Feds approve Y's diabetes program despite drug maker opposition

WASHINGTON — Federal regulators will move ahead with a national test of Medicare coverage for a YMCA diabetes prevention program over the objections of the pharmaceutical industry, which sells drugs including increasingly expensive insulin to treat disease.

The final rule, announced Wednesday by the Centers for Medicare and Medicaid Services, is designed to speed Medicare coverage of a program to combat a disease  that a quarter of people 65 and older have. National trade associations representing hospitals and doctors enthusiastically supported CMS' plan in comments filed with the agency.

The Pharmaceutical Research and Manufacturers of America (PhRMA) trade group, however, said in its comments that CMS is setting a "flawed precedent" and acting upon only "preliminary" evidence. A federal contractor studied the program for at least two years and the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) analyzed it for about 20 years before that.

In 2002, an independent safety board advising NIH said it would be unethical to withhold such an effective treatment from the placebo group in a study of 3,000 patients.

When it comes to diabetes, time is money. Those on Medicare with diabetes cost the federal government nearly twice that of people who do not have the disease — or nearly $16,000 a year.

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Funding, focus lacking for health care that gets results

The Diabetes Prevention Program, now offered at about 1,000 Ys around the country, helped people at high risk of developing diabetes lose about 5% of their body weight — enough to substantially reduce their risk of developing diabetes. The program combines nutrition, fitness and lifestyle education over a four-month period.

CMS hopes to expand the program, which starts January 2018, to more Ys and other groups certified by the CDC.

"I thought it was going to be one of the biggest home runs we were going to hit," says CMS Acting Administrator Andy Slavitt. "Who could possibly be against preventing disease except for people who maybe manufacture drugs to fight disease?"

PhRMA spokeswoman Allyson Funk insists her group "supports diabetes prevention efforts and the Diabetes Prevention Program."  Drug makers have problems with how CMS is expanding the program, she says.

PnRMA's comments, however, challenged several aspects of CMS' proposal, including that it would reduce spending and improve health care.

The program's expansion is being done on a sort of  fast-track basis through CMS's Innovation Center, which was funded through the Affordable Care Act.  The diabetes program is the first "demonstration project" to be approved for Medicare coverage. The traditional path to Medicare coverage would be a "several year process," says Robert Ratner, a physician who was a contract investigator for NIH who began working on the diabetes program in the 1990s.

"All they (PhRMA) want to do is increase the bureaucratic process of getting this approved," says Ratner, now chief scientific and medical officer at the American Diabetes Association.

When data show a test like this improves the quality of health care, "we have the authority to expand it to the entire Medicare population," says Patrick Conway, a physician who heads innovation and quality at CMS. "If the innovation center did not exist and we couldn’t have done this test, this program may have never been available."

When compared with similar people not in the diabetes program, CMS said the estimated savings of $2,650 for each person enrolled in the Diabetes Prevention Program over a 15-month period was more than enough to cover the cost of the program.

About 30 million people in the United States now have type 2 diabetes, which leads to an average of two deaths every five minutes. Another 86 million are at high risk of developing diabetes, because one in every three adults have higher than normal blood glucose levels, known as prediabetes. Along with type 2 diabetes, people with prediabetes are at increased risk for developing heart disease and stroke. Many people with prediabetes develop type 2 diabetes within 10 years.

Conversely, the American Medical Association noted that it was an early supporter of the diabetes program and partnered with the national Y to encourage doctors to refer patients to the program. That partnership was the basis for the certification by CMS' actuary that was cited in the proposed rule.  The American Hospital Association also supported making the Medicare funding of the program permanent.

Although EpiPens have been getting most of the drug pricing attention lately, insulin prices have done their own skyrocketing.  Sen. Bernie Sanders of Vermont, a former Democratic presidential candidate, tweeted a statistic from a Washington Post article this week that the price of Eli Lilly's Humalog insulin was up 700% in the last 20 years. The price Medicare paid for the insulin Lantus in 2014 — the most recent year available — went up 41% for a total cost of $1.7 billlion that year.

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Ezekiel Emanuel, an oncologist who was health policy adviser at the White House as the ACA was drafted, says the diabetes program "is exactly the kind of prevention program we should all want tested and expanded."

"Is the data perfect?  No. But it is good and suggests savings in the thousands of dollars," says Emanuel. "Do we need more research especially to improve the program even more?  Yes...but the perfect should not be the enemy of the good. "

The diabetes program is "proven to improve quality of care. Improve health outcomes and lower costs.," says Conway. "That is something we should all be for."