7/15/2012
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Newborn Screening
Saves Babies
One Foot At A Time
FAO & OAA Conference – Portland, OR July 20-21, 2012
Kathleen Huntington, MS, RD, LD Metabolic Clinic/Child Development & Rehabilitation Center
Oregon Health & Science University Portland, Oregon
Resolving The Paradox Optional Medical Food Reimbursement
vs Mandatory Newborn Screening
Medical Food Reimbursement Paradox
BUT Insurance Coverage for Treatment Is
Typically Denied
In the United States We Screen Babies For Rare
Conditions That Are Treatable
P A R A D O X one exhibiting inexplicable or contradictory aspects
All 50 States Mandate Expanded
Newborn Screening
~ 15 Inherited Metabolic Disorders Require Medical Nutritional Therapy
Only 16 States Mandate Treatment Coverage For All Screened Inherited Metabolic Disorders
out of 38 States That Have Passed Medical Food Legislative Mandates
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38 States Have Passed Treatment Mandates for Either State
or Private Payor Plan Coverage
• 1983- (1) Wisconsin
• 1985 – (1) Minnesota
• 1988- (1) Washington
• 1991- (1) Alaska
• 1992- (1) S.Dakota
• 1993-(1) Massachusetts
• 1995- (4) Maryland, Maine,
Florida, New Hampshire
• 1996- (2) Tennessee,
Pennsylvania
• 1997- (7) Connecticut, New
Jersey, New York, Nevada,
Oregon, Kansas, North
Carolina
• 1998 (3) Vermont, Utah, Nebraska
• 1999 (5) Arkansas, California Hawaii, Montana, Texas
• 2000 –(1) Arizona,
• 2001 (4) N.Dakota, Louisiana, Colorado, Virginia
• 2002- (2) Missouri, Kentucky
• 2003 –(2) New Mexico, Indiana
• 2007 – (1) Delaware
• 2008 – (1) Rhode Island
3- 1980’s 24 –1990’s
11 – 2000’s
Examples of State Mandate Differences
Mandate Passed: 1996 Disorder Covered: PKU only Medical Food: Formula only
Mandate Passed: 1997 Disorder Covered: All IEM Medical Food: Medical Protein, Low Protein Med Foods & Other Modules
9 Yrs old Diagnosis: PKU •Age based DRI : 34 Grams Protein • Estimated Energy: 1950 Calories •Tolerates 300 mg of Phenylalanine Per Day (= 6 grams protein) Provides ~ 450 calories
Case Example
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Cost/yr: $8,550 wholesale
1500 Calories
Medical Protein Formula
Natural Foods 23% 450 Calories
Modified Low Protein 44%
866
Med Formula + Low Protein Med Foods
Cost/yr: $6,750 wholesale
Calorie Distribution Calorie Distribution
1950 Calories 1950 Calories
Med Formula Only
Medical Formula 33% 634 Calories
Natural Foods 23% 450 Calories
38 State Medical Food Mandates & What They Mandate
0 10 20 30
All Disorders
Select Disorders
PKU Only
Formula + Low Protein Foods
Formula Only
16
16
6
28
10
Number of States
Typ
es o
f C
ove
rage
Since 2000, 11/38 mandates have been passed, 9 include coverage of low protein foods
No Tx Mandate PKU Tx Only Tx Select Disorders
16
Tx All Disorders
16 6 12
Mandate Distribution State by State
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Medical Food Reimbursement What’s Not Working
Lack of a State Mandate
or Dissimilar State Laws
ERISA
HCPC Codes
Make Healthcare Coverage An Uphill Battle
& Inconsistently Available
“In the absence of a specific inclusion or state mandate, …Aetna does not
cover specialized formula. It is determined that there is no applicable state mandate in this case because of the Washington State self-insured origin of this plan”.
Denials, Delays & Underinsurance
Undermines Preventive Healthcare
Medical Food Reimbursement What’s not working
Lack of a State Mandate or
Dissimilar State Laws
ERISA
HCPC Codes
Make Healthcare Coverage
An Uphill Battle
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ERISA Employee Retirement Income Security Act 1974
Original intent—regulate pension plans & address problem of conflicting regulations across the nation.
Its scope came to include health care provided as part of an employee’s benefit package
ERISA Employee Retirement Income Security Act 1974
Section 514 – allows ERISA to preempt any state regulation of employment benefits to facilitate uniformity to help keep national administration costs down and variation out .
--- Eliminated the state role in
regulating employee benefit
plans provided by self-insured
employers
ERISA Employee Retirement Income Security Act 1974
ERISA
ERISA
ERISA
ERISA
ERISA
ERISA
Nearly six in ten American private and public sector workers covered by employer-provided health care in 2010 were covered under a self-insured plan, up from about four in ten in 1999.
