Short title

This Act may be cited as the

Medicare Part D Long-Term Care Patient Protection Act of 2007

Findings

Congress finds as follows: (1)Medicare beneficiaries who are enrolled in the Medicare prescription drug program and who reside in long-term care facilities are among the most senior and frail of Medicare beneficiaries, and often are in need of the specialized pharmacy services such as those provided by long-term care pharmacies. (2)Since January 1, 2006, many of the approximately 65 percent of residents of long-term care facilities who are dually eligible for Medicaid and Medicare have been auto-enrolled as dual eligibles in prescription drug plans under Medicare part D. (3)For long-term care facility residents in particular, enrollment in a prescription drug plan under Medicare part D can be complex and confusing, and ensuring access to medically necessary medication is vital to maintaining their health, avoiding hospitalizations, and otherwise containing health care costs. (4)Part D enrollees residing in long-term care facilities may have been auto-enrolled in one of as few as 5 and as many as 20 different prescription drug plans, which may not be properly tailored to meet the specialized prescription drug needs of residents of nursing homes and other long-term care facilities. (5)Prescription drug plans under Medicare part D vary in terms of their formulary coverage of the prescription drugs most frequently prescribed for long-term care residents, their prior authorization and other drug utilization management controls, and their procedures for processing exceptions requests and prior authorization requests. (6)The Medicare prescription drug program should be strengthened to ensure that residents of long-term care facilities enjoy access to a prescription drug plan that meets their needs and the unique nature of the long-term care facility setting in which they reside. (7)Robust oversight of the Medicare prescription drug program is important to prevent fraud, protect beneficiaries, and maintain the program’s fiscal integrity, and the Federal anti-kickback statute and False Claims Act provide critical safeguards against potential abuse.

Including definition for long-term care pharmacy under Medicare part D

Section 1860D–41(a) of the Social Security Act (42 U.S.C. 1395w–151(a)) is amended by adding at the end the following:

(19)

Long-term care pharmacy

The term long-term care pharmacy means a pharmacy owned by or under contract with a long-term care facility to provide prescription drugs to residents of such facility.

Ensuring Medicare beneficiaries access to adequate long-term care pharmacy networks

(a)

In general

Section 1860D–4(b)(1)(C) of the Social Security Act (42 U.S.C. 1395w–104(b)(1)(C)) is amended by striking clause (iv) and inserting the following clauses:

(iv)

Adequate access for long-term care network pharmacies

Such rules shall require the PDP sponsor of the prescription drug plan to include in its network an adequate number of long-term care pharmacies with sufficient capacity and experience with long-term care facilities in a PDP region to service at least 90 percent of the number of residential beds in such facilities in such region. (v)

Convenient access for Indian Health Services

Such rules may include standards for pharmacies operated by the Indian Health Service, Indian tribes and tribal organizations, and urban Indian organizations (as defined in section 4 of the Indian Health Care Improvement Act).

(b)

Effective date

The amendment made by subsection (a) shall apply to plan years beginning on or after January 1, 2009.

Long-term care beneficiary protection arrangements under Medicare part D

(a)

In general

Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended— (1)in paragraph (1), by inserting after subparagraph (D) the following new subparagraph:

(E)A long-term care beneficiary protection arrangement described in paragraph (3).

; and

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

(3)

Long-term care beneficiary protection arrangement

A long-term care beneficiary protection arrangement described in this paragraph is, with respect to a PDP sponsor of a prescription drug plan, a policy that requires, at a minimum, each long-term care pharmacy that participates in the network of the plan and that is owned by or under contract with a long-term care facility to provide for the following: (A)

Comprehensive inventory and inventory capacity

A comprehensive inventory (and inventory capacity) of covered part D drugs commonly used in the long-term care facility (including in the case of a prescription drug plan that uses a formulary, a comprehensive inventory of all covered part D drugs included in such formulary) and an appropriately secured area for physical storage of such drugs, including any necessary additional security for storing controlled substances, as required by Federal and State law, for routine storage and maintenance of such drugs in the business setting of the pharmacy. (B)

