P.L. 114–255, Approved December 10, 2016 (130 Stat. 695)

21st Century Cures Act

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SEC. 1. [42U.S.C. 1305 note] 21st Century Cures Act

An Act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. This Act may be cited as the “21st Century Cures Act”.

Approved December 10, 2016.

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SEC. 704. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE PARTS C AND D.

(a) Drug Management Program for At-Risk Beneficiaries.—

(1)  In general.—Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end the following:

“(5) Drug management program for at-risk beneficiaries.—

“(A)  Authority to establish.—A PDP sponsor may establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B), the PDP sponsor may, in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary's access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by one or more prescribers selected under subparagraph (D), and dispensed for such beneficiary by one or more pharmacies selected under such subparagraph.

“(B) Requirement for notices.—

“(i)  In general.—A PDP sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor—

“(I)  provides to the beneficiary an initial notice described in clause (ii) and a second notice described in clause (iii); and

“(II)  verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse.

“(ii)  Initial notice.—An initial notice described in this clause is a notice that provides to the beneficiary—

“(I)  notice that the PDP sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse;

“(II)  information describing all State and Federal public health resources that are designed to address prescription drug abuse to which the beneficiary has access, including mental health services and other counseling services;

“(III)  notice of, and information about, the right of the beneficiary to appeal such identification under subsection (h) and the option of an automatic escalation to external review;

“(IV)  a request for the beneficiary to submit to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause (iii)(I);

“(V)  an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse, including an explanation of the drug management program established by the PDP sponsor pursuant to subparagraph (A);

“(VI)  clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the PDP sponsor; and

“(VII)  contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program (similar to the information provided by the Secretary in other standardized notices provided to part D eligible individuals enrolled in prescription drug plans under this part).

“(iii)  Second notice.—A second notice described in this clause is a notice that provides to the beneficiary notice—

“(I)  that the PDP sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse;

“(II)  that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such PDP sponsor for such plan;

“(III)  of the prescriber (or prescribers) and pharmacy (or pharmacies) selected for such individual under subparagraph (D);

“(IV)  of, and information about, the beneficiary's right to appeal such identification under subsection (h) and the option of an automatic escalation to external review;

“(V)  that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and

“(V)  that includes clear instructions that explain how the beneficiary can contact the PDP sponsor.

“(iv) Timing of notices.—

“(I)  In general.—Subject to subclause (II), a second notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 30 days after an initial notice described in clause (ii) is provided to the beneficiary.

“(II)  Exception.—In the case that the PDP sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking by the Secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the PDP sponsor to provide a second notice described in clause (iii) to the beneficiary on a date that is earlier than the date described in subclause (I), the PDP sponsor may provide such second notice on such earlier date.

“(C) At-risk beneficiary for prescription drug abuse.—

“(i)  In general.—For purposes of this paragraph, the term ‘at-risk beneficiary for prescription drug abuse’ means a part D eligible individual who is not an exempted individual described in clause (ii) and—

“(I)  who is identified as such an at-risk beneficiary through the use of clinical guidelines that indicate misuse or abuse of prescription drugs described in subparagraph (G) and that are developed by the Secretary in consultation with PDP sponsors and other stakeholders, including individuals entitled to benefits under part A or enrolled under part B, advocacy groups representing such individuals, physicians, pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers; or

“(II)  with respect to whom the PDP sponsor of a prescription drug plan, upon enrolling such individual in such plan, received notice from the Secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph (F).

“(ii)  Exempted individual described.—An exempted individual described in this clause is an individual who—

“(I)  receives hospice care under this title;

“(II)  is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or

“(III)  the Secretary elects to treat as an exempted individual for purposes of clause (i).

“(iii)  Program size.—The Secretary shall establish policies, including the guidelines developed under clause (i)(I) and the exemptions under clause (ii)(III), to ensure that the population of enrollees in a drug management program for at-risk beneficiaries operated by a prescription drug plan can be effectively managed by such plans.

“(iv)  Clinical contact.—With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by a PDP sponsor, the PDP sponsor shall contact the beneficiary's providers who have prescribed frequently abused drugs regarding whether prescribed medications are appropriate for such beneficiary's medical conditions.

“(D) Selection of prescribers and pharmacies.—

“(i)  In general.—With respect to each at- risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor, a PDP sponsor shall, based on the preferences submitted to the PDP sponsor by the beneficiary pursuant to clauses (ii)(IV) and (iii)(V) of subparagraph (B) (except as otherwise provided in this subparagraph) select—

“(I)  one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, individual who is authorized to prescribe frequently abused drugs (referred to in this paragraph as a ‘prescriber’) who may write prescriptions for such drugs for such beneficiary; and

“(II)  one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, pharmacy that may dispense such drugs to such beneficiary. For purposes of subclause (II), in the case of a pharmacy that has multiple locations that share real-time electronic data, all such locations of the pharmacy shall collectively be treated as one pharmacy.

“(ii)  Reasonable access.—In making the selections under this subparagraph—

“(I)  a PDP sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs (as defined in subparagraph (G)), taking into account geographic location, beneficiary preference, impact on costsharing, and reasonable travel time; and

“(II)  a PDP sponsor shall ensure such access (including access to prescribers and pharmacies with respect to frequently abused drugs) in the case of individuals with multiple residences, in the case of natural disasters and similar situations, and in the case of the provision of emergency services.

“(iii)  Beneficiary preferences.—If an at- risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor select in response to a notice under subparagraph (B), the PDP sponsor shall—

“(I)  review such preferences;

“(II)  select or change the selection of prescribers and pharmacies for the beneficiary based on such preferences; and

“(III)  inform the beneficiary of such selection or change of selection.

“(iv)  Exception regarding beneficiary preferences.—In the case that the PDP sponsor determines that a change to the selection of prescriber or pharmacy under clause (iii)(II) by the PDP sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary, the PDP sponsor may change the selection of prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in clause (iii). If the PDP sponsor changes the selection pursuant to the preceding sentence, the PDP sponsor shall provide the beneficiary with—

“(I)  at least 30 days written notice of the change of selection; and

“(II)  a rationale for the change.

“(v)  Confirmation.—Before selecting a prescriber or pharmacy under this subparagraph, a PDP sponsor must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in the drug management program for at-risk beneficiaries and that the prescriber and pharmacy has been selected as the beneficiary's designated prescriber and pharmacy.

“(E)  Terminations and appeals.—The identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph, a coverage determination made under a drug management program for at-risk beneficiaries, the selection of prescriber or pharmacy under subparagraph (D), and information to be shared under subparagraph (I), with respect to such individual, shall be subject to reconsideration and appeal under subsection (h) and the option of an automatic escalation to external review to the extent provided by the Secretary.

“(F) Termination of identification.—

“(i)  In general.—The Secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier of—

“(I)  the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription drug abuse described in subparagraph (C)(i); and

“(II)  the end of such maximum period of identification as the Secretary may specify.

“(ii)  Rule of construction.—Nothing in clause (i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph (C)(i) after such termination on the basis of additional information on drug use occurring after the date of notice of such termination.

“(G)  Frequently abused drug.—For purposes of this subsection, the term ‘frequently abused drug’ means a drug that is a controlled substance that the Secretary determines to be frequently abused or diverted.

“(H) Data disclosure.—

“(i)  Data on decision to impose limitation.—In the case of an at-risk beneficiary for prescription drug abuse (or an individual who is a potentially at-risk beneficiary for prescription drug abuse) whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, the Secretary shall establish rules and procedures to require the PDP sponsor to disclose data, including any necessary individually identifiable health information, in a form and manner specified by the Secretary, about the decision to impose such limitations and the limitations imposed by the sponsor under this part.

“(ii)  Data to reduce fraud, abuse, and waste.—The Secretary shall establish rules and procedures to require PDP sponsors operating a drug management program for at-risk beneficiaries under this paragraph to provide the Secretary with such data as the Secretary determines appropriate for purposes of identifying patterns of prescription drug utilization for plan enrollees that are outside normal patterns and that may indicate fraudulent, medically unnecessary, or unsafe use.

“(I)  Sharing of information for subsequent plan enrollments.—The Secretary shall establish procedures under which PDP sponsors who offer prescription drug plans shall share information with respect to individuals who are at-risk beneficiaries for prescription drug abuse (or individuals who are potentially at-risk beneficiaries for prescription drug abuse) and enrolled in a prescription drug plan and who subsequently disenroll from such plan and enroll in another prescription drug plan offered by another PDP sponsor.

“(J)  Privacy issues.—Prior to the implementation of the rules and procedures under this paragraph, the Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note), related to the sharing of data under subparagraphs (H) and (I) by PDP sponsors. Such clarification shall provide that the sharing of such data shall be considered to be protected health information in accordance with the requirements of the regulations promulgated pursuant to such section 264(c).

“(K)  Education.—The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, including education—

“(i)  provided by Medicare administrative contractors through the improper payment outreach and education program described in section 1874A(h); and

“(ii)  through current education efforts (such as State health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b-3 note)) and materials directed toward such enrollees.

“(L)  Application under ma-pd plans.—Pursuant to section 1860D-21(c)(1), the provisions of this paragraph apply under part D to MA organizations offering MA-PD plans to MA eligible individuals in the same manner as such provisions apply under this part to a PDP sponsor offering a prescription drug plan to a part D eligible individual.

“(M)  CMS compliance review.—The Secretary shall ensure that existing plan sponsor compliance reviews and audit processes include the drug management programs for at-risk beneficiaries under this paragraph, including appeals processes under such programs.”.

(2)  Information for consumers.—Section 1860D-4(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is amended by adding at the end the following:

“(v)  The drug management program for at-risk beneficiaries under subsection (c)(5).”.

