Post on 15-Jan-2016
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Expanded Coverage through the Affordable
Care Act: What it Means to You and Your
Business
Integra Users SeminarJanuary 23, 2014
Leigh Davitian, JDBrad Kile, PhD
Disclosures
Brad Kile is an independent consultant and has no financial interest or relationships to disclose.
Leigh Davitian is an independent consultant and has no financial interest or relationships to disclose.
Learning Objectives
List the main implications of the Affordable Care Act (ACA) on health professionals and the patient they serve.
Compare current reimbursement models with new financial incentives for providers under the ACA.
Assess new opportunities presented by the ACA for pharmacists to diversify and expand the services provided to beneficiaries
Explain how the new Health Insurance Exchanges (HIE) impact the demand for medications.
Identify how the Centers for Medicare and Medicaid Services considers the differences between Drug Regimen Review (DRR), Medication Therapy Management (MTM), and Comprehensive Medication Review (CMR) for individuals residing in long-term care settings
Identify the impact on demand for health care services as a result of Medicaid expansion and the availability of coverage through health insurance exchanges.
Presentation Outline
Affordable Care Act Implementation What is Happening Now and Big Picture Timeline and Benchmarks
New Payment Models ACA Provisions Payment for Medications and Medication Reviews
Expanded Coverage Under the ACA Health Insurance Exchanges Medicaid Expansion Key Policies
2014 Federal Agenda
Q & A
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Affordable Care Act Implementation
What is Happening Now
Major work must be done to handle monumental shift in coverage and eligibilityCoverage Health Insurance Exchanges Target is 30 million currently lacking coverage
Eligibility Medicaid extends to 133% federal poverty level Target is 17 million currently not eligible
ACA IMPLEMENTATION
2010-13 2014 2015-2020
Regulate Coverage Restructure
Industry Expansion Care Delivery
- Insurance - Individual - Quality
Reform Mandate ties to Payment
Big Picture on ACA
Expanded coverage through Health Insurance Exchanges and Medicaid Expansion
Impact on Employers
Impact on Individuals
Impact on Health Providers Program Integrity Adapting to Change Payment Models
LINKING CARE ACROSS SETTINGS TYING PAYMENT TO QUALITY
Enforcement Efforts under ACA
Compliance Programs
For over 14 years, the Office of Inspector General (OIG) has been encouraging Medicare and Medicaid providers to “adopt voluntary” compliance programs
Affordable Care Act (ACA), compliance programs are no longer voluntary for Medicare and Medicaid providers
Specifically, Section 6401 of ACA requires healthcare providers to establish compliance and ethics programs that contain certain “core elements” as a condition of their participation in the federal healthcare programs
To date, HHS has not defined the “core elements” but should not deter providers from implementing a workable, organic compliance program For now – show a good faith effort
Mandated Compliance Program
ALL Medicare providers MUST have comprehensive compliance program in place by March 23, 2013… 10 months ago!
Vague Elements Identified
Develop and distribution of written policies, procedures and standards of conduct
Designate a chief compliance officer in charge of operating the program
Implement regular education and training program for all “germane” employees
Develop an internal audit system to identify problem areas
Develop a system to report deficiencies and problem areas
Develop a process where employees can come forward without fear of retaliation
Develop a means to quickly remedy problems in a systematic, transparent way
Some Core Elements
Develop Written Policies
Looks like a code of ethics or standards of conduct
Similar to a “mantra” that all good business’ should put into place
Best practices for one’s own company Hiring good, quality employees remains important Criminal background checks especially with those in
middle/higher management
Compliance Officer
Select An Appropriate Compliance Officer
• The designation of a chief compliance officer and other appropriate bodies should a be full-time, longer term employee(s) that understand the business OR has served in this capacity in other businesses/organizations
• Many companies use their HR or office manager as designated officer• Caveat: Be sure officer has a keen understanding for all
aspects of the business• Choose wisely!!!
