7/15/2012

1

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

7/15/2012

2

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

7/15/2012

3

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

7/15/2012

4

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

7/15/2012

5

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

7/15/2012

6

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

7/15/2012

7

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.

7/15/2012

8

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

7/15/2012

9

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

7/15/2012

10

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

7/15/2012

11

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.

7/15/2012

12

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

7/15/2012

13

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 -

7/15/2012

14

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

7/15/2012

15

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!