(3)  Dual eligibles.—Section 1860D-1(b)(3)(D) of the Social Security Act (42 U.S.C. 1395w-101(b)(3)(D)) is amended by inserting “, subject to such limits as the Secretary may establish for individuals identified pursuant to section 1860D- 4(c)(5)” after “the Secretary”.

(b)  Utilization Management Programs.—Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection (a)(1), is further amended—

(1)  in paragraph (1), by inserting after subparagraph (D) the following new subparagraph:

“(E)  A utilization management tool to prevent drug abuse (as described in paragraph (6)(A)).”; and

(2)  by adding at the end the following new paragraph:

“(6) Utilization management tool to prevent drug abuse.—

“(A)  In general.—A tool described in this paragraph is any of the following:

“(i)  A utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies.

“(ii)  Retrospective utilization review to identify—

“(I)  individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate; and

“(II)  providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries.

“(iii)  Consultation with the contractor described in subparagraph (B) to verify if an individual enrolling in a prescription drug plan offered by a PDP sponsor has been previously identified by another PDP sponsor as an individual described in clause (ii)(I).

“(B)  Reporting.—A PDP sponsor offering a prescription drug plan (and an MA organization offering an MA-PD plan) in a State shall submit to the Secretary and the Medicare drug integrity contractor with which the Secretary has entered into a contract under section 1893 with respect to such State a report, on a monthly basis, containing information on—

“(i)  any provider of services or supplier described in subparagraph (A)(ii)(II) that is identified by such plan sponsor (or organization) during the 30-day period before such report is submitted; and

“(ii)  the name and prescription records of individuals described in paragraph (5)(C).

“(C)  CMS compliance review.—The Secretary shall ensure that plan sponsor compliance reviews and program audits biennially include a certification that utilization management tools under this paragraph are in compliance with the requirements for such tools.”.

(c) Expanding Activities of Medicare Drug Integrity Contractors (MEDICs).—

(1)  In general.—Section 1893 of the Social Security Act (42 U.S.C. 1395ddd) is amended by adding at the end the following new subsection:

“(j) Expanding Activities of Medicare Drug Integrity Contractors (MEDICs).—

“(1)  Access to information.—Under contracts entered into under this section with Medicare drug integrity contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA-PD plans, and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1860D-4(c)(5)(C).

“(2)  Requirement for acknowledgment of referrals.—If a PDP sponsor or MA organization refers information to a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall—

“(A)  acknowledge to the sponsor or organization receipt of the referral; and

“(B)  in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described in such paragraph, shall inform such sponsor or organization of such determination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor.

“(3) Making data available to other entities.—

“(A)  In general.—For purposes of carrying out this subsection, subject to subparagraph (B), the Secretary shall authorize MEDICs to respond to requests for information from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse.

“(B)  HIPAA compliant information only.—Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).”.

(d)  Treatment of Certain Complaints for Purposes of Quality or Performance Assessment.—Section 1860D-42 of the Social Security Act (42 U.S.C. 1395w-152) is amended by adding at the end the following new subsection:

“(d)  Treatment of Certain Complaints for Purposes of Quality or Performance Assessment.—In conducting a quality or performance assessment of a PDP sponsor, the Secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such PDP sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries.”.

(e)  Sense of Congress Regarding Use of Technology Tools To Combat Fraud.—It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under MA-PD plans and prescription drug plans under parts C and D of the Medicare program.

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(g) Effective Date; Rulemaking.—

(1)  In general.—The amendments made by this section shall apply to prescription drug plans (and MA-PD plans) for plan years beginning on or after January 1, 2019.

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(h)  Deposit of Savings Into Medicare Improvement Fund.—Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking “during and after fiscal year 2020, $0” and inserting “during and after fiscal year 2021, $140,000,000”.

SEC. 705. EXCLUDING ABUSE-DETERRENT FORMULATIONS OF PRESCRIPTION DRUGS FROM THE MEDICAID ADDITIONAL REBATE REQUIREMENT FOR NEW FORMULATIONS OF PRESCRIPTION DRUGS.

(a)  In General.—The last sentence of section 1927(c)(2)(C) of the Social Security Act (42 U.S.C. 1396r- 8(c)(2)(C)) is amended by inserting before the period at the end the following: “, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation”.

(b)  Effective Date.—The amendment made by subsection (a) shall apply to drugs that are paid for by a State in calendar quarters beginning on or after the date of the enactment of this Act.

SEC. 706. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND ABUSE.

(a)  In General.—Title XI of the Social Security Act is amended by inserting after section 1128J (42 U.S.C. 1320a-7k) the following new section:

“Section 1128K DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND ABUSE.—

“(a)  Reference to Predictive Modeling Technologies Requirements.—For provisions relating to the use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children's Health Insurance Program under title XXI, see section 4241 of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a-7m).

“(b)  Limiting Disclosure of Predictive Modeling Technologies.—In implementing such provisions under such section 4241 with respect to covered algorithms (as defined in subsection (c)), the following shall apply:

“(1)  Nonapplication of foia.—The covered algorithms used or developed for purposes of such section 4241 (including by the Secretary or a State (or an entity operating under a contract with a State)) shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code.

“(2) Limitation with respect to use and disclosure of information by state agencies.—

“(A)  In general.—A State agency may not use or disclose covered algorithms used or developed for purposes of such section 4241 except for purposes of administering the State plan (or a waiver of the plan) under the Medicaid program under title XIX or the State child health plan (or a waiver of the plan) under the Children's Health Insurance Program under title XXI, including by enabling an entity operating under a contract with a State to assist the State to identify or prevent waste, fraud, and abuse with respect to such programs.

“(B)  Information security.—A State agency shall have in effect data security and control policies that the Secretary finds adequate to ensure the security of covered algorithms used or developed for purposes of such section 4241 and to ensure that access to such information is restricted to authorized persons for purposes of authorized uses and disclosures described in subparagraph (A).

“(C)  Procedural requirements.—State agencies to which information is disclosed pursuant to such section 4241 shall adhere to uniform procedures established by the Secretary.

“(c)  Covered Algorithm Defined.—In this section, the term ‘covered algorithm’ —

“(1)  means a predictive modeling or other analytics technology, as used for purposes of section 4241(a) of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a-7m(a)) to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children's Health Insurance Program under title XXI; and

“(2)  includes the mathematical expressions utilized in the application of such technology and the means by which such technology is developed.”.

(b) Conforming Amendments.—

(1)  Medicaid state plan requirement.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended —

(A)  in paragraph (80), by striking “and” at the end;

(B)  in paragraph (81), by striking the period at the end and inserting “; and”; and

(C)  by inserting after paragraph (81) the following new paragraph:

“(82)  provide that the State agency responsible for administering the State plan under this title provides assurances to the Secretary that the State agency is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2).”.

(2)  State child health plan requirement.—Section 2102(a)(7) of the Social Security Act (42 U.S.C. 1397bb(a)(7)) is amended —

(A)  in subparagraph (A), by striking “, and” at the end and inserting a semicolon;

(B)  in subparagraph (B), by striking the period at the end and inserting “; and”; and (C) by adding at the end the following new subparagraph:

“(C)  to ensure that the State agency involved is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2).”.

SEC. 707. MEDICAID IMPROVEMENT FUND.

Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w- 1(b)(1)) is amended to read as follows:

“(1)  In general.—There shall be available to the Fund, for expenditures from the Fund for fiscal year 2021 and thereafter, $5,000,000.”.

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TITLE IV — DELIVERY

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SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND FUNCTIONALITY.

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(b) Significant Hardship Exception.—

(1) Application to eligible professionals.—

(A)  In case of decertification.—Section 1848(a)(7)(B) of the Social Security Act (42 U.S.C. 1395w-4(a)(7)(B)) is amended by inserting after the first sentence the following new sentence:

“The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph (A) with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such professional has been decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service Act.”.

(B)  Continued application under mips.—Section 1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w- 4(o)(2)(D)) is amended by adding at the end the following new sentence:

“The provisions of subparagraphs (B) and (D) of subsection (a)(7), shall apply to assessments of MIPS eligible professionals under subsection (q) with respect to the performance category described in subsection (q)(2)(A)(iv) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to payment adjustments made under subsection (a)(7)(A).”.

(2)  Application to eligible hospitals.—Section 1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first sentence the following new sentence:

“The Secretary shall exempt an eligible hospital from the application of the payment adjustment under subclause (I) with respect to a fiscal year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such hospital is decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service Act.”.

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SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.

(a)  In General.—Section 1862(l)(5) of the Social Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph:

“(D)  Local coverage determinations.—The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to make available on the Internet website of such contractor and on the Medicare Internet website, at least 45 days before the effective date of such determination, the following information:

“(i)  Such determination in its entirety.

“(ii)  Where and when the proposed determination was first made public.

“(iii)  Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.

“(iv)  A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.

“(v)  An explanation of the rationale that supports such determination.”.

(b)  Effective Date.—The amendment made by subsection (a) shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is 180 days after the date of enactment of this Act.

SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.

Section 1808 of the Social Security Act (42 U.S.C. 1395b-9) is amended by adding at the end the following new subsection:

“(d) Pharmaceutical and Technology Ombudsman.—

“(1)  In general.—Not later than 12 months after the date of enactment of this paragraph, the Secretary shall provide for a pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services who shall receive and respond to complaints, grievances, and requests that—

“(A)  are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought under this title; and

“(B)  are with respect to coverage, coding, or payment under this title for such products.

“(2)  Application.—The second sentence of subsection (c)(2) shall apply to the ombudsman under subparagraph (A) in the same manner as such sentence applies to the Medicare Beneficiary Ombudsman under subsection (c).”.

SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(t) Site-of-Service Price Transparency.—

“(1)  In general.—In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title, the Secretary shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an appropriate number of such items and services—

“(A)  the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and

“(B)  the estimated amount of beneficiary liability applicable to the item or service.

