Transcript Medicare Part D: Critical Updates for Infusion Providers A

Medicare Part D: Critical
Updates for Infusion Providers
A National Home Infusion Association
Audioconference
Sponsored by Innovatix, LLC
March 16, 2005
12:00noon -1:30pm EST
Presenters
• Lorrie Kline Kaplan
NHIA Executive Director
• Bruce Rodman
NHIA Director of Health Information Policy
• Alan Parver
Counsel to NHIA , Powell Goldstein LLP
• Dan Boston
Exec. VP & Partner, Health Policy Source
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Medicare Part D: Two pathways
of activity right now for
our community
• Aggressive advocacy: FIX THE PROBLEMS
• Work with CMS, Congress, the Administration, Part D,
and MA plans
• Education and information on the benefit as written
• Prepare providers to make sound business decisions
regarding participation in the program
• Assist Part D plans in understanding distinct issues
associated with home infusion
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Medicare Part D: Positive
Components for Home Infusion
• “Only specialized infusion pharmacies can
provide home infusion therapies”
• Part D plans must demonstrate that they provide
access to home infusion pharmacies
• Part D plans can establish distinct quality
standards for home infusion drugs for the
protection of beneficiaries
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Medicare Part D: Positive
Components for Home Infusion
• Part D plans can negotiate different
dispensing fees or drug reimbursement
to reflect increased costs of providing
infusion therapies
• Significant problems remain for home
infusion—no precedent for most aspects
of the plan
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Home Infusion Under
Part D
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Part D Prescription Drug Plans
• Two Types Of Plans Available:
– Stand-Alone Coverage Of Part D Drugs
• a/k/a Prescription Drug Plans (PDPs)
• Standard Coverage Or Actuarial Equivalent
– Most Medicare Advantage (Part C) Plans
Must Offer Part D Benefit To Members
• a/k/a Medicare Advantage – Prescription Drug
Plans (MA-PD Plans)
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Part D Plans
• Plans compete based on premiums and
negotiated drug prices
• At least 2 plans per region (34 regions)
– At least 1 must be a stand-alone PDP
• No limit on number of approved plans
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Standard Benefit 2006
Total Spending
$250
$2250
75% Plan Pays
$5100
Coverage Gap
(“Donut Hole”
$+
Deductible
≈ 95%
Total Beneficiary
Out-Of-Pocket
$250
25% Coinsurance
$750
Beneficiary Liability
$3600 TrOOP
Direct Subsidy/
Beneficiary Premium
15% Plan Pays
5% Coinsurance
Medicare Pays Reinsurance
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Enhanced Alternative Benefits
• Part D benefits beyond basic or
standard coverage; can be offered by
enhanced alternative plans in 2 forms
1) Reduced cost-sharing (reduced premiums,
coinsurance/ copays, and/or deductibles
and/or an increase in the initial coverage limit)
2) Coverage of non-Part D drugs
3) Coverage of supplies, equipment, services for
home infusion
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MA-PD Issues/Considerations
• Home infusion is part of the medical benefit
for most Medicare managed care (MA) plans
• How does Part D affect current programs?
• Will home infusion drugs be subject to donut
hole?
– Standard benefit –likely
– Enhanced alternative—not necessarily
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Low Income Subsidies
• Who is eligible?
– Medicare-Medicaid dual-eligibles
– Part D enrollees with income < 135% FPL
• Up to $12,569 (2004) and assets <$6,000 for
individuals
– Part D enrollees with incomes 135-150% FPL
• $12,569 -$13,965 (2004) and assets <$10,000
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Special Issues for Medicaid and
Low-Income Enrollees
• Dual-eligibles
– Auto-enrollment
– Medicaid will no longer cover drugs for dualeligibles
• Major concerns for long-term care
providers or others with high Medicaid %
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Home Infusion Coverage: Generally Stated
Home Infusion
Product or service
Medicare Patient
with Stand-Alone
PDP Plan
Medicare Advantage
Patient with MA-PD
Prescription Drugs
Yes + dispensing fee
Yes + dispensing fee
Equipment and
Supplies
No
Potentially by the MA
plan (in per diem)
Home nurse visits
No (Part A covers if
home bound)
Potentially by the MA
plan (or Part A)
Professional Pharmacy Yes: if directly related to
Services
drug dispensing
No: ongoing care
between drug dispensing
Yes: if directly related to
drug dispensing, or
Potentially all paid by MA
plan (in per diem)
Care Coordination
No
Potentially by the MA
plan (in per diem)
MTMP
Potentially:
--Is patient eligible?
