Download CMS-4157-FCMedicare Part C and D Final

CMS-4157-FC
Medicare Part C and D
Final Rule with Comment
for Contract Year 2013
Christian Bauer
Director, Division of Drug Plan Policy & Quality
1
Summary
• Published on April 12, 2012 [tentative]
• 60-day comment period for Independence of Long-Term
Care (LTC) Consultant Pharmacists [tentatively June 11,
2012]
• We have responded to comments and finalized 26
provisions for the Medicare Advantage (MA) program (Part
C) and prescription drug benefit program (Part D)
2
Subject Areas
A.
B.
C.
D.
E.
Implementing Statutory Provisions
Strengthening Beneficiary Protections
Excluding Poor Performers
Improving Program Efficiencies
Clarifying Program Requirements
3
Two Non-Finalized Provisions
• We did not finalize two provisions
• Independence of LTC Consultant Pharmacists
• Application of the Medicare Hospital-Acquired Conditions and
Present on Admission Indicator Policy to MA Organizations
4
Preamble Section
A. Implementing Statutory Provisions
5
Coverage Gap Discount Program
• Implements provisions of the Affordable Care Act
• Codifies the Coverage Gap Discount Program requirements
in new subpart W
• Primarily codifies the existing requirements in new subpart
W, but there are some changes and clarifications:
• For Example:
• Clarifies that all supplemental benefits offered by employer group
waiver plans are considered other, non-Medicare health coverage
always paid after the discount has been applied
• Requires manufacturers to maintain up-to-date NDC listings with
electronic database vendors (in addition to the FDA) that they
provide NDCs for pharmacy claims processing
6
Inclusion of Benzodiazepines and Barbiturates as Part D
Covered Drugs
• Implements provision of the Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA)
• Part D drugs will include, provided they meet all other
requirements to be a Part D drug:
• Barbiturates used for the medical indications of epilepsy,
cancer, or a chronic mental health disorder; and
• Benzodiazepines
• Effective for prescriptions dispensed on or after January 1,
2013
7
Pharmacy Benefit Manager’s Transparency Requirements
• Implements section 6005 of the Affordable Care Act
• Promotes transparency of financial transactions Part D
sponsors and entities providing PBM services
• Requires reporting of various PBM financial data elements
• Establishes confidentiality of PBM data
• Imposes penalties for sponsor or PBM failure to provide
PBM data to the Secretary
8
Preamble Section
B. Strengthening Beneficiary Protections
9
Good Cause and Reinstatement into a Cost Plan
• Last year, CMS established rules that allowed beneficiaries
involuntarily disenrolled from MA or Part D plans for failure
to pay premiums the opportunity to establish good cause
and request reinstatement
• In this rule we are extending this right to beneficiaries
enrolled in cost plans
• As outlined in §417.460(c):
• To be eligible for reinstatement, the enrollee would have to
pay all outstanding arrearages, including premiums that
accrued during the period of disenrollment; and
• The standard for good cause would be similar to the standard
established under MA and Part D
• This regulation is applicable starting 1/1/13
10
Requiring MA Plans to Issue ID Cards
• Revises §422.111 to require plans to provide member ID cards
with specific information
• Ensures consistency of information on enrollees’ plan
membership ID cards across all MA organizations, and that
providers have easy access to information necessary to verify
coverage/process claims
• Many MA organizations issue ID cards to their enrollees but,
absent regulatory requirements, we cannot ensure that all MA
organizations issue cards to their members, or that the
information is consistent across plans and useful to enrollees and
providers
• Based on comments received on the proposed rule concerning
what kind of information should be included on the card, we will
identify specific information to be included in upcoming guidance
11
Determination of Actuarially Equivalent Creditable Prescription
Drug Coverage
• The Affordable Care Act caused two actuarial values for
standard prescription drug coverage exist –
• a value applied to applicable beneficiaries (non-LIS), and
• a value for establishing the low-income subsidy (LIS)
• This regulation aligns the actuarial value calculation we use
for purposes of determining the Part D late enrollment
penalty with the actuarial value calculation used to
determine the value of the retiree drug subsidy
• Calculation excludes the value of gap discounts or coverage
• This change will be effective 6/1/2012
12
Who May File Part D Appeals with the Independent Review
Entity
• We are amending our regulations to allow prescribers the
ability to request a Part D reconsideration from the IRE on
an enrollee’s behalf without obtaining an appointed
representative form
• This change does not give physicians or other prescribers
appeal rights, it merely allows them to file an appeal on
behalf of an enrollee
• This provision is effective 1/1/13
13
Independence of LTC Consultant Pharmacists
• We considered a change that would require LTC consultant
pharmacists to be independent of the LTC facility’s
pharmacy, pharmaceutical manufacturers or distributors or
affiliates of these entities in order to:
• Ensure that consultant pharmacists decisions are objective
and unbiased and medication recommendations are based
solely on what is in the residents’ best interests
• Address our concerns with resident health and safety
• Reduce overprescribing, unnecessary use of high price brand
name drugs and inappropriate use of antipsychotics and other
drugs generally to be avoided among older LTC residents
14
Independence of LTC Consultant Pharmacists Con’t.