“(2)  Calculation of estimated beneficiary liability.—For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible.

“(3)  Implementation.—In carrying out this subsection, the Secretary—

“(A)  shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and

“(B)  may utilize mechanisms in existence on the date of enactment of this subsection, such as the portion of the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare Internet website), to make available such estimated amounts under such paragraph.

“(4)  Funding.—For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2017, to remain available until expended.”.

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TITLE V — SAVINGS

SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)), as amended by section 704(h) of the Comprehensive Addiction and Recovery Act of 2016, is amended by striking “$140,000,000” and inserting “$270,000,000”.

SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE MEDICAL EQUIPMENT.

Section 1903(i)(27) of the Social Security Act (42 U.S.C. 1396b(i)(27)) is amended by striking “January 1, 2019” and inserting “January 1, 2018”.

SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND OTHER AGREEMENTS.

(a)  In General.—Section 1128A of the Social Security Act (42 U.S.C. 1320a-7a) is amended by adding at the end the following new subsections:

“(o)  Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (q)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary provides funding—

“(1)  knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent;

“(2)  knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement;

“(3)  knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement;

“(4)  knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation (as defined in subsection (s)) to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or

“(5)  fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;

“shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under paragraph (1), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program.

“(p)  The provisions of subsections (c), (d), (g), and (h) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall be treated as including a reference to a specified claim (as defined in subsection (r)).

“(q)  For purposes of this subsection and subsections (o) and (p):

“(1)  The term ‘Department’ means the Department of Health and Human Services.

“(2)  The term ‘material’ means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.

“(3)  The term ‘other agreement’ includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward (regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor).

“(4)  The term ‘program beneficiary’ means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.

“(5)  The term ‘recipient’ includes a subrecipient or subcontractor.

“(6)  The term ‘specified State agency’ means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary.

“(r)  For purposes of this section, the term ‘specified claim’ means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that—

“(1)  is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or

“(2)  is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department's behalf or to advance a Department program or interest, and if the Department—

“(A)  provides or has provided any portion of the money or property requested or demanded; or

“(B)  will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded.

“(s)  For purposes of subsection (o), the term ‘obligation’ means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.”.

(b)  Conforming Amendments.—Section 1128A of the Social Security Act (42 U.S.C. 1320a-7a) is amended—

(1)  in subsection (e), by inserting “or specified claim” after “claim” in the first sentence; and

(2)  in subsection (f)—

(A)  in the matter preceding paragraph (1)—

(i)  by inserting “or specified claim (as defined in subsection (r))” after “district where the claim”; and

(ii)  by inserting “(or, with respect to a person described in subsection (o), the person)” after “claimant”; and

(B)  in the matter following paragraph (4), by inserting “(or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (q)(6)),” after “or a State agency”.

SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.

(a)  Treatment of Infusion Drugs Furnished Through Durable Medical Equipment.—Section 1842(o)(1) of the Social Security Act (42 U.S.C. 1395u(o)(1)) is amended—

(1)  in subparagraph (C), by inserting “(and including a drug or biological described in subparagraph (D)(i) furnished on or after January 1, 2017)” after “2005”; and (2) in subparagraph (D)—

(A)  by striking “infusion drugs” and inserting “infusion drugs or biologicals” each place it appears; and

(B)  in clause (i)—

(i)  by striking “2004” and inserting “2004, and before January 1, 2017”; and

(ii)  by striking “for such drug”.

(b) Noninclusion of DME Infusion Drugs Under DME Competitive Acquisition Programs..—

(1)  In general.—Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended—

(A)  by striking “and excluding” and inserting “, excluding”; and

(B)  by inserting before the period at the end the following: “, and excluding drugs and biologicals described in section 1842(o)(1)(D)”.

(2)  Conforming amendment.—Section 1842(o)(1)(D)(ii) of the Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by striking “2007” and inserting “2007, and before the date of the enactment of the 21st Century Cures Act.”.

SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID PROVIDERS.

(a) Increased Oversight and Reporting.—

(1)  State reporting requirements.—Section 1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)) is amended—

(A)  by redesignating paragraph (8) as paragraph (9); and

(B)  by inserting after paragraph (7) the following new paragraph:

“(8) Provider terminations.—

“(A)  In general.—Beginning on July 1, 2018, in the case of a notification under subsection (a)(41) with respect to a termination for a reason specified in section 455.101 of title 42, Code of Federal Regulations (as in effect on November 1, 2015) or for any other reason specified by the Secretary, of the participation of a provider of services or any other person under the State plan (or under a waiver of the plan), the State, not later than 30 days after the effective date of such termination, submits to the Secretary with respect to any such provider or person, as appropriate—

“(i)  the name of such provider or person;

“(ii)  the provider type of such provider or person;

“(iii)  the specialty of such provider's or person's practice;

“(iv)  the date of birth, Social Security number, national provider identifier (if applicable), Federal taxpayer identification number, and the State license or certification number of such provider or person (if applicable);

“(v)  the reason for the termination;

“(vi)  a copy of the notice of termination sent to the provider or person;

“(vii)  the date on which such termination is effective, as specified in the notice; and

“(viii)  any other information required by the Secretary.

“(B)  Effective date defined.—For purposes of this paragraph, the term ‘effective date’ means, with respect to a termination described in subparagraph (A), the later of—

“(i)  the date on which such termination is effective, as specified in the notice of such termination; or

“(ii)  the date on which all appeal rights applicable to such termination have been exhausted or the timeline for any such appeal has expired.”.

(2)  Contract requirement for managed care entities.—Section 1932(d) of the Social Security Act (42 U.S.C. 1396u-2(d)) is amended by adding at the end the following new paragraph:

“(5)  Contract requirement for managed care entities.—With respect to any contract with a managed care entity under section 1903(m) or 1905(t)(3) (as applicable), no later than July 1, 2018, such contract shall include a provision that providers of services or persons terminated (as described in section 1902(kk)(8)) from participation under this title, title XVIII, or title XXI shall be terminated from participating under this title as a provider in any network of such entity that serves individuals eligible to receive medical assistance under this title.”.

(3)  Termination notification database.—Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection:

“(ll)  Termination Notification Database.—In the case of a provider of services or any other person whose participation under this title or title XXI is terminated (as described in subsection (kk)(8)), the Secretary shall, not later than 30 days after the date on which the Secretary is notified of such termination under subsection (a)(41) (as applicable), review such termination and, if the Secretary determines appropriate, include such termination in any database or similar system developed pursuant to section 6401(b)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 1395cc note; Public Law 111-148).”.

(4)  No federal funds for items and services furnished by terminated providers.—Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended—

(A)  in subsection (i)(2)—

(i)  in subparagraph (A), by striking the comma at the end and inserting a semicolon;

(ii)  in subparagraph (B), by striking “or” at the end; and

(iii)  by adding at the end the following new subparagraph:

“(D)  beginning on July 1, 2018, under the plan by any provider of services or person whose participation in the State plan is terminated (as described in section 1902(kk)(8)) after the date that is 60 days after the date on which such termination is included in the database or other system under section 1902(ll); or”; and

(B)  in subsection (m), by inserting after paragraph (2) the following new paragraph:

“(3)  No payment shall be made under this title to a State with respect to expenditures incurred by the State for payment for services provided by a managed care entity (as defined under section 1932(a)(1)) under the State plan under this title (or under a waiver of the plan) unless the State—

“(A)  beginning on July 1, 2018, has a contract with such entity that complies with the requirement specified in section 1932(d)(5); and

“(B)  beginning on January 1, 2018, complies with the requirement specified in section 1932(d)(6)(A).”.

(5)  Development of uniform terminology for reasons for provider termination.—Not later than July 1, 2017, the Secretary of Health and Human Services shall, in consultation with the heads of State agencies administering State Medicaid plans (or waivers of such plans), issue regulations establishing uniform terminology to be used with respect to specifying reasons under subparagraph (A)(v) of paragraph (8) of section 1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)), as added by paragraph (1), for the termination (as described in such paragraph (8)) of the participation of certain providers in the Medicaid program under title XIX of such Act or the Children's Health Insurance Program under title XXI of such Act.

(6)  Conforming amendment.—Section 1902(a)(41) of the Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking “provide that whenever” and inserting “provide, in accordance with subsection (kk)(8) (as applicable), that whenever”.

(b) Increasing Availability of Medicaid Provider Information.—

(1)  FFS provider enrollment.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended by inserting after paragraph (77) the following new paragraph:

“(78)  provide that, not later than January 1, 2017, in the case of a State that pursuant to its State plan or waiver of the plan for medical assistance pays for medical assistance on a fee- for-service basis, the State shall require each provider furnishing items and services to, or ordering, prescribing, referring, or certifying eligibility for, services for individuals eligible to receive medical assistance under such plan to enroll with the State agency and provide to the State agency the provider's identifying information, including the name, specialty, date of birth, Social Security number, national provider identifier (if applicable), Federal taxpayer identification number, and the State license or certification number of the provider (if applicable);”.

(2)  Managed care provider enrollment.—Section 1932(d) of the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by subsection (a)(2), is amended by adding at the end the following new paragraph:

“(6) Enrollment of participating providers.—

“(A)  In general.—Beginning not later than January 1, 2018, a State shall require that, in order to participate as a provider in the network of a managed care entity that provides services to, or orders, prescribes, refers, or certifies eligibility for services for, individuals who are eligible for medical assistance under the State plan under this title (or under a waiver of the plan) and who are enrolled with the entity, the provider is enrolled consistent with section 1902(kk) with the State agency administering the State plan under this title. Such enrollment shall include providing to the State agency the provider's identifying information, including the name, specialty, date of birth, Social Security number, national provider identifier, Federal taxpayer identification number, and the State license or certification number of the provider.

