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
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
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.
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
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
"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
When data show a test like this improves the quality of health care, "we have the authority to expand to 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.
Although EpiPens have been getting most of the drug pricing attention lately, insulin prices have done their own skyrocketing.
"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."