[Employer Health Benefits: 2010 Annual Survey sponsored
by the Kaiser Family Foundation and Health Research and Educational Trust (―KFF study‖) http://ehbs.kff.org/]
2010
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Medical Food Reimbursement What’s not working
Lack of a State Mandate
or Dissimilar State Laws
ERISA
HCPC Codes
Make Healthcare Coverage
An Uphill Battle
HCPCS – B Codes Enteral Nutrition
Purpose: Products listed under the B codes primarily revolve around malnutrition & malabsorption
Fee Schedule :
100 calories/unit
Product System:
Formulas, solutions, pumps, disposables
Enteral Nutrition - A form of nutrition that is delivered into
the digestive system as a liquid
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Current Medical Food Reimbursement Codes
B4155 -- Incomplete/Modular Nutrients . Includes carbohydrates (e.g. glucose
polymers) proteins/amino acids (e.g. glutamine, arginine) ,fat (e.g. medium chain triglycerides) or combination
B4157 -- Enteral formula nutritionally complete, for special metabolic needs for inherited disease of metabolism
B4162 -- Enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism
Both include Proteins, Fats, Carbohydrates, Vitamins and Minerals, may include Fiber
All 3 specify --- Administered through an enteral feeding tube 100 calories = 1 unit
Add the BO modifier to the HCPC if the product is being administered orally and not by a feeding tube.
HCPCS For Unique Applications -- but Not Used Universally
S9435 -- Medical Foods for Inborn Errors of Metabolism
S9434 -- Modified Solid Food Supplements for Inborn Errors of
Metabolism
● < 1 gram of protein/serving
● Does not include natural food naturally low in protein
● And/or prescribed by a physician
HCPCS For Unique Applications -- but Not Used Universally
S9435 -- Medical Foods for Inborn Errors of Metabolism
S9434 -- Modified Solid Food Supplements for Inborn Errors of
Metabolism
The S Codes for reporting • Drugs • Services • Supplies
For which there are no national codes & for meeting the particular needs of the private sector
These codes -- •Used by the Medicaid program •Not payable by Medicare.
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HCPCS For Unique Applications -- but Not Used Universally
S9435 -- Medical Foods for Inborn Errors of Metabolism
S9434 -- Modified Solid Food Supplements for Inborn Errors of
Metabolism
CURRENT HCPCS DON’T WORK for Inherited Disorders of Amino Acid Metabolism
100 Calories = 1 Unit Malabsorption and Malnutrition Are NOT The Issue
A New HCPCS Should Reference the Clinical Purpose of the Enteral Product
for Inherited Disorders of Amino Acid Metabolism
1 Gram of Protein = 1 Unit
Medical Protein Product is Allocated Based on Protein Content NOT
Calories
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HCPCS That Don’t Apply
Create Opportunities
for Insurance to say NO
Insurance Policy
Not Allowed Not Covered
No Way No How
In turn requires time consuming appeals
Generally, to be considered a medical food, a product must meet the following criteria:
a) The product is a food for oral or tube feeding; b) The product is labeled for the dietary management of a medical disorder, disease, or condition; and c) Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods are to be used under medical supervision. d) The term "medical foods” does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in its natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. 1. U.S. Food and Drug Administration, Compliance Program Guidance Manual, Chapter 21– Food Composition, Standards, Labeling
and Economics 2. Frequently Asked Questions About Medical Foods Federal Register,60663,1996 FDA, Office of Nutritional Products May 2007
The Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HPCS) coding identifies that
administration of enteral therapy must be given by feeding tube – nasogastric, jejuno- stomy or gastrostomy tubes.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads//ncd103c1_Part3.pdf
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We Need HCPC Reimbursement
Codes That Bridge the Gap
2010: Medical food mandates increase the cost of
a health insurance policy by less than 1%.
http://www.cahi.org/cahi_contents/resources/pdf/MandatesintheStates2010.pdf
Mandated Benefit Definition
PKU/Metabolic Disorders
Inherited metabolic diseases such as … PKU, which is a genetically determined abnormality caused by a missing enzyme called phenylalanine hydroxylase.
Mandate provides for evaluation, education, treatment and supplies like formula or special foods.
Council for Affordable Health Insurance
(Active advocate for market-oriented solutions to the problems
in America’s health care system)
Infant Formulas Typically Used for
VLCAD, LCHAD & TFP
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Medical Food Options for those 1 year – Adulthood
DX (Incidence
/yr)1,2
Average Cost
Per Infant
Year
Average
Cost Per
Year for
180
Average
Cost per
Person
1-10 yr old
Cost of Tx
for 1-10 yr
old/yr
Long-Chain 3 Hydroxyacyl CoA
Dehydrogenase
(LCHAD)
20
\
$3,650
$660
Thousand
$1,800
$3.6
million
Tri Functional Protein Deficiency
(TFP) 20
Very long-chain acyl-coenzyme A
dehydrogenase
(VLCAD) 140
Total 180
180
Infants
1800
Dx
(total of
10 yrs)
Estimated costs for treating a one year cohort of infants
with a Fatty Acid Oxidation Disorder
based on incidence of disease by NBS.
