Carving out a role for the dietary supplement industry in health care reform has taken on a double-edged approach. While supporting legislation focused on establishing spending on supplements as health care expenses, the industry also backs including wellness and prevention programs in health care reform plans.

On the legislation front, Rep. Dan Burton introduced a bill to make dietary supplements eligible as deductible medical expenses.

And in reform discussions, health policy experts acknowledge the importance of nutritional supplements to wellness and prevention.

Right Time For Legislation?

Language in Burton's Dietary Supplement Tax Fairness Act of 2009, H.R. 3263, appeared in previous legislation, but not when health care reform was a top priority for Congress and the White House.

The Indiana Republican's ¹ bill, introduced July 20, would amend the Internal Revenue Code to categorize supplements, foods for special dietary use and medical foods as medical expenses provided that the products "comply with applicable good manufacturing practices prescribed by [FDA] or with other comparable standards."

However, government affairs executives in the supplement industry say Burton's bill is likely too broad to move in Congress. Instead, they anticipate separate legislation that aims to allow purchases of supplements and meal replacement products to be covered under flexible spending arrangements and only if the products are eligible for a full or qualified health claim.

That bill, the Tax Equity for Meal Replacements and Supplements Act of 2009, is slated to be introduced by Reps. Earl Blumenauer, D-Ore., and Ginny Brown-Waite, R-Fla. Both sit on the House Ways and Means Committee, which has jurisdiction over FSAs and other types of pre-tax accounts.

Daniel Fabricant, interim executive director and CEO of the Natural Products Association, said the sponsors seem to have momentarily pulled back on the FSA-based legislation as health care reform overall has "somewhat stalled."

Media reports indicated July 23 that the Senate has abandoned plans to hold a vote on a health care bill before Congress' August recess.

However, Fabricant added, when the broader agenda regains momentum, language relating to tax benefits and supplement purchases may be "tacked on."

A Burton spokesman confirmed the goal is to add H.R. 3263 as an amendment to a larger health care bill, though Democrats' control of the process will make it difficult for a Republican-sponsored measure to gain traction.

Nonetheless, Burton's legislation could have bipartisan appeal. House Oversight and Government Reform Committee Chairman Edolphus Towns, D-N.Y., sponsored a previous incarnation of the bill in 2007 (² Also see "Capitol Hill In Brief" - Pink Sheet, 26 March, 2007.).

Alternative Medicine A "Win-Win"

In a June 30 letter, Burton urges congressional colleagues to get on board with the complementary and alternative forms of medicine many U.S. consumers already use.

"Opening our health care system to alternative treatment methods will help patients, enhance conventional treatment options, generate new approaches and techniques for treating illness and help lower health care costs; a win-win for everyone," he writes.

Burton introduced H.R. 3263 with no co-sponsors, though his spokesman said his office is seeking support for the bill from members of the Dietary Supplement Caucus, which Burton co-chairs.

He offered a separate supplement-related bill July 20 -- the DSHEA Full Implementation and Enforcement Act of 2009, H.R. 3262, which would authorize appropriations for FDA activities related to the Dietary Supplement Health and Education Act, starting with $20 million in fiscal 2010 and ending with $65 million in fiscal 2014.

Burton and Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., a key supplement industry ally, introduced this language in legislation before, without success (³ 'The Tan Sheet' June 18, 2007, In Brief).

Industry stakeholders say DSHEA imposes sufficient controls over supplement manufacturing, but FDA does not have resources to execute the enforcement authorities the act provides.

Finding A Place In Wellness And Prevention

Mike Greene, senior director of government relations for the Council for Responsible Nutrition, pointed out there are myriad ways for nutritional products to find their way into health care reform.

"There is no specific dietary supplement vehicle" for cracking the legislative agenda, he said, adding that CRN would like to see the healthy living ideals of its "Life...supplemented" campaign codified in law (⁴ Also see "People In Brief" - Pink Sheet, 15 December, 2008.).

Still, CRN prefers that supplements enjoy the same fiscal benefits that characterize other medical products and procedures.

"It's very difficult to read the tea leaves on these legislative proposals," Greene said.

"I think as long as it accomplishes the final goal of providing Americans the tools to purchase the supplements they want and deduct them from their flexible spending accounts, then CRN would support that."

One version of the House's health care reform legislation, the America's Affordable Health Choices Act of 2009, H.R. 3200, establishes a prevention and wellness trust with funding through 2019, lays out a national prevention and wellness strategy and sets up task forces on clinical and community preventive services.

In the other chamber, Sen. Tom Harkin, D-Iowa, pushed for the wellness and prevention provisions included in the Affordable Health Choices Act the Health, Education, Labor and Pensions Committee approved July 15 (⁵ Also see "Sen. Harkin Defends DSHEA, Promotes Supplements In Health Legislation" - Pink Sheet, 20 July, 2009.).

The HELP bill establishes community-based demonstration projects to measure the health benefits and cost savings associated with calcium plus vitamin D, folic acid and fish oil supplementation.

Another bill, Sen. Kirsten Gillibrand's Improved Nutrition and Physical Activity Act, also takes a community-based approach for promoting nutrition in areas with high rates of childhood obesity. The New York Democrat introduced S. 1503 July 22.

Investments In Health Infrastructure

In a July 22 media conference call on health care reform, health policy scholars from the American Enterprise Institute for Public Policy Research said the U.S. should move away from inefficient insurance plans that cover too much and toward consumer-directed health care through greater use of health savings accounts and similar arrangements.

"What you really want is something that would incentivize the insurers to put consumers in much more control over what they spend, give consumers a lot more interest in cost-effective health care," said Jack Calfee, an economist and resident scholar at AEI.

AEI resident fellow Tom Miller, a former senior health economist for the Joint Economic Committee, said health care reform legislation contains numerous mentions of wellness and prevention programs as functions of the medical delivery system.

However, community programs are better facilitators for wellness programs, and emphasis should be refocused on broader community-based education to help establish healthier lifestyles across the U.S. population, Miller said.

While that might seem a boon for supplements under savings or reimbursement arrangements, Miller noted health care reform needs to find immediate, demonstrable cost savings -- something supplements do not typically evince.

Mandy Krauthamer of the Doctors for America health care reform advocacy group acknowledged the Congressional Budget Office does not measure the long-term benefits and cost savings associated with nutritional supplementation or other self-care.

While Miller said substantive changes in prevention and wellness policy could be stricken from legislation, Krauthamer said in an interview she sees bipartisan agreement on its importance.

"Most of the back and forth over what are we keeping, what are we getting rid of, is not around the prevention and wellness," said Krauthamer, DFA's policy director.

-- Dan Schiff (d.schiff@elsevier.com)

Legislation Seeks Space For Supplements On Health Care Reform Slate

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