Contract with Eligible Medicare Advantage (MA) Organization Pursuant to
Sections 1851 through 1859 of the Social Security Act for the Operation
of a Medicare Advantage Coordinated Care Plan(s)
CONTRACT (#H5711)
Between
Centers for Medicare & Medicaid Services (hereinafter referred to as CMS)
and
QMedCare of New Jersey, Inc.
--------------------------------------------------------------------------------
(hereinafter referred to as the MA Organization)
CMS and the MA Organization, an entity which has been determined to be an
eligible Medicare Advantage Organization by the Administrator of the Centers for
Medicare & Medicaid Services under 42 CFR 422.503, agree to the following for
the purposes of sections 1851 through 1859 of the Social Security Act
(hereinafter referred to as the Act):
(NOTE: Citations indicated in brackets are placed in the text of this contract
to note the regulatory authority for certain contract provisions. All references
to Part 422 are to 42 CFR Part 422.)
You must check off AND initial each required Addendum type to reflect the
coverage offered under the H (▇▇▇) number associated with this contract Addendum
Type
_____________________________________________________________Initials
[X] Part D Addendum /s/ JM
[ ] Employer-Only MA-PD Addendum (800 Series) _____________
[ ] Employer-Only MA Only Addendum (800 Series) _____________
[ ] Variances/Waivers (Provided directly to
Demonstration Organizations by CMS) _____________
[ ] Regional Preferred Provider Organization Addendum _____________
(Provided directly to RPPOs by CMS _____________
Article I
Term of Contract
The term of this contract shall be from the date of signature by CMS' authorized
representative through December 31, 2007, after which this contract may be
renewed for successive one-year periods in accordance with 42 CFR 422.505(c) and
as discussed in Paragraph A in Article VII below. [422.505]
This contract governs the respective rights and obligations of the parties as of
the effective date set forth above, and supersedes any prior agreements between
the MA Organization and CMS as of such date. MA organizations offering Part D
also must execute an Addendum to the Medicare Managed Care Contract Pursuant to
Sections 1 860D- 1 through 1 860D-42 of the Social Security Act for the
Operation of a Voluntary Medicare Prescription Drug Plan (hereafter the "Part D
Addendum"). For MA Organizations offering MA-PD plans, the Part D Addendum
governs the rights and obligations of the parties relating to the provision of
Part D benefits, in accordance with its terms, as of its effective date.
Article II
Coordinated Care Plan
A. The Medicare Advantage Organization agrees to operate one or more coordinated
care plans as defined in 42 CFR 422.4(a)(1)(iii)), including at least one MA-PD
plan as required under 42 CFR 422.4(c), as described in its final Plan Benefit
Package (PBP) bid submission (benefit and price bid) proposal as approved by CMS
and as attested to in the Medicare Advantage Attestation of Benefit Plan and
Price, and in compliance with the requirements of this contract and applicable
Federal statutes, regulations, and policies.
B. Except as provided in paragraph (C) of this Article, this contract is deemed
to incorporate any changes that are required by statute to be implemented during
the term of the contract and any regulations or policies implementing or
interpreting such statutory provisions.
C. CMS will not implement, other than at the beginning of a calendar year,
requirements under 42 CFR Part 422 that impose a new significant cost or burden
on MA organizations or plans, unless a different effective date is required by
statute. [422.521]
Article III
Functions To Be Performed By Medicare Advantage Organization
A. PROVISION OF BENEFITS
1. The MA Organization agrees to provide enrollees in each of its MA plans the
basic benefits as required under ss.422.101 and, to the extent applicable,
supplemental benefits under ss.422.102 and as established in the MA
Organization's final benefit and price bid proposal as approved by CMS and
listed in the MA Organization Plan Attestation of Benefit Plan and Price, which
is attached to this contract. The MA Organization agrees to provide access to
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such benefits as required under subpart C in a manner consistent with
professionally recognized standards of health care and according to the access
standards stated in ss.422.112.
2. The MA Organization agrees to provide post-hospital extended care services,
should an MA enrollee elect such coverage, through a skilled nursing home
facility according to the requirements of section 1852(l) of the Act and
ss.422.133. A skilled nursing home facility is a facility in which an MA
enrollee resided at the time of admission to the hospital, a facility that
provides services through a continuing care retirement community, a facility in
which the spouse of the enrollee is residing at the time of the enrollee's
discharge from the hospital, or hospital, or wherever the enrollee resides
immediately before admission for extended care services. [422. 133;
422.504(a)(3)]
B. ENROLLMENT REQUIREMENTS
1. The MA Organization agrees to accept new enrollments, make enrollments
effective, process voluntary disenrollments, and limit involuntary
disenrollments, as provided in subpart B of part 422.
2. The MA Organization shall comply with the provisions of ss.422.110 concerning
prohibitions against discrimination in beneficiary enrollment, other than in
enrolling eligible beneficiaries in a CMA-approved special needs plan that
exclusively enrolls special needs individuals as consistent with ss.ss.422.2,
422.4(a)(1)(iv) and 422.52. [422 .504(a) (2)]
C. BENEFICIARY PROTECTIONS
1. The MA Organization agrees to comply with all requirements in subpart M of
part 422, governing coverage determinations, grievances, and appeals.
[422.504(a)(7)]
2. The MA Organization agrees to comply with the confidentiality and enrollee
record accuracy requirements in ss.422.118.
3. Beneficiary Financial Protections. The MA Organization agrees to comply with
the following requirements:
(a) Each MA Organization must adopt and maintain arrangements
satisfactory to CMS to protect its enrollees from incurring liability for
payment of any fees that are the legal obligation of the MA Organization. To
meet this requirement the MA Organization must--
(i) Ensure that all contractual or other written arrangements
with providers prohibit the Organization's providers from holding any
beneficiary enrollee liable for payment of any fees that are the legal
obligation of the MA Organization; and
(ii) Indemnify the beneficiary enrollee for payment of any
fees that are the legal obligation of the MA Organization for services
furnished by providers that do not contract, or that have not otherwise
entered into an agreement with the MA Organization, to provide services
to the organization's beneficiary enrollees. [422.504(g)(1)]
(b) The MA Organization must provide for continuation of enrollee
health care benefits-
(i) For all enrollees, for the duration of the contract period
for which CMS payments have been made; and
(ii) For enrollees who are hospitalized on the date its
contract with CMS terminates, or, in the event of the MA Organization's
insolvency, through the date of discharge. [422.504(g)(2)]
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(c) In meeting the requirements of this section (C), other than the
provider contract requirements specified in paragraph (C)(3)(a) of this Article,
the MA Organization may use--
(i) Contractual arrangements;
(ii) Insurance acceptable to CMS;
(iii) Financial reserves acceptable to CMS; or
(iv) Any other arrangement acceptable to CMS. [422.504(g)(3)]
D. PROVIDER PROTECTIONS
1. The MA Organization agrees to comply with all applicable provider
requirements in 42 CFR Part 422 Subpart E, including provider certification
requirements, anti-discrimination requirements, provider participation and
consultation requirements, the prohibition on interference with provider advice,
limits on provider indemnification, rules governing payments to providers, and
limits on physician incentive plans. [422.504(a)(6)]
2. Prompt Payment.
(a) The MA Organization must pay 95 percent of "clean claims" within 30
days of receipt if they are claims for covered services that are not furnished
under a written agreement between the organization and the provider.
(i) The MA Organization must pay interest on clean claims that
are not paid within 30 days in accordance with sections 181 6(c)(2) and
1 842(c)(2) of the Act.
(ii) All other claims from non-contracted providers must be
paid or denied within 60 calendar days from the date of the request.
[422.520(a)]
(b) Contracts or other written agreements between the MA Organization
and its providers must contain a prompt payment provision, the terms of which
are developed and agreed to by both the MA Organization and the relevant
provider. [422.520(b)]
(c) If CMS determines, after giving notice and opportunity for hearing,
that the MA Organization has failed to make payments in accordance with
subparagraph (2)(a) of this section, CMS may provide--
(i) For direct payment of the sums owed to providers; and (ii)
For appropriate reduction in the amounts that would otherwise be paid
to the MA Organization, to reflect the amounts of the direct payments
and the cost of making those payments. [422.520(c)]
E. QUALITY IMPROVEMENT PROGRAM
1. The MA Organization agrees to operate, for each plan that it offers, an
ongoing quality improvement program as stated in accordance with Section 1852(e)
of the Social Security Act and 42 CFR 422.152.