1.McHugh et al, 2011; Genet Med.13:230–54 2.Das AM et al, 2006 Clin Chem. 52: 530-534
Organic Acidemias, Incidence, Average Medical Food Tx Cost
Newborn Screening Diagnosis Incidence/Yr1
PKU 300
Propionic Acidemia 20 MMA MUT 20 Isovaleric Acidemia 20 Glutaric Acidemia (GA1) 40
OAA Total 100 1. Weaver MA et al, 2010, Gen in Med. 12 (6) 364-369.
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IEMs & Incidence
Inborn Errors of Metabolism Incidence/Yr1,2
PKU 300
Organic Acidemias 100
FAOs 180
Homocystinuria 25
Maple Syrup Disorder 25
Tyrosinemia Type 1 15
Urea Cycle 140
Total ~800 1. Weaver MA et al, 2010, Gen in Med. 12 (6) 364-369. 2. http://www.ncbi.nlm.nih.gov/books/NBK1217/ 3. McHugh et al, 2011; Genet Med.13:230–54 4. Das AM et al, 2006 Clin Chem. 52: 530-534
Organic Acidemias, Incidence, Average Medical Food Tx Cost
Newborn Screening Diagnosis
Range of Wholesale Medical Protein Costs per age based protein requirements
Infancy AVERAGE Adult
PKU $1,125 $4,700 $8,525
Propionic Acidemia $1,900 $6,200 $11,000
MMA MUT $1,900 $6,200 $11,000
Isovaleric Acidemia $2,000 $6,700 $12,500
Glutaric Acidemia (GA1) $1,950 $6,400 $11,450
OAA AVERAGE $6,400 1. Weaver MA et al, 2010, Gen in Med. 12 (6) 364-369.
Inborn Errors of Metabolism
Wholesale Costs for Medical Formulas or Medical Protein
Total Costs/yr
For Infants
Total Costs/yr for 1 yr-
10 years
Total for All
Amino Acids Disorder,
Organic Acidemias (500/yr) $900,000 $24,075,000 $24, 975,000
(5,000 total)
FAOs (180/yr) $657,000 $2,916,000
$3,573,000
(1,800 total)
Urea Cycle (140/yr) $168,000 $2,268,000
$2,436,000
(1,400 total)
Total
$1,725,
million
$29,259
million
$30,984 million
(8,200 total)
Estimated Costs for Patients Infants + Previous 9 years
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Medical Food Tx Costs vs Total Healthcare $ Per Year in US
Total = $2.3 Trillion Source: Martin A.B. et al., “Growth In US Health Spending Remained Slow in 2010; Health Share of Gross Domestic Product Was Unchanged from 2009,” Health Affairs, 2012.
$30,984 million is a little more than 1000th of 1% of of $2.3 Trillion
Options for Fixing the Problem
Legislative
Policy
Advocacy
Medical Foods Equity Act Co-Sponsors
6 Senators Incl: 1- NJ, 2-NY, 1-DE, 1- CT. 1-PA 17 Representatives Incl: 1-CA, 1-CO, 1-DE, 2-FL, 2-GA, 1-IA, 1-IL, 1-MA, 1-MD, 1-NY, 1-OH, 1-OR, 2-Tx, 1-VA -
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Section 3: Coverage in federal health programs of medically necessary food and food modified to be low protein
Coverage under the Medicare Program
Coverage under the Medicaid Program
Coverage under CHIP
Coverage under TRICARE
Section 4: Coverage in the private insurance market of medically necessary food and food modified to be low protein
Coverage under group health plans (including ERISA)
Coverage for plans sold in the individual market
Included in the definition of essential health benefits for qualified health plan
Medical Foods Equity Act 2011– Summary Sen. John Kerry
Affordable Care Act
http://hcafnews.com/tag/patient-protection-and-affordable-care-act/
December, 2011, the Department of Health and Human Services (HHS) issued a “pre-rule bulletin” announcing its decision to offer “flexibility” to the states in the selection of essential health benefits. There will be no national set of essential health benefits. Each state can choose its essential health benefits from the following four choices: 1. The largest plan by enrollment in any of the three largest
small group insurance products in the State’s small group market 2. Any of the largest three State employee health benefit plans by enrollment 3. Any of the largest three national FEHBP plan options by enrollment 4. The largest insured commercial non-Medicaid Health Maintenance Organization (HMO) operating in the State.
Each State Must Rally to Include Medical Foods and Modified Low Protein Foods as EHBs
Option 2: Maximize the Preventative Potential of the
Newborn Screening System
Pass the Medical Foods Equity Act
Include Medical Foods as Essential Benefits
Update the HCPCS To Reflect Clinical Purpose
ERISA
Act as if what you do makes a difference. It
does. Will James
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Newborn screening is just the first
step…….
It’s a long road of many coordinated
events and many years of
challenges for the individual family
-- but coverage for treatment
shouldn’t be so difficult to access.
Let’s get rid of the obstacles!