The Best of Times for Informatics

The View from Washington

Doug Peddicord
Washington Health Strategies Group
May 26, 2010
 Topics for Today

• AMIA’s Public Policy Work

• ARRA – from HIPAA 2 to Meaningful Use
• The Impact of Health Care Reform
• The Informatics Agenda Going Forward –
‘show me the money’ vs. ‘where’s the beef?’
 AMIA Public
ub c Policy
o cy and
a d Go
Government
e e
Relations

• Establishing relationships with legislators, policy

makers funders
makers,

• H
Having
i a say (i
(influencing)
fl i ) llegislation
i l ti and
d
regulation

• ‘Lobbying’
 Public Policy and Government Relations
G l and
Goals d Obj
Objectives
ti

• Make a difference for the biomedical and health

informatics community; for AMIA members; and for AMIA
• Build relations with and educate Congress about issues
important to AMIA and its members
• Present AMIA as a resource to members of Congress
and the Administration
• Spread awareness about AMIA, health information
technology and informatics
• Provide objective input into the public policy discourse
and help inform public policymakers
 Positioning
g AMIA
• AMIA’s 4,000 members advance the use of health
information and communications technology gy in clinical
care and clinical research, personal health management,
public health/population, and translational science, with
the ultimate objective
j of improving
p g health. Our members
work throughout the health system in various clinical
care, research, academic, government, and commercial
organizations.
g
• AMIA is a source of informed, unbiased opinions on
policy issues relating to the national health information
i f t t
infrastructure, uses andd protection
t ti off clinical
li i l andd
personal health information, and public health
considerations.
 Being Heard on Legislation

• Find a champion for your point of view

(Members matter) – e.g., AMIA 10 X 10
• Make connections – constituents, grassroots
contacts and personal relationships make a
difference
• Work
W k theth bill – provide
id lletters
tt off support,
t provide
id
testimony, recruit co-sponsors
• Be clear on your
o r ‘asks’ – amend when hen you
o can
can,
support or oppose when the time comes
Being A Resource (Staff Often Matter More)

• Establish credibility (answer two questions)

– What do you want?
– Who won’t like it?
– Anecdotes and hard data both matter (but brevity is
always key; one-pager is a term of art on the Hill)
– When asked, provide feedback (opinions, examples,
answers, alternatives) immediately – 12 to 24 hours
used to be good enough; in the age of blackberries
blackberries,
try 2 to 3 hours – being timely is as important as
being right
 After Legislation Becomes Regulation

• The regulatory
g ypprocess is more open
p and
transparent – primacy and recency are less
important (but you still have to show up!)
• Establishing
E bli hi relationships
l i hi within
i hi the
h regulatory
l
agencies is more likely to be based on expertise;
it’s
it s time to check your passion at the door
• Precision and clarity are key – think like a lawyer
(or an English major)
• Be thorough – and respond within the time
allowed
 A Few ‘Rules’
Rules

• Public policy advocacy is a contact sport: in-

person, by phone, by e-mail, etc.; “ninety
percent of life is just showing up”
• Primacy and recency are powerful determinants
of influence, as is repetition
• What’s
Wh t’ iimportant?
t t? C Connections
ti ((personal,
l
constituent) – expertise – responsiveness –
credibility
• Participation (Hill Day, for example) is essential
AMIA Advocacy in Action – From HIPAA to
ARRA
 In the Beginning Was… HIPAA

• Administrative Simplification – with the goal of

reducing overhead costs and creating an
electronic
l t i h health
lth care environment
i t

• But the misalignment off incentives and lack off

interoperability and other standards is
persistently problematic – and we bump along
educating, advocating, doing demos, etc.
 And then 13 years later – ARRA

• The legislative process on steroids: the 111th

Congress convenes on January 6, 2009 – and
the President signs a $787 billion ‘stimulus
stimulus bill’
bill
on February 17
• The House – Ways & Means (Medicare) and
Energy & Commerce (Medicaid) takes the lead
• Focus on ‘shovel
shovel ready’
ready infrastructure projects –
and HIT (!)
 ARRA

• $17
$17.22 billion + in EHR incentives for hospitals
and physicians
• $2 billion to ONC
• $1.5 billion to HRSA
• $1.3
$1 3 billion to NCRR
• $8.2 billion to NIH
• $1.1
$1 1 billion for CER
 ARRA and HITECH

• AMIA
AMIA’ss interests:

9 Codification and funding of ONC

9 HIT incentives (W&M)
9 HIT standards (HELP)
9 Workforce (Wu, Carper)
9 ‘Meaningful
g use’ ((W&M))
9 Privacy (E&C, HELP)
 ARRA Incentives