“(B)  Rule of construction.—Nothing in subparagraph (A) shall be construed as requiring a provider described in such subparagraph to provide services to individuals who are not enrolled with a managed care entity under this title.”.

(c) Coordination With CHIP.—

(1)  In general.—Section 2107(e)(1) of the Social Security Act (42 U.S.C. 1397gg(e)(1)) is amended—

(A)  by redesignating subparagraphs (B), (C), (D), (E), (F), (G), (H), (I), (J), (K), (L), (M), (N), and (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), (O), (P), (Q), and (R), respectively;

(B)  by inserting after subparagraph (A) the following new subparagraphs:

“(B)  Section 1902(a)(39) (relating to termination of participation of certain providers).

“(C)  Section 1902(a)(78) (relating to enrollment of providers participating in State plans providing medical assistance on a fee-for-service basis).”;

(C)  by inserting after subparagraph (K) (as redesignated by subparagraph (A)) the following new subparagraph:

“(L)  Section 1903(m)(3) (relating to limitation on payment with respect to managed care).”; and

(D)  in subparagraph (P) (as redesignated by subparagraph (A)), by striking “(a)(2)(C) and (h)” and inserting “(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating to contract requirement for managed care entities), (d)(6) (relating to enrollment of providers participating with a managed care entity), and (h) (relating to special rules with respect to Indian enrollees, Indian health care providers, and Indian managed care entities)”.

(2)  Excluding from medicaid providers excluded from chip.—Section 1902(a)(39) of the Social Security Act (42 U.S.C. 1396a(a)(39)) is amended by striking “title XVIII or any other State plan under this title” and inserting “title XVIII, any other State plan under this title (or waiver of the plan), or any State child health plan under title XXI (or waiver of the plan) and such termination is included by the Secretary in any database or similar system developed pursuant to section 6401(b)(2) of the Patient Protection and Affordable Care Act”.

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SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER DIRECTORY.

(a)  In General.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended—

(1)  in paragraph (81), by striking “and” at the end;

(2)  in paragraph (82), by striking the period at the end and inserting “; and”; and

(3)  by inserting after paragraph (82) the following new paragraph:

“(83)  provide that, not later than January 1, 2017, in the case of a State plan (or waiver of the plan) that provides medical assistance on a fee-for-service basis or through a primary care case-management system described in section 1915(b)(1) (other than a primary care case management entity (as defined by the Secretary)), the State shall publish (and update on at least an annual basis) on the public website of the State agency administering the State plan, a directory of the physicians described in subsection (mm) and, at State option, other providers described in such subsection that—

“(A)  includes—

“(i)  with respect to each such physician or provider—

“(I)  the name of the physician or provider;

“(II)  the specialty of the physician or provider;

“(III)  the address at which the physician or provider provides services; and

“(IV)  the telephone number of the physician or provider; and

“(ii)  with respect to any such physician or provider participating in such a primary care case-management system, information regarding—

“(I)  whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title; and

“(II)  the physician's or provider's cultural and linguistic capabilities, including the languages spoken by the physician or provider or by the skilled medical interpreter providing interpretation services at the physician's or provider's office; and

“(B)  may include, at State option, with respect to each such physician or provider—

“(i)  the Internet website of such physician or provider; or

“(ii)  whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title.”.

(b)  Directory Physician or Provider Described.—Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended by section 5005(a)(3), is further amended by adding at the end the following new subsection:

“(mm)  Directory Physician or Provider Described.—A physician or provider described in this subsection is—

“(1)  in the case of a physician or provider of a provider type for which the State agency, as a condition on receiving payment for items and services furnished by the physician or provider to individuals eligible to receive medical assistance under the State plan, requires the enrollment of the physician or provider with the State agency, a physician or a provider that—

“(A)  is enrolled with the agency as of the date on which the directory is published or updated (as applicable) under subsection (a)(83); and

“(B)  received payment under the State plan in the 12-month period preceding such date; and

“(2)  in the case of a physician or provider of a provider type for which the State agency does not require such enrollment, a physician or provider that received payment under the State plan (or a waiver of the plan) in the 12-month period preceding the date on which the directory is published or updated (as applicable) under subsection (a)(83).”.

(c) Rule of Construction.—

(1)  In general.—The amendment made by subsection (a) shall not be construed to apply in the case of a State (as defined for purposes of title XIX of the Social Security Act) in which all the individuals enrolled in the State plan under such title (or under a waiver of such plan), other than individuals described in paragraph (2), are enrolled with a medicaid managed care organization (as defined in section 1903(m)(1)(A) of such Act (42 U.S.C. 1396b(m)(1)(A))), including prepaid inpatient health plans and prepaid ambulatory health plans (as defined by the Secretary of Health and Human Services).

(2)  Individuals described.—An individual described in this paragraph is an individual who is an Indian (as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)) or an Alaska Native.

(d)  Exception for State Legislation.—In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet one or more additional requirements imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.

(a)  In General.—Section 1917(d)(4)(A) of the Social Security Act (42 U.S.C. 1396p(d)(4)(A)) is amended by inserting “the individual,” after “for the benefit of such individual by”.

(b)  Effective Date.—The amendment made by subsection (a) shall apply to trusts established on or after the date of the enactment of this Act.

SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH RESPECT TO EXPENDITURES UNDER MEDICAID FOR AGENTS USED FOR COSMETIC PURPOSES OR HAIR GROWTH.

(a)  In General.—Section 1903(i)(21) of the Social Security Act (42 U.S.C. 1396b(i)(21)) is amended by inserting “section 1927(d)(2)(C) (relating to drugs when used for cosmetic purposes or hair growth), except where medically necessary, and” after “drugs described in”.

(b)  Effective Date.—The amendment made by subsection (a) shall apply with respect to calendar quarters beginning on or after the date of the enactment of this Act.

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SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.

(a)  In General.—Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—

(1)  in subsection (s)(2)—

(A)  by striking “and” at the end of subparagraph (EE);

(B)  by inserting “and” at the end of subparagraph (FF); and

(C)  by inserting at the end the following new subparagraph:

“(GG)  home infusion therapy (as defined in subsection (iii)(1));”; and

(2)  by adding at the end the following new subsection:

“(iii) Home Infusion Therapy.—

“(1)  The term ‘home infusion therapy’ means the items and services described in paragraph (2) furnished by a qualified home infusion therapy supplier (as defined in paragraph (3)(D)) which are furnished in the individual's home (as defined in paragraph (3)(B)) to an individual—

“(A)  who is under the care of an applicable provider (as defined in paragraph (3)(A)); and

“(B)  with respect to whom a plan prescribing the type, amount, and duration of infusion therapy services that are to be furnished such individual has been established by a physician (as defined in subsection (r)(1)) and is periodically reviewed by a physician (as so defined) in coordination with the furnishing of home infusion drugs (as defined in paragraph (3)(C)) under part B.

“(2)  The items and services described in this paragraph are the following:

“(A)  Professional services, including nursing services, furnished in accordance with the plan.

“(B)  Training and education (not otherwise paid for as durable medical equipment (as defined in subsection (n)), remote monitoring, and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier.

“(3)  For purposes of this subsection:

“(A)  The term `applicable provider' means—

“(i)  a physician;

“(ii)  a nurse practitioner; and

“(iii)  a physician assistant.

“(B)  The term ‘home’ means a place of residence used as the home of an individual (as defined for purposes of subsection (n)).

“(C)  The term ‘home infusion drug’ means a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment (as defined in subsection (n)). Such term does not include the following:

“(i)  Insulin pump systems.

(ii)  A self-administered drug or biological on a self- administered drug exclusion list.

“(D) (i)  The term ‘qualified home infusion therapy supplier’ means a pharmacy, physician, or other provider of services or supplier licensed by the State in which the pharmacy, physician, or provider or services or supplier furnishes items or services and that—

“(I)  furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs;

“(II)  ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis;

“(III)  is accredited by an organization designated by the Secretary pursuant to section 1834(u)(5); and

“(IV)  meets such other requirements as the Secretary determines appropriate, taking into account the standards of care for home infusion therapy established by Medicare Advantage plans under part C and in the private sector.

“(ii)  A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or supplier to meet the requirements of this subparagraph.”.

(b)  Payment and Related Requirements for Home Infusion Therapy.—Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 4011, is further amended by adding at the end the following new subsection:

“(u) Payment and Related Requirements for Home Infusion Therapy.—

“(1) Payment.—

“(A) Single payment.—

“(i)  In general.—Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement a payment system under which a single payment is made under this title to a qualified home infusion therapy supplier for items and services described in subparagraphs (A) and (B) of section 1861(iii)(2)) furnished by a qualified home infusion therapy supplier (as defined in section 1861(iii)(3)(D)) in coordination with the furnishing of home infusion drugs (as defined in section 1861(iii)(3)(C)) under this part.

“(ii)  Unit of single payment.—A unit of single payment under the payment system implemented under this subparagraph is for each infusion drug administration calendar day in the individual's home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type.

“(iii)  Limitation.—The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under section 1848 for infusion therapy services furnished in a calendar day if furnished in a physician office setting, except such single payment shall not reflect more than 5 hours of infusion for a particular therapy in a calendar day.

“(B)  Required adjustments.—The Secretary shall adjust the single payment amount determined under subparagraph (A) for home infusion therapy services under section 1861(iii)(1) to reflect other factors such as—

“(i)  a geographic wage index and other costs that may vary by region; and

“(ii)  patient acuity and complexity of drug administration.

“(C) Discretionary adjustments.—

“(i)  In general.—Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of subparagraph (B)) to reflect outlier situations and other factors as the Secretary determines appropriate.

