The initiative, the biggest expansion of Medicare since its creation in 1965, proved wildly popular. It now serves more than 35 million people, delivering critical medicines to patients who might otherwise be unable to afford them. Its price tag is far lower than expected.
But an investigation by ProPublica has found the program, in its drive to get drugs into patients' hands, has failed to properly monitor safety. An analysis of four years of Medicare prescription records shows that some doctors and other health professionals across the country prescribe large quantities of drugs that are potentially harmful, disorienting or addictive. Federal officials have done little to detect or deter these hazardous prescribing patterns.
Searches through hundreds of millions of records turned up physicians such as the Miami psychiatrist who has given hundreds of elderly dementia patients the same antipsychotic, despite the government's most serious "black box" warning that it increases the risk of death. He believes he has no other options.
Some doctors are using drugs in unapproved ways that may be unsafe or ineffective, records showed. An Oklahoma psychiatrist regularly prescribes the Alzheimer's drug Namenda for autism patients as young as 12; he says he thinks it calms them. Autism experts said there is scant scientific support for this practice.
The data, obtained under the Freedom of Information Act, makes public for the first time the prescribing practices and identities of doctors and other health-care providers. The information does not include patient names or the reasons why doctors prescribed particular drugs, so reporters interviewed the physicians to learn their rationales.
Medicare has access to reams of data about its patients, their diagnoses and the medical services they received. It could analyze all of this information to determine whether patients are being prescribed appropriate drugs for their conditions.
But officials at the Centers for Medicare and Medicaid Services say the job of monitoring prescribing falls to the private health plans that administer the program, not the government. Congress never intended for CMS to second-guess doctors - and didn't give it that authority, officials said.
"CMS's payments don't go to physicians, don't go to pharmacies. They go to plans, which is how our oversight framework has been established," Jonathan Blum, the agency's director of Medicare, said in an interview. The philosophy "really has been to defer to physicians" about whether a drug is medically necessary, he said.
Asked repeatedly to cite which provision in the law limits their oversight of prescribers, CMS officials could not do so.
The Office of the Inspector General of the Department of Health and Human Services has repeatedly criticized CMS for its failure to police the program, known as Part D. In report after report, the inspector general has advised CMS officials to be more vigilant. Yet the agency has rejected several key recommendations as unnecessary or overreaching.
Other experts in prescription drug monitoring also said Medicare should use its data to identify troubling prescribing patterns and take steps to investigate or restrict unsafe practitioners. That's what state Medicaid programs for the poor routinely do.
"For Medicare to just turn a blind eye and refuse to look at data in front of them . . . it's just beyond comprehension," said John Eadie, director of the Prescription Drug Monitoring Program Center of Excellence at Brandeis University.
"They're putting their patients at risk."
Although Medicare hands responsibility to private insurers, experts say they are ill-equipped for the task. Insurers have access solely to the prescriptions for their members - not to a provider's prescriptions across multiple health plans.
Only Medicare can see that.
"A red flag can turn out to be nothing, or it can turn out to be something really, really horrible," said Kathryn Locatell, a California physician who specializes in geriatrics and elder abuse. "You won't know unless you flag it."
In lawsuits and disciplinary records, state and federal authorities cite a number of reasons that doctors prescribe improperly. Some run mills where patients get prescriptions if they pay cash for a visit. Others have relationships with drug companies that influence what they prescribe. Regulators say some doctors choose inappropriate medications under pressure from families or facilities.
Research also shows that doctors often don't keep up with the latest studies and drug warnings.
ProPublica's examination of Part D data from 2007 through 2010 showed that, in many cases, Medicare failed to act against providers who have been suspended or disciplined by other regulatory authorities.
Doctors barred by state Medicaid programs for questionable prescribing remain able to dole out the same drugs under Medicare. So can dozens of practitioners who have been criminally charged or convicted for problem prescribing, or who have been disciplined by state medical boards.
The Part D records detail 1.1 billion claims in 2010 alone, including prescriptions and refills dispensed. ProPublica has created an online tool, Prescriber Checkup, to allow anyone to search for individual providers and see which drugs they prescribe.
About 70 providers each churned out more than 50,000 prescriptions and refills in 2010, the data show, averaging at least 137 a day.
A few had high tallies because they work in institutional settings, such as nursing homes, or operate busy clinics. In other cases, doctors said they think the prescriptions of their colleagues were attributed to them. They acknowledged in interviews that their numbers should have sparked questions.
Some families say they, too, think Medicare should be paying closer attention.
When 79-year-old Mable "Nanny" Webb's family put her in a nursing home near Fort Worth in 2004 to rehabilitate her back, she came under the care of Adolphus Ray Lewis, who would later become one of Medicare's busiest prescribers.
Records show that the Texas medical board temporarily restricted Lewis's license in 1998 for improper prescribing of painkillers and that he was sued repeatedly for malpractice. But Webb's family didn't know that.
While under Lewis's supervision, Webb developed a urinary tract infection that went untreated and was given a painkiller in doses that were excessive and dangerous for her condition, court testimony shows. Within a month, she died.
Webb's relatives sued. During the 2008 trial, Lewis admitted responsibility for her death, testifying that he had not reduced the dosage ordered by a nurse he supervised.
A jury ordered Lewis to pay $1.6 million in damages to Webb's relatives. They later settled for a lesser amount - one of at least eight malpractice settlements in cases involving Lewis since the mid-1990s, according to court records and interviews.
Yet Lewis continued to prescribe, racking up nearly 99,000 Medicare prescription claims including refills in 2010, fifth-most in the country. He wrote 46,000 more under Medicaid that same year. He declined to comment for this article.
Webb's granddaughter, Michelle Wheeler, said that though it's too late for her family, information about a doctor's drug choices could help others decide who should care for their loved ones.
"Everybody should be able to know that," she said.
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Medicare Drug Program Putting Seniors, People With Disabilities At Risk