**(a) Special rules relating to offering of qualified prescription drug coverage**
(1) **In general** — An MA organization on and after January 1, 2006—
(A) may not offer an MA plan described in [section 1395w–21(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/A&num=0&edition=prelim) in an area unless either that plan (or another MA plan offered by the organization in that same service area) includes required prescription drug coverage (as defined in paragraph (2)); and
(B) may not offer prescription drug coverage (other than that required under parts A and B) to an enrollee—
(i) under an MSA plan; or
(ii) under another MA plan unless such drug coverage under such other plan provides qualified prescription drug coverage and unless the requirements of this section with respect to such coverage are met.
(2) **Qualifying coverage** — For purposes of paragraph (1)(A), the term “required coverage” means with respect to an MA–PD plan—
(A) basic prescription drug coverage; or
(B) qualified prescription drug coverage that provides supplemental prescription drug coverage, so long as there is no MA monthly supplemental beneficiary premium applied under the plan (due to the application of a credit against such premium of a rebate under [section 1395w–24(b)(1)(C) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–24/b/1/C&num=0&edition=prelim)).
**(b) Application of default enrollment rules**
(1) **Seamless continuation** — In applying [section 1395w–21(c)(3)(A)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/c/3/A/ii&num=0&edition=prelim), an individual who is enrolled in a health benefits p
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Stable record: federal_law:legal_authorities:record_usc_d25106ad9ef83d150cc703cd Source file: Laws/federal/codes/united-states-code/title-42/section-1395bb-application-to-medicare-advantage-program-and-related-managed-care-progr--d888004c91.md Pages: Not recorded – Not recorded Passage SHA-256: 78d39c3edf58c6c424b0703a2c26c53118f9b841a3e2fa42b1b4c6a54a9ef55f Retained source evidence SHA-256: 6ed2a521b53a586595d8ec6baff16b90dd714c6422d400a2ac5d08f47de8644f
Source location: Title 42, Chapter 7, § 1395bb; chapter-007-social-security.md
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**(a) Special rules relating to offering of qualified prescription drug coverage**
(1) **In general** — An MA organization on and after January 1, 2006—
(A) may not offer an MA plan described in [section 1395w–21(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/A&num=0&edition=prelim) in an area unless either that plan (or another MA plan offered by the organization in that same service area) includes required prescription drug coverage (as defined in paragraph (2)); and
(B) may not offer prescription drug coverage (other than that required under parts A and B) to an enrollee—
(i) under an MSA plan; or
(ii) under another MA plan unless such drug coverage under such other plan provides qualified prescription drug coverage and unless the requirements of this section with respect to such coverage are met.
(2) **Qualifying coverage** — For purposes of paragraph (1)(A), the term “required coverage” means with respect to an MA–PD plan—
(A) basic prescription drug coverage; or
(B) qualified prescription drug coverage that provides supplemental prescription drug coverage, so long as there is no MA monthly supplemental beneficiary premium applied under the plan (due to the application of a credit against such premium of a rebate under [section 1395w–24(b)(1)(C) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–24/b/1/C&num=0&edition=prelim)).
**(b) Application of default enrollment rules**
(1) **Seamless continuation** — In applying [section 1395w–21(c)(3)(A)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/c/3/A/ii&num=0&edition=prelim), an individual who is enrolled in a health benefits plan shall not be considered to have been deemed to make an election into an MA–PD plan unless such health benefits plan provides any prescription drug coverage.
(2) **MA continuation** — In applying [section 1395w–21(c)(3)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/c/3/B&num=0&edition=prelim), an individual who is enrolled in an MA plan shall not be considered to have been deemed to make an election into an MA–PD plan unless—
(A) for purposes of the election as of January 1, 2006, the MA plan provided as of December 31, 2005, any prescription drug coverage; or
(B) for periods after January 1, 2006, such MA plan is an MA–PD plan.
(3) **Discontinuance of MA–PD election during first year of eligibility** — In applying the second sentence of [section 1395w–21(e)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/e/4&num=0&edition=prelim) in the case of an individual who is electing to discontinue enrollment in an MA–PD plan, the individual shall be permitted to enroll in a prescription drug plan under part D at the time of the election of coverage under the original medicare fee-for-service program.