Compliance Officers Duties
• Compliance Officer SHOULD be very familiar with:• All pertinent CMS regulations governing Medicare providers
conditions of participation and regulations on a state and federal level
• Coordination of Benefits• Primary insurances role• Secondary insurances role• Private payors
• False Claims Act• Anti-kickback regulations• HIPAA regulations• ACA provisions!!
TrainingRegularly review and update training programs for ALL employees who“touch” Medicare billing, coding, claims, etc
Test employees’ understanding of training topics
Maintain documentation to show which employees received training
Make sure the Board of Directors receive training Starts at the top!
Attend conferences and webinars, subscribe to publications and OIG’s email list
Monitor OIG’s website and other government resources
Some Core Elements
Some Core Elements
Lines of CommunicationHave open lines of communication between you and employees
Maintain an anonymous “ reporting method” to report issues
Retaliation is a serious for not-reporting Enforce a non-retaliation policy for employees who
report potential problems
Use surveys or other tools to get feedback on training and on the compliance program
Use newsletters or internal websites to maintain visibility with employees
Some Core Elements
Internal AuditingCreate an audit plan and re-evaluate it regularly
Identify your organization’s risk areas
Perform proactive reviews in regards to coding, billing, contracting, business associates
Identify REAL value added services that promote quality of care to customers and their end users
Create corrective action plans to fix the problem
Contracting Trends
• How long has your contract been in place?
• When did you last review your contracts?
• When did you last amend your contract?
• Do you even know where your contracts are stored?
• Are they standard template contracts?
• Are they different and customized for each customer?
• Did legal counsel write the contracts?
• Did legal counsel at least review the contracts?
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Contract Due Diligence:Know the Other Party
• Do thorough due diligence
• Have you done business with them before?• Strengths• Weaknesses• Suspicions activities
• Identify any Medicare exclusions
• Have they been in business under another name before?
• Understand your customers current financial position
• Understand your customers residents/beneficiaries current clinical needs
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Contract Due DiligenceClearly Define Services
Set clear expectations for both sides Detailed provisions Short is NOT sweet
Be thorough with your language Entire agreement in single document No side emails or discussions No “hand-shakes” No napkin provisions
Perform services only in agreement Side services can cause conflicts and misunderstandings Could lead to heighten suspicion
Don’t start services until the agreement is fully executed
Amendments need to be IN WRITING
In a Nutshell …
A compliance program must be “effective in detecting and preventing criminal, civil, and administrative violations” and “in promoting quality of care” within your business and as it pertains to Medicare, Medicaid and other government payor programs …
Audits and Investigations: How do you Respond?
Audits
Fact Pattern:
You are a health care provider and on a random Monday a man enters your place of business and introduces himself. He hands your receptionist an “official” piece of paper and insists it be delivered to the person in charge. Appears to be legal documents.
What should the receptionist do?
Who Entered your POB?
• Who is it?• Important to identify what organization person is representing• Should show identification
• Private Organizations under Contract with CMS• Program Safeguard Contractors • Recovery Audit Contractors• Zone Program Integrity Contractors• Medicare Carriers
• Federal Law Enforcement:• HHS-OIG• FBI• DOD• IRS• FDA
What Type of Document?
What type of document is being served/delivered?
• HHS-OIG Subpoena
• Search Warrant
• Request for general documentation
• Request for employee files
• Request for billing or coding information
• Request for patient information
Protocol in Place
• Do all employees know how to respond to such an occurrence?
• Does your employer have a protocol in place?• Covered in the companies compliance program• Written policy distributed to all employees
• Phone tree Owner/Chief Executive Officer Office Manager Compliance Officer General Counsel
• Do you have rights NOT to respond?
In a Nutshell:Protocol in Place
Point of contact person Employee in authority Knows your business operations
Want to limit amount of persons interacting with law enforcement or agency
Want to show “deference” to the process but privileges are in place to protect employees Sixth Amendment – Right to Counsel
Government has a right to talk to your employees NEVER tell employees to NOT talk or interact
Want to put policies in place to control the situation
Can One be Proactive in this “Complicated”
Environment?
Provider Status: Reality or Fiction
Question:
Why are Pharmacists NOT Bona Fide Health care providers?