--Do you provide?
Potentially:
--Is patient eligible?
--Do you provide?
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Home Infusion Coverage: Details
• Not covered:
– Enteral nutrition
– Vitamins and minerals added to TPN
– Heparin when used for flushing
– Out of formulary without grant of “exception”
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Home Infusion Coverage:
Parts A/B vs. Part D
• A drug coverable under Parts A or B as
prescribed, administered and dispensed to
the patient cannot be paid under Part D
– Example: If meets DMERC coverage policy,
cannot be covered by Part D. Otherwise, it can
be covered*
– Example: If meets Part B Carrier coverage
policy for physician AIC, can be covered by Part
D if administered in home*
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*Formulary restrictions apply
Coverage: The Dispensing Fee
• According to CMS, payment can include
compensation for “reasonable pharmacy costs”,
including costs of:
– Compounding
– Pharmacist’s time in verifying patient information
– Performing QA activities associated with preparing
the drug
– Professional services, such as patient counseling, if
related to QA activities or to satisfy state pharmacy
practice standards
– Overhead associated with the facility and equipment
– Home delivery
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Coverage: Dispensing Fee (2)
• Different dispensing fee could be established for
home infusion pharmacies vs. retail pharmacies
• PDPs and MA-PDs not supposed to reimburse
in the dispensing fee for:
– Equipment and supplies
– Care coordination
– Professional pharmacy services unrelated to
dispensing nor compensated through MTMP
– Nursing visits
• However…
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Coverage: What About Rates?
• Concept of Part D: market forces set rates
– No Medicare fee schedules or allowances
• Drug payment is negotiable
– Does not have to be ASP-based
• Dispensing fee is negotiable
• Both rates must be sufficient to ensure access
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No Secondary Coverage?
• CMS: “Enrollees will have access to home infusion
services, though they may have to pay for supplies,
equipment, and professional services out-of-pocket
particularly if they are enrolled in a Part D plan –
especially a standalone PDP—and have no source of
supplemental coverage”
• If you participate, must you accept all patients?
– Probably a contractual issue
• Are these patients “appropriate for home infusion”?
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Your Costs for Coordination of
Benefits (COB)
• Patients may have secondary coverage for the drug
and Part D plans must coordinate with:
–
–
–
–
–
–
–
–
–
State Pharmaceutical Assistance Programs (SPAPs)
Medicaid programs (including 1115 waiver programs)
Group health plans
FEHBP plans
TRICARE and VA
Indian Health Service (IHS)
Rural Health Centers
Federally Qualified Health Centers
Other entities as CMS determines
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Your Costs for COB (2)
• Patients may have secondary coverage for
non-drug products and services:
– Medicare Advantage plan
– Medicaid programs
– Group health plans (retiree)
– FEHBP plans
– TRICARE and VA
– IHS
– Etc.
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Your Costs for COB (3)
• All Medicare secondary payer rules apply
• The TrOOP
– True-Out-Of-Pocket costs = $3,600/yr.