Pharmacy operation and prescription orders

Sufficient pharmacy operations and prescription orders capabilities, including— (i)the services of a dispensing pharmacist to meet the requirements of pharmacy practice for dispensing covered part D drugs to residents of the long-term care facility and for the performance of drug utilization review for routine screenings for allergies to such drugs and interactions of such drugs, to identify potential adverse reactions to such drugs, to identify inappropriate usage of such drugs by residents of the long-term care facility, and to promote cost effective therapy in the long-term care facility; (ii)the use of pharmacy software and systems sufficient to meet the needs of ordering covered part D drugs for part D eligible individuals who are residents of the long-term care facility and distribution of such drugs to such facility; (iii)the availability of written copies of the pharmacy’s procedures manual at each nurses’ unit in the long-term care facility; (iv)the provision of ongoing inservice training to assure that the staff of the long-term care facility is proficient in the long-term care pharmacy’s processes for ordering and receiving medications; and (v)following procedures specified by the State Board of Pharmacy for the State in which the long-term care pharmacy is located for the appropriate handling of unused covered part D drugs following discontinuance of such drug by an individual or the transfer, discharge, or death of such individual. (C)

Special packaging

The capacity to provide covered part D drugs in packaging required by the long-term care facility (such as unit of use packaging, bingo cards, cassettes, unit doses, or other special packaging), including access to, or arrangements with, a vendor to furnish supplies and equipment, including labels, auxiliary labels, and packing machines, for furnishing covered part D drugs in such packaging. (D)

Intravenous medications

The capacity to provide intravenous covered part D drugs to part D eligible individuals who are residents of the long-term care facility, including access to specialized facilities for the preparation of such intravenous drugs and access to or arrangements with a vendor to furnish special equipment and supplies as well as pharmacists and technicians trained in administering such drugs intravenously. (E)

Compounding and alternative forms of drug composition

The capacity to provide specialized formulations for the administration of covered part D drugs as required for part D eligible individuals who are residents of the long-term care facility, including such residents who are unable to swallow or ingest covered part D drugs through normal routes or who may require tablets to be split or crushed or provided in suspensions or gel forms to facilitate effective administration of the drug. (F)

Pharmacist on-call service

A pharmacist who is on-call 24 hours a day and 7 days a week to conduct consultations by means of telephone or other similar electronic communication device and fill prescription requests. (G)

Delivery service

The provision of covered part D drugs to the long-term care facility, including— (i)regular delivery service seven days each week; (ii)emergency delivery service available 24 hours a day, 7 days a week; (iii)specific delivery arrangements established through agreements between the long-term care pharmacy and the long-term care facility; and (iv)safe and secure exchange systems for delivery of such drugs to the long-term care facility, including medication cassettes or other standard delivery systems that may be exchanged on a routine basis for automatic restocking. (H)

Emergency supplies

Emergency supply of covered part D drugs as required by the long-term care facility in compliance with State requirements. (I)

Emergency log books

A system for— (i)logging covered part D drugs (and charges for such drugs) used from an emergency supply; and (ii)a comprehensive record of the covered part D drugs ordered for and administered to each part D eligible individual who is a resident of the long-term care facility. (J)

Miscellaneous reports, forms, and prescription ordering supplies

Reports, forms, and prescription ordering supplies necessary for the delivery of quality pharmacy care in the long-term care facility, including provider order forms, monthly management reports to assist the long-term care facility in managing orders, medication administration records, treatment administration records, interim order forms for new prescription orders, and boxes or folders for order storage and reconciliation in the facility.

Notwithstanding any other provision of law, nothing in this paragraph shall restrict a PDP sponsor and a long-term care pharmacy from entering into an agreement to provide additional protections as they deem appropriate and necessary for the protection of part D eligible individuals residing in long-term care facilities.

(b)

Conforming amendment

Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended in the heading by adding at the end the following:

; Long-term care beneficiary protection policy

. (c)

Effective date

The amendments made by this section shall apply to plan years beginning on or after January 1, 2009.