Why Pharmacist Profession DID NOT want to be Bona Fide Providers
Lack of confidence to consultant “patients”
Exposure to malpractice Liability for improper information shared with “patient”
Malpractice insurance costs
Lack of time to consultant “patients”
Lack of ability to dispense volume of inventory if time is needed to consult Profession attached to product NOT professional
services
Lack of ability to meet financial demands
That was then; This is NOW
Role of pharmacists has changed over years Academically Clinically
Medication management Patient consultations
Mandated in select health care settings OBRA ’87 Diabetes Education Immunization providers Medication Therapy Management under Part D
So – why do we still not have provider status?
Lack of Status Runs Deep
Understanding the evolved role of pharmacists Legislators Regulators Payors Industry participants
Not merely an intermediary between vendor and consumer
Pennsylvania Supreme Court Case
Lack of Status Runs Deep
Medicare trust fund being threatened by insolvency “Ever-shrinking” pie
Allowing for compensation in a “coster not a saver” Political battle: New spending versus cuts
Ancillary health care groups threatened by inclusion
PHARMACY MUST BECOME and STAY UNITED Remain vigilant, tenacious and persevere
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Expanded Coverage Under the ACA
Health Insurance Exchanges
Health Insurance Exchanges (Marketplaces) Virtual insurance marketplaces for individuals and
employers to shop for coverage Distributors of health care, not deliverers Commercial insurers will manage care within
federal/state requirements Facilitate support/subsidies for individuals based
on need
Health Insurance Exchanges
What has to be covered? Actuarial equivalent calculated for each state Essential Health Benefits
Prescription drugs Ambulatory patient services Emergency services Hospitalization Maternity and newborn care Mental and behavioral health Rehab and Lab services Preventive / wellness care Pediatric care
Health Insurance Exchanges
HIE plan options tiered as “precious metals” Actuarial Value
90%+ Platinum
80%+ Gold
70%+ Silver
60%+ Bronze
HIE – Facilitating Subsidies
Support provided via HIEs, consumer assistance “Navigators” Help determine eligibility for financial assistance
HEIs required to tell consumers if they are eligible for coverage through state Medicaid or CHIP programs
Help for those with incomes between 100% - 400% of FPL Reduced cost sharing < 250%; lower deductibles and copays
Premium tax credits – refundable and advanceable at time of purchase through HIE
Insurance Reform
Incentives for Insurers
Increased demand
Diversity of insurance pools
Financial incentives for covering those with pre-existing conditions
Tighter Regulation of Insurers Premiums can vary only based on: age, tobacco use, family size, and
geography
Medical Loss Ratio – must spend at least 80% of premiums on direct care
Health Insurance Exchanges
Health Insurance Exchanges Virtual insurance marketplaces for individuals and
employers to shop for coverage Distributors of health care, not deliverers Commercial insurers will manage care within
federal/state requirements Facilitate support/subsidies for individuals based on
need
Impact on Businesses
Penalties for Not Providing Affordable Coverage
Small businesses <50 employees NOT required to offer coverage
Businesses >50 employees will pay a penalty $2,000 per employee (excluding the first 30
employees) if they do not offer coverage for employees who average 30 or more hours per week
No penalty for part-time employees
Health Insurance Exchanges
Impact on providers Payment
Care delivery
Competition
Consolidation of contracts
Medicaid in transition
60 million Americans covered by Medicaid (1 in 5)
ACA expands eligibility in 2014; will lead to approximately 16 million more individuals in Medicaid
All states operate some Medicaid Managed Care (MMC), except Alaska, New Hampshire and Wyoming
65% covered by MMC, but payments account for only 20% of Medicaid spend – due to exclusion of high-cost populations
Medicaid in transition
States moving aggressively to place high-cost population into MMC: disabled, elderly, nursing home residents, dual eligible, mental heath
Motivation of States Improve care delivery and payment systems Focus on high-cost/high needs Budget pressures Medicaid expansion under ACA Federal funding incentives:
“Person-centered systems of care” Medicaid “health homes” Demos on integration for dual eligibles
Medicaid Expansion
Targets those individuals at or below 133% of federal poverty level
Federal government will pay 100% of the cost for expansion for 2014, 2015, 2016
Federal share tiers down to 90% for 2020 State participation varies Help for those “left behind’ in states that do
not expand eligibility
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New Payment Models
New Reimbursement MODELS
• Accountable Care Organizations
• Bundled Payment• Hospital Readmissions• Value Based Purchasing
Revisiting the Key Concepts
Typing Payment to Quality
Linking Care Across Settings
Beyond ACOs, these concepts are central to: Part B Reform (replacing the SGR) Bundled Payments Value-based Purchasing
Population Health Management
Evolution of PHM in non-government programs
PHM and the Affordable Care Act
Key Concepts: Typing Payment to Quality Linking Care Across Settings
ACO Basics
ACO: Controlling entity and a related set of providers
that agree jointly to be held accountable for the cost and quality of care delivered to a defined patient population
over time and across all care settings.