2. Chronic Care Improvement Program
(a) Each MA organization (other than MA private-fee-for-service plans)
must have a chronic care improvement program and must establish criteria for
participation in the program. The CCIP must have a method for identifying
enrollees with multiple or sufficiently severe chronic conditions who meet the
criteria for participation in the program and a mechanism for monitoring
enrollees' participation in the program.
(b) Plans have flexibility to choose the design of their program;
however, in addition to meeting the requirements specified above, the CCIP
selected must be relevant to the plan's MA population. MA organizations are
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required to submit annual reports on their CCIP program to CMS.
3. Performance Measurement and Reporting: The MA Organization shall measure
performance under its MA plans using standard measures required by CMS, and
report (at the organization level) its performance to CMS. The standard measures
required by CMS during the term of this contract will be uniform data collection
and reporting instruments, to include the Health Plan and Employer Data
Information Set (HEDIS), Consumer Assessment of Health Plan Satisfaction (CAHPS)
survey, and Health Outcomes Survey (HOS). These measures will address clinical
areas, including effectiveness of care, enrollee perception of care and use of
services; and non-clinical areas including access to and availability of
services, appeals and grievances, and organizational characteristics.
[422.152(b)(1), (e)]
4. Utilization Review:
(a) An MA Organization for an MA coordinated care plan must use written
protocols for utilization review and policies and procedures must reflect
current standards of medical practice in processing requests for initial or
continued authorization of services and have in effect mechanisms to detect both
underutilization and over utilization of services. [422.152(b)]
(b) For MA regional preferred provider organizations (RPPOs) and MA
local preferred provider organizations (PPOs) that are offered by an
organization that is not licensed or organized under State law as an HMOs, if
the MA Organization uses written protocols for utilization review, those
policies and procedures must reflect current standards of medical practice in
processing requests for initial or continued authorization of services and
include mechanisms to evaluate utilization of services and to inform enrollees
and providers of services of the results of the evaluation. [422.152(e)]
5. Information Systems:
(a) The MA Organization must:
(i) Maintain a health information system that collects,
analyzes and integrates the data necessary to implement its quality
improvement program;
(ii) Ensure that the information entered into the system
(particularly that received from providers) is reliable and complete;
(iii) Make all collected information available to CMS.
[422.152(f)(1)]
6. External Review
The MA Organization will comply with any requests by Quality Improvement
Organizations to review the MA Organization's medical records in connection with
appeals of discharges from hospitals, skilled nursing facilities, and home
health agencies.
F. COMPLIANCE PLAN
The MA Organization agrees to implement a compliance plan in accordance with the
requirements of ss.422.503 (b)(4)(vi). [422.503(b)(4)(vi)]
G. COMPLIANCE DEEMED ON THE BASIS OF ACCREDITATION
CMS may deem the MA Organization to have met the quality improvement
requirements of ss.1852(e) of the Act and ss.422.152, the confidentiality and
accuracy of enrollee records requirements of ss. 1852(h) of the Act and
ss.422.118, the anti-discrimination requirements of ss.1852(b) of the Act and
ss.422.110, the access to services requirements of ss.1852(d) of the Act and
ss.422.112, and the advance directives requirements of ss.1852(i) of the Act and
ss.422.128, the
5
provider participation requirements of ss.1 852(j) of the Act and 42 CFR Part
422, Subpart F, and the applicable requirements described in ss.423.165, if the
MA Organization is fully accredited (and periodically reaccredited) by a
private, national accreditation organization approved by CMS and the
accreditation organization used the standards approved by CMS for the purposes
of assessing the MA Organization's compliance with Medicare requirements. The
provisions of ss.422.156 shall govern the MA Organization's use of deemed status
to meet MA program requirements.
H. PROGRAM INTEGRITY
1. The MA Organization agrees to provide notice based on best knowledge,
information, and belief to CMS of any integrity items related to payments from
governmental entities, both federal and state, for healthcare or prescription
drug services. These items include any investigations, legal actions or matters
subject to arbitration brought involving the MA Organization (or MA
Organization's firm if applicable) and its subcontractors (excluding contracted
network providers), including any key management or executive staff, or any
major shareholders (5% or more), by a government agency (state or federal) on
matters relating to payments from governmental entities, both federal and state,
for healthcare and/or prescription drug services. In providing the notice, the
sponsor shall keep the government informed of when the integrity item is
initiated and when it is closed. Notice should be provided of the details
concerning any resolution and monetary payments as well as any settlement
agreements or corporate integrity agreements.
2. The MA Organization agrees to provide notice based on best knowledge,
information, and belief to CMS in the event the MA Organization or any of its
subcontractors is criminally convicted or has a civil judgment entered against
it for fraudulent activities or is sanctioned under any Federal program
involving the provision of health care or prescription drug services.
I. MARKETING
1. The MA Organization may not distribute any marketing materials, as defined in
42 CFR 422.80(b) and in the Marketing Materials Guidelines for Medicare
Advantage-Prescription Drug Plans and Prescription Drug Plans (Medicare
Marketing Guidelines), unless they have been filed with and not disapproved by
CMS in accordance with ss.422.80. The file and use process set out at
ss.422.80(a)(2) must be used, unless the MA organization notifies CMS that it
will not use this process.
2. CMS and the MA Organization shall agree upon language setting forth the
benefits, exclusions and other language of the Plan. The MA Organization bears
full responsibility for the accuracy of its marketing materials. CMS, in its
sole discretion, may order the MA Organization to print and distribute the
agreed upon marketing materials, in a format approved by CMS. The MA
Organization must disclose the information to each enrollee electing a plan as
outlined in 42 CFR 422.111.
3. The MA Organization agrees that any advertising material, including that
labeled promotional material, marketing materials, or supplemental literature,
shall be truthful and not misleading. All marketing materials must include the
Contract number. All membership identification cards must include the Contract
number on the front of the card.
4. The MA Organization must comply with the Medicare Marketing Guidelines, as
well as all applicable statutes and regulations, including and without
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limitation Section 1851(h) of the Act and 42 CFR ss.ss.422.80, 422.111 and
423.50. Failure to comply may result in sanctions as provided in 42 CFR Part 422
Subpart O.
Article IV
CMS Payment to MA Organization
A. The MA Organization agrees to develop its annual benefit and price bid
proposal and submit to CMS all required information on premiums, benefits, and
cost sharing, as required under 42 CFR Part 422 Subpart F. [422.504(a)(10)]
B. Methodology. CMS agrees to pay the MA Organization under this contract in
accordance with the provisions of section 1853 of the Act and 42 CFR Part 422
Subpart G. [422.504(a)(9)]
C. Attestation of payment data (Attachments A, B, and C). As a condition for
receiving a monthly payment under paragraph B of this article, and 42 CFR Part
422 Subpart G, the MA Organization agrees that its chief executive officer
(CEO), chief financial officer (CFO), or an individual delegated with the
authority to sign on behalf of one of these officers, and who reports directly
to such officer, must request payment under the contract on the forms attached
hereto as Attachment A (enrollment attestation) and Attachment B (risk
adjustment data) which attest to (based on best knowledge, information and
belief, as of the date specified on the attestation form) the accuracy,
completeness, and truthfulness of the data identified on these attachments. The
Medicare Advantage Plan Attestation of Benefit Plan and Price must be signed and
attached to the executed version of this contract.
1. Attachment A requires that the CEO, CFO, or an individual delegated with the
authority to sign on behalf of one of these officers, and who reports directly
to such officer, must attest based on best knowledge, information, and belief
that each enrollee for whom the MA Organization is requesting payment is validly
enrolled, or was validly enrolled during the period for which payment is
requested, in an MA plan offered by the MA Organization. The MA Organization
shall submit completed enrollment attestation forms to CMS, or its contractor,
on a monthly basis. (NOTE: The forms included as attachments to this contract
are for reference only. CMS will provide instructions for the completion and
submission of the forms in separate documents. MA Organizations should not take
any action on the forms until appropriate CMS instructions become available.)
