Title: The Emerging Market in Medicare Part D and Sponsor Compliance Strategies A Presentation to the Pharm
1The Emerging Market in Medicare Part D and
Sponsor Compliance Strategies A Presentation to
the Pharmaceutical Compliance CongressNovember
8, 2005
- John Gorman
- President/CEO
- Gorman Health Group, LLC
- 2176 Wisconsin Avenue, NW
- Washington, DC 20007
- (202) 364-8283
- Fax (202) 244-8324
- www.gormanhealthgroup.com
2Todays Agenda
- The Emerging Market in Medicare Part D
- Medicare Advantage Local and Regional Outlook
- Prescription Drug Plans (PDPs)
- Employers and Retiree Groups
- Medicare Fraud, Waste and Abuse (FWA) Issues and
Sanctions - Compliance and FWA Elements
- Medicare Prescription Drug Integrity Contractors
- (MEDICs) and Their Role
- Part D Plan Sponsor FWA Exposure
- PBM Integrity
- Subcontractor Oversight
- Keys to Minimizing Exposure
- Conclusions
3New Medicare Part DBeneficiaries Will Have
Several Coverage Options
Medicare Options
- Regional Options
- Blended benchmark
- Stabilization fund
- Risk Corridors
Prescription Drug-only Plan (PDP)/ FFS Add-On
Must offer benefits equivalent to standard
coverage
Medicare Advantage PPO Option
Medicare Advantage HMO Option
Must offer benefits equivalent to standard
coverage on at least one plan in portfolio
Local (county-based) Options
Medicare Advantage PPO Option
Special Needs Plan (SNP) Option
Other Options
If insufficient number of PDPs or PPOs emerge in
the market
Must offer benefits equivalent to standard
coverage to receive subsidy
Limited Risk or Fallback Drug-Only Plan
Qualified Employer Plan
4Medicare Risk Contracts1985 to 2005
Source CMS, October 2005. Note 570 PDPs will
launch on January 1, 2006.
5Convergence of Health Policy Factors Create
Opportunities for SNPs
Lock-In Exemptions
SNPs
Medicaid Reform
Part D Auto-Enroll of Duals
Risk Adjustment
6Regional PPO Sponsors and Revenue vs. Cost
Region 1 118.7
Region 2 107.7
Region 3 111.1
Region 23 119.6
Region 19 116.0
Region 11 110.3
HUM
UHC
NPA
HUM
Region 22 111.6
Region 6 114.0
Region 12 114.7
Region 4 106.2
Region 14 110.9
WLP
HUM
HUM
WLP
AET
WLP
SIE
HUM
Region 24 108.6
Region 5 107.7
Region 15 111.9
Region 7 119.9
Region 13 112.4
Region 18 110.0
Region 20 117.7
Region 21 117.9
AET
HUM
HUM
Region 10 111.7
HUM
Region 8 114.3
HUM
HUM
HNT
HUM
Region 16 110.4
Region 17 111.0
BSC
Region 9 109.7
HUM
Region 26 110.8
HUM
UHC
HUM
Region 25 139.9
UHC
Source GHG analysis adapted from CMS 2005 MA
Payment Rates and 99 FFS Cost Files, January
2005.
7Competitive Landscape for PDPs -- 2006
8Impact of Dual Assignments on PDPs
Source Lehman Brothers and GHG Analysis,
September 2005.
9PDPs to Watch
Source company reports
10Part D Final Benchmarks for 2006
11Summary
- The minimum number of plans participating in any
of the regions is 11 (Region 34, Alaska). - The maximum amount of plans participating is 20
plans (NY, TX, OR/WA). - In 37 states 100 of Medicare eligibles will have
access to a PPO plan. - The number of auto-assigned beneficiaries per
organization in a given region will range from as
low as 2,000 to the 6 plans in Alaska to as high
as 133,000 individuals in the 7 plans in
California.
