The need for
legislation and
how to proceed:
aka Policy 101+
Kayt Marra,
MA, CD-N
Declarations
I am currently a consultant for Nutricia North
America, a company that specializes in
medical nutrition therapy for patients with
metabolic, allergy, and gastrointestinal
conditions.
I have secured grant funding from Biomarin
Pharmaceuticals in order to conduct
educational programs for our patients with PKU
and related disorders.
The Issue
Once Mito is suspect or diagnosed securing
coverage for treatment is often difficult. Part of
the issue is a lack of evidence based treatment
for this group of diverse conditions.
Additionally, not all patients respond equally to
the same cocktails and not all providers see the
benefit of utilizing them. Regardless, those with
MITO suffer with multi-system issues.
The audience
Patients and providers alike are frustrated with the
status quo. Understanding how the system works
and how policy can change is critical.
Patients with MITO need to become active in the
process. This segment on policy and legislation will
aim at minimizing knowledge gaps and
empowering patients and care givers to become
part of the policy process as well understand what is
available regarding research and MITO and how this
can influence care.
Outline
•
•
•
•
•
Review of how government works
Why nutritional formula/supplements are
not routinely covered
• NYS legislative history regarding formula
Health care-hurdles
Current Mito related legislation
How to advocate medically and
politically.
Government
COMPARISON OF HOUSE OF
REPRESENTATIVES AND SENATE
HOUSE











TWO-YEAR TERM
435 MEMBERS
CONGR. DISTR. BASED ON EQUAL
POPULATION
SMALLER CONSTITUENCY
RULES COMMITTEE
STRICT RULES
DEBATE EST. BY RULES COMMITTEE
POWERFUL COMMITTEE CHAIRS
POLICY STAFF SPECIALISTS
RIDERS TO BILLS NOT ALLOWED
LESS MEDIA COVERAGE
SENATE










SIX-YEAR TERM
100 MEMBERS – TWO PER STATE
STATE-WIDE –NOT POPULATION
BASED
LARGER CONSTITUENCY
NO RULES COMMITTEE
FLEXIBLE AND FEW RULES
UNLIMITED DEBATE
POLICY STAFF GENERALISTS
RIDERS ALLOWED
GREATER MEDIA COVERAGE
COMPARISON OF HOUSE OF
REPRESENTATIVES AND SENATE
HOUSE





CLOSED RULES W/ NO
AMENDMENTS TO BILLS
CLOSER TO THE PEOPLE OF THE
DISTRICT
NO POWER TO REVIEW OR RATIFY
TREATIES
ALL APPROPRIATION BILLS START
HERE
MORE COMMITTEES
SENATE