– Part of the statute
• After 2006, increases by annual % increase in
per capita Part D drug expenditure
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Standard Benefit 2006
Total Spending
$250
$2250
$5100
75% Plan Pays
Coverage Gap
$+
Deductible
≈ 95%
Total Beneficiary
Out-Of-Pocket
$250
25% Coinsurance
$750
Beneficiary Liability
$3600 TrOOP
Direct Subsidy/
Beneficiary Premium
15% Plan Pays
5% Coinsurance
Medicare Pays Reinsurance
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Your Costs for COB (4)
• Adding to complexity even for retail:
– Secondary and MSP coverage
– Co-pay % and donut hole depends on TrOOP
– CMS to online automate/adjudicate secondary
payments at point-of-sale & report to Part D plan
– How much secondary online adjudication
occurs now in retail?
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Your Costs for COB (5)
• Adjustments/recoups given updated status to Part D plan
of beneficiary status within TrOOP
• $3,600 to collect if patient is over indigent thresholds
• Demonstrating to secondary that you did not get
complete Part D payment because:
– Deductible, co-pay (25%, 5% or whatever), or donut hole
– Necessary drugs/vitamins not paid for, e.g. heparin for flush
– Equipment, supplies, nurse visits, professional pharmacy
services, care coordination not covered and unlikely you can bill
them to demonstrate a denial EOB
• Likely to be even worse than current DMERC denial situation!
• How will secondary payers understand all of this to
correctly pay your claims?
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Insurance Verification Becomes
Even More Critical and Complex
• You must check for Part D coverage (standard or
otherwise), wrap-around, and other coverage
• You must be experts at what is coverable under Part B
vs. Part D vs. other secondary
• You must know what is fully or nearly covered for
Medicaid and indigent patients
• ALERT: On 1/1/06, dual-eligibles switch to Part D
– No drug coverage if you aren’t in the dual eligibles Part D
plan network
– Transfer them or sign up for Part D is your choice
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Claiming and Coding:
NHIA Advocacy
• NHIA has fought long and hard for home IV claiming
simplification via:
– Standardized coding of charge lines on claims
– Single consolidated claims include charges for services, supplies,
equip and drugs to single primary payer
NOT “SPLIT BILLING”
– Electronic claiming as path to faster adjudication
– X12N 837 professional claiming for your professional medical practice
of home infusion
– Coverage by medical benefit as has been predominant in
private/Medicare for 15+ yrs (drugs and all else)
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Claiming and Coding: Achievements
• HCPCS per diem S-codes now the standard for
submitting claims to private payers
• Infusion providers are lowering DSOs through X12N
837 electronic claiming
• CMS recognized since early 2003 that home
infusion isn’t retail pharmacy:
– Retail NCPDP claim doesn’t meet home IV claiming
requirements
– X12N 837 required per HIPAA for home IV
• 1/14/05: HHS Secretary letter affirms 837 for home
IV (posted on www.nhianet.org)
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Claiming and Coding: Part D Rule
• CMS again recognizes differences and
distinguishes between retail vs. home infusion
pharmacies in Part D final rule
• CMS requires Part D plans to comply with HIPAA
regulations (Part D Rule: 423.50)
– This means home IV claims to PDPs and MA-PDs
should be submitted via X12N 837
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Claiming and Coding: Issues
• The benefit is structured by CMS as primarily a
retail prescription drug benefit
• Accurate calculation of co-pays at point of sale
(TrOOP) requires on-line adjudication
• Online adjudication is fundamental and NCPDP is
assumed
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Part D Networks Must Include
Home Infusion Pharmacies
• Part D plans must “provide adequate
access to home infusion pharmacies”
• No requirement for specialty pharmacies
that do not provide home infusion services
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Part D Pharmacy Networks
• CMS deadline to Part D plans to demonstrate they
have home infusion networks in place: August 1
• PDPs and MA-PDs can negotiate separate
contractual terms for infusion pharmacies
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Any Willing Pharmacy
• Any willing pharmacy requirements apply
to home infusion
• BUT: MA-PD plans that own and operate
their own pharmacies can apply to waive
any willing provider if they can meet
access standards
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Formularies
• Part D plans may submit their own
classification system for CMS review, or…
• Use USP model guidelines (146 classes)
• CMS will evaluate to ensure access to
medically necessary drugs and no