12Part D Projections 2006
- GHG expects in 2006
- 112B in revenues generated for private plans (up
from 51B in 2005) 38 (42B) through PDPs - 900,000 new beneficiaries in MA products (5.8M in
2005) - 14.3M in PDPs (including duals and low-income)
- Therefore, over 21M beneficiaries in some form of
managed care in 2006
13Strategies Employers Are Likely to Pursue in 2006
14Retiree Health Benefits Two Choices for Employers
- For 2006, Expect Most Employers to Choose RDS but
some may prefer Part D - Actuarial Equivalence - employer plan may not
qualify for the RDS - Part D offers higher subsidies, especially for
employers with low utilization - Tax status - governmental entities or nonprofits
do not realize the tax benefits of RDS - Retirees already in MA plans
- LIS may be better off in Part D
- Administrative Part D plans handle
administration and financial risk
15Retiree Health Benefits Two Choices for Employers
- For 2007 and Beyond, expect a shift to Part D
- Market will be known
- Financial benefits of Part D will be clearer
- Time to submit Part D applications
- Fewer employers will qualify for the RDS, e.g.
percent of plans meeting cap
16Employer Options for Retiree Drug Coverage
17Impacts of Retiree Drug Coverage Options
18Impact of Likely Employer Strategies -- 2006
- 77 of retirees likely to be in plans that
continue drug benefit coverage and accept the 28
subsidy - 6 of retirees likely to be in plans that
supplement Medicare drug coverage - 4 of retirees likely to be in plans that
discontinue drug coverage - 13 of retirees in plans that do not yet know
their strategy or had a different strategy
Source Kaiser/Hewitt Survey, December 2004.
19Privatization of the Drug Market
Total U.S. Drug Spending
After Medicare Drug Benefit
Before Medicare Drug Benefit
Consumer Out-of-Pocket 18
Consumer Out-of-Pocket 30
Private Health Insurance 48
Medicaid, Other Public 12
Private Health Insurance 70
Medicaid, Other Public 22
Sources CMS, National Health Spending, 2002
and CBO, Issues in Designing a Prescription Drug
Benefit for Medicare, Oct, 2002.
20Compliance Strategies for Part D Sponsors
21Government Oversight Structures
- CMS Part C D Monitoring Programs
- 2-3 year on-site, regularly - scheduled audit
cycle, depending on risk assessment for MA plans
(3 years for PD plan) - Focused/targeted desk and on-site audits,
depending on risk assessment - MEDICS Monitor and evaluate data and trends to
identify potential fraud, abuse, and waste in the
Medicare Part D Program. - Receive reports from contractors and
beneficiaries - Develop and refer cases to the appropriate Law
Enforcement (LE) Agency or to CMS for
administrative action as necessary - Inspector General
- Civil Money penalties
- Exclusion
- Department of Justice
- Civil and Criminal Prosecution
22Medicare Part D Compliance Plan Required Elements
- 7 Required Elements of a Part D Compliance
Program - Written policies, procedures and standards of
conduct regarding compliance with all applicable
Federal and State standards - Compliance Officer and Committee accountable to
senior management - Effective training programs for employees,
contractors, agents and directors - Effective lines of communication
- Enforcement through well-publicized disciplinary
guidelines - Effective internal monitoring and auditing
- Prompt response to detected offenses (e.g.
payment or delivery of drugs) and development of
corrective action initiatives (e.g. repayment of
overpayments and disciplinary actions) - Comprehensive Fraud and Abuse Program
- Detect, correct, and prevent fraud, waste, and
abuse - Voluntary self-reporting of potential fraud or
misconduct - Separate plan or integrate with the other 7
compliance plan elements
23Medicare Compliance and FWA Risks
- Standard Part C Compliance Tests that will Apply
to Part D Sponsors - Fails to provide medically necessary services, if
adverse effect - Imposes excess charges on enrollees
- Discourages enrollment due to health status
- Misrepresents or Falsifies information
- Employs or contracts with excluded individuals
and entities - Substantially fails to carry out the contract,
inefficient administration of the contract, or no
longer substantially meets the contract
requirements
24Medicare Compliance and FWA Risks
- Administrative Sanctions
- Contract Termination
- Intermediate Sanctions (Suspension of enrollment
and payment) - Exclusion from all Federal Programs
- Civil Monetary Penalties
- 25,000 for each failure to provide medically
necessary services, health screening or
falsification of information to the Secretary - 25,000 for each determination of failure to
carry out the contract if adverse effect