Payment Incentives to
Contain Cost and Improve Care
Quality Care Achieved through
Performance Measures
Voluntary Provider
Participation Beneficiaries Assigned, not
Enrolled Local Provider Accountability for Quality and
Efficiency
ACO Incentives and Implications
Coverage
ACOs have financial incentives to focus on therapy selection and adherence as
tools to avoid more costly services. Implications: Increased utilization of
services/products aimed at managing chronic diseases and those with data to
support outcomes.
Access
Value proposition and accessibility are key for any provider seeking access
to ACO patients.Implications: Providers must
communicate value of products/services and understand conditions ACOs
emphasize.
Providers/ACOs
Value through cost-effective care.Cost containment through outcomes-based decisions.
Implications: ACOs driven to risk-based relationships with providers
Consumers
Emphasis on efficiency with less resources impacts customer access to
a provider’s products/services.Implications: Incentives alter utilization.
ACOs: Structural Distinctions from HMOs
Shifts Accountability for Care from Insurers to Providers- Care coordination and financial management at point of care
Beneficiary Participation is “invisible”- Beneficiaries may not be notified of ACO assignment and not required to receive services within the ACO
Flexible Provider Participation- Different payment models may be used: risk-based (bundled payments, full/partial capitation) and fee-for-service
Medicare ACOs
Medicare Shared Savings Program Pioneer ACO Model
Minimum Number of Beneficiaries
5,000 15,000; 5,000 for rural ACOs
Upside/Downside Risk
Track 1: Upside risk only
Track 2: Upside and downside throughout participation
Upside and downside risk
Payment ModelFee-for-service (FFS) + Shared Savings FFS + Shared Savings with transition to
population-based payment
Shared Savings/Losses Potential
Track 1: 50% max shared savings potential; no shared losses
Track 2: 60% max shared savings potential; 40-60% max shared losses based on quality score
Increased percentage of shared savings and losses
Beneficiary Assignment
Quarterly preliminary prospective assignment; annual final retrospective reconciliation
Choice of prospective or retrospective alignment
Medicare ACOs: Quality Measures
MSSP and Pioneer use the same quality measures and MUST MEET QUALITY TARGETS before they are eligible for shared savings.
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1. Patient/caregiver experience (7 measures)
2. Preventive health (8 measures)
3. At-risk population (12 measures)
4. Care coordination (6 measures)
No Medicare ACOs
AK
HI
CA (23)
AZ (8)
NV (3)
OR(2)
MT(1) MN
(5)
NE(2)
SD(1)
ND(1)
ID(1)
WY(1)
OK(2)
KS(1)
CO (2)
UT(1)
TX (17)
NM (3)
SC (4)
FL (32)
GA (13)
AL(2)
MS (3)
LA(2)
AR(2)
MO(4)
IA (7)
VA(7)
NC (8)TN (8)
IN (10)
KY (8)
IL (13)
MI (10)
WI (9)
PA (6)
NY (19)
WV(1)
VT (4)
ME (4)
RI-2
DE - 1MD - 10
NJ
MANH
WA(2)
OH(8)
D.C. - 3
Both MSSP and Pioneer ACOs
MSSP ACOs
8
18
NJ -10
Source: CMS Medicare Shared Savings Program website: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/index.html?redirect=/sharedsavingsprogram/.