“(ii)  Requirement of budget neutrality.—Any adjustment under this subparagraph shall be made in a budget neutral manner.

“(2)  Considerations.—In developing the payment system under this subsection, the Secretary may consider the costs of furnishing infusion therapy in the home, consult with home infusion therapy suppliers, consider payment amounts for similar items and services under this part and part A, and consider payment amounts established by Medicare Advantage plans under part C and in the private insurance market for home infusion therapy (including average per treatment day payment amounts by type of home infusion therapy).

“(3) Annual updates.—

“(A)  In general.—Subject to subparagraph (B), the Secretary shall update the single payment amount under this subsection from year to year beginning in 2022 by increasing the single payment amount from the prior year by the percentage increase in the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year.

“(B)  Adjustment.—For each year, the Secretary shall reduce the percentage increase described in subparagraph (A) by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in a percentage being less than 0.0 for a year, and may result in payment being less than such payment rates for the preceding year.

“(4)  Authority to apply prior authorization.—The Secretary may, as determined appropriate by the Secretary, apply prior authorization for home infusion therapy services under section 1861(iii)(1).

“(5) Accreditation of qualified home infusion therapy suppliers.—

“(A)  Factors for designation of accreditation organizations.—The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):

“(i)  The ability of the organization to conduct timely reviews of accreditation applications.

“(ii)  The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D)).

“(iii)  Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.

“(iv)  Such other factors as the Secretary determines appropriate.

“(B)  Designation.—Not later than January 1, 2021, the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).

“(C) Review and modification of list of accreditation organizations.—

“(i)  In general.—The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).

“(ii)  Special rule for accreditations done prior to removal from list of designated accreditation organizations.—In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect.

“(D)  Rule for accreditations made prior to designation.—In the case of a supplier that is accredited before January 1, 2021, by an accreditation organization designated by the Secretary under subparagraph (B) as of January 1, 2019, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2023, for the remaining period such accreditation is in effect.

“(6)  Notification of infusion therapy options available prior to furnishing home infusion therapy.—Prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan described in section 1861(iii)(1) for the individual shall provide notification (in a form, manner, and frequency determined appropriate by the Secretary) of the options available (such as home, physician's office, hospital outpatient department) for the furnishing of infusion therapy under this part.”.

(c) Conforming Amendments.—

(1)  Payment reference.—Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—

(A)  by striking “and” before “(AA)”; and

(B)  by inserting before the semicolon at the end the following: “, and (BB) with respect to home infusion therapy, the amount paid shall be an amount equal to 80 percent of the lesser of the actual charge for the services or the amount determined under section 1834(u)”.

(2)  Direct payment.—The first sentence of section 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is amended—

(A)  by striking “and” before “(H)”; and

(B)  by inserting before the period at the end the following: .

(3)  Exclusion from home health services.—Section 1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the first sentence, by inserting the following before the period at the end: “and home infusion therapy (as defined in subsection (iii)(i))”.

(d)  Effective Date.—The amendments made by this section shall apply to items and services furnished on or after January 1, 2021.

TITLE XII — MEDICAID MENTAL HEALTH COVERAGE

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SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS.

(a)  In General.—Section 1905(a)(16) of the Social Security Act (42 U.S.C. 1396d(a)(16)) is amended—

(1)  by striking “effective January 1, 1973” and inserting “(A) effective January 1, 1973”; and

(2)  by inserting before the semicolon at the end the following:

“, and, (B) for individuals receiving services described in subparagraph (A), early and periodic screening, diagnostic, and treatment services (as defined in subsection (r)), whether or not such screening, diagnostic, and treatment services are furnished by the provider of the services described in such subparagraph”.

(b)  Effective Date.—The amendments made by subsection (a) shall apply with respect to items and services furnished in calendar quarters beginning on or after January 1, 2019.

SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR PERSONAL CARE SERVICES AND HOME HEALTH CARE SERVICES UNDER MEDICAID.

(a)  In General.—Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended by inserting after subsection (k) the following new subsection:

“(l) (1)  (1) Subject to paragraphs (3) and (4), with respect to any amount expended for personal care services or home health care services requiring an in-home visit by a provider that are provided under a State plan under this title (or under a waiver of the plan) and furnished in a calendar quarter beginning on or after January 1, 2019 (or, in the case of home health care services, on or after January 1, 2023), unless a State requires the use of an electronic visit verification system for such services furnished in such quarter under the plan or such waiver, the Federal medical assistance percentage shall be reduced—

“(A) in the case of personal care services.—

“(i)  for calendar quarters in 2019 and 2020, by .25 percentage points;

“(ii)  for calendar quarters in 2021, by .5 percentage points;

“(iii)  for calendar quarters in 2022, by .75 percentage points; and

“(iv)  for calendar quarters in 2023 and each year thereafter, by 1 percentage point; and

“(B) in the case of home health care services.—

“(i)  for calendar quarters in 2023 and 2024, by .25 percentage points;

“(ii)  for calendar quarters in 2025, by .5 percentage points;

“(iii)  for calendar quarters in 2026, by .75 percentage points; and

“(iv)  for calendar quarters in 2027 and each year thereafter, by 1 percentage point.

“(2)  Subject to paragraphs (3) and (4), in implementing the requirement for the use of an electronic visit verification system under paragraph (1), a State shall—

“(A)  consult with agencies and entities that provide personal care services, home health care services, or both under the State plan (or under a waiver of the plan) to ensure that such system—

“(i)  is minimally burdensome;

“(ii)  takes into account existing best practices and electronic visit verification systems in use in the State; and

“(iii)  is conducted in accordance with the requirements of HIPAA privacy and security law (as defined in section 3009 of the Public Health Service Act);

“(B)  take into account a stakeholder process that includes input from beneficiaries, family caregivers, individuals who furnish personal care services or home health care services, and other stakeholders, as determined by the State in accordance with guidance from the Secretary; and

“(C)  ensure that individuals who furnish personal care services, home health care services, or both under the State plan (or under a waiver of the plan) are provided the opportunity for training on the use of such system.

“(3)  Paragraphs (1) and (2) shall not apply in the case of a State that, as of the date of the enactment of this subsection, requires the use of any system for the electronic verification of visits conducted as part of both personal care services and home health care services, so long as the State continues to require the use of such system with respect to the electronic verification of such visits.

“(4) (A)  In the case of a State described in subparagraph (B), the reduction under paragraph (1) shall not apply—

“(i)  in the case of personal care services, for calendar quarters in 2019; and

“(ii)  in the case of home health care services, for calendar quarters in 2023.

“(B)  For purposes of subparagraph (A), a State described in this subparagraph is a State that demonstrates to the Secretary that the State—

“(i)  has made a good faith effort to comply with the requirements of paragraphs (1) and (2) (including by taking steps to adopt the technology used for an electronic visit verification system); and

“(ii)  in implementing such a system, has encountered unavoidable system delays.

“(5)  In this subsection:

“(A)  The term ‘electronic visit verification system’ means, with respect to personal care services or home health care services, a system under which visits conducted as part of such services are electronically verified with respect to—

“(i)  the type of service performed;

“(ii)  the individual receiving the service;

“(iii)  the date of the service;

“(iv)  the location of service delivery;

“(v)  the individual providing the service; and

“(vi)  the time the service begins and ends.

“(B)  The term ‘home health care services’ means services described in section 1905(a)(7) provided under a State plan under this title (or under a waiver of the plan).

“(C)  The term ‘personal care services’ means personal care services provided under a State plan under this title (or under a waiver of the plan), including services provided under section 1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a wavier under section 1115.

“(6) (A)  In the case in which a State requires personal care service and home health care service providers to utilize an electronic visit verification system operated by the State or a contractor on behalf of the State, the Secretary shall pay to the State, for each quarter, an amount equal to 90 per centum of so much of the sums expended during such quarter as are attributable to the design, development, or installation of such system, and 75 per centum of so much of the sums for the operation and maintenance of such system.

“(B)  Subparagraph (A) shall not apply in the case in which a State requires personal care service and home health care service providers to utilize an electronic visit verification system that is not operated by the State or a contractor on behalf of the State.”.

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TITLE XV — PROVISIONS RELATING TO MEDICARE PART A

SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS-DRG CODES FOR SIMILAR HOSPITAL SERVICES.

Section 1886 of the Social Security Act (42 U.S.C. 1395ww) is amended by adding at the end the following new subsection:

“(t) Relating Similar Inpatient and Outpatient Hospital Services.—

“(1)  Development of hcpcs version of ms-drg codes.—Not later than January 1, 2018, the Secretary shall develop HCPCS versions for MS-DRGs that are similar to the ICD-10-PCS for such MS-DRGs such that, to the extent possible, the MS-DRG assignment shall be similar for a claim coded with the HCPCS version as an identical claim coded with a ICD-10-PCS code.

“(2)  Coverage of surgical ms-drgs.—In carrying out paragraph (1), the Secretary shall develop HCPCS versions of MS-DRG codes for not fewer than 10 surgical MS-DRGs.

“(3) Publication and dissemination of the hcpcs versions of ms-drgs.—

“(A)  In general.—The Secretary shall develop a HCPCS MS- DRG definitions manual and software that is similar to the definitions manual and software for ICD-10-PCS codes for such MS-DRGs. The Secretary shall post the HCPCS MS-DRG definitions manual and software on the Internet website of the Centers for Medicare & Medicaid Services. The HCPCS MS-DRG definitions manual and software shall be in the public domain and available for use and redistribution without charge.

“(B)  Use of previous analysis done by medpac.—In developing the HCPCS MS-DRG definitions manual and software under subparagraph (A), the Secretary shall consult with the Medicare Payment Advisory Commission and shall consider the analysis done by such Commission in translating outpatient surgical claims into inpatient surgical MS-DRGs in preparing chapter 7 (relating to hospital short-stay policy issues) of its ‘Medicare and the Health Care Delivery System’ report submitted to Congress in June 2015.