Long-term care beneficiary access and assistance

(a)

In general

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:

(c)

Assistance for residents of long-term care facilities

(1)

In general

Nothing in this part shall prohibit a part D eligible individual who is a resident of a long-term care facility, or an authorized representative of such individual, from seeking or receiving assistance from a health care professional or other appropriate individual who works at the facility or from the individual’s physician for purposes of selecting, enrolling, disenrolling, or changing enrollment in a prescription drug plan or MA–PD plan. (2)

Authority to advise in selection of and enrollment in plans

Any physician, health care professional, or other appropriate individual who works at a long-term care facility may— (A)advise any part D eligible individual residing in the facility, or an authorized representative of such individual, regarding the adequacy of the individual’s prescription drug coverage in meeting the individual’s prescription drug needs (including the individual’s anticipated prescription drug needs); and (B)make recommendations to such an individual, with respect to such coverage, including a recommendation to change enrollment or enroll in a specific prescription drug plan or MA–PD plan that best meets the individual’s current and anticipated prescription drug needs. (3)

Authority to assist certain auto-enrolled part D eligible individuals in changes of enrollment

(A)

In general

In the case of a part D eligible individual who is enrolled in a prescription drug plan pursuant to section 1860D–1(b)(1)(C), if such individual— (i)resides in a long-term care facility, (ii)is incapable of changing such enrollment, or filing a grievance or coverage determination, redetermination, or appeal under section 1860D–4, and (iii)does not have an authorized representative available to assist the individual in changing such enrollment, or filing such a grievance or coverage determination, redetermination, or appeal, respectively,

the individual’s physician, health care professional, or other appropriate individual who works at the long-term care facility may act on the individual’s behalf to facilitate the change of enrollment of the individual to the most appropriate prescription drug plan under this part for the individual or to file such a grievance or coverage determination, redetermination, or appeal, respectively.

(B)

Clarification

Nothing in this paragraph shall be construed as modifying or altering the rights and responsibilities of designated representatives and authorized representatives under State law. (4)

Requirements for assistance

Any individual who assists a Medicare part D eligible individual residing in a long-term care facility pursuant to this subsection shall— (A)inform the resident or the authorized representative of the resident if such individual or the facility has a contractual or financial relationship with a prescription drug plan under this part or an MA–PD plan under part C; (B)not receive any remuneration from the resident or the prescription drug plan or MA–PD plan involved, with respect to the enrollment of such resident in such plan; (C)in the case of a resident who is a full-benefit dual eligible individual (as defined in section 1935(c)(6)), recommend the resident enroll in or change enrollment to a prescription drug plan only if such plan has a monthly beneficiary premium that does not exceed the premium assistance available under section 1860D–14(a)(1)(A)); and (D)provide the resident or the authorized representative of the resident with a written copy of any advice provided by the individual, with respect to an enrollment, disenrollment, or change of enrollment decision, which includes a statement that the resident may decline such advice, change any decision made pursuant to such advice, or request the assistance of a different individual. (5)

Clarifications

(A)

In general

Nothing in this subsection shall be construed as superseding or otherwise impeding the right of a part D eligible individual who resides in a long-term care facility to make the individual’s own prescription drug plan enrollment decisions under this part. (B)

Non-preemption of State laws

Nothing in this subsection shall be construed as superseding or otherwise affecting any State law regarding the right of an individual described in subparagraph (A) to make decisions described in such subparagraph or the right of a representative of such an individual (or other designated person) to make such decisions on behalf of the individual.

(b)

Immediate coverage upon entry into long-term care facilities

Section 1860D–1(b)(1)(A) of the Social Security Act (42 U.S.C. 1395w–101(b)(1)(A)) is amended to read as follows:

(A)

In general

The Secretary shall establish— (i)a process for the enrollment, disenrollment, termination, and change of enrollment of part D eligible individuals in prescription drug plans consistent with this subsection; and (ii)in the case of a part D eligible individual who becomes a resident of a long-term care facility, a process for the immediate enrollment of such individual in a prescription drug plan upon the establishment of such residency (and upon such enrollment, immediately effective coverage under such plan) or, in the case of a part D eligible individual who is a resident in a long-term care facility, who is enrolled in a prescription drug plan, and who changes such enrollment to a different prescription drug plan, a process for the immediate enrollment of such individual in the different prescription drug plan (and upon such enrollment, immediately effective coverage under such plan).