(4) **Rules regarding enrollees in MA plans not providing qualified prescription drug coverage** — In the case of an individual who is enrolled in an MA plan (other than an MSA plan) that does not provide qualified prescription drug coverage, if the organization offering such coverage discontinues the offering with respect to the individual of all MA plans that do not provide such coverage—
(i) the individual is deemed to have elected the original medicare fee-for-service program option, unless the individual affirmatively elects to enroll in an MA–PD plan; and
(ii) in the case of such a deemed election, the disenrollment shall be treated as an involuntary termination of the MA plan described in subparagraph (B)(ii) of [section 1395ss(s)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395ss/s/3&num=0&edition=prelim) for purposes of applying such section.
The information disclosed under [section 1395w–22(c)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–22/c/1&num=0&edition=prelim) for individuals who are enrolled in such an MA plan shall include information regarding such rules.
**(c) Application of part D rules for prescription drug coverage** With respect to the offering of qualified prescription drug coverage by an MA organization under this part on and after January 1, 2006—
(1) **In general** — Except as otherwise provided, the provisions of this part shall apply under part C with respect to prescription drug coverage provided under MA–PD plans in lieu of the other provisions of part C that would apply to such coverage under such plans.
(2) **Waiver** — The Secretary shall waive the provisions referred to in paragraph (1) to the extent the Secretary determines that such provisions duplicate, or are in conflict with, provisions otherwise applicable to the organization or plan under part C or as may be necessary in order to improve coordination of this part with the benefits under this part.
(3) **Treatment of MA owned and operated pharmacies** — The Secretary may waive the requirement of [section 1395w–104(b)(1)(C) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–104/b/1/C&num=0&edition=prelim) in the case of an MA–PD plan that provides access (other than mail order) to qualified prescription drug coverage through pharmacies owned and operated by the MA organization, if the Secretary determines that the organization’s pharmacy network is sufficient to provide comparable access for enrollees under the plan.
**(d) Special rules for private fee-for-service plans that offer prescription drug coverage** With respect to an MA plan described in [section 1395w–21(a)(2)(C) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/C&num=0&edition=prelim) that offers qualified prescription drug coverage, on and after January 1, 2006, the following rules apply:
(1) **Requirements regarding negotiated prices** — Subsections (a)(1) and (d)(1) of [section 1395w–102 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-102&num=0&edition=prelim) and [section 1395w–104(b)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–104/b/2/A&num=0&edition=prelim) shall not be construed to require the plan to provide negotiated prices (described in subsection (d)(1)(B) of such section), but shall apply to the extent the plan does so.
(2) **Modification of pharmacy access standard and disclosure requirement** — If the plan provides coverage for drugs purchased from all pharmacies, without charging additional cost-sharing, and without regard to whether they are participating pharmacies in a network or have entered into contracts or agreements with pharmacies to provide drugs to enrollees covered by the plan, subsections (b)(1)(C) and (k) of [section 1395w–104 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-104&num=0&edition=prelim) shall not apply to the plan.
(3) **Drug utilization management program and medication therapy management program not required** — The requirements of subparagraphs (A) and (C) of [section 1395w–104(c)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–104/c/1&num=0&edition=prelim) shall not apply to the plan.
(4) **Application of reinsurance** — The Secretary shall determine the amount of reinsurance payments under [section 1395w–115(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–115/b&num=0&edition=prelim) using a methodology that—
(A) bases such amount on the Secretary’s estimate of the amount of such payments that would be payable if the plan were an MA–PD plan described in [section 1395w–21(a)(2)(A)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/A/i&num=0&edition=prelim) and the previous provisions of this subsection did not apply; and
(B) takes into account the average reinsurance payments made under [section 1395w–115(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–115/b&num=0&edition=prelim) for populations of similar risk under MA–PD plans described in such section.
(5) **Exemption from risk corridor provisions** — The provisions of [section 1395w–115(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–115/e&num=0&edition=prelim) shall not apply.
(6) **Exemption from negotiations** — Subsections (d) and (e)(2)(C) of [section 1395w–111 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-111&num=0&edition=prelim) shall not apply and the provisions of [section 1395w–24(a)(5)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–24/a/5/B&num=0&edition=prelim) prohibiting the review, approval, or disapproval of amounts described in such section shall apply to the proposed bid and terms and conditions described in [section 1395w–111(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–111/d&num=0&edition=prelim).