AMENDMENTS ALLOWED
CLOSER TO NATIONAL
CONSTITUENCY
POWER TO REVIEW AND RATIFY
TREATIES
AMENDMENTS ON BUDGET BILLS
FEWER COMMITTEES
DR Rubin How Our Government Really
Works, 2013
Participation in Government
Citizen participation nationally
Voter turnout dipped from 62.3 percent of eligible
citizens voting in 2008 to an estimated 57.5 in 2012. That
figure was also below the 60.4 level of the 2004
election but higher than the 54.2 percent turnout in the
2000 election.
Despite an increase of over eight million citizens in the
eligible population, turnout declined from 131 million
voters in 2008 to an estimated 126 million voters in
2012 when all ballots are tallied. Some 93 million
eligible citizens did not vote.
http://bipartisanpolicy.org/news/press-releases/2012/11/2012election-turnout-dips-below-2008-and-2004-levels-number-eligible
NYS Citizen participation
“One obstacle to consolidation of governments that is
frequently cited is a perceived loss of local control over
services and spending decisions.
The theory is that the further away the voter is from the
decision maker, the less accountability the decision
maker will feel toward their needs and concerns.
The irony is that based on voter participation numbers,
the closer the voter gets to the decision maker, the
fewer cast votes.”
In other words the closer to home the election the less likely we are to
participate.
http://www.nyslocalgov.org/pdf/Voter_Participation_in_Elections.pdf
NY voter participant rates
http://bipartisanpolicy.org/news/press-releases/2012/11/2012-election-turnoutdips-below-2008-and-2004-levels-number-eligible
NYC
Presidential 55%
Gubernatorial 31%
General election
30% (odd yr. ballot
proposition)
Outside NYC
Presidential 68%
Gubernatorial 46%
General election
36% (odd yr. ballot
proposition)
FDR and Hubert Humphrey on
government
Let us never forget that government is ourselves
and not an alien power over us. The ultimate
rulers of our democracy are not a President and
Senators and Congressmen and government
officials, but the voters of this country.
It was once said that the moral test of
government is how that government treats
those who are in the dawn of life, the children;
those who are in the twilight of life, the elderly;
and those who are in the shadows of life, the
sick, the needy, and the handicapped.
New York State Government
State government
Under the Tenth Amendment to the Constitution, all
powers not granted to the federal government are
reserved for the states and the people. All state
governments are modeled after the federal
government and consist of three branches:
executive, legislative, and judicial. The Constitution
mandates that all states uphold a "republican form"
of government, however, the three-branch structure
is not required.
http://www.whitehouse.gov/our-government/state-and-local-government
New York State Legislature
The New York State Legislature is bicameral and consists of a State Senate
and Assembly. The Assembly consists of 150 members; the Senate varies in
its number of members, but currently has 62. The Assembly is headed by
the Speaker; the Senate is headed by the President, a post held ex officio
by the Lieutenant Governor, who only has a tie-breaking "casting vote", but
more often it is presided over by the Temporary President or by a senator of
the Majority Leader's choosing.
The Legislature is empowered to make laws, subject to the Governor's
power to veto. However, the veto may be overridden by the Legislature if
there is a two-thirds majority in favor of overriding in each House.
Furthermore, it has the power to propose amendments to the New York
Constitution by a majority vote and then another majority vote following an
election. If so proposed, the amendment becomes valid if agreed to by the
voters at a referendum. The session laws are published in the official Laws of
New York. The permanent laws of a general nature are codified in the
Consolidated Laws of New York.
https://www.budget.ny.gov/citizen/structure/structure.html#legislative
New York State Assembly
http://assembly.state.ny.us/ Use this
address to reference the home page and
find out who your assembly member is.
There are 150 assembly members – based
on equal number of constituents -129,652.
Sheldon Silver is the current speaker of the
house with a number of leadership positions
built into the assembly system.
NYS Senate
http://www.nysenate.gov/ Use this address to reference the home
page and find out who your NYS Senator member is.
The New York State Senate, under the State's first Constitution
which was adopted in 1777, consisted of 24 members, elected
from and by the freeholders of the state possessing one hundred
pounds over and above all indebtedness. Since that time there
has been a number of reapportioning, the last being in 2002.
There are currently 62 NYS Senators.
Key leaders include: Dean G. Skelos –Republican Conference
leader. Jeffrey D. Klein – Independent Democratic Conference
leader and Andrea Stewart-Cousins –Democratic Conference
Leader
http://www.nysenate.gov/
What the NYS Senate does
In addition to passing legislative proposals and NYS
constitutional amendments, the Senate confirms or
rejects nominations made by the Governor for
particular State and judicial offices. It also sits at
times as a court of impeachment, and can be
convened in extraordinary session to perform either
of these functions.
Current Federal Acts that govern
supplements, formula, and health care
The Dietary Supplement Health and Education Act of
1994
(DSHEA)
Definition - A dietary supplement is any product which contains one or more
dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino
acids or other ingredients used to supplement the diet. Dietary supplement
ingredients may not be regulated as food additives.
Safety- The legislation maintains FDA's authority to safeguard the public against
any unsafe product. A dietary supplement can be removed from the market if
FDA shows that it presents "a significant or unreasonable risk of illness or injury" or
that it contains "a poisonous or deleterious substance which may render it
injurious to health." FDA can act immediately against any product that presents
an "imminent hazard to public health or safety."
New Products - Before marketing a new dietary ingredient, a manufacturer must
supply FDA with adequate information to provide "reasonable assurance that the
ingredient does not present a significant or unreasonable risk of illness or injury."
This information must be supplied at least 75 days before marketing. A "new
dietary ingredient" is one that is first marketed after October 15, 1994.
http://www.crnusa.org/leg.html#dshea
Additional organizations monitoring the use of
supplements, food and drug