“(4)  Definition and reference.—In this subsection:

“(A)  HCPCS.—The term ‘HCPCS’ means, with respect to hospital items and services, the code under the Healthcare Common Procedure Coding System (HCPCS) (or a successor code) for such items and services.

SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE HOSPITAL READMISSION PROGRAM.

(a)  Transitional Adjustment for Dual Eligible Population.—Section 1886(q)(3) of the Social Security Act (42 U.S.C. 1395ww(q)(3)) is amended—

(1)  in subparagraph (A), by inserting ``subject to subparagraph (D),'' after ``purposes of paragraph (1),''; and

(2)  by adding at the end the following new subparagraph:

“(D) Transitional adjustment for dual eligibles.—

“(i)  In general.—In determining a hospital's adjustment factor under this paragraph for purposes of making payments for discharges occurring during and after fiscal year 2019, and before the application of clause (i) of subparagraph (E), the Secretary shall assign hospitals to groups (as defined by the Secretary under clause (ii)) and apply the applicable provisions of this subsection using a methodology in a manner that allows for separate comparison of hospitals within each such group, as determined by the Secretary.

“(ii)  Defining groups.—For purposes of this subparagraph, the Secretary shall define groups of hospitals, based on their overall proportion, of the inpatients who are entitled to, or enrolled for, benefits under part A, and who are full-benefit dual eligible individuals (as defined in section 1935(c)(6)). In defining groups, the Secretary shall consult the Medicare Payment Advisory Commission and may consider the analysis done by such Commission in preparing the portion of its report submitted to Congress in June 2013 relating to readmissions.

“(iii)  Minimizing reporting burden on hospitals.—In carrying out this subparagraph, the Secretary shall not impose any additional reporting requirements on hospitals.

“(iv)  Budget neutral design methodology.—The Secretary shall design the methodology to implement this subparagraph so that the estimated total amount of reductions in payments under this subsection equals the estimated total amount of reductions in payments that would otherwise occur under this subsection if this subparagraph did not apply.”.

(b)  Changes in Risk Adjustment.—Section 1886(q)(3) of the Social Security Act (42 U.S.C. 1395ww(q)(3)), as amended by subsection (a), is further amended by adding at the end the following new subparagraph:

“(E) Changes in risk adjustment.—

“(i)  Consideration of recommendations in impact reports.—The Secretary may take into account the studies conducted and the recommendations made by the Secretary under section 2(d)(1) of the IMPACT Act of 2014 (Public Law 113-185; 42 U.S.C. 1395lll note) with respect to the application under this subsection of risk adjustment methodologies. Nothing in this clause shall be construed as precluding consideration of the use of groupings of hospitals.

“(ii)  Consideration of exclusion of patient cases based on v or other appropriate codes.—In promulgating regulations to carry out this subsection with respect to discharges occurring after fiscal year 2018, the Secretary may consider the use of V or other ICD-related codes for removal of a readmission. The Secretary may consider modifying measures under this subsection to incorporate V or other ICD-related codes at the same time as other changes are being made under this subparagraph.

“(iii)  Removal of certain readmissions.—In promulgating regulations to carry out this subsection, with respect to discharges occurring after fiscal year 2018, the Secretary may consider removal as a readmission of an admission that is classified within one or more of the following: transplants, end-stage renal disease, burns, trauma, psychosis, or substance abuse. The Secretary may consider modifying measures under this subsection to remove readmissions at the same time as other changes are being made under this subparagraph.”.

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SEC. 15004. REGULATORY RELIEF FOR LTCHS.

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(b)  Modification to Medicare Long-Term Care Hospital High Cost Outlier Payments.—Section 1886(m) of the Social Security Act (42 U.S.C. 1395ww(m)) is amended by adding at the end the following new paragraph:

“(7) Treatment of high cost outlier payments.—

“(A)  Adjustment to the standard federal payment rate for estimated high cost outlier payments.—Under the system described in paragraph (1), for fiscal years beginning on or after October 1, 2017, the Secretary shall reduce the standard Federal payment rate as if the estimated aggregate amount of high cost outlier payments for standard Federal payment rate discharges for each such fiscal year would be equal to 8 percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year.

“(B)  Limitation on high cost outlier payment amounts.—Notwithstanding subparagraph (A), the Secretary shall set the fixed loss amount for high cost outlier payments such that the estimated aggregate amount of high cost outlier payments made for standard Federal payment rate discharges for fiscal years beginning on or after October 1, 2017, shall be equal to 99.6875 percent of 8 percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year.

“(C)  Waiver of budget neutrality.—Any reduction in payments resulting from the application of subparagraph (B) shall not be taken into account in applying any budget neutrality provision under such system.

“(D)  No effect on site neutral high cost outlier payment rate.—This paragraph shall not apply with respect to the computation of the applicable site neutral payment rate under paragraph (6).”.

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SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN HOSPITALS.

(a)  In General.—Subsection (d)(1)(B)(iv) of section 1886 of the Social Security Act (42 U.S.C. 1395ww) is amended—

(1)  in subclause (I), by striking “or” at the end;

(2)  in subclause (II)—

(A)  by striking “, or” at the end and inserting a semicolon;

(B)  by redesignating such subclause as clause (vi) and by moving it to immediately follow clause (v); and

(C)  in clause (v), by striking the semicolon at the end and inserting “, or”; and

(3)  by striking “(iv)(I) a hospital” and inserting “(iv) a hospital”.

(b)  Conforming Payment References.—The second sentence of subsection (d)(1)(B) of such section is amended—

(1)  by inserting “(as in effect as of such date)” after “clause (iv)”; and

(2)  by inserting “(or, in the case of a hospital described in clause (iv)(II), as so in effect, shall be classified under clause (vi) on and after the effective date of such clause (vi) and for cost reporting periods beginning on or after January 1, 2015, shall not be subject to subsection (m) as of the date of such classification)” after “so classified”.

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(d) Conforming Technical Amendments.—

(1)  Section 1899B(a)(2)(A)(iv) of the Social Security Act (42 U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking “1886(d)(1)(B)(iv)(II)” and inserting “1886(d)(1)(B)(vi)”.

(2)  Section 1886(m)(5)(F) of such Act (42 U.S.C. 1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii) by striking “(d)(1)(B)(iv)(II)” and inserting “(d)(1)(B)(vi)”.

SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CERTAIN SPINAL CORD SPECIALTY HOSPITALS.

(a)  Exception.—Section 1886(m)(6) of the Social Security Act (42 U.S.C. 1395ww(m)(6)) is amended—

(1)  in subparagraph (A)(i), by striking “and (E)” and inserting “, (E), and (F)”; and

(2)  by adding at the end the following new subparagraph:

“(F)  Temporary exception for certain spinal cord specialty hospitals.—For discharges in cost reporting periods beginning during fiscal years 2018 and 2019, subparagraph (A)(i) shall not apply (and payment shall be made to a long-term care hospital without regard to this paragraph) if such discharge is from a long-term care hospital that meets each of the following requirements:

“(i)  Not-for-profit.—The long-term care hospital was a not-for-profit long-term care hospital on June 1, 2014, as determined by cost report data.

“(ii)  Primarily providing treatment for catastrophic spinal cord or acquired brain injuries or other paralyzing neuromuscular conditions.—Of the discharges in calendar year 2013 from the long-term care hospital for which payment was made under this section, at least 50 percent were classified under MS-LTCH-DRGs 28, 29, 52, 57, 551, 573, and 963.

“(iii) Significant out-of-state admissions.—

“(I)  In general.—The long-term care hospital discharged inpatients (including both individuals entitled to, or enrolled for, benefits under this title and individuals not so entitled or enrolled) during fiscal year 2014 who had been admitted from at least 20 of the 50 States, determined by the States of residency of such inpatients and based on such data submitted by the hospital to the Secretary as the Secretary may require.

“(II)  Implementation.—Notwithstanding any other provision of law, the Secretary may implement subclause (I) by program instruction or otherwise.

“(III)  Non-application of paperwork reduction act.—Chapter 35 of title 44, United States Code, shall not apply to data collected under this clause.”.

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TITLE XVI — PROVISIONS RELATING TO MEDICARE PART B

SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE PAYMENT SYSTEM FOR SERVICES FURNISHED BY MID-BUILD OFF-CAMPUS OUTPATIENT DEPARTMENTS OF PROVIDERS.

(a)  In General.—Section 1833(t)(21) of the Social Security Act (42 U.S.C. 1395l(t)(21)) is amended—

(1)  (1) in subparagraph (B) —

(A)  in clause (i), by striking ``clause (ii)'' and inserting ``the subsequent provisions of this subparagraph''; and

(B)  by adding at the end the following new clauses:

“(iii)  Deemed treatment for 2017.—For purposes of applying clause (ii) with respect to applicable items and services furnished during 2017, a department of a provider (as so defined) not described in such clause is deemed to be billing under this subsection with respect to covered OPD services furnished prior to November 2, 2015, if the Secretary received from the provider prior to December 2, 2015, an attestation (pursuant to section 413.65(b)(3) of title 42 of the Code of Federal Regulations) that such department was a department of a provider (as so defined).

“(iv)  Alternative exception beginning with 2018.—For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2018 or a subsequent year, the term ‘off-campus outpatient department of a provider’ also shall not include a department of a provider (as so defined) that is not described in clause (ii) if —

“(I)  the Secretary receives from the provider an attestation (pursuant to such section 413.65(b)(3)) not later than December 31, 2016 (or, if later, 60 days after the date of the enactment of this clause), that such department met the requirements of a department of a provider specified in section 413.65 of title 42 of the Code of Federal Regulations;

“(II)  the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under section 1866(j); and

“(III)  the department met the mid-build requirement of clause (v) and the Secretary receives, not later than 60 days after the date of the enactment of this clause, from the chief executive officer or chief operating officer of the provider a written certification that the department met such requirement.