25Medicare Compliance and FWA Risks
- Criminal Penalties (felony conviction and up to 5
year imprisonment) - Knowing and willful false statement or
misrepresentation of fact in application for
benefit or payment under a federal health care
program - Knowing and willful kickback, bribe or rebate to
inappropriately secure federal funds -
- False Claims (Whistleblowers) Act
- Signature acknowledging that information is being
submitted for purposes of obtaining Federal funds
triggers the FCA - FCA prohibits false or fraudulent claims
- Treble damages and up to 11,000 per claim
- Whistleblowers receive up to 30 of the recovery
- Liability extends to those who submit the false
claim and those who cause the submission of the
false claim - Intent to defraud is not required mistake or
negligence with system wide effects sufficient
26MEDIC Part D - Data Analysis
- Utilization Management
- Medication Adherence and Persistence
- Quality Assurance
- Performance Measures
- Coverage Determination
- Long Term Care (LTC) - Pharmacy Access
- Complaint Tracking
27CMS Data Collection Management Information
Integrated Repository
- Performance Assessment
- Data mining and standard reports will be used to
inform CMS of Plans performance under Part D - Standard Required Reports
- PDE data (claims data)
- Eligibility data
- Complaint data (CTM)
- Plan-reported data (HPMS)
- Plan-finder data
28MEDICS Role In CMS Compliance and FWA Review
Audit CMS Defense against the Mississippi
River of Dollars
- IDIQ Contract (Indefinite Delivery Indefinite
Quantity Solicitation) - Of the 21 Examples of General Fraud, Waste and
Abuse in the MEDIC Statement of Work, 15 were
targeted toward PBM or pharmacy related issues
and business practices 6 were Beneficiary fraud
issues - PBMs and Part D Sponsors will be at risk for the
acts of their downstream pharmacy contractors for
false claim submission - Of the 12 Examples of potential Financial Fraud,
all 12 will impact PBMs - Effective cost allocation systems critical for
administrative services - Rebate contracts will be under scrutiny
29General Fraud and Abuse Issues
- Misrepresenting the enrollment, encounter, or
prescription drug event data - Improper reporting of prescriptions dispensed to
maximize payments. - Billing for services not furnished and/or drugs
not provided. - Billing that appears to be a deliberate
application for duplicate payment - Soliciting, offering, or receiving a kickback,
bribe, or rebate - Billing based on gang visits
- Billing non-covered prescriptions as covered
items - Billing under Part A or Part B, and also under
Part D
30General Fraud and Abuse Issues (Continued)
- Dispensing without a prescription
- Billing for recycled prescription drugs
- Submitting false Medicare claims
- Receiving duplicative co-pays or premiums from
beneficiaries - Billing for brand when generics are dispensed
- Altering scripts or data to obtain a higher
payment amount - Misrepresentations of dates, descriptions of
prescriptions or services
31MEDICS Role In CMS Compliance and FWA Review
Audit CMS Defense against the Mississippi
River of Dollars
- 8 MEDICs selected
- NDCHealth
- Delmarva Foundation for Medical Care
- Electronic Data Systems (EDS)
- IntegriGuard
- Livanta
- Maximus Federal Services
- Perot Systems Government Services
- Science Applications International Corporation
(SAIC)
32MEDICS Role In CMS Compliance and FWA Review
Audit CMS Defense against the Mississippi
River of Dollars
- MEDICs Responsibilities include
- Review Part D and RDS plan compliance data to
detect fraud - Review bids and FWA components of compliance
plans - Coordinate with law officials
- Conduct investigations, including audits of PDPs
and sub-contractors - MEDICs will annually audit at least 1/3 of PDP
and MA plans - Risk Based Audit Strategy conduct more
investigation and analysis with unusual billing
patterns
33MEDICS Role In CMS Compliance and FWA Review
Audit CMS Defense against the Mississippi
River of Dollars
- MEDICs Responsibilities (contd)
- Review improper enrollment and eligibility
- Review improper marketing and distribution
- Audit RDS sponsors, including RDS eligibility and
claims review - Conduct Part D, MA and RDS complaint
investigations
34MEDIC Audit Target Drivers
- Near Term
- Beneficiary Complaint Data (e.g. sales
misrepresentation) - Past PBM issues identified in legal proceedings
will be focus of audit - Areas where there are questions of transparency
- Eligibility and Claims Data audits for Retiree
Drug Subsidy - Longer Term
- PDE data and comparisons with other Medicare
Claims Data - Whistleblowers
- Routine on-site audit reviews (P T, FWA
implementation etc.)