National Center for Complementary and
Alternative Medicine (NIH) http://nccam.nih.gov/
Office of Dietary Supplements (ODS), National
Institutes of Health (NIH) http://ods.od.nih.gov/
U.S. Food and Drug Administration (FDA)
http://www.fda.gov/
Center for Food Safety and Applied Nutrition
(CFSAN)
http://www.fda.gov/AboutFDA/CentersOffices/Offi
ceofFoods/CFSAN/
Federal Acts and formula

Regulated by the Food and Drug Administration
(FDA)under the Food, Drug, and Cosmetic Act of 1938
(Pub. L. 75-717, 52 Stat.1040)
 In 1972 The FDA made the decision to take specialty
formulas off of the drug list based on the following:
 The formulas were widely accepted by the
medical community as treatment.
 Medical supervision of their use ensured patient
safety.
 It would promote innovation by formula
manufacturers.
 Assurance was given that the products would be
available at a reasonable cost to the consumer.
Morgan & Baggott, 2006; Marra, 2012
New York State response
formula coverage

In the early 1990’s patients and families living
with inborn metabolic diseases joined
together to push for state legislation that
would mandate the coverage of formula for
patients with these conditions as well as the
coverage of diabetes supplies.

In 1997 revision to the NYS insurance law § 3221
Article 43 provided for the coverage of formulas
for the treatment of inborn metabolic diseases,
diseases of gastrointestinal issues, and severe
food allergy.
Timing is everything
During this period of time The Welfare Reform Act
had placed the individual states in a position that
would require them to lose grant as aid monies that
was covering many patients with inborn metabolic
diseases, diabetes and malabsorptive issues
through primary or secondary Medicaid.
This piece of legislation was good not only for the
patients but for the state as it mandated insurance
companies to cover the cost of these chronic and
often expensive treatments.
Marra, 2013
The Employee Retirement Income
Security Act of 1974 (ERISA)
What does this have to do with insurance?
PLENTY!
This federal act allows employers who
provide employees with self-insured health
policies to opt out of all state mandates.
NYS has been a leader with regard to
legislating health care reforms which are
negated under ERISA.
The Affordable Health Care
Act
Affordable care act: pros and
cons
PROS:
19-26 year olds can be covered on a parent’s health plan.
 Individuals with a pre-existing condition can’t be denied
coverage.
 The federal government will assist individual states to pay for the
coverage of those who can’t afford coverage.
 The CBO projects that individuals being treated earlier for chronic
conditions could save insurance companies and the country $$
 Closing the “donut hole” for medications and Medicare.
 No caps – good for patient but tough on the economic wallet.
CONS:
 Did not address rising health care costs. Particularly Rx and
technology.
 Shortage of health care professionals to see the influx of patients –
particularly PCPs
 Higher drug costs in response to dealing with the “donut hole.”
 Cost of covering pre-existing conditions and technology has
been cited as a concern for rising costs.
 Insurance costs (premiums, coinsurances, copays)for individuals
in the general market will rise to compensate.

http://www.cbo.gov/taxonomy/term/45/featured
Comparison family coverage
before and after the AHCA
Pre AHCA







Office visits – PCP 20
Office visits specialist 30
Urgent Care
30
Emergency room 250
Hospitalization 500
Medication 10/20/40 through
local pharmacy
No co-insurance
Post AHCA