2. Attachment B requires that the CEO, CFO, or an individual delegated with the
authority to sign on behalf of one of these officers, and who reports directly
to such officer, must attest to (based on best knowledge, information and
belief, as of the date specified on the attestation form) that the risk
adjustment data it submits to CMS under ss.422.3 10 are accurate, complete, and
truthful. The MA Organization shall make annual attestations to this effect for
risk adjustment data on Attachment B and according to a schedule to be published
by CMS. If such risk adjustment data are generated by a related entity,
contractor, or subcontractor of an MA Organization, such entity, contractor, or
subcontractor must similarly attest to (based on best knowledge, information,
and belief, as of the date specified on the attestation form) the accuracy,
completeness, and truthfulness of the data. [422.504(l)]
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3. The Medicare Advantage Plan Attestation of Benefit Plan and Price (which is
attached hereto) requires that the CEO, CFO, or an individual delegated with the
authority to sign on behalf of one of these officers, and who reports directly
to such officer, must attest (based on best knowledge, information and belief,
as of the date specified on the attestation form) that the information and
documentation comprising the bid submission proposal is accurate, complete, and
truthful and fully conforms to the Bid Form and Plan Benefit Package
requirements; and that the benefits described in the CMS-approved proposal bid
submission agree with the benefit package the MA Organization will offer during
the period covered by the proposal bid submission. This document is being sent
separately to the MA Organization and must be signed and attached to the
executed version of this contract, and is incorporated herein by reference.
[422.502(l)]
Article V
MA Organization Relationship with Related Entities,
Contractors, and Subcontractors
A. Notwithstanding any relationship(s) that the MA Organization may have with
related entities, contractors, or subcontractors, the MA Organization maintains
full responsibility for adhering to and otherwise fully complying with all terms
and conditions of its contract with CMS. [422.504(i)(1)]
B. The MA Organization agrees to require all related entities, contractors, or
subcontractors to agree that--
(1) HHS, the Comptroller General, or their designees have the right to
inspect, evaluate, and audit any pertinent contracts, books, documents, papers,
and records of the related entity(s), contractor(s), or subcontractor(s)
involving transactions related to this contract; and
(2) HHS, the Comptroller General, or their designees have the right to
inspect, evaluate, and audit any pertinent information for any particular
contract period for 10 years from the final date of the contract period or from
the date of completion of any audit, whichever is later. [422.504(i)(2)]
C. The MA Organization agrees that all contracts or written arrangements into
which the MA Organization enters with providers, related entities, contractors,
or subcontractors (first tier and downstream entities) shall contain the
following elements:
(1) Enrollee protection provisions that provide--
(a) Consistent with Article III(C), arrangements that prohibit
providers from holding an enrollee liable for payment of any fees that
are the legal obligation of the MA Organization; and
(b) Consistent with Article III(C), provision for the
continuation of benefits.
(2) Accountability provisions that indicate that the MA Organization
may only delegate activities or functions to a provider, related entity,
contractor, or subcontractor in a manner consistent with requirements set forth
at paragraph D of this article.
8
(3) A provision requiring that any services or other activity performed
by a related entity, contractor or subcontractor in accordance with a contract
or written agreement between the related entity, contractor, or subcontractor
and the MA Organization will be consistent and comply with the MA Organization's
contractual obligations to CMS. [422.504(i)(3)]
D. If any of the MA Organization's activities or responsibilities under this
contract with CMS is delegated to other parties, the following requirements
apply to any related entity, contractor, subcontractor, or provider:
(1) Written arrangements must specify delegated activities and
reporting responsibilities.
(2) Written arrangements must either provide for revocation of the
delegation activities and reporting requirements or specify other remedies in
instances where CMS or the MA Organization determine that such parties have not
performed satisfactorily.
(3) Written arrangements must specify that the performance of the
parties is monitored by the MA Organization on an ongoing basis.
(4) Written arrangements must specify that either--
(a) The credentials of medical professionals affiliated with
the party or parties will be either reviewed by the MA Organization; or
(b) The credentialing process will be reviewed and approved by
the MA Organization and the MA Organization must audit the
credentialing process on an ongoing basis.
(5) All contracts or written arrangements must specify that the related
entity, contractor, or subcontractor must comply with all applicable Medicare
laws, regulations, and CMS instructions.
[422.504(i)(4)]
E. If the MA Organization delegates selection of the providers, contractors, or
subcontractors to another organization, the MA Organization's written
arrangements with that organization must state that the MA Organization retains
the right to approve, suspend, or terminate any such arrangement.
[422.504(i)(5)]
F. As of the date of this contract and throughout its term, the MA Organization
(1) Agrees that any physician incentive plan it operates meets the
requirements of ss.422.208, and
(2) Has assured that all physicians and physician groups that the MA
Organization's physician incentive plan places at substantial financial risk
have adequate stop-loss protection in accordance with ss.422.208(f). [422.208]
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Article VI
Records Requirements
A. MAINTENANCE OF RECORDS
1. The MA Organization agrees to maintain for 10 years books, records,
documents, and other evidence of accounting procedures and practices that--
(a) Are sufficient to do the following:
(i) Accommodate periodic auditing of the financial records
(including data related to Medicare utilization, costs, and computation
of the benefit and price bid) of the MA Organization.
(ii) Enable CMS to inspect or otherwise evaluate the quality,
appropriateness and timeliness of services performed under the
contract, and the facilities of the MA Organization.
(iii) Enable CMS to audit and inspect any books and records of
the MA Organization that pertain to the ability of the organization to
bear the risk of potential financial losses, or to services performed
or determinations of amounts payable under the contract.
(iv) Properly reflect all direct and indirect costs claimed to
have been incurred and used in the preparation of the benefit and price
bid proposal.
(v) Establish component rates of the benefit and price bid for
determining additional and supplementary benefits.
(vi) Determine the rates utilized in setting premiums for
State insurance agency purposes and for other government and private
purchasers; and
(b) Include at least records of the following:
(i) Ownership and operation of the MA Organization's
financial, medical, and other record keeping systems.
(ii) Financial statements for the current contract period and
six prior periods.
(iii) Federal income tax or informational returns for the
current contract period and six prior periods.
(iv) Asset acquisition, lease, sale, or other action.
(v) Agreements, contracts (including, but not limited to, with
related or unrelated prescription drug benefit managers) and
subcontracts.
(vi) Franchise, marketing, and management agreements.
(vii) Schedules of charges for the MA Organization's
fee-for-service patients.
(viii) Matters pertaining to costs of operations.
(ix) Amounts of income received, by source and payment.
(x) Cash flow statements.
(xi) Any financial reports filed with other Federal programs
or State authorities. [422.504(d)]
2. Access to facilities and records. The MA Organization agrees to the
following:
(a) The Department of Health and Human Services (HHS), the Comptroller
General, or their designee may evaluate, through inspection or other means--
(i) The quality, appropriateness, and timeliness of services
furnished to Medicare enrollees under the contract;
(ii) The facilities of the MA Organization; and
10
(iii) The enrollment and disenrollment records for the current
contract period and ten prior periods.
(b) HHS, the Comptroller General, or their designees may audit,
evaluate, or inspect any books, contracts, medical records, documents, papers,
patient care documentation, and other records of the MA Organization, related
entity, contractor, subcontractor, or its transferee that pertain to any aspect
of services performed, reconciliation of benefit liabilities, and determination
of amounts payable under the contract, or as the Secretary may deem necessary to
enforce the contract.
(c) The MA Organization agrees to make available, for the purposes
specified in section (A) of this article, its premises, physical facilities and
equipment, records relating to its Medicare enrollees, and any additional
relevant information that CMS may require, in a manner that meets CMS record
maintenance requirements.