CT- 10
States with Medicare ACOs
PR
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Medicare ACOs by County
CMS Resources
Key Dates for 2014
January 1, 2014, 123 new ACOS provide services to 1.5 million more Medicare beneficiaries >half are physician-led and serve fewer than 10,000 beneficiaries 1 in 5 ACOs include community health centers, rural health
clinics, and critical access hospitals that serve low-income and rural communities.
Milestone: 360 ACOs have been established, serving over 5.3 million Americans with Medicare
Summer of 2014, opportunities announced for new ACOs to begin January 2015.
Commercial Market Implications
# 1 Entities currently running Medicare ACOs are re-structuring their care models for non-Medicare patients.
Implication: ACO influence spans well beyond Medicare
# 2 Commercial payers partnering with providers to form and support ACOs across the country
Implication: Commercial players engaging opportunities
# 3 Commercial ACOs will use multiple models Providers with access to ACOs now will have distinct
advantage as ACOs spread
Bundled Payments
Affordable Care Act Medicare: By 1/1/13 national, voluntary for 8 patient conditions Medicaid: By 10/1/12 demonstration program in up to 8 states NOT IMPLEMENTED (YET)
Happening Now
Testing 4 models through CMS Innovation Center Model 1: Retrospective Acute Care Hospital Stay Only Model 2: Retrospective Acute Care Hospital Stay plus Post-
Acute Care Model 3: Retrospective Post-Acute Care Only Model 4: Prospective Acute Care Hospital Stay Only
Bundled Payments
• January 2013, CMS announced the 450+ health care organizations selected to participate in the Bundled Payments for Care Improvement (BPCI) initiative.
• Four models tested • Organizations choose up to 48 clinical episodes of
care to test.
• Organizations enter into payment arrangements that include financial and performance accountability for episodes of care.
Innovation.cms.gov/initiatives/Bundled-Payments/
Hospital Readmissions
Hospital Readmissions Reduction Program
Adjusts hospital payments based on the $ value of each hospital’s % of potentially preventable Medicare readmissions
Started Oct 1, 2012: three conditions: heart failure, heart attack and pneumonia
Oct 1, 2015: COPD, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, vascular surgery and others as determined by HHS
HHS calculates and make publicly available information on all patient hospital readmission rates
Hospital Value Based Purchasing
For discharges occurring on or after Oct 1, 2012, hospital are now measured
Two Domains: Clinical Process of Care: comprised of 12 clinical process measures Patient Experience of Care: Hospital Consumer Assessment of Healthcare Providers
and Systems (HCAHPS)
For 2014, measures expanded to include: 3 Mortality outcome measures; 8 hospital acquired Condition measures; 2 Agency
for Healthcare Research and Quality (AHRQ) composite measures
ACA calls for VBP in nursing homes, hospice and ambulatory surgical centers
Short Cycle Dispensing
14-day-or-less dispensing requirement for Part D enrollees residing in LTC facility began January 1, 2013
Brand-name oral solid medications only
Definition of “dispensing fee” modified to include costs associated with the acquisition and maintenance of technology to maintain reasonable pharmacy costs
Use of automated dispensing is not mandated
Short Cycle Dispensing
The facility selects the dispensing methodology or methodologies to be used in concert with their contracted LTC pharmacy
The Part D sponsor cannot choose or mandate any particular dispensing methodology
Uniform with respect to each LTC facility and will apply to all Part D sponsors and pharmacies dispensing to enrollees in that facility
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Medication Management
LTC and Medication Management
Medication Therapy Choice
Prescriber
Formularies and Utilization
Management Tools:
Part D, Medicaid, Pharmacy, Facility
Monthly DRR by Consultant
Pharmacists
Medication Therapy
Management by ? for Part D Surveyor
Oversight for Compliance
Medication Reviews and utilization
Drug Regimen Review Antipsychotic Medication Use Independence of Consultant
Pharmacists Potential Conflicts of Interest Effectiveness Impact on Patients Cost to government
Difference between MTM and DRR
January 2012 CMS Memo:
“We believe that there is potential overlap in these reviews that could possibly result in conflicting reviews and recommendations for prescribers and facility staff, as well as excess costs in the health care sector.”