(c)

Effective date

The amendments made by this section shall apply to plan years beginning on or after January 1, 2009.

Long-term care formulary structure and design for long-term care residents

(a)

In general

Section 1860D–4(b)(3) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)) is amended by adding at the end the following:

(G)

Long-term care formulary structure and design

(i)

Formulary Structure

The formulary must take into account the needs of part D eligible individuals who are residents of long-term care facilities by including all covered part D drugs that are medically necessary to such residents at all levels of care, including alternative dosage forms, such as liquid that can be administrated through feeding tubes, intravenous medications, or intramuscular injections. Access to necessary medications for long-term care residents may be provided through formulary inclusion, utilization management tools, or exceptions processes. The PDP sponsor shall consider the special circumstances applicable to such individuals when making a coverage determination under subsection (g) and shall base such determination on the individual’s health condition, and the interrelationship between the long-term care facility in which the individual resides, the individual’s physician, and the individual’s long-term care pharmacy, as well as applicable laws and regulations governing the operation of, and care furnished by, the long-term care pharmacy. The formulary of the prescription drug plan may not discourage enrollment in such plan by part D eligible individuals residing in long-term care facilities. (ii)

Coverage During Exceptions Process

The PDP sponsor shall provide a 31-day emergency supply of covered part D drugs not included in the formulary for a part D eligible individual who is a resident of a long-term care facility for any period not included in the period described in clause (iii) during which an exception for such individual is being processed. (iii)

Transition processes

The PDP sponsor shall establish and implement an appropriate transition process, with respect to receiving benefits under this part, for part D eligible individuals who are residents (or who are becoming residents) in a long-term care facility and who first enroll in the prescription drug plan and for part D eligible individuals enrolled in such plan when such individuals become residents of long-term care facilities. Such transition process shall include the provision of appropriate temporary or emergency supplies of covered part D drugs included in the formulary, as well as of covered part D drugs not included in the formulary, for at least the 90-day period, or 180-day period if clinically necessary, immediately following the date of enrollment in the plan or the date on which the individual first becomes a resident of the facility, as applicable.

(b)

Effective date

The amendment made by subsection (a) shall apply to plan years beginning on or after January 1, 2009.

Elimination of part D cost-sharing for certain non-institutionalized full-benefit dual eligible individuals

(a)

In General

Section 1860D–14(a)(1)(D)(i) of the Social Security Act (42 U.S.C. 1395w–114(a)(1)(D)(i)) is amended— (1)in the heading, by striking Institutionalized individuals—In and inserting

Elimination of cost-sharing for certain full-benefit dual eligible individuals—

(I)

Institutionalized individuals

; and

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

(II)

Certain other individuals

In the case of an individual who is a full-benefit dual eligible individual and who is a resident of a facility described in subclause (III) or who is receiving home and community-based services in a home setting provided under a home and community-based waiver approved for the State under section 1915 or 1115, the elimination of any beneficiary coinsurance described in section 1860D–2(b)(2) (for all amounts through the total amount of expenditures at which benefits are available under section 1860D–2(b)(4)). (III)

Facility described

For purposes of subclause (II), a facility described in this subclause is an assisted living facility or a resident care program facility (as such terms are defined by the Secretary), a board and care facility (as defined in section 1903(q)(4)(B)), or any other facility that is licensed or certified by the State involved and is determined appropriate by the Secretary, such as a community mental health center that meets the requirements of section 1913(c) of the Public Health Service Act, a psychiatric health facility, a mental health rehabilitation center, and a mental retardation developmental disability facility.

(b)

Effective date

The amendments made by subsection (a) shall apply to drugs dispensed on or after the date of the enactment of this Act.