35MEDIC Audit Target Drivers
- The Good News on MEDICS
- All New to Medicare Part D
- First Timers or with Some Experience
- Data will take time to gather ? But get it right
from the start
36General Keys To Avoiding the Inspector General
- Listen to the Noise surrounding Part D
- Identify potential CMS or Congressional hot
button issues and address them e.g.
Beneficiaries can find appropriate education
materials - Avoid Misinterpretation of Part D Requirements
Ever watchful for changing CMS regulation or
guidance - Pay attention to past industry criticisms, jibes
and legal proceedings and develop policies and
oversight in the areas of concern - Assess and audit current business and operational
practices at a granular level to identify areas
of exposure or lack of controls - Require process by process policy review and
standards and FWA monitoring requirements - Ensure documentation of procedures and process
descriptions - Ensure diligence in systems configuration
auditing to catch errors prior to submission
37Further Keys To Avoiding the Inspector General
- Implement granular financial auditing, process
controls, monitoring - Use central tracking system for all internal FWA
control reporting - Establish routine monitoring and audits of
operations - Review appropriate staffing for internal auditors
- Review staffing, scope and frequency of pharmacy
audit - Monitor Enrollee grievance and appeals activity
- Enrollees who dont get things trigger
problems - Early Warning System
- Develop corrective action plans
- Establish processes for self-reporting of
potential FWA - Encourage / Incent Internal FWA issue
identification referrals - Make the FWA department well known
- Thorough training at all levels
38Part D Compliance FWA Exposure - Overview
- 5 Critical Areas for a Part D Plan Sponsor
- Part D Specific Requirements Audits in areas
such as TrOOP, Copay application, COB, PDE data,
formulary changes, etc. - PBM Integrity Major PBMs are high profile
candidates for FWA audits in areas like pricing,
rebates, benefit adjudication, etc. - Subcontractor Oversight and FWA Issues Retail
pharmacies, LTC pharmacies (Part A/D), enrollment
contractor etc. - Beneficiary-Prescriber FWA Identification and
Management Identifying and managing these
issues - Sales Misrepresentation and Fraud- a new issue
for PDP Sponsors and a common CMS target and
reason for sanction based on complaints
39Part D Compliance FWA Exposure - Overview
- For Each 5 Critical Areas, Part D Plan Sponsors
should develop - Tracking and Reporting mechanisms to report to
CMS and the MEDICS - Audit and Monitoring Strategies with designated
Resources - On-Site or Desk Audit
- Conducted by the Part D plan sponsor, the PBM, or
Audit organization - Corrective Action strategies
- Training
- Self-reporting of suspected FWA
40Part D Specific Requirements - FWA Touch Points
- Enrollment Accuracy LIS, Duals, Late Penalty,
Proper Effective Dates - Beneficiary Billing Accuracy
- Direct bill vs. SSA
- Proper Refunds to Beneficiaries, Charities
- Premiums, cost sharing and accounting
- Reconciliations
- General Administrative Cost Allocations
- Specific program cost allocations, e.g. MTMP
41Part D Specific Requirements - FWA Touch Points
(Continued)
- Formulary development and beneficiary
notification of formulary changes - Generic vs. Brand
- Appeals and Grievances
- Monitoring, Feedback Loops and Disciplinary
Programs - COB data collection, working with the COB
Facilitator
42Part D Specific Requirements - FWA Touch Points
(Continued)
- TrOOP accumulation
- Includes only eligible cost sharing, e.g.
includes beneficiary payments and excludes group
health plan payments - Properly includes all 6 payment fields
- Patient Pay Amount
- Other TrOOP
- Low Income Cost Sharing Subsidy Amount (LICS)
- Covered D Plan Paid Amount (CPP)
- Non-covered Plan Paid Amount, (NPP)
- Patient Liability Reduction due to Other Payer
Amount (PLRO)
43Part D Specific Requirements - FWA Touch Points
(Continued)
- PDE (Prescription Drug Event) data accuracy
- 100 claims data necessary to calculate risk
adjustment, LICS, reinsurance, and risk corridor
payments - Proper reflection of costs to be included or
excluded in each of the 4 payment calculations,
e.g. - Only Part D drugs covered under the specific plan
- Risk corridor calculations must exclude
administrative costs, patient pay amounts,
induced utilization, rebates, reinsurance subsidy - Reinsurance calculations must reflect full TrOOP
accounting - All calculations must properly account for all
rebates, discounts, and other price concessions
44 PBM Integrity FWA Touch Points
- Pharmacy Contracting, Term Application and
Disclosure - Proper Benefit Set Up And Adjudication at POS
- Eligibility Accuracy and benefit plan assignment
- Drug Pricing AWP, MAC etc.