(d) HHS, the Comptroller General, or their designee's right to inspect,
evaluate, and audit extends through 10 years from the final date of the contract
period or completion of audit, whichever is later unless-
(i) CMS determines there is a special need to retain a
particular record or group of records for a longer period and notifies
the MA Organization at least 30 days before the normal disposition
date;
(ii) There has been a termination, dispute, or fraud or
similar fault by the MA Organization, in which case the retention may
be extended to 10 years from the date of any resulting final resolution
of the termination, dispute, or fraud or similar fault; or
(iii) HHS, the Comptroller General, or their designee
determines that there is a reasonable possibility of fraud, in which
case they may inspect, evaluate, and audit the MA Organization at any
time. [422.504(e)]
B. REPORTING REQUIREMENTS
1. The MA Organization shall have an effective procedure to develop, compile,
evaluate, and report to CMS, to its enrollees, and to the general public, at the
times and in the manner that CMS requires, and while safeguarding the
confidentiality of the doctor-patient relationship, statistics and other
information as described in the remainder of this section (B). [422.516(a)]
2. The MA Organization agrees to submit to CMS certified financial information
that must include the following:
(a) Such information as CMS may require demonstrating that the
organization has a fiscally sound operation, including:
(i) The cost of its operations;
(ii) A description, submitted to CMS annually and within 120
days of the end of the fiscal year, of significant business
transactions (as defined in ss.422.500) between the MA Organization and
a party in interest showing that the costs of the transactions listed
in paragraph (2)(a)(v) of this section do not exceed the costs that
would be incurred if these transactions were with someone who is not a
party in interest; or
(iii) If they do exceed, a justification that the higher costs
are consistent with prudent management and fiscal soundness
requirements.
(iv) A combined financial statement for the MA Organization
and a party in interest if either of the following conditions is met:
11
(aa) Thirty-five percent or more of the costs of
operation of the MA Organization go to a party in interest.
(bb) Thirty-five percent or more of the revenue of a
party in interest is from the MA Organization. [422.516(b)]
(v)Requirements for combined financial statements.
(aa) The combined financial statements required by
paragraph (2)(a)(iv) must display in separate columns the
financial information for the MA Organization and each of the
parties in interest.
(bb) Inter-entity transactions must be eliminated in
the consolidated column.
(cc) The statements must have been examined by an
independent auditor in accordance with generally accepted
accounting principles and must include appropriate opinions
and notes.
(dd) Upon written request from the MA Organization
showing good cause, CMS may waive the requirement that the
organization's combined financial statement include the
financial information required in paragraph (2)(a)(v) with
respect to a particular entity. [422.516(c)]
(vi) A description of any loans or other special financial
arrangements the MA Organization makes with contractors,
subcontractors, and related entities.
(b) Such information as CMS may require pertaining to the disclosure of
ownership and control of the MA Organization. [422.504(f)(1)(ii)]
(c) Patterns of utilization of the MA Organization's services.
3. The MA Organization agrees to participate in surveys required by CMS and to
submit to CMS all information that is necessary for CMS to administer and
evaluate the program and to simultaneously establish and facilitate a process
for current and prospective beneficiaries to exercise choice in obtaining
Medicare services. This information includes, but is not limited to:
(a) The benefits covered under the MA plan;
(b) The MA monthly basic beneficiary premium and MA monthly
supplemental beneficiary premium, if any, for the plan.
(c) The service area and continuation area, if any, of each plan and
the enrollment capacity of each plan;
(d) Plan quality and performance indicators for the benefits under the
plan including --
(i) Disenrollment rates for Medicare enrollees electing to
receive benefits through the plan for the previous 2 years;
(ii) Information on Medicare enrollee satisfaction;
(iii) The patterns of utilization of plan services;
(iv) The availability, accessibility, and acceptability of the
plan's services;
(v) Information on health outcomes and other performance
measures required by CMS;
(vi) The recent record regarding compliance of the plan with
requirements of this part, as determined by CMS; and
(vii) Other information determined by CMS to be necessary to
assist beneficiaries in making an informed choice among MA plans and
traditional Medicare;
(e) Information about beneficiary appeals and their disposition;
(f) Information regarding all formal actions, reviews, findings, or
other similar actions by States, other regulatory bodies, or any other
certifying or accrediting organization;
(g) Any other information deemed necessary by CMS for the
administration or evaluation of the Medicare program. [422.504(f)(2)]
12
4. The MA Organization agrees to provide to its enrollees and upon request, to
any individual eligible to elect an MA plan, all informational requirements
under ss.422.64 and, upon an enrollee's, request, the financial disclosure
information required under ss.422.5 16. [422.504(f)(3)]
5. Reporting and disclosure under ERISA.
(a) For any employees' health benefits plan that includes an MA
Organization in its offerings, the MA Organization must furnish, upon request,
the information the plan needs to fulfill its reporting and disclosure
obligations (with respect to the MA Organization) under the Employee Retirement
Income Security Act of 1974 (ERISA).
(b) The MA Organization must furnish the information to the employer or
the employer's designee, or to the plan administrator, as the term
"administrator" is defined in ERISA. [422.516(d)]
6. Electronic communication. The MA Organization must have the capacity to
communicate with CMS electronically. [422.504(b)]
7. Risk Adjustment data. The MA Organization agrees to comply with the
requirements in ss.422.3 10 for submitting risk adjustment data to CMS.
[422.504(a)(8)]
Article VII
Renewal of the MA Contract
▇. ▇▇▇▇▇▇▇ of contract: In accordance with ss.422.505, following the
initial contract period, this contract is renewable annually only if-
(1) The MA Organization has not provided CMS with a notice of
intention not to renew; [422 .506(a)]
(2) CMS and the MA Organization reach agreement on the bid
under 42 CFR Part 422, Subpart F; and [422.505(d)]
(3) CMS informs the MA Organization that it authorizes a
renewal.
B. Nonrenewal of contract
(1) Nonrenewal by the Organization.
(a) In accordance with ss.422.506, the MA Organization may
elect not to renew its contract with CMS as of the end of the term of
the contract for any reason, provided it meets the time frames for
doing so set forth in subparagraphs (b) and (c) of this paragraph.
(b) If the MA Organization does not intend to renew its
contract, it must notify--
(i) CMS, in writing, by the first Monday in June of
the year in which the contract would end, pursuant to
ss.422.506
(ii) Each Medicare enrollee, at least 90 days before
the date on which the nonrenewal is effective. This notice
must include a written description of all alternatives
available for obtaining Medicare services within the service
area including alternative MA plans, Medigap options, and
original Medicare and prescription drug plans and must receive
CMS approval prior to issuance.
(iii) The general public, at least 90 days before the
end of the current calendar year, by publishing a CMS-approved
notice in one or more newspapers of general circulation in
each community located in the MA Organization's service area.
13
(c) CMS may accept a nonrenewal notice submitted after the
applicable annual non-renewal notice deadline if --
(i) The MA Organization notifies its Medicare
enrollees and the public in accordance with subparagraph
(1)(b)(ii) and (1 )(b)(iii) of this section; and
(ii) Acceptance is not inconsistent with the
effective and efficient administration of the Medicare
program.
(d) If the MA Organization does not renew a contract under
subparagraph (1), CMS will not enter into a contract with the
Organization for 2 years from the date of contract separation unless
there are special circumstances that warrant special consideration, as
determined by CMS. [422 .506(a)]
(2) CMS decision not to renew.
(a) CMS may elect not to authorize renewal of a contract for
any of the following reasons:
(i) The MA Organization's level of enrollment, growth
in enrollment, or insufficient number of contracted providers
is determined by CMS to threaten the viability of the
organization under the MA program and or be an indicator of
beneficiary dissatisfaction with the MA plan(s) offered by the
organization.
(ii) For any of the reasons listed in ss.422.510(a)
[Article VIII, section (B)(1 )(a) of this contract], which
would also permit CMS to terminate the contract.
(iii) The MA Organization has committed any of the
acts in ss.422.752(a) that would support the imposition of
intermediate sanctions or civil money penalties under 42 CFR
Part 422 Subpart O.
(iv) The MA Organization did not submit a benefit and
price bid or the benefit and price bid was not acceptable
[422.505(d)]
(b) Notice. CMS shall provide notice of its decision whether
to authorize renewal of the contract as follows:
(i) To the MA Organization by May 1 of the contract
year, except in the event of (2)(a)(iv) above, for which
notice will be sent by September 1.
