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/2012/11/2012-election-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 rateshttp://

bipartisanpolicy.org/news/press-releases/2012/11/2012-election-turnout-dips-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 governmentUnder 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 LegislatureThe 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 Senatehttp://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 doesIn 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/OfficeofFoods/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 everythingDuring 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 non-health 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 registryhttp://www.umdf.org/site/apps/nlnet/content2.aspx?c=8qKOJ0MvF7LUG&b=7933761&ct=14160299&notoc=1 Mayo Clinic Mitochondrial Disease Biobankhttp://www.mayo.edu/research/centers-programs/mitochondrial-disease-biobank/overviewMDA Sponsored Mito registryhttp://mda.org/quest/mitochondrial-disease-registry-seeks-participants Orphanethttp://www.orpha.net/consor4.01/www/cgi-bin/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 MDALocally• Mito Hope and Help• Amanda’s Journey Foundation• The Thomas Patrick Morrison

Foundation• The Albany Medical Center