discrimination against any beneficiary groups
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Formularies (2)
• At least 2 drugs per class
• Some classes broad2 covered drugs will
be inadequate
• Example: USP category 118,“immunologic
agents” includes
– immune suppressants
– Immune stimulants
– Immunomodulators
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Formularies:
Considerations for Part D Plans
•
NHIA recommends open formulary for home
infusion
–
Rarely if ever used in private sector
•
Pharmacists and other home infusion professionals
should be on the P&T cmttee
•
Decisions should reflect other clinical and cost
factors
–
Patient factors, supplies, drug delivery device, VAD, dosing schedule,
nursing considerations
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Formularies: Considerations for
Part D Plans (2)
• Home infusion patients require additional
protections
• Patients often need to continue the drug initiated
in inpatient (or other) stay
• Need an efficient exceptions process
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Part D Plan Use of Mail-Order
• Part D plans can “encourage” enrollees to
use mail-order—but can’t require it
• Differential co-pays for preferred vs. nonpreferred pharmacies
• CMS cannot intervene
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Quality Standards
• Primarily based on state pharmacy practice act
• Part D plans can establish additional quality
standards for home infusion pharmacies
– Many state laws are not adequate
• CMS “encourages plans and their network
pharmacy providers to establish and agree
upon additional QA standards as necessary,
including those required for accreditation.”
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Quality Standards
• Private plans use accreditation to credential
providers (limited exceptions to ensure access)
– JCAHO, ACHC, CHAP
– An assessment of the entire patient care process
• Quality standards coming for Part B home IV
suppliers, to be implemented by accreditors
• Accredited providers cannot provide a lower
standard of care for Part D patients
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Medication Therapy Management
• Designed to optimize therapeutic outcomes for
“targeted beneficiaries” by improving medication
use, reducing adverse drug events
• Furnished by pharmacist or other qualified
provider (i.e., physician, PBM, etc.)
• Fees must reflect time and resources required to
implement program
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MTM (2)
• Targeted beneficiaries:
– Multiple diseases
+
– Multiple drugs
+
– Cost threshold (Likely to incur)
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Important Part D Dates
Plan Notice of Intent
February 18, 2005
Plans Apply
March 23, 2005
Plans Submit Formulary
Plans Submit Bid
April 18, 2005
June 6, 2005
Plans Submit Home IV
Pharmacy Network to CMS
August 1, 2005
CMS awards bids
September 2, 2005
Plans start marketing to
beneficiaries
Open enrollment for 2006
October 1
Nov. 15, 2005 - May 15, 2006
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NHIA Advocacy Areas
• A lost opportunity for Medicare cost-savings
• Fix Part D or find a more appropriate benefit
• Cover the required services, supplies,
equipment
– Drug-only coverage not meaningful!
– New home IVIG benefit is a perfect example
• Adopt prevailing quality standards
• Educate plans on home infusion under Part D
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NHIA Advocacy Activities
• Grassroots campaign
– Letter writing, key member contacts, fly-ins
• NHIA Legislative Defense Fund ensures
vigorous representation for NHIA members
(legislative and regulatory)
• Per Diem Cost Study with Abt Associates
– July 2005 completion date
– Contact us for more information
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Legislative Outlook
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Summary and Wrap-up
• Plans submit infusion networks to CMS Aug. 1
• Providers must each make an individual business
decision whether to participate
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–
–
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Impact on Medicare managed care, Medicaid, retirees
Accreditation issues
Complex coordination of benefits
Services, supplies, and equipment for those w/no
secondary
– Risk and liability—professional and financial
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An Ongoing Process for All of Us
• Stay Up-to-Date!!
– NHIA members-only Part D resource page
• Join NHIA if you haven’t already—we need your
support!
• Support the NHIA LDF
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• Send questions to [email protected]
• Join: www.nhianet.org
• Support Legislative Defense Fund:
www.nhianet.org
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Thank you
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