(ii) To the MA Organization's Medicare enrollees by
mail at least 90 days before the end of the current calendar
year.
(iii) To the general public at least 90 days before
the end of the current calendar year, by publishing a notice
in one or more newspapers of general circulation in each
community or county located in the MA Organization's service
area.
(c) Notice of appeal rights. CMS shall give the MA
Organization written notice of its right to reconsideration of the
decision not to renew in accordance with ss. 422.644. [422.506(b)]
14
Article VIII
Modification or Termination of the Contract
A. Modification or Termination of Contract by Mutual Consent
1. This contract may be modified or terminated at any time by written mutual
consent.
(a) If the contract is modified by written mutual consent, the MA
Organization must notify its Medicare enrollees of any changes that CMS
determines are appropriate for notification within time frames specified by CMS.
[422.508(a)(2)]
(b) If the contract is terminated by written mutual consent, except as
provided in section (A)(2) of this Article, the MA Organization must provide
notice to its Medicare enrollees and the general public as provided in section
B(2)(b)(ii) and B(2)(b)(iii) of this Article. [422.508(a)(1)]
2. If this contract is terminated by written mutual consent and replaced the day
following such termination by a new MA contract, the MA Organization is not
required to provide the notice specified in section B of this article.
[422.508(b)]
B. Termination of the Contract by CMS or the MA Organization
1. Termination by CMS.
(a) CMS may terminate a contract for any of the following reasons:
(i) The MA Organization has failed substantially to carry out
the terms of its contract with CMS.
(ii) The MA Organization is carrying out its contract with CMS
in a manner that is inconsistent with the effective and efficient
implementation of 42 CFR Part 422.
(iii) CMS determines that the MA Organization no longer meets
the requirements of 42 CFR Part 422 for being a contracting
organization.
(iv) There is credible evidence that the MA Organization
committed or participated in false, fraudulent or abusive activities
affecting the Medicare program, including submission of false or
fraudulent data.
(v) The MA Organization experiences financial difficulties so
severe that its ability to make necessary health services available is
impaired to the point of posing an imminent and serious risk to the
health of its enrollees, or otherwise fails to make services available
to the extent that such a risk to health exists.
(vi) The MA Organization substantially fails to comply with
the requirements in 42 CFR Part 422 Subpart M relating to grievances
and appeals.
(vii) The MA Organization fails to provide CMS with valid risk
adjustment data as required under ss.422.3 10 and 423.329(b)(3).
(viii) The MA Organization fails to implement an acceptable
quality improvement program as required under 42 CFR Part 422 Subpart
D.
(ix) The MA Organization substantially fails to comply with
the prompt payment requirements in ss.422.520.
(x) The MA Organization substantially fails to comply with the
service access requirements in ss.422.112.
(xi) The MA Organization fails to comply with the requirements
of ss.422.20 8 regarding physician incentive plans.
15
(xii) The MA Organization substantially fails to comply with
the marketing requirements in 422.80.
(b) Notice. If CMS decides to terminate a contract for reasons other
than the grounds specified in section (B)(1)(a) above, it will give notice of
the termination as follows:
(i) CMS will notify the MA Organization in writing 90 days
before the intended date of the termination.
(ii) The MA Organization will notify its Medicare enrollees of
the termination by mail at least 30 days before the effective date of
the termination.
(iii) The MA Organization will notify the general public of
the termination at least 30 days before the effective date of the
termination by publishing a notice in one or more newspapers of general
circulation in each community or county located in the MA
Organization's service area.
(c) Immediate termination of contract by CMS.
(i) For terminations based on violations prescribed in
paragraph (B)(1)(a)(v) of this article, CMS will notify the MA
Organization in writing that its contract has been terminated effective
the date of the termination decision by CMS. If termination is
effective in the middle of a month, CMS has the right to recover the
prorated share of the capitation payments made to the MA Organization
covering the period of the month following the contract termination.
(ii) CMS will notify the MA Organization's Medicare enrollees
in writing of CMS' decision to terminate the MA Organization's
contract. This notice will occur no later than 30 days after CMS
notifies the plan of its decision to terminate this contract. CMS will
simultaneously inform the Medicare enrollees of alternative options for
obtaining Medicare services, including alternative MA Organizations in
a similar geographic area and original Medicare.
(iii) CMS will notify the general public of the termination no
later than 30 days after notifying the MA Organization of CMS' decision
to terminate this contract. This notice will be published in one or
more newspapers of general circulation in each community or county
located in the MA Organization's service area.
(d) Corrective action plan
(i) General. Before terminating a contract for reasons other
than the grounds specified in section (B)( 1 )(a)(v) of this article,
CMS will provide the MA Organization with reasonable opportunity, not
to exceed time frames specified at 42 CFR Part 422 Subpart N, to
develop and receive CMS approval of a corrective action plan to correct
the deficiencies that are the basis of the proposed termination.
(ii) Exception. If a contract is terminated under section
(B)(1)(a)(v) of this article, the MA Organization will not have the
opportunity to submit a corrective action plan.
(e) Appeal rights. If CMS decides to terminate this contract, it will
send written notice to the MA Organization informing it of its termination
appeal rights in accordance with 42 CFR Part 422 Subpart N. [422.510]
2. Termination by the MA Organization
(a) Cause for termination. The MA Organization may terminate this
contract if CMS fails to substantially carry out the terms of the contract.
(b) Notice. The MA Organization must give advance notice as follows:
(i) To CMS, at least 90 days before the intended date of
termination. This notice must specify the reasons why the MA
Organization is requesting contract termination.
16
(ii) To its Medicare enrollees, at least 60 days before the
termination effective date. This notice must include a written
description of alternatives available for obtaining Medicare services
within the service area, including alternative MA and MA-PD plans, PDP
plans, Medigap options, and original Medicare and must receive CMS
approval.
(iii) To the general public at least 60 days before the
termination effective date by publishing a CMS-approved notice in one
or more newspapers of general circulation in each community or county
located in the MA Organization's geographic area.
(c) Effective date of termination. The effective date of the
termination will be determined by CMS and will be at least 90 days after the
date CMS receives the MA Organization's notice of intent to terminate.
(d) CMS' liability. CMS' liability for payment to the MA Organization
ends as of the first day of the month after the last month for which the
contract is in effect, but CMS shall make payments for amounts owed prior to
termination but not yet paid.
(e) Effect of termination by the organization. CMS will not enter into
an agreement with the MA Organization for a period of two years from the date
the Organization has terminated this contract, unless there are circumstances
that warrant special consideration, as determined by CMS. [422.512]
Article IX
Requirements of Other Laws and Regulations
A. The MA Organization agrees to comply with--
(1) Federal laws and regulations designed to prevent or ameliorate
fraud, waste, and abuse, including, but not limited to, applicable provisions of
Federal criminal law, the False Claims Act (31 USC 3729 et seq.) , and the
anti-kickback statute (section 11 28B(b) of the Act): and
(2) HIPAA administrative simplification rules at 45 CFR parts 160, 162,
and 164. [422.504(h)]
B. The MA Organization maintains ultimate responsibility for adhering to and
otherwise fully complying with all terms and conditions of its contract with
CMS, notwithstanding any relationship(s) that the MA organization may have with
related entities, contractors, or subcontractors. [422.504(i)]
C. In the event that any provision of this contract conflicts with the
provisions of any statute or regulation applicable to an MA Organization, the
provisions of the statute or regulation shall have full force and effect.
17
Article X
Severability
The MA Organization agrees that, upon CMS' request, this contract will be
amended to exclude any MA plan or State-licensed entity specified by CMS, and a
separate contract for any such excluded plan or entity will be deemed to be in
place when such a request is made. [422.504(k)]
Article XI
Miscellaneous
A. Definitions. Terms not otherwise defined in this contract shall have the
meaning given to such terms in 42 CFR Part 422.
B. Alteration to Original Contract Terms. The MA Organization agrees that it has
not altered in any way the terms of this contract presented for signature by
CMS. The MA Organization agrees that any alterations to the original text the MA
Organization may make to this contract shall not be binding on the parties.