Carrot and Stick Approach

• $17.2 billion for HIT funding will be
distributed through Medicare and Medicaid
payment incentives
• Carrot: Incentives will be offered to both
physicians
p y and hospitals
p ((the first
‘payment year’ will be no earlier than
2011)
• Stick: The bill stipulates that Medicare
fees will be reduced for ‘non EHR
physician users starting in 2015
 The Price To Be Paid – HIPAA 2

• Breach notification
• Ban on sale of PHI
• Expanded
E d d patient
ti t access rights
i ht
• PHR provisions
• Restricted disclosures for self-pay
• A
Accounting
ti ffor disclosures
di l ffor T
Treatment,
t t
Payment, and Operations
 More HIPAA 2

• Business Associates now covered by Security

and relevant parts of Privacy rules
• BA Agreements required for HIEs, RHIOs
• Limits re: minimum necessaryy and Limited Data
Sets
• New marketing restrictions
• Much tougher enforcement
 Proposed Rules and Guidances Issued

• Breach Reporting
• (Guidance re:) when PHI is considered “not
unsecured
unsecured”
• GINA
• HIPAA Enforcement
• Meaningful Use payment incentives
• HIT Standards and Certification
• eRX for Controlled Substances
 Guidances and Regulations Still To Come
• Guidance on minimum necessary
• Guidance regarding de-identification of PHI
• Promulgation of regulations on what
information is to be included in the accounting
of disclosures by covered entities and business
associates
• ‘Omnibus’ rule implementing new marketing,
self-pay ‘sale’
self-pay, sale and other restrictions;
extension of jurisdiction over BAs and PHRs;
improved
p p
patient access;; etc.
A Look At The Patient Protection and
Affordable Care Act
 An Historic Accomplishment

Health reform promises to usher in a new era in American

health care, supporters say
It will:
• Cover 32 million
C illi uninsured
i d
• Improve affordability of coverage for millions now having difficulty
paying health insurance premiums, medical bills, or accumulated
medical
di l d
debtbt
• Eliminate donut hole in Medicare Rx coverage; institute a new
voluntary long-term care financing program
• Begin to move to an organized integrated delivery system with
coordinated care, reducing errors, duplication, and waste
 Source of Insurance Coverage Pre-Reform
anddU
Under
d Aff
Affordable
d bl CCare A
Act,
t 2019

159 M (56%)
162 M (57%) ESI
ESI 23 M (8%)
54 M (19%) Uninsured
Uninsured 24 M (9%) Exchanges
16 M (6%) (Private Plans)
Other
16 M (6%) Other
Oth
15 M (5%)
Nongroup 10 M (4%)
Nongroup
35 M (12%) Medicaid
51 M (18%) Medicaid

Pre-Reform Affordable Care Act

A
Among 282 million
illi people
l under
d age 65
 Snapshot of Major Reforms

2010 Health Reform

I
Implementation
l t ti Timeline
Ti li
2018

Insurance
Reforms
• 2010 protections, incl. high-
risk pool, ban lifetime caps
• 2014 expanded reforms
• Individual mandate
• State-based exchanges & tax
subsidies
• National long-term care
program
Employers
p y Tax Reforms Prescription
p
• Small business tax credit • Increase Medicare tax for high-
income earners
Drugs
• Eliminate Part D deduction
• Limit FSAs • Follow-on biologics pathway
• Penalties for employers with
more than 50 FTEs not offering • Tax high-cost plans • Medicaid rebate increase
coverage
• Employer and individual • Improved Medicare Rx
• Auto-enrollment for large penalties coverage, including branded
employers di
discounts
t
• Industry excise taxes
• 90-day waiting period limits • Industry excise tax
• Comparative Effectiveness
Research

Medicare Medicaid Quality

• $523b payment reductions
• Improve Part D & prevention
coverage
• Increase Part B & D premiums
• Independent Payment
Commission (IPAB)
• Expand eligibility to 133% FPL
• Increase primary care
reimbursement
• Enhance federal matching
funds
• Streamlined enrollment
Q y
• National QI strategy
• CMS Innovation Center
• Pilots on bundled payments,
medical home, ACOs
• Expand PQRI
Workforce
• Advisory Committee to
develop national strategy
• Loans & scholarships to
increase supply and training
• Redistribute GME slots
 Health Insurance Reforms: 2010

APRIL JULY SEPTEMBER END OF 2010

Temporary high risk Young adults on Annual review of

State option to expand
pool parent’s
parent s plans premium increases
Medicaid to adults
ad lts to
133% FPL
Employer retiree health Small business tax Public reporting by
benefits reinsurance credits insurers on share of
premiums spent on non-
No ppre-existing
g medical costs
condition exclusions
for children Coverage and no cost-
sharing for preventive
Prohibitions against care in Medicare
lifetime benefit caps &
rescissions
i i $250 rebates for Part D
enrollees in "donut hole"
 Health Insurance Reforms: 2011-2013
2011 2013