“We believe that better care coordination and cost efficiencies would result from arrangements that include the LTC consultant pharmacist in the conduct of Part D MTM services for beneficiaries in the long term care setting.”
LTC and Medication Management
Three Major Trends
Integration of Reviews DRR is facility requirement; MTM and CMR are Part D
requirements.
Conflicts of Interest (potential or real)
Reviews influenced by financial implications of medications? Should reviewers be independent?
Class-Specific Scrutiny Government focus on different classes of medications over time. Currently: antipsychotic medications and hydrocodone products.
Reimbursement for Pharmaceuticals
Many polices with a single goal…
Replacing the “fundamentally flawed nature of AWP-based reimbursement” and the “inflated published prices” that cause the government to “pay too much for certain drugs” - Office of the Inspector General
Reimbursement
Medicaid – Average Manufacturer Price (AMP) ACA modified the Federal Upper Limit (FUL) for Medicaid multiple
source drugs
Effective October 1, 2010, FUL as no less than 175 percent of the weighted average (determined on the basis of utilization) of the most recently reported monthly average AMP
CMS issuing draft AMP-based FUL reimbursement files for review and comment only for multiple source drugs weighted average of monthly AMPs in a FUL group not posting monthly AMPs for individual drugs
Average Manufacturer Price
Applies to Medicaid Reimbursement, Broader Implications 2012 Proposed Rule CMS proposes to define “retail community pharmacy” for
manufacturer AMP calculations. “an independent pharmacy, a chain pharmacy, a supermarket
pharmacy, and a mass merchandiser pharmacy that is licensed as a pharmacy by the State and that dispenses medications to the general public at retail prices.”
Excludes from AMP sales to PBMs, LTC pharmacies, mail order pharmacies, and others.
CMS notice in Fall 2013, says Final Rule will be issued in January 2014
Reimbursement
Medicaid – developing alternate benchmarks CMS contracts with Myers & Stauffer, LC, to perform surveys
Part I - Retail Community Pharmacy Consumer Prices National Average Retail Prices (NARP) for Medicaid Covered Outpatient Drugs
PART II - Drug Acquisition Costs Paid By Retail Community Pharmacies
National Drug Acquisition Cost (NADAC)
Reimbursement
Dispensing Fees If reimbursement is actual acquisition cost, what would
the dispensing fee need to be to providers?
What is the cost to dispense?
What are the differences for different setting like LTC?
Beyond Medicare and Medicaid, what are the implications for other payors?
Reimbursement
Medicare Part B – Average Sales Price (ASP)
3-6 month lag time is problematic OIG Feb 2013 report calls for
competitive bidding of DME infused medications
CAP option for physicians is not an option
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2014 Federal Agenda
Part B Sustainable Growth Rate
House Energy and Commerce Committee bill Replaces SGR with a system that incentivizes quality and
efficiency starting in 2019. 5 years of stable Medicare payments starting next year, with
reimbursements growing 0.5% for each year between then and 2018.
Starting in 2019, the "Update Incentive Program" would place at risk a certain amount of fee-for-service payments and base those reimbursements on quality measures.
Controlled Substances
Federal Action“Food and Drug Administration Safety and Innovation Act”
Draft provision NOT in the final bill was reclassification of all hydrocodone-containing products to Schedule II
Final bill requires FDA hold public meeting January, 2013 Panel recommends changing classification
DEA Proposed Rule
Proposed Dec. 2012; comments due Feb. 19, 2013.
Proposes to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles.
Expand the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities (LTCF).
No manufacturer, distributor, reverse distributor, or retail pharmacy is required to be a collector under the proposal.
