29 of the Code of Federal Regulations (or as subsequently redesignated).
In the case of a hospital which has an agreement in effect with an organization described in subparagraph (F), which organization’s contract with the Secretary under part B of subchapter XI of this chapter is terminated on or after October 1, 1984, the hospital shall not be determined to be out of compliance with the requirement of such subparagraph during the six month period beginning on the date of the termination of that contract.
(2)
(A)
A provider of services may charge such individual or other person
(i)
the amount of any deduction or coinsurance amount imposed pursuant to section
1395e
(a)(1), (a)(3), or (a)(4), section
1395l(b), or section
1395x
(y)(3) of this title with respect to such items and services (not in excess of the amount customarily charged for such items and services by such provider), and
(ii)
an amount equal to 20 per centum of the reasonable charges for such items and services (not in excess of 20 per centum of the amount customarily charged for such items and services by such provider) for which payment is made under part B of this subchapter or which are durable medical equipment furnished as home health services (but in the case of items and services furnished to individuals with end-stage renal disease, an amount equal to 20 percent of the estimated amounts for such items and services calculated on the basis established by the Secretary). In the case of items and services described in section
1395l
(c) of this title, clause (ii) of the preceding sentence shall be applied by substituting for 20 percent the proportion which is appropriate under such section. A provider of services may not impose a charge under clause (ii) of the first sentence of this subparagraph with respect to items and services described in section
1395x
(s)(10)(A) of this title and with respect to clinical diagnostic laboratory tests for which payment is made under part B of this subchapter. Notwithstanding the first sentence of this subparagraph, a home health agency may charge such an individual or person, with respect to covered items subject to payment under section
1395m
(a) of this title, the amount of any deduction imposed under section
1395l
(b) of this title and 20 percent of the payment basis described in section
1395m
(a)(1)(B) of this title. In the case of items and services for which payment is made under part B of this subchapter under the prospective payment system established under section
1395l
(t) of this title, clause (ii) of the first sentence shall be applied by substituting for 20 percent of the reasonable charge, the applicable copayment amount established under section
1395l
(t)(5) [1] of this title. In the case of services described in section
1395l
(a)(8) of this title or section
1395l
(a)(9) of this title for which payment is made under part B of this subchapter under section
1395m
(k) of this title, clause (ii) of the first sentence shall be applied by substituting for 20 percent of the reasonable charge for such services 20 percent of the lesser of the actual charge or the applicable fee schedule amount (as defined in such section) for such services.
(B)
Where a provider of services has furnished, at the request of such individual, items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under this subchapter, such provider of services may also charge such individual or other person for such more expensive items or services to the extent that the amount customarily charged by it for the items or services furnished at such request exceeds the amount customarily charged by it for the items or services with respect to which payment may be made under this subchapter.
(C)
A provider of services may in accordance with its customary practice also appropriately charge any such individual for any whole blood (or equivalent quantities of packed red blood cells, as defined under regulations) furnished him with respect to which a deductible is imposed under section
1395e
(a)(2) of this title, except that
(i)
any excess of such charge over the cost to such provider for the blood (or equivalent quantities of packed red blood cells, as so defined) shall be deducted from any payment to such provider under this subchapter,
(ii)
no such charge may be imposed for the cost of administration of such blood (or equivalent quantities of packed red blood cells, as so defined), and
(iii)
such charge may not be made to the extent such blood (or equivalent quantities of packed red blood cells, as so defined) has been replaced on behalf of such individual or arrangements have been made for its replacement on his behalf. For purposes of this subparagraph, whole blood (or equivalent quantities of packed red blood cells, as so defined) furnished an individual shall be deemed replaced when the provider of services is given one pint of blood for each pint of blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual with respect to which a deduction is imposed under section
1395e
(a)(2) of this title.
(D)
Where a provider of services customarily furnishes items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under this subchapter, such provider, notwithstanding the preceding provisions of this paragraph, may not, under the authority of subparagraph (B)(ii) of this paragraph, charge any individual or other person any amount for such items or services in excess of the amount of the payment which may otherwise be made for such items or services under this subchapter if the admitting physician has a direct or indirect financial interest in such provider.