2011 2013

Insurers must spend at least 85% of premiums Insurer administrative simplification

(large group) or 80% (small group/individual) on requirements
medical costs or provide rebates to enrollees
Limits on contributions to flexible spending
50% discounts on brand-name drugs to accounts to $2500/year
Medicare part D enrollees in the donut hole

Over-the-counter drug costs reimbursement

restrictions in flexible spending accounts and
account based health plans

Increased tax on non-medical distributions from

h lth savings
health i accounts
t (HSA
(HSAs))

Establish national, voluntary insurance program

for purchasing community living assistance
services and supports (CLASS program)
 Health Insurance Reforms: 2014-2018
2014 2018

2014 2018

Medicaid expanded to at least 133% FPL Excise tax on high cost employer
plans
Insurance market reforms including no rating on
health

State insurance exchanges

Essential benefit standard

Premium and cost sharing credits for exchange

plans

Premium increases a criteria for carrier

exchange

Increase in small business tax credit

Individual requirement to have insurance

Employer shared responsibility penalties

 Taxes and Penalties
• Medicare payroll tax increases by 0.9% for
i di id l earning
individuals i more thenth $200,000
$200 000 and d couples
l
earning more than $250,000 – and a new 3.8% tax on
unearned income
• Individual mandate – With exceptions, individuals are
required to have health insurance and will be penalized
(fined) if they do not
not. (In 2016 $695 per year or 2
2.5%
5% of
income)
• Employer
p y mandate – employers p y with more than 50 full-
time employees must provide insurance, and will be
assessed a penalty as a percentage of payroll
 Health Care Reform: AMIA Input

9 Additional directions to ONC; e.g., funding for

a study of workforce training costs
9 Additional HIT incentives; e.g., increased
payments to ‘meaningful’ users by private
(non-public) insurers
9 HIT standards (HELP)
9 Privacy – fending off ‘HIPAA 3’
9 Anticipating and addressing unintended
consequences
 Major HIT Provisions

• Sec. 1104. Administrative Simplification

– Operating Rules
– Streamlined Process for development/adoption of standards

• Sec. 1561. HIT Enrollment Standards and Protocols

– Interoperable and secure standards for enrolling individuals in
Federal and State programs.
 Major HIT Provisions

• Sec. 6703. Elder Justice Act.

– Certified Electronic Health Record Grant Program
• New systems, upgrades, or for staff education and training
• Grantees must pparticipate
p in state-based health information exchanges
g
• Appropriates $52.5 million over 3-years beginning in FY 2011

• Sec. 10109. Additional Financial and Administrative

Transactions.
Transactions
– Additional operating rules for any additional standards
– ICD-9 to ICD-10 Crosswalk
• ICD
ICD-9-CM
9 CM CCoordination
di ti anddM
Maintenance
i t C
Committee
itt meeting
ti byb JJanuary 1,
1
2011.
• Viewed as a code set.
 What’ss Next For The PPACA?
What
• ‘Corrections’ and implementing regulations
• Ongoing workforce and education/training issues
• Migration of HIT emphasis to new sites of care (LTC,
MH))
• Comparative effectiveness research (CER)
• Patient safety
• Consumer engagement
• Quality initiatives: bundled payments, medical home,
ACOs; expand PQRI
• Implementation of ICD 10
• Connecting Meaningful Use to Payments
The Informatics Agenda Going Forward
 ‘Show Me The Money’ vs. ‘Where’s The
B f’
Beef’
• From the CMS payment incentives to the FDA’s FDA s
Sentinel Initiative, NIH CTSAs to multi-agency
CER, beginning to deliver on the promise of
informatics will be key; the Meaningful Use
process illustrates the tension between those
who
h would ld iimplement
l t ttools
l versus th
those who
h
aim to transform health care; [relatively] ‘big
dollars’ have the potential to lead to ‘big
dollars big
scandals’; extraordinarily short timelines may
occasion some big g misstepsp
 Other Tensions

• Quality of care versus rationing

• Pay for quality, bundled care, accountable care
versus p
provider autonomy y
• Data stewardship versus privacy [privacy never
goes away]
g y]
• How long will the unusual influence of the Policy
and Standards Committees last?
• The unknown politics of health care post mid-
term elections
 AMIA Priorities and Strategies for 2011

• Workforce and Training (ONC, HHS)

• Informatics Science and Research (NLM,
(NLM NIH
CTSAs)
• Patient Safety and Quality of Care (CMS,
(CMS AHRQ
AHRQ,
FDA, CDC, NIH)
– Comparative Effectiveness
Thank you

• Questions, comments?

Doug Peddicord
Washington Health Strategies Group
dpeddicord@obwlaw.com
p @