C. Approval to Begin Marketing and Enrollment. The MA Organization agrees that
it must complete CMS operational requirements prior to receiving CMS approval to
begin Part C marketing and enrollment activities. Such activities include, but
are not limited to, establishing and successfully testing connectivity with CMS
systems to process enrollment applications (or contracting with an entity
qualified to perform such functions on the MA Organization's Sponsor's behalf)
and successfully demonstrating capability to submit accurate and timely price
comparison data. To establish and successfully test connectivity, the MA
Organization must, 1) establish and test physical connectivity to the CMS data
center, 2) acquire user identifications and passwords, 3) receive, store, and
maintain data necessary to perform enrollments and send and receive transactions
to and from CMS, and 4) check and receive transaction status information.
D. Incorporation of Applicable Addenda. All addenda checked off and initialed on
the cover sheet of this contract by the MA Organization are hereby incorporated
by reference.
18
In witness whereof, the parties hereby execute this contract.
FOR THE MA ORGANIZATION
/s/ ▇▇▇▇ ▇▇▇▇▇▇ CEO
------------------------------ ----------------------------------------
Printed Name Title
/s/ ▇▇▇▇ ▇▇▇▇▇▇ 9/13/06
------------------------------ ----------------------------------------
Signature Date
QMedCare of New Jersey, Inc. ▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
------------------------------ ----------------------------------------
Organization Address
FOR THE CENTERS FOR MEDICARE & MEDICAID SERVICES
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇ 9/28/06
------------------------------ ----------------------------------------
▇▇▇▇▇ ▇. ▇▇▇▇▇ Date
Acting Director
Medicare Advantage Group
Center for Beneficiary Choices
19
ATTESTATION OF ENROLLMENT INFORMATION
RELATING TO CMS PAYMENT
TO A MEDICARE ADVANTAGE ORGANIZATION
Pursuant to the contract(s) between the Centers for Medicare & Medicaid
Services (CMS) and (INSERT NAME OF MA ORGANIZATION), hereafter referred to as
the MA Organization, governing the operation of the following Medicare Advantage
plans (INSERT PLAN IDENTIFICATION NUMBERS HERE), the MA Organization hereby
requests payment under the contract, and in doing so, makes the following
attestation concerning CMS payments to the MA Organization. The MA Organization
acknowledges that the information described below directly affects the
calculation of CMS payments to the MA Organization and that misrepresentations
to CMS about the accuracy of such information may result in Federal civil action
and/or criminal prosecution. This attestation shall not be considered a waiver
of the MA Organization's right to seek payment adjustments from CMS based on
information or data which does not become available until after the date the MA
Organization submits this attestation.
1. The MA Organization has reported to CMS for the month of (INDICATE
MONTH AND YEAR) all new enrollments, disenrollments, and changes in enrollees'
institutional status with respect to the above-stated MA plans. Based on best
knowledge, information, and belief as of the date indicated below, all
information submitted to CMS in this report is accurate, complete, and truthful.
2. The MA Organization has reviewed the CMS monthly membership report
and reply listing for the month of (INDICATE MONTH AND YEAR) for the
above-stated MA plans and has reported to CMS any discrepancies between the
report and the MA Organization's records. For those portions of the monthly
membership report and the reply listing to which the MA Organization raises no
objection, the MA Organization, through the certifying CEO/CFO, will be deemed
to have attested, based on best knowledge, information, and belief as of the
date indicated below, to their accuracy, completeness, and truthfulness.
/s/▇▇▇▇ ▇▇▇▇▇▇ CEO
(INDICATE TITLE [CEO, CFO, or delegate])
on behalf of
QMedCare of New Jersey, Inc.
(INDICATE MA ORGANIZATION)
09/13/06
DATE
20
ATTESTATION OF RISK ADJUSTMENT DATA INFORMATION RELATING TO
CMS PAYMENT TO A MEDICARE ADVANTAGE ORGANIZATION
Pursuant to the contract(s) between the Centers for Medicare & Medicaid
Services (CMS) and (INSERT NAME OF MA ORGANIZATION), hereafter referred to as
the MA Organization, governing the operation of the following Medicare Advantage
plans (INSERT PLAN IDENTIFICATION NUMBERS HERE), the MA Organization hereby
requests payment under the contract, and in doing so, makes the following
attestation concerning CMS payments to the MA Organization. The MA Organization
acknowledges that the information described below directly affects the
calculation of CMS payments to the MA Organization or additional benefit
obligations of the MA Organization and that misrepresentations to CMS about the
accuracy of such information may result in Federal civil action and/or criminal
prosecution.
The MA Organization has reported to CMS during the period of (INDICATE
DATES) all (INDICATE TYPE OF DATA - INPATIENT HOSPITAL, OUTPATIENT HOSPITAL, OR
PHYSICIAN) risk adjustment data available to the MA Organization with respect to
the above-stated MA plans. Based on best knowledge, information, and belief as
of the date indicated below, all information submitted to CMS in this report is
accurate, complete, and truthful.
/s/▇▇▇▇ ▇▇▇▇▇▇ CEO
(INDICATE TITLE [CEO, CFO, or delegate])
on behalf of
QMedCare of New Jersey, Inc.
(INDICATE MA ORGANIZATION)
09/13/06
DATE
21
ADDENDUM TO MEDICARE MANAGED CARE CONTRACT PURSUANT TO
SECTIONS 1860D-1 THROUGH 1860D-42 OF THE SOCIAL SECURITY ACT
FOR THE OPERATION OF A VOLUNTARY MEDICARE PRESCRIPTION
DRUG PLAN
H5711
The Centers for Medicare & Medicaid Services (hereinafter referred to as "CMS")
and QMedCare of New Jersey, Inc. , a managed care organization (herein after
referred to as the MA-PD Sponsor) agree to amend the contract (INSERT "H" OR "R"
NUMBER) governing the MA-PD Sponsor's operation of a Part C plan described in
Section 1851(a)(2)(A) of the Social Security Act (hereinafter referred to as
"the Act") or a Medicare cost plan to include this addendum under which the
MA-PD Sponsor shall operate a Voluntary Medicare Prescription Drug Plan pursuant
to sections 1860D-1 through 1860D-42 (with the exception of section 1860D-22 and
1860D-31) of the Act.
This addendum is made pursuant to Subpart L of 42 CFR Part 417 (in the case of
cost plan sponsors offering a Part D benefit) and Subpart K of 42 CFR Part 422
(in the case of an MA-PD Sponsor offering a Part C plan).
NOTE: For purposes of this addendum, unless otherwise noted, reference to an
"MA-PD Sponsor" or "MA-PD Plan" is deemed to include a cost plan sponsor or a MA
private fee-for-service contractor offering a Part D benefit.
A-1
Article I
Medicare Voluntary Prescription Drug Benefit
A. The MA-PD Sponsor agrees to operate one or more Medicare Voluntary
Prescription Drug Plans as described in its application and related
materials, including but not limited to all the attestations contained
therein and all supplemental guidance, for Medicare approval and in
compliance with the provisions of this addendum, which incorporates in its
entirety the Solicitation For Applications for New Medicare Advantage
Prescription Drug Plan (MA-PD) Sponsors, released on January 24, 2006
[applicable to Medicare Part C contractors] or the Solicitation for
Applications for New Cost Plan Sponsors, released on January 24, 2006
[applicable to Medicare cost plan contractors] (hereinafter collectively
referred to as the addendum"). The MA-PD Sponsor also agrees to operate in
accordance with the regulations at 42 CFR ss.423.1 through 42 CFR
ss.423.910 (with the exception of Subparts Q, R, and S), sections 1860D-1
through 1860D-42 (with the exception of sections 1860D-22(a) and 1860D-31)
of the Social Security Act, and the applicable solicitation identified
above, as well as all other applicable Federal statutes, regulations, and
policies. This addendum is deemed to incorporate any changes that are
required by statute to be implemented during the term of this addendum and
any regulations or policies implementing or interpreting such statutory
provisions.
B. CMS agrees to perform its obligations to the MA-PD Sponsor consistent with
the regulations at 42 CFR ss.423.1 through 42 CFR ss.423.910 (with the
exception of Subparts Q, R, and S), sections 1860D-I through 1860D-42 (with
the exception of sections 1860D-22(a) and 1860D-31) of the Social Security
Act, and the applicable solicitation, as well as all other applicable
Federal statutes, regulations, and policies.