(3)
(A)
Under the agreement required under paragraph (1)(F)(ii), the peer review organization must perform functions (other than those covered under an agreement under paragraph (1)(F)(i)) under the third sentence of section
1320c–3
(a)(4)(A) of this title and under section
1320c–3
(a)(14) of this title with respect to services, furnished by the hospital, critical access hospital, facility, or agency involved, for which payment may be made under this subchapter.
(B)
For purposes of payment under this subchapter, the cost of such an agreement to the hospital, critical access hospital, facility, or agency shall be considered a cost incurred by such hospital, critical access hospital, facility, or agency in providing covered services under this subchapter and shall be paid directly by the Secretary to the peer review organization on behalf of such hospital, critical access hospital, facility, or agency in accordance with a schedule established by the Secretary.
(C)
Such payments—
(i)
shall be transferred in appropriate proportions from the Federal Hospital Insurance Trust Fund and from the Federal Supplementary Medical Insurance Trust Fund, without regard to amounts appropriated in advance in appropriation Acts, in the same manner as transfers are made for payment for services provided directly to beneficiaries, and
(ii)
shall not be less in the aggregate for a fiscal year—
(II)
in the case of facilities, critical access hospitals, and agencies, than the amounts the Secretary determines to be sufficient to cover the costs of such organizations’ conducting the activities described in subparagraph (A) with respect to such facilities, critical access hospitals, or agencies under part B of subchapter XI of this chapter.
(b)
Termination or nonrenewal of agreements
(1)
A provider of services may terminate an agreement with the Secretary under this section at such time and upon such notice to the Secretary and the public as may be provided in regulations, except that notice of more than six months shall not be required.
(2)
The Secretary may refuse to enter into an agreement under this section or, upon such reasonable notice to the provider and the public as may be specified in regulations, may refuse to renew or may terminate such an agreement after the Secretary—
(A)
has determined that the provider fails to comply substantially with the provisions of the agreement, with the provisions of this subchapter and regulations thereunder, or with a corrective action required under section
1395ww
(f)(2)(B) of this title,
(B)
has determined that the provider fails substantially to meet the applicable provisions of section
1395x of this title,
(3)
A termination of an agreement or a refusal to renew an agreement under this subsection shall become effective on the same date and in the same manner as an exclusion from participation under the programs under this subchapter becomes effective under section
1320a–7
(c) of this title.
(4)
(A)
A hospital that fails to comply with the requirement of subsection (a)(1)(V) of this section (relating to the Bloodborne Pathogens standard) is subject to a civil money penalty in an amount described in subparagraph (B), but is not subject to termination of an agreement under this section.
(B)
The amount referred to in subparagraph (A) is an amount that is similar to the amount of civil penalties that may be imposed under section 17 of the Occupational Safety and Health Act of 1970 [29 U.S.C. 666] for a violation of the Bloodborne Pathogens standard referred to in subsection (a)(1)(U) [4] of this section by a hospital that is subject to the provisions of such Act [29 U.S.C. 651 et seq.].
(C)
A civil money penalty under this paragraph shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section
1320a–7a of this title are imposed and collected under that section.
(c)
Refiling after termination or nonrenewal; agreements with skilled nursing facilities
(1)
Where the Secretary has terminated or has refused to renew an agreement under this subchapter with a provider of services, such provider may not file another agreement under this subchapter unless the Secretary finds that the reason for the termination or nonrenewal has been removed and that there is reasonable assurance that it will not recur.
(2)
Where the Secretary has terminated or has refused to renew an agreement under this subchapter with a provider of services, the Secretary shall promptly notify each State agency which administers or supervises the administration of a State plan approved under subchapter XIX of this chapter of such termination or nonrenewal.
(d)
Decision to withhold payment for failure to review long-stay cases
If the Secretary finds that there is a substantial failure to make timely review in accordance with section
1395x
(k) of this title of long-stay cases in a hospital, he may, in lieu of terminating his agreement with such hospital, decide that, with respect to any individual admitted to such hospital after a subsequent date specified by him, no payment shall be made under this subchapter for inpatient hospital services (including inpatient psychiatric hospital services) after the 20th day of a continuous period of such services. Such decision may be made effective only after such notice to the hospital and to the public, as may be prescribed by regulations, and its effectiveness shall terminate when the Secretary finds that the reason therefor has been removed and that there is reasonable assurance that it will not recur. The Secretary shall not make any such decision except after reasonable notice and opportunity for hearing to the institution or agency affected thereby.