(7) **Treatment of incurred costs without regard to formulary** — The exclusion of costs incurred for covered part D drugs which are not included (or treated as being included) in a plan’s formulary under [section 1395w–102(b)(4)(C)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–102/b/4/C/i&num=0&edition=prelim) shall not apply insofar as the plan does not utilize a formulary.
**(e) Application to reasonable cost reimbursement contractors**
(1) **In general** — Subject to paragraphs (2) and (3) and rules established by the Secretary, in the case of an organization that is providing benefits under a reasonable cost reimbursement contract under [section 1395mm(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395mm/h&num=0&edition=prelim) and that elects to provide qualified prescription drug coverage to a part D eligible individual who is enrolled under such a contract, the provisions of this part (and related provisions of part C) shall apply to the provision of such coverage to such enrollee in the same manner as such provisions apply to the provision of such coverage under an MA–PD local plan described in [section 1395–21(a)(2)(A)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395–21/a/2/A/i&num=0&edition=prelim) and coverage under such a contract that so provides qualified prescription drug coverage shall be deemed to be an MA–PD local plan.
(2) **Limitation on enrollment** — In applying paragraph (1), the organization may not enroll part D eligible individuals who are not enrolled under the reasonable cost reimbursement contract involved.
(3) **Bids not included in determining national average monthly bid amount** — The bid of an organization offering prescription drug coverage under this subsection shall not be taken into account in computing the national average monthly bid amount and low-income benchmark premium amount under this part.
**(f) Application to PACE**
(1) **In general** — Subject to paragraphs (2) and (3) and rules established by the Secretary, in the case of a PACE program under [section 1395eee of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395eee&num=0&edition=prelim) that elects to provide qualified prescription drug coverage to a part D eligible individual who is enrolled under such program, the provisions of this part (and related provisions of part C) shall apply to the provision of such coverage to such enrollee in a manner that is similar to the manner in which such provisions apply to the provision of such coverage under an MA–PD local plan described in [section 1395w–21(a)(2)(A)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/A/ii&num=0&edition=prelim) and a PACE program that so provides such coverage may be deemed to be an MA–PD local plan.
(2) **Limitation on enrollment** — In applying paragraph (1), the organization may not enroll part D eligible individuals who are not enrolled under the PACE program involved.
(3) **Bids not included in determining standardized bid amount** — The bid of an organization offering prescription drug coverage under this subsection is not be taken into account in computing any average benchmark bid amount and low-income benchmark premium amount under this part.
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Federal law — U.S. Code and appendices · legal_authorities
§ 1395bb. Effect of accreditation
(a) Accreditation by American Osteopathic Asso-
ciation or other national accreditation body
(1) If the Secretary finds that accreditation of
a provider entity (as defined in paragraph (4)) by
the American Osteopathic Association or any
other national accreditation body demonstrates
that all of the applicable conditions or require-
ments of this subchapter (other than the re-
quirements of section 1395m(j) of this title) are
met or exceeded—
(A) in the case of a provider entity not de-
scribed in paragraph (3)(B), the Secretary shall
treat such entity as meeting those conditions
or requirements with respect to which the
Secretary made such finding; or
(B) in the case of a provider entity described
in paragraph (3)(B), the Secretary may treat
such entity as meeting those conditions or re-
quirements with respect to which the Sec-
retary made such finding.
(2) In making such a finding, the Secretary
shall consider, among other factors with respect
to a national accreditation body, its require-
ments for accreditation, its survey procedures,
its ability to provide adequate resources for con-
ducting required surveys and supplying informa-
tion for use in enforcement activities, its moni-
toring procedures for provider entities found out
of compliance with the conditions or require-
ments, and its ability to provide the Secretary
with necessary data for validation.
(3)(A) Except as provided in subparagraph (B),
not later than 60 days after the date of receipt
of a written request for a finding under para-
graph (1) (with any documentation necessary to
make a determination on the request), the Sec-
retary shall publish a notice identifying the na-
tional accreditation body making the request,
describing the nature of