- Claims Edit Processing Accuracy (e.g. Part A, B
and excluded drugs)
45 PBM Integrity FWA Touch Points (Continued)
- Mail Order Prescription Fills
- Rebate Accounting and Pass Through ? Member
level detail and transparency - E-Prescribing
46Subcontractor Oversight
- Retail Pharmacy
- Monitor dispensing activity of specifically
identified retail pharmacies - Retail audit by PBM or Audit organization to
identify outlier pharmacies - Desk audit on all outlier claims to determine
- Appropriateness of RX dispensed
- Correct quantity and strength of medication
- Correct administration of benefit design and
trend management programs - Instances of potential fraud and abuse
- On Site audit of pharmacies that continue outlier
dispensing performance
47Subcontractor Oversight
- Retail Pharmacy (continued)
- Automated reporting editing systems can include
the following triggers - Dispensing volume of high profile medications
(e.g. controlled substances, medications targeted
for re-sale or addicted medications) - Significant number or percent of U C claims
- Multiple instances of reversed or altered claims
- Multiple pharmacy overrides to excluded or Prior
Authorized medications - Excessive units per day dispensing
- High dollar medications
48Subcontractor Oversight
- Retail Pharmacy (continued)
- Individual Pharmacist Audit - Based on
conclusions from the on-site audit, more focused
audits of individual pharmacists may be warranted
to review - Potential cases of trafficking
- Potential cases of fraud and abuse
- Retail Pharmacy audits also may include review
of - Disclosure of low cost generic
- Non-submission of zero-balance claims
- COB Audits Duplicate Billing
49Subcontractor Oversight
- LTC Pharmacies
- Example Determining whether LTC pharmacy filed
claims should be part of a Part A Skilled Nursing
Benefit - Proper destruction or return of drugs
- Enrollment and Premium Billing Subcontractors
- Developing appropriate metrics and audit
protocols - Insurance Subsidiaries
- Enforcing integrity downstream
- Re-insurance costs if provided by subsidiaries
- Subsidiary service pricing and cost allocations
50Beneficiary and Prescriber FWA
- New populations and schemes may require enhanced
system edits - Addressing Issues common within the Medicaid
population - Development of Beneficiary and Prescriber Fraud,
Monitoring, Investigation and Referral Unit - Divining whether Grandma Smith or her nephew
Billy is responsible for the rash of inhaler
purchases - Physician submission of claim for same drug
dispensed at retail pharmacy or by infusion
provider
51Beneficiary and Prescriber FWA
- Physician Auditing
- Identified from review of automated or ad hoc PBM
Rx Utilization and Prescriber Utilization Reports - Focused on identification of
- High volume prescribing of specific high dollar
or abuse type of medications - Volume based tracking (number of claims, total
drug spend, targeted drugs) - Review of controlled substance prescribing
patterns - Cross check of patients to eliminate critically
ill patients - Summary reports to PBM or Part D plan sponsor for
further review
52Beneficiary and Prescriber FWA
- Beneficiary Auditing
- Identified from automated PBM Reports or
desk/on-site audits - Focused review of individual patient RX
utilization focusing on - Zip code analysis of where RXs are picked up
- Potential for Grey Market second hand selling
of drugs with or without the beneficiaries
knowledge - Multiple pharmacy utilization for the same RX
- Multiple physician visits to generate same RX
53Retiree Drug Subsidy FWA
- Employer or Union Plan Sponsors are accountable
for accuracy and completeness of all information
submitted to CMS - Application includes attestation that plan
sponsor is submitting a claim to the government - May delegate major data submission to CMS to
subcontractors, but still accountable - Oversight of subcontractors, including PBMs, is
critical - While Attestations are sufficient for payment,
ultimately all data must be tracked to the
individual retiree level by employer benefit
option - Timeline Final reconciliation 15 months after
the end of the plan year - Prevention of errors and omissions essential
through monitoring and audits
54Retiree Drug Subsidy FWA
- CMS and OIG have announced that RDS audits will
be a priority - MEDICs tasked to review
- Actuarial Equivalence documentation to support