“(v)  Mid-build requirement described.—The mid-build requirement of this clause is, with respect to a department of a provider, that before November 2, 2015, the provider had a binding written agreement with an outside unrelated party for the actual construction of such department.

“(vii)  Audit.—Not later than December 31, 2018, the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department of a provider to which such clause applies. If the Secretary finds as a result of an audit under this clause that the applicable requirements were not met with respect to such department, the department shall not be excluded from the term ‘off- campus outpatient department of a provider’ under such clause.

“(viii)  Implementation.—For purposes of implementing clauses (iii) through (vii):

“(I)  Notwithstanding any other provision of law, the Secretary may implement such clauses by program instruction or otherwise.

“(II)  Subchapter I of chapter 35 of title 44, United States Code, shall not apply.

“(III)  For purposes of carrying out this subparagraph with respect to clauses (iii) and (iv) (and clause (vii) insofar as it relates to clause (iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to remain available until December 31, 2018.”; and

(2)  in subparagraph (E), by adding at the end the following new clause:

“(iv)  The determination of an audit under subparagraph (B)(vii).”.

(b)  Effective Date.—The amendments made by this section shall be effective as if included in the enactment of section 603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).

SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER POLICY.

(a)  In General.—Section 1833(t)(21)(B) of the Social Security Act (42 U.S.C. 1395l(t)(21)(B)), as amended by section 16001(a), is amended—

(1)  by inserting after clause (v) the following new clause:

“(vi)  Exclusion for certain cancer hospitals.—For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2017 or a subsequent year, the term ‘off-campus outpatient department of a provider’ also shall not include a department of a provider (as so defined) that is not described in clause (ii) if the provider is a hospital described in section 1886(d)(1)(B)(v) and—

“(I)  in the case of a department that met the requirements of section 413.65 of title 42 of the Code of Federal Regulations after November 1, 2015, and before the date of the enactment of this clause, the Secretary receives from the provider an attestation that such department met such requirements not later than 60 days after such date of enactment; or

“(II)  in the case of a department that meets such requirements after such date of enactment, the Secretary receives from the provider an attestation that such department meets such requirements not later than 60 days after the date such requirements are first met with respect to such department.”;

(2)  in clause (vii), by inserting after the first sentence the following:

; and

(3)  in clause (viii)(III), by adding at the end the following:

“For purposes of carrying out this subparagraph with respect to clause (vi) (and clause (vii) insofar as it relates to such clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to remain available until expended.”.

(b)  Offsetting Savings.—Section 1833(t)(18) of the Social Security Act (42 U.S.C. 1395l(t)(18)) is amended—

(1)  in subparagraph (B), by inserting “, subject to subparagraph (C),” after “shall”; and

(2)  by adding at the end the following new subparagraph:

“(C)  Target pcr adjustment.—In applying section 419.43(i) of title 42 of the Code of Federal Regulations to implement the appropriate adjustment under this paragraph for services furnished on or after January 1, 2018, the Secretary shall use a target PCR that is 1.0 percentage points less than the target PCR that would otherwise apply. In addition to the percentage point reduction under the previous sentence, the Secretary may consider making an additional percentage point reduction to such target PCR that takes into account payment rates for applicable items and services described in paragraph (21)(C) other than for services furnished by hospitals described in section 1886(d)(1)(B)(v). In making any budget neutrality adjustments under this subsection for 2018 or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph.”.

(c)  Effective Date.—The amendments made by this section shall be effective as if included in the enactment of section 603 of the Bipartisan Budget Act of 2015 (Public Law 114-74).

SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY SURGICAL CENTERS FOR MEANINGFUL USE AND MIPS.

Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C. 1395w- 4(a)(7)(D)) is amended—

(1)  by striking “hospital-based eligible professionals” and all that follows through “No payment” and inserting the following: “hospital-based and ambulatory surgical center-based eligible professionals.—

“(i)  Hospital-based.— No payment”;

and

(2)  by adding at the end the following new clauses:

“(ii)  Ambulatory surgical center-based.—Subject to clause (iv), no payment adjustment may be made under subparagraph (A) for 2017 and 2018 in the case of an eligible professional with respect to whom substantially all of the covered professional services furnished by such professional are furnished in an ambulatory surgical center.

“(iii)  Determination.—The determination of whether an eligible professional is an eligible professional described in clause (ii) may be made on the basis of—

“(I)  the site of service (as defined by the Secretary); or

“(II)  an attestation submitted by the eligible professional. Determinations made under subclauses (I) and (II) shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services.

“(iv)  Sunset.—Clause (ii) shall no longer apply as of the first year that begins more than 3 years after the date on which the Secretary determines, through notice and comment rulemaking, that certified EHR technology applicable to the ambulatory surgical center setting is available.”.

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SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM TENENS ARRANGEMENTS UNDER MEDICARE.

(a)  In General.—The first sentence of section 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by section 5012, is further amended—

(1)  by striking “and” before “(I)”; and

(2)  by inserting before the period at the end the following:

“, and (J) in the case of outpatient physical therapy services furnished by physical therapists in a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act), a medically underserved area (as designated pursuant to section 330(b)(3)(A) of such Act), or a rural area (as defined in section 1886(d)(2)(D)), subparagraph (D) of this sentence shall apply to such services and therapists in the same manner as such subparagraph applies to physicians’ services furnished by physicians”.

(b) Effective Date; Implementation.—

(1)  Effective date.—The amendments made by subsection (a) shall apply to services furnished beginning not later than six months after the date of the enactment of this Act.

(2)  Implementation.—The Secretary of Health and Human Services may implement subparagraph (J) of section 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)), as added by subsection (a)(2), by program instruction or otherwise.

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SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING INFORMATION FROM COMPETITIVE BIDDING PROGRAMS.

(a)  In General.—Section 1834(a)(1)(G) of the Social Security Act (42 U.S.C. 1395m(a)(1)(G)) is amended by adding at the end the following new sentence:

“In the case of items and services furnished on or after January 1, 2019, in making any adjustments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under section 1842(s)(3)(B), the Secretary shall—

“(i)  solicit and take into account stakeholder input; and

“(ii)  take into account the highest amount bid by a winning supplier in a competitive acquisition area and a comparison of each of the following with respect to non- competitive acquisition areas and competitive acquisition areas:

“(I)  The average travel distance and cost associated with furnishing items and services in the area.

“(II)  The average volume of items and services furnished by suppliers in the area.

“(III)  The number of suppliers in the area.”.

(b) Conforming Amendments.—

(1)  Section 1834(h)(1)(H)(ii) of the Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is amended by striking “the Secretary” and inserting “subject to subsection (a)(1)(G), the Secretary”.

(2)  Section 1842(s)(3)(B) of the Social Security Act (42 U.S.C. 1395m(s)(3)(B)) is amended by striking “the Secretary” and inserting “subject to section 1834(a)(1)(G), the Secretary”.

TITLE XVII — OTHER MEDICARE PROVISIONS

SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR MEDICARE ADVANTAGE PLANS FAILING TO ACHIEVE MINIMUM QUALITY RATINGS.

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(b)  Delay in MA Contract Termination Authority for Plans Failing To Achieve Minimum Quality Ratings.—Section 1857(h) of the Social Security Act (42 U.S.C. 1395w-27(h)) is amended by adding at the end the following new paragraph:

“(3)  Delay in contract termination authority for plans failing to achieve minimum quality rating.—During the period beginning on the date of the enactment of this paragraph and through the end of plan year 2018, the Secretary may not terminate a contract under this section with respect to the offering of an MA plan by a Medicare Advantage organization solely because the MA plan has failed to achieve a minimum quality rating under the 5-star rating system under section 1853(o)(4).”.

SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA REPORTING FOR MEDICARE.

Section 1874 of the Social Security Act (42 U.S.C. 1395kk) is amended by adding at the end the following new subsection:

“(g) Requirement for Enrollment Data Reporting.—

“(1)  In general.—Each year (beginning with 2016), the Secretary shall submit to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on Medicare enrollment data (and, in the case of part A, on data on individuals receiving benefits under such part) as of a date in such year specified by the Secretary. Such data shall be presented—

“(A)  by Congressional district and State; and

“(B)  in a manner that provides for such data based on—

“(i)  fee-for-service enrollment (as defined in paragraph (2));

“(ii)  enrollment under part C (including separate for aggregate enrollment in MA-PD plans and aggregate enrollment in MA plans that are not MA-PD plans); and

“(iii)  enrollment under part D.

“(2)  Fee-for-service enrollment defined.—For purpose of paragraph (1)(B)(i), the term `fee-for-service enrollment' means aggregate enrollment (including receipt of benefits other than through enrollment) under—

“(A)  part A only;

“(B)  part B only; and

“(C)  both part A and part B.”.

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SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY NEWLY ENROLLED PROVIDERS OR SUPPLIERS WITHIN A TEMPORARY MORATORIUM AREA.

(a)  Medicare.—Section 1866(j)(7) of the Social Security Act (42 U.S.C. 1395cc(j)(7)) is amended—

(1)  in the paragraph heading, by inserting “; nonpayment” before the period; and

(2)  by adding at the end the following new subparagraph:

“(C) Nonpayment.—

“(i)  In general.—No payment may be made under this title or under a program described in subparagraph (A) with respect to an item or service described in clause (ii) furnished on or after October 1, 2017.

“(ii)  Item or service described.—An item or service described in this clause is an item or service furnished—

“(I)  within a geographic area with respect to which a temporary moratorium imposed under subparagraph (A) is in effect; and

“(II)  by a provider of services or supplier that meets the requirements of clause (iii).