(e)
“Provider of services” defined
For purposes of this section, the term “provider of services” shall include—
(1)
a clinic, rehabilitation agency, or public health agency if, in the case of a clinic or rehabilitation agency, such clinic or agency meets the requirements of section
1395x
(p)(4)(A) of this title (or meets the requirements of such section through the operation of subsection (g) or (ll)(2) of section
1395x of this title), or if, in the case of a public health agency, such agency meets the requirements of section
1395x
(p)(4)(B) of this title (or meets the requirements of such section through the operation of subsection (g) or (ll)(2) of section
1395x of this title), but only with respect to the furnishing of outpatient physical therapy services (as therein defined), (through the operation of section
1395x
(g) of this title) with respect to the furnishing of outpatient occupational therapy services, or (through the operation of section
1395x
(ll)(2) of this title) with respect to the furnishing of outpatient speech-language pathology; and
(2)
a community mental health center (as defined in section
1395x
(ff)(3)(B) of this title), but only with respect to the furnishing of partial hospitalization services (as described in section
1395x
(ff)(1) of this title).
(f)
Maintenance of written policies and procedures
(1)
For purposes of subsection (a)(1)(Q) of this section and sections
1395i–3
(c)(2)(E),
1395l
(s),
1395w–25
(i),
1395mm
(c)(8), and
1395bbb
(a)(6) of this title, the requirement of this subsection is that a provider of services, Medicare+Choice organization, or prepaid or eligible organization (as the case may be) maintain written policies and procedures with respect to all adult individuals receiving medical care by or through the provider or organization—
(A)
to provide written information to each such individual concerning—
(i)
an individual’s rights under State law (whether statutory or as recognized by the courts of the State) to make decisions concerning such medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives (as defined in paragraph (3)), and
(B)
to document in a prominent part of the individual’s current medical record whether or not the individual has executed an advance directive;
(C)
not to condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive;
(D)
to ensure compliance with requirements of State law (whether statutory or as recognized by the courts of the State) respecting advance directives at facilities of the provider or organization; and
(E)
to provide (individually or with others) for education for staff and the community on issues concerning advance directives.
Subparagraph (C) shall not be construed as requiring the provision of care which conflicts with an advance directive.
(2)
The written information described in paragraph (1)(A) shall be provided to an adult individual—
(B)
in the case of a skilled nursing facility, at the time of the individual’s admission as a resident,
(C)
in the case of a home health agency, in advance of the individual coming under the care of the agency,
(3)
In this subsection, the term “advance directive” means a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State) and relating to the provision of such care when the individual is incapacitated.
(4)
For construction relating to this subsection, see section
14406 of this title (relating to clarification respecting assisted suicide, euthanasia, and mercy killing).
(g)
Penalties for improper billing
Except as permitted under subsection (a)(2) of this section, any person who knowingly and willfully presents, or causes to be presented, a bill or request for payment inconsistent with an arrangement under subsection (a)(1)(H) of this section or in violation of the requirement for such an arrangement, is subject to a civil money penalty of not to exceed $2,000. The provisions of section
1320a–7a of this title (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section
1320a–7a
(a) of this title.
(h)
Dissatisfaction with determination of Secretary; appeal by institutions or agencies; single notice and hearing
(1)
(A)
Except as provided in paragraph (2), an institution or agency dissatisfied with a determination by the Secretary that it is not a provider of services or with a determination described in subsection (b)(2) of this section shall be entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as is provided in section
405
(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section
405
(g) of this title, except that, in so applying such sections and in applying section
405
(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively.
(B)
An institution or agency described in subparagraph (A) that has filed for a hearing under subparagraph (A) shall have expedited access to judicial review under this subparagraph in the same manner as providers of services, suppliers, and individuals entitled to benefits under part A of this subchapter or enrolled under part B of this subchapter, or both, may obtain expedited access to judicial review under the process established under section
1395ff
(b)(2) of this title. Nothing in this subparagraph shall be construed to affect the application of any remedy imposed under section
1395i–3 of this title during the pendency of an appeal under this subparagraph.