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Impact on Health Reform on Device Development and Funding
1. Impact of Healthcare
Reform on Device
Development and
Funding
Donald Rucker, MD, MBA
COO, OSU IDEA Studio
Associate Dean for Innovation
2. 2
US Healthcare Expenditures
Source: Kaiser Family Foundation. Data from Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics
Group, at http://www.cms.hhs.gov/NationalHealthExpendData/ (Historical data from NHE summary including share of GDP, CY 1960-2008,
file nhegdp08.zip; Projected data from NHE Projections 2009-2019, Forecast summary and selected tables, file proj2009.pdf).
$8,047
(2009)
$2,814
(1990)
Historical Projected
In 2012, the U.S. spent $2.8 trillion on health care,
or $8,915 per capita
$13,387
(2019)
3. “Healthcare Reform”
ARRA HITECH Act 2009
Patient Protection and Affordable Care Act
(PPACA)
Health Care and Education Reconciliation Act
of 2010
6. Affordable Care Act
ACA is driving major
changes in how people
purchase health insurance
though much of the dynamic
still to play out
Federal government already
controls ~50% of healthcare
spending
Medical equipment
manufacturer environment
rarely a specific
consideration
7. 7
Hope: Achieve “Triple Aim” for US Healthcare
with payment reform
a) Better care for individuals
b) Better health for populations
c) Lower growth in Medicare
Parts A and B expenditures
8. One slide review of US payment system
8
Federal government
Medicare Part A - hospitals – bundled DRG’s
Medicare Part B – outpatients – fee for service
(FFS) via CPT codes
Medicare Part C – Medicare Advantage – HMO
Medicare Part D – drug spending
Medicaid – mix of FFS and capitation
Private insurers
FFS off of Medicare rates / codes
HMO’s like Kaiser
Other
VA, DOD, HIS, corrections
9. 9
Q: What does this mean for device manufacturers?
A: Need to understand provider reimbursement
10. The drive toward “accountable care”
Demographic/ Population
Changes
Management of
Chronic Disease
Technology & IT
Infrastructure
Healthcare Quality Initiatives
Bundled/ Episodic
Reimbursement
Payor Reform
Appropriate Utilization
11. Origin of the Accountable Care Organization
Term came from a discussion
between Elliot Fisher of
Dartmouth and Glenn Hackbarth
of MedPAC at a 2006 meeting
Extended hospital medical staff
that could act as a virtual
organization
Fisher ES, Staiger DO, Bynum
JPW, et al. “Creating Accountable
Care Organizations: The
Extended Hospital Medical Staff”.
Health Affairs, 26(1) w44-w57,
2007.
12. 12
Two Models for ACO Risk Sharing
Same eligibility requirements and quality performance standards
for both
Regular fee-for-service payment
for physicians and hospitals
ACO shares in savings with Medicare
No penalty for losses in Years 1,2, 3
Track 1: One-sided Model
Regular fee-for-service payment
for physicians and hospital
ACO shares in savings and losses
with Medicare in all 3 years
Greater opportunity for rewards
Track 2: Two-sided Model
13. Provider Participation
Eligible providers who can form an ACO under
this program:
ACO professionals in group practice arrangements.
Networks of individual practices of ACO professionals.
Partnerships or joint venture arrangements between hospitals and ACO
professionals.
Hospitals employing ACO professionals.
Such other groups of providers of services and suppliers as the
Secretary determines appropriate.
Primary care physicians may choose to
participate (limited to 1 ACO annually)
Specialists and hospitals could participate in more than 1 ACO
14. 14
Medicare Beneficiary Participation
A preliminary prospective beneficiary assignment to ACOs
• Beneficiaries identified quarterly
• Two Step Assignment process
• Beneficiaries who have received at least one primary care from a primary care
physician
• Beneficiaries who have not rec’d any primary care services from a primary care
physician but have rec’d primary care services rendered by any other ACO professional
ACO providers must notify patients they are in an ACO
Medicare fee-for-service beneficiaries may continue to receive care
from any Medicare provider they choose. However, if their primary
care physician is in an ACO, they will be included in the ACO or will
have to find another non-ACO primary care doctor.
ACO must notify the beneficiary that the beneficiary’s claims data may
be shared with other providers in the ACO to coordinate care.
Providers must give beneficiaries the opportunity to opt-out of the data
sharing arrangements.
15.
16. Moral hazard: Quality Measures as counterbalance
How well your doctors communicate
Readmissions (risk-adjusted)
% Physicians meeting Stage 1 HITECH Meaningful Use
Requirements
% Primary Care Physicians using Clinical Decision
Support
Health Care Acquired Conditions Composite
Mammography screening
Colorectal cancer screening
Diabetes: Hemoglobin A1c
Cardiac function testing
17. 18
Early results of this model
• 360 Medicare ACO’s as of 12.23.2013
• Cover 5.3 million Medicare Beneficiaries (roughly 10%)
• Most are physician led and have under 10,000 beneficiaries
• Pioneer ACO’s - as of July 2013
• 18 of 32 achieved some savings
• 13 of these saved enough to get a payment
• 14 of 32 spent more than expected
• 2 of these spent enough to get a penalty
• 7 shifted to regular ACO program
• 2 dropped out totally
• Private ACO’s – too early to tell
• Mass BCBS Alternative Quality Contract >> 2-3% savings
• Kaiser consistent savings for 60 years
18. 19
The Great Risk Shift
Toward Accountable Care
Source: Health Care Advisory Board interviews and analysis.