“(ii)  Requirements.—For purposes of clause (ii), the requirements of this clause are that a provider of services or supplier—

“(I)  enrolls under this title on or after the effective date of such temporary moratorium; and

“(II)  is within a category of providers of services and suppliers (as described in subparagraph (A)) subject to such temporary moratorium.

“(iv)  Prohibition on charges for specified items or services.—In no case shall a provider of services or supplier described in clause (ii)(II) charge an individual or other person for an item or service described in clause (ii) furnished on or after October 1, 2017, to an individual entitled to benefits under part A or enrolled under part B or an individual under a program specified in subparagraph (A).”.

(b) Conforming Amendments.—

(1) Medicaid.—

(A)  In general.—Section 1903(i)(2) of the Social Security Act (42 U.S.C. 1396b(i)(2)), as amended by section 5005(a)(4), is further amended—

(i)  in subparagraph (C), by striking “or” at the end; and

(ii)  by adding at the end the following new subparagraph:

“(E)  with respect to any amount expended for such an item or service furnished during calendar quarters beginning on or after October 1, 2017, subject to section 1902(kk)(4)(A)(ii)(II), within a geographic area that is subject to a moratorium imposed under section 1866(j)(7) by a provider or supplier that meets the requirements specified in subparagraph (C)(iii) of such section, during the period of such moratorium; or”.

(B)  Exception with respect to access.—Section 1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C. 1396a(kk)(4)(A)(ii)) is amended to read as follows:

“(ii) Exceptions.—

“(I)  Compliance with moratorium.—A State shall not be required to comply with a temporary moratorium described in clause (i) if the State determines that the imposition of such temporary moratorium would adversely impact beneficiaries' access to medical assistance.

“(II)  FFP available.—Notwithstanding section 1903(i)(2)(E), payment may be made to a State under this title with respect to amounts expended for items and services described in such section if the Secretary, in consultation with the State agency administering the State plan under this title (or a waiver of the plan), determines that denying payment to the State pursuant to such section would adversely impact beneficiaries' access to medical assistance.”.

(C)  State plan requirement with respect to limitation on charges to beneficiaries.—Section 1902(kk)(4)(A) of the Social Security Act (42 U.S.C. 1396a(kk)(4)(A)) is amended by adding at the end the following new clause:

“(iii)  Limitation on charges to beneficiaries.—With respect to any amount expended for items or services furnished during calendar quarters beginning on or after October 1, 2017, the State prohibits, during the period of a temporary moratorium described in clause (i), a provider meeting the requirements specified in subparagraph (C)(iii) of section 1866(j)(7) from charging an individual or other person eligible to receive medical assistance under the State plan under this title (or a waiver of the plan) for an item or service described in section 1903(i)(2)(E) furnished to such an individual.”.

(2) Correcting amendments to related provisions.—

(A)  Section 1866(j).—Section 1866(j) of the Social Security Act (42 U.S.C. 1395cc(j)) is amended—

(i)  in paragraph (1)(A)—

(I)  by striking “paragraph (4)” and inserting “paragraph (5)”;

(II)  by striking “moratoria in accordance with paragraph (5)” and inserting “moratoria in accordance with paragraph (7)”; and

(III)  by striking “paragraph (6)” and inserting “paragraph (9); and

(ii)  by redesignating the second paragraph (8) (redesignated by section 1304(1) of Public Law 111-152) as paragraph (9).

(B)  Section 1902(kk).—Section 1902(kk) of such Act (42 U.S.C. 1396a(kk)) is amended—

(i)  in paragraph (1), by striking “section 1886(j)(2)” and inserting “section 1866(j)(2)”;

(ii)  in paragraph (2), by striking “section 1886(j)(3)” and inserting “section 1866(j)(3)”;

(iii)  in paragraph (3), by striking “section 1886(j)(4)” and inserting “section 1866(j)(5)”; and

(iv)  in paragraph (4)(A), by striking “section 1886(j)(6)” and inserting “section 1866(j)(7)”.

SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE UNDER MEDICARE ADVANTAGE.

Section 1851(e)(2) of the Social Security Act (42 U.S.C. 1395w- 21(e)(2)) is amended—

(1)  in subparagraph (C)—

(A)  in the heading, by inserting “from 2011 through 2018” after “45-day period”; and

(B)  by inserting “and ending with 2018” after “beginning with 2011”; and

(2)  by adding at the end the following new subparagraph:

“(G) Continuous open enrollment and disenrollment for first 3 months in 2016 and subsequent years.—

“(i) “(I)  in the case of an MA eligible individual who is enrolled in an MA plan, at any time during the first 3 months of a year (beginning with 2019); or

“(II)  in the case of an individual who first becomes an MA eligible individual during a year (beginning with 2019) and enrolls in an MA plan, during the first 3 months during such year in which the individual is an MA eligible individual; such MA eligible individual may change the election under subsection (a)(1).

“(ii)  Limitation of one change during open enrollment period each year.—An individual may change the election pursuant to clause (i) only once during the applicable 3- month period described in such clause in each year. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under paragraph (4).

“(iii)  Limited application to part d.—Clauses (i) and (ii) of this subparagraph shall only apply with respect to changes in enrollment in a prescription drug plan under part D in the case of an individual who, previous to such change in enrollment, is enrolled in a Medicare Advantage plan.

“(iv)  Limitations on marketing.—Pursuant to subsection (j), no unsolicited marketing or marketing materials may be sent to an individual described in clause (i) during the continuous open enrollment and disenrollment period established for the individual under such clause, notwithstanding marketing guidelines established by the Centers for Medicare & Medicaid Services.''.

SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES TO CHOOSE A MEDICARE ADVANTAGE PLAN.

(a) Removing Prohibition.—

(1)  In general.—Section 1851(a)(3) of the Social Security Act (42 U.S.C. 1395w-21(a)(3)) is amended—

(A)  by striking subparagraph (B); and

(B)  by striking “eligible individual” and all that follows through “In this title, subject to subparagraph (B),” and inserting “eligible individual.—In this title,”.

(2) Conforming amendments.—

(A)  Section 1852(b)(1) of the Social Security Act (42 U.S.C. 1395w-22(b)(1)) is amended—

(i)  by striking subparagraph (B); and

(ii)  by striking “Beneficiaries” and all that follows through “A Medicare+Choice organization” and inserting “Beneficiaries.— A Medicare Advantage organization”.

(B)  Section 1859(b)(6) of the Social Security Act (42 U.S.C. 1395w-28(b)(6)) is amended, in the last sentence, by striking “may waive” and all that follows through “subparagraph and”.

(3)  Effective date.—The amendments made by this subsection shall apply with respect to plan years beginning on or after January 1, 2021.

(b)  Excluding Costs for Kidney Acquisitions From MA Benchmark.—Section 1853 of the Social Security Act (42 U.S.C. 1395w-23) is amended—

(1)  in subsection (k)—

(A)  in paragraph (1)—

(i)  in the matter preceding subparagraph (A), by striking “paragraphs (2) and (4)” and inserting “paragraphs (2), (4), and (5)”; and

(ii)  in subparagraph (B)(i), by striking “paragraphs (2) and (4)” and inserting “paragraphs (2), (4), and (5)”; and

(B)  by adding at the end the following new paragraph:

“(5)  Exclusion of costs for kidney acquisitions from capitation rates.—After determining the applicable amount for an area for a year under paragraph (1) (beginning with 2021), the Secretary shall adjust such applicable amount to exclude from such applicable amount the Secretary's estimate of the standardized costs for payments for organ acquisitions for kidney transplants covered under this title (including expenses covered under section 1881(d)) in the area for the year.”; and

(2)  in subsection (n)(2)—

(A)  in subparagraph (A)(i), by inserting “and, for 2021 and subsequent years, the exclusion of payments for organ acquisitions for kidney transplants from the capitation rate as described in subsection (k)(5)” before the semicolon at the end;

(B)  in subparagraph (E), in the matter preceding clause (i), by striking “subparagraph (F)” and inserting “subparagraphs (F) and (G)”; and

(C)  by adding at the end the following new subparagraph:

“(G)  Application of kidney acquisitions adjustment.—The base payment amount specified in subparagraph (E) for a year (beginning with 2021) shall be adjusted in the same manner under paragraph (5) of subsection (k) as the applicable amount is adjusted under such subsection.”.

(c) FFS Coverage of Kidney Acquisitions.—

(1)  In general.—Section 1852(a)(1)(B)(i) of the Social Security Act (42 U.S.C. 1395w-22(a)(1)(B)(i)) is amended by inserting “or coverage for organ acquisitions for kidney transplants, including as covered under section 1881(d)” after “hospice care”.

(2)  Conforming amendment.—Section 1851(i) of the Social Security Act (42 U.S.C. 1395w-21(i)) is amended by adding at the end the following new paragraph:

“(3)  FFS payment for expenses for kidney acquisitions.—Paragraphs (1) and (2) shall not apply with respect to expenses for organ acquisitions for kidney transplants described in section 1852(a)(1)(B)(i).”.

(3)  Effective date.—The amendments made by this subsection shall apply with respect to plan years beginning on or after January 1, 2021.

SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES UNDER THE MEDICARE SHARED SAVINGS PROGRAM.

Section 1899(c) of the Social Security Act (42 U.S.C. 1395jjj(c)) is amended—

(1)  by striking ``utilization of primary'' and inserting ``utilization of—

(2)  in paragraph (1), as added by paragraph (1) of this section, by striking the period at the end and inserting “; and”;

(3)  by adding at the end the following new paragraph:

“(2)  in the case of performance years beginning on or after January 1, 2019, services provided under this title by a Federally qualified health center or rural health clinic (as those terms are defined in section 1861(aa)), as may be determined by the Secretary.”.

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