C. CMS agrees that it will not implement, other than at the beginning of a
calendar year, regulations under 42 CFR Part 423 that impose new,
significant regulatory requirements on the MA-PD Sponsor. This provision
does not apply to new requirements mandated by statute.
D. This addendum is in no way intended to supersede or modify 42 CFR, Parts
417, 422. or 423. Failure to reference a regulatory requirement in this
addendum does not affect the applicability of such requirements to the
MA-PD Sponsor and CMS.
Article II
Functions to be Performed by the MA-PD Sponsor
A. ENROLLMENT
1. MA-PD Sponsor agrees to enroll in its MA-PD plan only Part D-eligible
beneficiaries as they are defined in 42 CFR ss.423.30(a) and who have
elected to enroll in MA-PD Sponsor's Part C or Section 1876 benefit.
A-2
2. If the MA-PD Sponsor is a cost plan sponsor, the MA-PD Sponsor
acknowledges that its Section 1876 plan enrollees are not required to
elect enrollment in its Part D plan.
B. PRESCRIPTION DRUG BENEFIT
1. MA-PD Sponsor agrees to provide the required prescription drug
coverage as defined under 42 CFR ss.423.100 and, to the extent
applicable, supplemental benefits as defined in 42 CFR ss.423.100 and
in accordance with Subpart C of 42 CFR Part 423. MA-PD Sponsor also
agrees to provide Part D benefits as described in the MA-PD Sponsor's
Part D bid(s) approved each year by CMS (and in the Attestation of
Benefit Plan and Price, attached hereto).
2. MA-PD ▇▇▇▇▇▇▇ agrees to calculate and collect beneficiary Part D
premiums in accordance with 42 CFR ss.ss.423.286 and 423.293.
3. If the MA-PD Sponsors is a cost plans sponsor, it acknowledge that its
Part D benefit is offered as an optional supplemental service in
accordance with 42 CFR ss.417.440(b)(2)(ii).
C. DISSEMINATION OF PLAN INFORMATION
1. MA-PD ▇▇▇▇▇▇▇ agrees to provide the information required in 42 CFR
ss.423.48.
2. MA-PD Sponsor agrees to disclose information related to Part D
benefits to beneficiaries in the manner and the form specified by CMS
under 42 CFR ss.ss.423.128 and 423.50 and in the "Marketing Materials
Guidelines for Medicare Advantage-Prescription Drug Plans (MA-PDs) and
Prescription Drug Plans (PDPs)."
3. MA-PD Sponsor certifies that all materials it submits to CMS under the
File and Use Certification authority described in the Marketing
Materials Guidelines are accurate, truthful, not misleading, and
consistent with CMS marketing guidelines.
D. QUALITY ASSURANCE/UTILIZATION MANAGEMENT
MA-PD Sponsor agrees to operate quality assurance, cost, and utilization
management, medication therapy management programs, and support electronic
prescribing in accordance with Subpart D of 42 CFR Part 423.
E. APPEALS AND GRIEVANCES
MA-PD Sponsor agrees to comply with all requirements in Subpart M of 42 CFR
Part 423 governing coverage determinations, grievances and appeals, and
formulary exceptions. MA-PD Sponsor acknowledges that these requirements
are separate and distinct from the appeals and grievances requirements
applicable to the MA-PD Sponsor through the operation of its Part C or cost
plan benefits.
A-3
F. PAYMENT TO MA-PD SPONSOR
1. MA-PD Sponsor and CMS agree that payment paid for Part D services
under the addendum will be governed by the rules in Subpart G of 42
CFR Part 423.
2. If the MA-PD Sponsor is participating in the Part D Reinsurance
Payment Demonstration, described in 70 FR 9360 (Feb. 25, 2005), it
affirms that it will not seek payment under the demonstration for
services provided to employer group enrollees.
G. BID SUBMISSION AND REVIEW
If the MA-PD Sponsor intends to participate in the Part D program for the
future year, MA-PD Sponsor agrees to submit a future year's Part D bid,
including all required information on premiums, benefits, and cost-sharing,
by the applicable due date, as provided in Subpart F of 42 CFR Part 423 so
that CMS and the MA-PD Sponsor may conduct negotiations regarding the terms
and conditions of the proposed bid and benefit plan renewal. MA-PD Sponsor
acknowledges that failure to submit a timely bid under this section may
affect the sponsor's ability to offer a Part C plan, pursuant to the
provisions of 42 CFR ss.422.4(c).
H. COORDINATION WITH OTHER PRESCRIPTION DRUG COVERAGE
1. MA-PD Sponsor agrees to comply with the coordination requirements with
State Pharmacy Assistance Programs (SPAPs) and plans that provide
other prescription drug coverage as described in Subpart J of 42 CFR
Part 423.
2. MA-PD ▇▇▇▇▇▇▇ agrees to comply with Medicare Secondary Payer
procedures as stated in 42 CFR ss.423.462.
I. SERVICE AREA AND PHARMACY ACCESS
1. The MA-PD Sponsor agrees to provide Part D benefits in the service
area for which it has been approved by CMS to offer Part C or cost
plan benefits utilizing a pharmacy network and formulary approved by
CMS that meet the requirements of 42 CFR ss.423.120.
2. The MA-PD Sponsor agrees to ensure adequate access to Part D-covered
drugs at out-of-network pharmacies according to 42 CFR ss.423.124.
3. MA-PD Sponsor agrees to provide benefits by means of point-of-service
systems to adjudicate prescription drug claims in a timely and
efficient manner in compliance with CMS standards, except when
necessary to provide access in underserved areas, I/T/U pharmacies (as
defined in 42 CFR ss.423.100), and longterm care pharmacies (as
defined in 42 CFR ss.423.100).
A-4
4. MA-PD ▇▇▇▇▇▇▇ agrees to contract with any pharmacy that meets the
MA-PD ▇▇▇▇▇▇▇'s reasonable and relevant standard terms and conditions.
If MA-PD Sponsor has demonstrated that it historically fills 98% or
more of its enrollees' prescriptions at pharmacies owned and operated
by the MA-PD Sponsor (or presents compelling circumstances that
prevent the sponsor from meeting the 98% standard or demonstrates that
its Part D plan design will enable the sponsor to meet the 98%
standard during the contract year), this provision does not apply to
MA-PD Sponsor's plan.
5. The provisions of 42 CFR ss.423.120(a) concerning the TRICARE retail
pharmacy access standard do not apply to MA-PD Sponsor if the Sponsor
has demonstrated to CMS that it historically fills more than 50% of
its enrollees' prescriptions at pharmacies owned and operated by the
MA-PD Sponsor. MA-PD Sponsors excused from meeting the TRICARE
standard are required to demonstrate retail pharmacy access that meets
the requirements of 42 CFR ss.422.112 for a Part C contractor and 42
CFR ss.417.416(e) for a cost plan contractor.
J. COMPLIANCE PLAN/PROGRAM INTEGRITY
MA-PD Sponsor agrees that it will develop and implement a compliance plan
that applies to its Part D-related operations, consistent with 42 CFR
ss.423.504(b)(4)(vi).
K. LOW-INCOME SUBSIDY
MA-PD ▇▇▇▇▇▇▇ agrees that it will participate in the administration of
subsidies for low-income individuals according to Subpart P of 42 CFR Part
423.
L. BENEFICIARY FINANCIAL PROTECTIONS
The MA-PD Sponsor agrees to afford its enrollees protection from liability
for payment of fees that are the obligation of the MA-PD Sponsor in
accordance with 42 CFR ss.423.505(g).
M. RELATIONSHIP WITH RELATED ENTITIES, CONTRACTORS, AND SUBCONTRACTORS
1. The MA-PD Sponsor agrees that it maintains ultimate responsibility for
adhering to and otherwise fully complying with all terms and
conditions of this addendum.
2. The MA-PD Sponsor shall ensure that any contracts or agreements with
subcontractors or agents performing functions on the MA-PD Sponsor's
behalf related to the operation of the Part D benefit are in
compliance with 42 CFR ss.423.505(i).