DEA Proposed Rule
Key provisions related to LTC include: LTCFs would be permitted to dispose of controlled
substances on behalf of an ultimate user who resides or has resided at the LTCF.
LTCFs would be required to transfer controlled substances in Schedules II through V into collection receptacles immediately, but no longer than three business days after it is determined that the ultimate user no longer needs or wants, or should discontinue use of the controlled substance.
If the LTCF does not have access to an on-site collection receptacle, they are not otherwise permitted to dispose of a controlled substance on behalf of an ultimate user.
Federal Oversight
FDA of Drug Quality and Security Act:
Compounding response to the meningitis outbreak
Track and Trace administered by FDA to track a drug from its
origination, through the manufacturing process, to the point of sale
DMEPOS Competitive Bidding
Round 2 Starts July 1 8 product categories 91 Competitive Bid Areas 13,126 contracts awarded to 799 suppliers 45% savings
National Diabetic Testing Supplies 52 locations for mail-order/home delivery Retail payment to = mail-order 72% savings
Round 1 Recompete Underway
Unused Medications in LTC
Current Reality
No uniform approach due to lack of clarity on rules
The Drug Enforcement Administration (DEA)
Environmental Protection Agency (EPA)
Centers for Medicare and Medicaid Services (CMS)
Food and Drug Administration (FDA)
DEA Proposed Rule
Proposed Dec. 2012; No action after.
Proposes to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles.
Expand the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities (LTCF).
No manufacturer, distributor, reverse distributor, or retail pharmacy is required to be a collector under the proposal.
DEA Proposed Rule
Key provisions related to LTC include: LTCFs would be permitted to dispose of controlled
substances on behalf of an ultimate user who resides or has resided at the LTCF.
LTCFs required to transfer Schedules II through V into collection receptacles immediately, but no longer than three business days after it is determined that the ultimate user no longer needs or wants, or should discontinue use of the controlled substance.
If the LTCF does not have access to an on-site collection receptacle, they are not otherwise permitted to dispose of a controlled substance on behalf of an ultimate user.
Controlled Substances
Reclassification of all hydrocodone-containing products to Schedule II
FDA hold public meeting Panel recommends changing classification
Legislation introduced in Congress
Change not definite, but could come at any time after Rulemaking process
Commission on LTC Recommendations
Report to Congress – Sept 30, 2013 Framework for Reform
SERVICE DELIVERY A more responsive, integrated, person-centered, and fiscally sustainable
LTSS delivery system that ensures people can access quality services in settings they choose.
FINANCE A sustainable balance of public and private financing for long-term
services and supports (LTSS) that enables individuals with functional limitations to remain in the workforce or in appropriate care settings of their choice.
Part B Drugs and Biologics
Average Sales Price (ASP) + 6% 2011 and 2012 legislative threat - reduce to ASP + 3% June 2013 House Hearing, discussion looks at reform
H.R. 800, would exclude customary prompt pay discounts extended by manufacturers to wholesalers from ASP calculation.
H.R. 1428, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act – ESRD.
H.R. 1416, the Cancer Patient Protection Act, would exempt Medicare Part B drug payments from sequestration.
ACA: Major Shift
LINKING CARE ACROSS SETTINGS Breaking down care silos through payment incentives
Rehospitalizations
Bundled Payments Program
Accountable Care Organizations (ACOs)
ACA: Major Shift
TYING PAYMENT TO QUALITY Sweeping change in approach to payments
Quality outcomes replace utilization as payment drivers
Value-based Purchasing
Bundled Payments Program
Accountable Care Organizations (ACOs)
Existing Quality Programs Minimum Data Set 3.0 Nursing Home Compare Data
Tying it All Together
Expanded coverage leads to increase in demand for health services
Know the payment incentives to know your customers
Understand who is who when it comes to medication reviews
Prepare for changes from Federal oversight
Thank You!
Leigh Davitiansldavitian@dumbartonassociates.com
Brad Kile, PhDbkile@dumbartonassociates.com