Provisions related to improper assessment of beneficiary cost-sharing obligations

(a)

Resolution of inappropriate assessment of long-term care beneficiary cost-sharing obligations

Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following:

(4)

Resolution of inappropriate assessment of long-term care beneficiary cost-sharing obligations

(A)

In general

The Secretary shall not enter into a contract with a PDP sponsor for the offering of a prescription drug plan for a year unless the PDP sponsor provides assurances to the satisfaction of the Secretary that— (i)to the extent the PDP sponsor, or information provided to the PDP sponsor by or on behalf of the Secretary, fails to correctly identify a part D eligible individual who is residing in a long-term care facility and who is receiving covered part D drugs from a long-term care pharmacy, as a full benefit dual eligible individual (as defined in section 1935(c)(6)) or as a subsidy-eligible individual (as defined in section 1860D–14(a)(3)), and any cost-sharing obligation is incorrectly assessed against such individual, the PDP sponsor shall accept from the long-term care pharmacy any applicable evidence described in subparagraph (B) and the attestation described in subparagraph (C) to demonstrate that the individual is eligible for an adjustment to (or exempt from) such cost-sharing; (ii)upon receipt of such evidence that demonstrates the individual is so eligible (or so exempt), the PDP sponsor shall make such adjustment to (or exempt the individual from) any such cost-sharing; and (iii)not later than 60 days after receipt of such evidence that demonstrates such eligibility, the PDP sponsor will reimburse the individual any improperly assessed cost-sharing or, in the case that the individual (or a representative of such individual) has not paid the improperly assessed cost-sharing amount, timely reimburse the long-term care pharmacy for such improperly assessed amount, but in no case may the PDP sponsor send payments under this clause directly to a full benefit dual eligible individual or a subsidy eligible individual residing in a long-term care facility unless the PDP sponsor has direct evidence that such individual has actually paid such cost-sharing amount. (B)

Evidence Described

For purposes of subparagraph (A), evidence described in this subparagraph is the following: (i)For purposes of determining the status of an individual as a full benefit dual eligible individual, a plan ID number to establish such individual has coverage for covered part D drugs under a prescription drug plan or under an MA–PD plan and a Medicaid ID number to establish such individual is determined eligible by the State involved for medical assistance for full benefits under title XIX. (ii)For purposes of determining institutionalized status of an individual, the date on which the individual entered a long-term care facility, or any medical institution for which payment is made under this title or title XIX, including intermediate care facilities for the mentally retarded, psychiatric hospitals, and assisted living facilities. (C)

Attestation

For purposes of subparagraph (A), the attestation described in this subparagraph, with respect to a pharmacy and a prescription drug plan is an attestation from the pharmacy, subject to audit, that the evidence described in subparagraph (B) that is provided by such pharmacy to the plan is accurate.

(b)

Immediate reduction in cost-sharing upon admission into institution

Section 1860D–14(a)(1)(D)(i) of the Social Security Act (42 U.S.C. 1395w–114(a)(1)(D)(i)) is amended by inserting upon the admission of such individual or couple, respectively, to the institution, before the elimination of. (c)

Effective date

The amendments made by this section shall apply to plan years beginning on or after January 1, 2009.

10.

Report to Congress

(a)

In general

Section 1860D–4(b)(1) of the Social Security Act (42 U.S.C. 1395w–104(b)(1)) is amended by adding at the end the following:

(F)

Annual report on access to covered part D drugs for long-term care residents

The Secretary shall submit to Congress an annual report on the adequacy of the access to covered part D drugs available to part D eligible individuals who are residents of long-term care facilities through long-term care pharmacies participating in networks of prescription drug plans. Such a report shall include— (i)the extent to which part D long-term care performance and service standards governing the delivery of specialized long-term care services, as specified by the Secretary, to part D eligible individuals, including any guidance issued by the Secretary and industry best practices, are being met; (ii)the percentage of such residents who are enrolled in a prescription drug plan that meets the prescription drug needs of such residents; and (iii)the number of exceptions and prior authorization requests submitted by such residents and the number of such exceptions and requests that are approved by the prescription drug plans involved.

(b)

Effective date

The amendment made by subsection (a) shall apply to plan years beginning on or after January 1, 2009.