Office visits – PCP 25
Office visit specialist 40
Urgent care
40
Emergency room 500
Family deductible 2500
In network co-insurance 20%
Out of network 40%
Meds – Maintenance RX
through mail order. Multiple
issues -Variability noted with
cost savings. Some meds
not heat stable. Changed
before the 90 day renewal.
Is rising health care cost
real or imagined?
“Although a median-income US family of four with employer-based health
insurance saw its gross annual income increase from $76,000 in 1999 to
$99,000 in 2009 (in current dollars), this gain was largely offset by increased
spending to pay for health care. Monthly spending increases occurred in
the family’s health insurance premiums (from $490 to $1,115), out-of-pocket
health spending (from $135 to $235), and taxes devoted to health care
(from $345 to $440). After accounting for price increases in other goods and
services, the family had $95 more in monthly income to devote to nonhealth spending in 2009 than in 1999. By contrast, had the rate of health
care cost growth not exceeded general inflation, the family would have
had $545 more per month instead of $95—a difference of nearly $5,400 per
year. Even the $95 gain was artificial, because tax collections in 2009 were
insufficient to cover actual increases in federal health spending. As a result,
we argue, the burdens imposed on all payers by steadily rising health care
spending can no longer be ignored.”
A Decade of Health Care cost Growth Has Wiped Out Real Income Gains
For An Average US Family D.I. Auerbach and A.L. Kellermann Health Affairs
September 2011
Mito Legislation
Massachusetts House Bill 977
In 2007, MitoAction introduced a bill to the Massachusetts legislature to
mandate coverage of vitamins and supplements for all mitochondrial
disease patients in the state of Massachusetts. Over the past seven years,
representatives from MitoAction, the patient community, and the Medical
Advisory Board have continued to champion this bill through the legislative
process.
In 2012, a committee was formed within MitoAction and representatives
from UMDF, Solace Nutrition, America's Compounding Center, Acton
Pharmacy, Epic4Health, and the medical community were invited to join to
address the issues surrounding coverage of the Mito cocktail.
In 2013, a cost-benefit analysis was completed by Compass Health, which
determined that the cost of coverage would be pennies per resident if the
legislation were passed.
Now, in March 2014, the bill is going before the financial committee for
review.
http://www.mitoaction.org/house-bill-977
The power of collective data
patient registries
Numbers!
The Importance of Patient Registries in
improving care and outcome
UMDF sponsored registry
http://www.umdf.org/site/apps/nlnet/content2.aspx?c
=8qKOJ0MvF7LUG&b=7933761&ct=14160299&notoc=1
Mayo Clinic Mitochondrial Disease Biobank
http://www.mayo.edu/research/centersprograms/mitochondrial-disease-biobank/overview
MDA Sponsored Mito registry
http://mda.org/quest/mitochondrial-disease-registryseeks-participants
Orphanet
http://www.orpha.net/consor4.01/www/cgibin/ResearchTrials_RegistriesMaterials_Simple.php?lng=
EN&LnkId=3377&Typ=Pat&fdp=y&from=rightMenu
Where do we go from here?
Personal action plan



If you are not part of the current lobby effort for
Mito contact UMDF to find out more
Find out more information regarding the Mito
specific registries
If you are not a registered voter then become one


If you are find out who your national
representatives are and where they stand with
regard to proposed Mito legislation and ask them
to sign on.
Let you state legislators know about your personal
story and how Mito has negatively influenced your
life. Use the guidelines set up by UMDF to assist
you.
Group Action plan




Find others in the Mito community that are
willing to participate in lobby day events.
Consider attending the capital hill day next
June. Numbers speak.
Be active in promoting Mito in a positive
fashion that would draw others to more about
the condition.
Participate in registries – guides research, best
practice, and will work to get current
treatments recognized as billable therapies.
Ex. enzyme therapy for CF
So this means using a little
muscle
And possibly more time than
you thought
And working a little harder
than you anticipated
But you can’t have a finish without a
Thank you to all the organizations that have laid
the ground work
 Mito
Action
 UMDF
 MDA
Locally
• Mito Hope and Help
• Amanda’s Journey Foundation
• The Thomas Patrick Morrison Foundation
• The Albany Medical Center