Building Accountability through Experiments in Payment
Pay-for-
Performance
Hospital-Physician
Bundling
Episodic Bundling
Capitation/Shared-Savings Models
Degree of
Shared Risk
Care Continuum
19. 20
Bundled Payments Drive Delivery System Integration
Fee-for-Service Environment Bundled Payment Environment
Individual Payments
Reinforce Siloed Care Delivery
Lump Sum Payments Drive Integration
through Shared Accountability
Hospital
Services
Post-Acute
Services
Physician
Services
Payer
Hospital
Services
Post-Acute
Services
Physician
Services
Source: Health Care Advisory Board interviews and analysis.
Payer
22. What happened in 1965?
We know from the first day of Economics 101 that in the
entire history of mankind there have been only two ways
to allocate scarce resources
PRICE
QUEUES (lines, rationing, access controls, subsidies)
EVERYTHING in reform has to boil down to some mix of
buying healthcare through competitive market prices or
government rationing / subsidies.
23. Government is the buyer
Today, most of US healthcare is bought by the federal
government
Since 1965 Medicare has been the de facto healthcare
policy for both the federal government and private payers
Historically what to buy not an issue
Medicare Law – Title XVIII - All services must be certified
as medically necessary or must be a defined benefit
preventative service
Medicare set “fixed” prices
Numbers of hospitals, doctors constrained
24. How could CMS shop?
You know how consumers shop!
Price
Quality
Value (function of price and quality)
How could CMS shop?
Price - all fixed at the same level
Quality
Value - tough to calculate without price information
25. CMS Shopping for Healthcare - 2014
Key to understanding healthcare reform
A search for value – trying to be a consumer
Outcomes are very hard to measure
Comparative Effectiveness – not that successful
Quality as a proxy for value and hopefully outcomes
PQRI
RHQDAPU
PPACA – Hospital Value Based Purchasing
Meaningful Use
Accountable Care Organizations
Lots of Quality Measures – Few tied directly to clinical outcomes
26.
27. Where do Quality Measures Come From?
Ideally, from medical science
Evidence Based Medicine
AHRQ – Effective Healthcare Program
Comparative Effectiveness in ARRA Law
Patient Centered Outcomes Research
Institute – PPACA
Reality = the process is part clinical
evidence and part politics
Increasing role with “SGR” fix just
reported out of Congressional
committee
29. Today’s Medicare prices (DRG‘s, CPT codes)
PRICE is the fundamental economic language for informing
rational decisions for BOTH consumers and producers
How does Medicare “speak” PRICE
Medicare sets prices – some too high, some too low
Medicare tries to work around mis-pricing by cross-subsidization
Many provisions in PPACA are attempts to redress cost errors
“Medical home”, “utilization rate”, physician owned hospitals
30. Can price / efficiency information sneak back in?
A form of market-based prices of
healthcare services can occur
privately
HMO’s, capitation and Accountable
Care Organizations are ways to
purchase and provide an efficient mix
of healthcare services, at least, within
an organization
PBM’s force price in with “tiered
payments”
Employers force price in by
increasing co-pays
Price transparency – laws, Castlight
31. “But my device is already market priced…”
32
Your device is likely priced at the current market
rate
BUT the services of clinicians who decide to use
your device are not
SO YOU have to figure out, over time, how do
the “ordering” clinician’s incentives to order your
device change
Challenging transition period for providers as
caught between contradictory payment models
32. Side note: Sunshine Law
33
Sen. Grassley’s effort to provide transparency
Drug & device manufacturers and suppliers have
to report all “transfers of value” to physicians and
hospitals over $10 ($100 per year)
Track: since August 1, 2013
Report: March 41, 2014
Public Website: September 30, 2104
33. Upcoming?
SGR (Sustainable Growth Rate) Fix
>> Value-Based Purchasing reporting consolidated
Challenges for device manufacturer’s
Federal perceptions on use and value
Co-pays
Cuts until access clearly imperiled
Wonderful opportunities
New focus on value and automation and business
practices
Many inefficiencies to arbitrage
More spending on devices, less on labor
34. Conclusions
1. 2010 Healthcare reform legislation includes thousands
of provisions and we don’t know how they will ultimately
play out
2. Healthcare payment based on individual quality
measures is limited
3. Most likely next step to reduce expenditures will be
bundled payments which force delivery systems, not
Medicare, to make the hard choices of how to deliver
care and what care to deliver
4. Device manufacturers, more than ever, need to sell the
efficiency and outcomes-based value of their products.
Providers will be much more likely to listen.