• Many commenters – both supporters and opponents of the
independence requirement – noted that other agents,
including LTC facility medical directors, nurse practitioners
and physician assistants and the residents' attending
physicians, contribute to drug overutilization and
inappropriate drug use in LTC facilities
• We agree that an independence requirement solely for
consultant pharmacists would not solve overutilization,
would be highly disruptive to much of the LTC industry, and
would single out one party, but leave the others to continue
unaffected
• As a result, we are not finalizing the requirement at this time
15
Independence of LTC Consultant Pharmacists Con’t.
• We are soliciting further comment to assist us to better
define the problem and frame a more comprehensive
solution to address our concerns regarding medication
management and quality in LTC
• Specifically, we are soliciting comment related to the
following three issues:
• Enhancing medication management and the effectiveness of
medication review
• Data collection and use
• Increasing transparency
16
Independence of LTC Consultant Pharmacists Con’t.
• We strongly encourage the LTC industry in general to
voluntarily adopt changes to increase transparency
• Separate contracting for LTC consulting services from
dispensing and other pharmacy services
• Payment by LTC facilities of a fair market rate for consultant
pharmacist services
• Disclosure of any affiliations that would pose a potential
conflict of interest or the execution of an integrity agreement
• Should marked improvement in inappropriate utilization not
occur, we will use future notice and comment rulemaking to
propose requirements to address our concerns
17
Preamble Section
C. Excluding Poor Performers
18
CMS Termination of Health Care Prepayment Plans
• Strengthens our bases for terminating Health Care
Prepayment Plans (HCPPs) by clarifying and consolidating
current regulations
• Plans may be terminated if they do not substantially comply
with requirements including the following:
• Adequate access to providers (and appropriate
documentation)
• Retention of financial records related to costs payable to CMS
19
Plan Performance Ratings as a Measure of Admin. and Mgmt.
Arrangements and as a Basis for Termination or Non-Renewal
• CMS would have the option to terminate MA organization or
Part D sponsor contracts that achieve plan ratings of less
than three stars for three straight years
• Consistently low plan ratings are evidence of an
organization’s substantial failure to comply with its Medicare
contract
20
Denial of Applications Submitted by Part C and D Sponsors
with a Part Contract Termination of CMS-Initiated Non-Renewal
• CMS may include any CMS-initiated contract termination or
non-renewal executed within the previous 38 months as a
negative factor in its past contract performance when
evaluating the terminated organization’s application for a
new Medicare contract
• This period is longer than the standard 14-month look-back
for past performance assessment and reflects the dramatic
negative impact contract terminations have on the Medicare
program and beneficiaries
21
Preamble Section
D. Improving Program Efficiencies
22
Cost Contract Plan Public Notification Requirements in Cases
on Non-Renewal
• Removes the public notification requirement for nonrenewing cost contract plans, making requirements
consistent for cost, MA, and Part D plans
• Previously, non-renewing cost contract plans had to notify
enrollees individually and publish in a newspaper in the
plan’s service area notification of the non-renewal. Plans
must still notify enrollees individually of non-renewals
• We inadvertently did not apply this provision to cost plans in
our previous rulemaking removing the public notification
requirements for MA plans
23
Additional Benefit Flexibility for Certain Dual Eligible Special
Needs Plans
• Permits dual eligible special needs plans (SNPs) meeting
certain requirements to offer additional supplemental
benefits beyond those other MA plans may offer
• Facilitates integration of care, reduces need for nursing
home care, and accomplishes other dual SNP health care
goals
• Part of our effort to integrate Medicare and Medicaid
coverage services, improve patient care, and lower costs
• Qualified D-SNPs may offer the following additional
categories of supplemental benefits: Non-skilled in-home
support services; in-home food delivery; supports for
caregivers; home assessments, modifications, and assistive
devices for home safety; and adult day care services
24
Clarifying Coverage of Durable Medical Equipment
• Clarifies that plans may limit coverage of durable medical
equipment (DME) to specific brands/manufacturers as long
as plans provide all categories of DME and meet specific
beneficiary protection requirements ensuring access
• Strikes a balance between flexibility for plans and access for
enrollees
• Based on public comments on the proposed rule, the
provision ensures that DME items which must be tailored to
individuals may only be limited based on
brand/manufacturer if certain conditions are met (please see
the 2013 Call Letter for additional information). We will
update the list of such items annually. For 2013, the list of
such items includes: speech-generating devices, oxygen,
wheelchairs, powered mattress systems, and diabetic
supplies
25
Broker and Agent Requirements
• Permits MA plans and Part D sponsors to select
compensation amounts for agents/brokers that are at or
below the fair market value rates CMS sets each year
• Each year plans must report to CMS if they are using
independent broker/agents and the amounts they will pay
their brokers/agents
26
Establishment and Application of Daily Cost-Sharing Rate
• Beginning January 1, 2014, Medicare Part D sponsors must
apply a daily cost-sharing rate to prescriptions for less than
a month’s supply (unless an exception applies due to the
type of drug involved), and in the case of a monthly
copayment, multiply it by the days supply actually dispensed
• Taking advantage of a daily cost-sharing requirement is
voluntary for the beneficiary in consultation with the
prescriber or pharmacist
• Designed to reduce a significant portion of the current costs
of discontinued chronic medications by incentivizing
beneficiaries to ask their prescribers for less than a month’s
supply when prescribed an initial fill of a chronic medication
with higher cost-sharing (e.g., a “trial fill”)
27
Establishment and Application of Daily Cost-Sharing Rate
Con’t.