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N. CERTIFICATION OF DATA THAT DETERMINE PAYMENT
MA-PD Sponsor must provide certifications in accordance with 42 CFR
ss.423.505(k).
Article III
Record Retention and Reporting Requirements
A. MAINTENANCE OF RECORDS
MA-PD Sponsor agrees to maintain records and provide access in accordance
with 42 CFR ss.ss.423.504(d) and 505(d) and (e).
B. GENERAL REPORTING REQUIREMENTS
The MA-PD Sponsor agrees to submit to information to CMS according to 42
CFR ss.ss.423.505(0, 423.514, and the "Final Medicare Part D Reporting
Requirements," a document issued by CMS and subject to modification each
program year.
C. CMS LICENSE FOR USE OF PLAN FORMULARY
PDP Sponsor agrees to submit to CMS each plan's formulary information,
including any changes to its formularies, and hereby grants to the
Government[, and any person or entity who might receive the formulary from
the Government,] a non-exclusive license to use all or any portion of the
formulary for any purpose related to the administration of the Part D
program, including without limitation publicly distributing, displaying,
publishing or reconfiguration of the information in any medium, including
▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇, and by any electronic, print or other means of
distribution.
Article IV
HIPAA Transactions/Privacy/Security
A. MA-PD ▇▇▇▇▇▇▇ agrees to comply with the confidentiality and enrollee record
accuracy requirements specified in 42 CFR ss.423.136.
B. MA-PD ▇▇▇▇▇▇▇ agrees to enter into a business associate agreement with the
entity with which CMS has contracted to track Medicare beneficiaries' true
out-of-pocket costs.
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Article V
Addendum Term and Renewal
A. TERM OF ADDENDUM
This addendum is effective from the date of CMS' authorized
representative's signature through December 31, 2007. This addendum shall
be renewable for successive one-year periods thereafter according to 42 CFR
ss.423.506. MA-PD Sponsor shall not conduct Part D-related marketing
activities prior to October 1, 2006 and shall not process enrollment
applications prior to November 15, 2006. MA-PD Sponsor shall begin
delivering Part D benefit services on January 1, 2007.
B. QUALIFICATION TO RENEW ADDENDUM
1. In accordance with 42 CFR ss.423.507, the MA-PD Sponsor will be
determined qualified to renew this addendum annually only if (a) CMS
informs the MA-PD Sponsor that it is qualified to renew its addendum;
and (b) The MA-PD Sponsor has not provided CMS with a notice of
intention not to renew in accordance with Article VII of this
addendum.
2. Although MA-PD Sponsor may be determined qualified to renew its
addendum under this Article, if the MA-PD Sponsor and CMS cannot reach
agreement on the Part D bid under Subpart F of 42 CFR Part 423, no
renewal takes place, and the failure to reach agreement is not subject
to the appeals provisions in Subpart N of 42 CFR Parts 422 or 423.
(Refer to Article XI for consequences of non-renewal on the Part C
contract and the ability to enter into a Part C contract.)
Article VI
Nonrenewal of Addendum
A. NONRENEWAL BY THE MA-PD SPONSOR
1. MA-PD Sponsor may non-renew this addendum in accordance with 42 CFR
423.507(a).
2. If the MA-PD Sponsor non-renews this addendum under this Article, CMS
cannot enter into a Part D addendum with the organization for 2 years
unless there are special circumstances that warrant special
consideration, as determined by CMS.
B. NONRENEWAL BY CMS
CMS may non-renew this addendum under the rules of 42 CFR 423.507(b).
(Refer to Article X for consequences of non-renewal on the Part C contract
and the ability to enter into a Part C contract.)
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Article VII
Modification or Termination of Addendum by Mutual Consent
This addendum may be modified or terminated at any time by written mutual
consent in accordance with 42 CFR 423.508. (Refer to Article X for consequences
of non-renewal on the Part C contract and the ability to enter into a Part C
contract.)
Article VIII
Termination of Addendum by CMS
CMS may terminate this addendum in accordance with 42 CFR 423.509. (Refer to
Article X for consequences of non-renewal on the Part C contract and the ability
to enter into a Part C contract.)
Article IX
Termination of Addendum by the MA-PD Sponsor
A. The MA-PD Sponsor may terminate this addendum only in accordance with 42
CFR 423.510.
B. CMS will not enter into a Part D addendum with an organization that has
terminated its addendum within the preceding 2 years unless there are
circumstances that warrant special consideration, as determined by CMS.
C. If the addendum is terminated under section A of this Article, the MA-PD
Sponsor must ensure the timely transfer of any data or files. (Refer to
Article X for consequences of non-renewal on the Part C contract and the
ability to enter into a Part C contract.)
Article X
Relationship Between Addendum and Part C Contract or 1876 Cost Contract
A. MA-PD Sponsor acknowledges that, if it is a Medicare Part C contractor, the
termination or nonrenewal of this addendum by either party may require CMS
to terminate or non-renew the Sponsor's Part C contract in the event that
such non-renewal or termination prevents the MA-PD Sponsor from meeting the
requirements of 42 CFR ss.422.4(c), in which case the Sponsor must provide
the notices specified in this contract, as well as the notices specified
under Subpart K of 42 CFR Part 422. MA-PD Sponsor also acknowledges that
Article X.B. of this addendum may prevent the sponsor from entering into a
Part C contract for two years following an addendum termination or
non-renewal where such non-renewal or termination prevents the MA-PD
Sponsor from meeting the requirements of 42 CFR ss.422.4(c).
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B. The termination of this addendum by either party shall not, by itself,
relieve the parties from their obligations under the Part C or cost plan
contracts to which this document is an addendum.
C. In the event that the MA-PD Sponsor's Part C or cost plan contract (as
applicable) is terminated or nonrenewed by either party, the provisions of
this addendum shall also terminate. In such an event, the MA-PD Sponsor and
CMS shall provide notice to enrollees and the public as described in this
contract as well as 42 CFR Part 422, Subpart K or 42 CFR Part 417, Subpart
K, as applicable.
Article XI
Intermediate Sanctions
The MA-PD Sponsor shall be subject to sanctions and civil monetary
penalties, consistent with Subpart 0 of 42 CFR Part 423.
Article XII
Severability
Severability of the addendum shall be in accordance with 42 CFR
ss.423.504(e).
Article XIII
Miscellaneous
A. DEFINITIONS: Terms not otherwise defined in this addendum shall have the
meaning given such terms at 42 CFR Part 423 or, as applicable, 42 CFR Part
422 or Part 417.
B. ALTERATION TO ORIGINAL ADDENDUM TERMS: The MA-PD Sponsor agrees that it has
not altered in any way the terms of the MA-PD addendum presented for
signature by CMS. MA-PD Sponsor agrees that any alterations to the original
text the MA-PD Sponsor may make to this addendum shall not be binding on
the parties.
C. ADDITIONAL CONTRACT TERMS: The MA-PD Sponsor agree to include in this
addendum other terms and conditions in accordance with 42 CFR
ss.423.505(j).
D. CMS APPROVAL TO BEGIN MARKETING AND ENROLLMENT ACTIVITIES: The MA-PD
Sponsor agrees that it must complete CMS operational requirements related
to its Part D benefit prior to receiving CMS approval to begin MA-PD plan
marketing activities relating to its Part D benefit. Such activities
include, but are not limited to, establishing and successfully testing
connectivity with CMS systems to process enrollment applications (or
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contracting with an entity qualified to perform such functions on MA-PD
Sponsor's behalf) and successfully demonstrating the capability to submit
accurate and timely price comparison data. To establish and successfully
test connectivity, the PDP Sponsor must, 1) establish and test physical
connectivity to the CMS data center, 2) acquire user identifications and
passwords, 3) receive, store, and maintain data necessary to perform
enrollments and send and receive transactions to and from CMS, and 4) check
and receive transaction status information.
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PART C/D BENEFIT PLAN(S) DESCRIPTION
TO BE ATTACHED TO MA CONTRACT
SECTION 1876/PART D OPTIONAL SUPPLEMENTAL BENEFIT PLAN
DESCRIPTION TO BE ATTACHED TO SECTION 1876 CONTRACT
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