attestation that Plan Sponsor coverage is
equivalent to Part D - Accuracy of RDS Payments review actual claims
and rebate data to support RDS payment requests - Creditable Coverage Disclosures review to
assure consistent with Medicare requirements - OIG 2005 OIG workplan includes audits of CMS
controls and 2006 audits will focus on AE,
payments and CC notices
55Retiree Drug Subsidy FWA Touch Points
- Actuarial Equivalence Attestations
- Supporting documentation for the gross and net
tests - Benefit combination assumptions for net test
- Assumptions on integrated medical and drug
premiums - Subsidy Claims and Rebate Data
- Controls and monitoring to assure that only
claims for eligible costs are submitted, e.g. no
Part B or excluded drugs - Controls and monitoring to assure that complete
and accurate rebate data is submitted - Controls to assure no administrative costs are
submitted
56Retiree Drug Subsidy FWA Touch Points
- Retiree Lists
- Controls and monitoring to assure that only
validated retirees and dependents are submitted - Cross checks with CMS eligibility data
- Creditable Coverage Notifications
- Controls to assure that active workers and
retirees get notices - Documentation to support claims that coverage is
creditable for each benefit option - Controls to assure that notices for
non-creditable coverage were issued
57What Does the Future Hold?
58Part D Key Implementation Dates
59Part D Key Implementation Dates
60The Politics of the MMA
- 2005 budget reconciliation will likely include
12B in Medicare savings - Elimination of Stabilization Fund for Regional
PPOs. - Codify budget neutrality policy for risk
adjustment - Outstanding MedPAC recommendation to reduce MA
county benchmarks to 100 FFS, but no consensus
on Hill to advance. - Program appears stable for foreseeable future.
- Impact of Medicaid reform
- Greater flexibility to states
- Emphasis on Aged/Blind/Disabled into managed
care. - Underscores positioning for SNPs one-stop
shopping
612007 Strategic Considerations
- Part D sponsors will be facing contraction of
aggregate reinsurance - Part D sponsors will be ratcheting-up control
mechanisms - Step therapy, prior authorization, quantity
limits, strict formularies - Will evidence-based practices dictate preferred
drugs or tier placement in a therapeutic class?
62Immunizing for FWA
- Conduct Operations GAP Analysis
- Part D and RDS Operations Analysis
- Compliance Program Review and Assessment
- Review PBM Operations for FWA Exposure
- Monitoring and audit mechanisms and staffing
- Performance metrics Internal and External
Reports - Policies and procedures assessment and review
- Systems tests
- Contract requirements
- Management Oversight
63Immunizing for FWA
- Ongoing FWA Program Development
- Business Process Workflow Documentation
- Policy and Procedure Development
- Internal Audit Procedures and Policies
- Subcontractor oversight program development
- Data Analysis to detect beneficiary, prescriber,
pharmacy FWA - Staff and Subcontractor training
- System logic review for benefit adjudication
- Sales program FWA monitoring program development
64New Marketplace
- Expanded role of private plans growing
influence of PBMs, and of Medicare regulators on
them. - Increased information for plans, patients and
government. - Eventual price (rebate) transparency
- comparative drug information
- increased emphasis on medical evidence and
outcomes - Growing pressure on price and performance.
- PDP competition and premium pressures
- pay-for-performance for providers
- cost-effectiveness for drugs
- Expanding out of pocket costs for beneficiaries
- Increased competition
- Dozens of PDPs all majors will play
- increased incentives for generic substitution
65The Challenges
- Moving purchasers toward value-based purchasing
- Better data on outcomes and quality
- Pay for performance -- quality indicators
- Integrating disease management and MTMP
- Plan influence on provider decision-making
- Proving the market works
- Helping the PDPs and MA-PDs survive
- Encouraging accelerated movement toward
integrated health plans - Minimizing government intervention,
reference-based pricing/price controls, PDP
failure - Helping CMS become a successful purchaser (rather
than a regulator)
66How to Reach Us
Gorman Health Group, LLC (202)
364-8283 jgorman_at_gormanhealthgroup.com