• An additional benefit is facilitating the synchronization of
prescriptions for beneficiaries through reduced-cost-sharing,
as well as the reduction of unused drugs
• Estimate of the potential savings to the Part D program are
$150 million in 2013/$1.8 billion total by 2018 and takes into
account additional dispensing fees, how many beneficiaries
will request trial fills, and average days supply
28
Preamble Section
E. Clarifying Program Requirements
29
Extending MA and Part D Program Disclosure Requirements to
Section 1876 cost Contract Plans
• Ensures that cost contract plans disclose to beneficiaries at
the time of enrollment and annually, thereafter, detailed
information about plan benefits, service area, and other plan
information via the ANOC/EOC
• This is consistent with previous rulemaking in which we
extended the MA and Part D marketing requirements to cost
contract plans
30
Clarification of, and Extension to Local Preferred Provider
Plans, of RPPO Plan Single Deductible Requirements
• Extends the RPPO single deductible requirements to
LPPOs, thus leveling the playing field between RPPOs and
LPPOs and increasing transparency to beneficiaries
• Provides that, if an RPPO or LPPO elects to have a
deductible, the deductible applies to both in and out-ofnetwork covered services with the exception of in-network
zero cost sharing Medicare preventive services. However,
the PPO has the option to exclude any or all Part A and B innetwork services from the deductible requirement
• Clarifies that there may be no deductible for preventive
services
31
Application Requirements for Special Needs Plans
• Provides CMS authority to deny SNP applications based on
failure to meet the following existing requirements:
implementation of an evidence-based model of care;
evidence of a contract with State Medicaid agencies in the
State(s) in which the SNP operates; and operation of a
quality improvement program
• Provides SNPs with appeal rights during the application
cycle
32
Clarification of Contract Requirements for First Tier and
Downstream Entities
• This provision clarifies the existing requirement that MAOs
and Part D sponsors include language in all contracts with
first tier and downstream entities that makes explicit their
obligations to the MAOs and Part D sponsors with respect to
the performance of Medicare-related functions
33
Valid Prescriptions
• Codifies long-standing policy that drugs cannot be eligible
for Part D coverage unless they are dispensed upon
prescriptions that are valid under applicable State law
• Does not in any way preempt existing State requirements or
create new Federal requirements
34
Medication Therapy Management comprehensive Medication
Reviews and Beneficiaries in LTC Settings
• We clarified the requirements for MTM programs to offer
CMRs to all targeted beneficiaries, including in LTC settings
• The annual CMR must include an interactive, person-toperson, or telehealth consultation performed by a
pharmacist or other qualified provider with a written
summary in CMS’ standardized format
• In the event the beneficiary is unable to accept the offer to
participate in the CMR (cognitively impaired), the MTM
provider is encouraged to reach out to the beneficiary's
prescriber, caregiver, or other authorized individual to take
part in the beneficiary's CMR
35
Employer Group Waiver Plans Requirement to Follow All Part D
Rules Not Explicitly Waived
• Underscores that, even though CMS waives benefit
package review, all EGWPs must meet all other Part D
requirements unless explicitly waived or modified by CMS
36
Access to Covered Part D Drugs Through Use of Standardized
Technology and National Provider Identifiers
• Beginning January 1, 2013, all Medicare Part D PDEs must
contain an active and valid individual prescriber NPIs
• Sponsors will be required to ensure that the lack of an active
and valid individual prescriber NPI on a network pharmacy
claim does not unreasonably delay a beneficiary's access to
a covered Part D drug (e.g., generally not more than 24
hours)
• Sponsors will be required engage in point-of-sale NPI
validation communication with pharmacies, and if this
communication does not produce an active and valid NPI,
sponsors will be required to pay the claim anyway
37
Access to Covered Part D Drugs Through Use of Standardized
Technology and NPI Con’t.
• If an active and valid NPI cannot be obtained
retrospectively, sponsors will not be able to submit the PDE
to CMS, and will only be able to recoup payment from a
network pharmacy if the sponsor has engaged in the POS
communication
• Vast majority of prescribers have NPIs, they can also be
obtain voluntarily, and options are being explored to require
them for those few prescribers who do not voluntarily do so
• Medicare beneficiaries do not have to know their
prescriber’s NPI to be reimbursed for a claim
38