In 2010, the "investigative journalist organization" known as ProPubilca, through donations from the Pew Foundation and several other organizations geared towards attacking industry, began the "Dollars for Docs" campaign. As we have covered extensively since the launch of that campaign, ProPublica aggregated the payment reporting data of approximately 15 manufacturers who were reporting their payments publicly—either as a requirement of a corporate integrity agreement (CIA) with HHS-OIG, or voluntarily—and then created a searchable, aggregated website.
Additionally, ProPublica teamed up with national and local media outlets and organizations to help other reporters create stories about their local physicians and payments they may have received from industry—most of the time only showing the potentially negative side of such payments, rather than discussing the tremendous value physician-industry collaboration holds. This campaign shows a future trend of things to come once CMS begins to make public physician and hospital payments under the Physician Payments Sunshine Act.
Unfortunately, the "Dollars for Docs" campaign was not the last stop for ProPublica. Several weeks ago, ProPublica launched a new project, known as the "Prescriber Checkup." This new initiative, authored mostly by the same people from the Dollars for Docs Campaign, allows anyone in the public to search for their doctor to see how much money their physician is reimbursed by Medicare Part D—the government's drug program.
According to a Frequently Asked Question (FAQ) document regarding the new initiative, the purpose of the Prescriber Checkup is to make it easy for patients to "search for doctors and other health providers who are active in Medicare's prescription drug program, part D." It allows patients to find out "how many prescriptions each wrote and which drugs were prescribed." It also allows people to compare their doctor to others in his or her specialty and state. ProPublica maintained that it is making this data, which it obtained under the Freedom of Information Act, available to "help consumers stay informed," and that until now, the "identities of doctors and the drugs they prescribed in Medicare Part D have not been public."
The prescribing data comes from pharmacies who transmit information to Part D plans about the patient, the prescriber, the drug, its strength and retail cost. The plans pay the claims and then submit the data to the Centers for Medicare and Medicaid Services, which oversees Medicare. The website allows people to:
- see whether or not a drug is commonly prescribed
- see which drugs other doctors frequently prescribe and compare them with medications you or a family member are taking or are considering.
- see whether your doctor is prescribing a drug that his or her peers do not routinely choose.
In comparing prescribers with their peers, the database lists a provider's "top drugs" ranked in "order of total claims." Adjacent to that provider's rank is the same drug's rank among all prescribers in the state with the same specialty. For example, a provider's No. 1 drug may be Lipitor, while for others in the specialty Lipitor ranks No. 12. When there are 10 or fewer prescribers in a specialty in a given state, no comparison rankings are shown. Only drugs prescribed at least 50 times by a provider are shown.
Patients can also search by drugs; ProPublica lists the 500 most-prescribed drugs in Part D, and if your drug is on the list, you can click to "view the top prescribers." The database also indicates whether the average length of a provider's prescriptions is higher or lower than normal. The Prescriber Checkup app indicates that a prescriber's average prescription length was significantly higher or lower from his or her peers if it was more than two standard deviations from providers in the same specialty and state for that drug.
In addition, a chart compares prescribers to others in their state and specialty. It compares providers to each of their peers and then calculates an average for each provider. So on the chart, when a provider appears far to the right from others, it means his or her drug preferences and volume markedly differ from others.
Interestingly, the publication of the Part D prescribing data comes almost simultaneous to a federal court in Florida vacating an injunction issued in 1979 that barred the Department of Health and Human Services (HHS) from disclosing certain Medicare claims data for physicians. As reported by MedPage Today and the American Health Lawyers Association (AHLA), on May 31st, 2013, the U.S. District Court for the Middle District of Florida vacated a decision involving the Florida Medical Association (FMA) and later the American Medical Association (AMA), which in 1979 sough to enjoin HHS' predecessor from releasing further lists identifying physicians or groups of physicians who received a certain level of Medicare reimbursements. HHS made such a disclosure in 1977 and amended its regulations that same year to specifically allow such disclosures.
In 1979, a Florida federal court granted an injunction in favor of physicians and other plaintiffs after finding that the disclosure was covered by Freedom of Information Act (FOIA) Exemption 6, which provides that FOIA "does not apply to matters that are . . . personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy," and therefore violated the Privacy Act. The injunction permanently enjoined HHS from disclosing any lists of annual Medicare reimbursement amounts for any years that would individually identify a recertified class of physicians. Florida Med. Ass'n v. Department of Health Educ. & Welfare, 479 F. Supp. 1291 (M.D. Fla. 1979).
Based on the recent vacated injunction, however, Medicare claim payment information, including physicians private information (including names, addresses, etc.) may now be published or at least publicly available for other people or groups to publish. One of the reasons the court vacated the 1979 decision was because that injunction was too broad, and the court noted that the vacating decision would not necessarily "trigger an immediate release of identifiable Medicare claims data." However, as this story shows—such payments are already public. The new case is Florida Med. Ass'n v. Department of Health, Educ. & Welfare, No. 3:78-CV-178-34-MCR (M.D. Fla. May 31, 2013).
Given the impending publication of payment information under the Physician Payment Sunshine Act, coupled with ProPubilca's new Prescriber Checkup site, it is likely only a matter of time before physicians and physician groups petition courts for further remedies to prevent this private personal and financial information from being disclosed—similar to what occurred with the STOCK Act. Moreover, now that Part D data is already available for physicians—at least for the FY 2010—it is already clear that DOJ, OIG, and CMS will have the ability to "data mine" Part D data with payments to physicians and teaching hospitals from drug and device companies to see if there are any improper influences, potential conflicts, kickbacks, and high or unusual rates of prescribing that may show a lack of medical necessity or other potentially improper behavior.
Prescriber Checkup
ProPublica obtained prescribing data from Medicare's prescription drug benefit, known as Part D, under the Freedom of Information Act. The data for 2010 includes 1.1 billion prescriptions written by 1.7 million doctors, nurses and other providers. The data does not include prescriptions that were written during hospital or short skilled nursing home stays because those are paid for under different parts of Medicare.
This database lists 350,000 of those providers who wrote 50 or more prescriptions for at least one drug that year. Nearly three-fourths went to patients 65 and older; the rest were for disabled patients. About 70 providers each churned out more than 50,000 prescriptions and refills in 2010, the data show, averaging at least 137 a day.
One of the problems with ProPublica's data, as they acknowledge, is that some prescriptions may be attributed to a doctor, but another prescriber is actually writing the prescription. For example, while Indiana physician Daniel J. Hurley led the country with more than 160,000 prescriptions under Part D in 2010, he told ProPublica that nursing home pharmacies "had credited him with prescriptions by other health professionals in his practice, a quirk Medicare should want to address."
ProPublica said it also received a list of only those prescriptions written for patients 65 and older in 2010, which allowed them to identify physicians who were prescribing drugs that are considered particularly risk for older patients—based on the American Geriatrics Society Beers list of drugs that may be inappropriate for seniors. CMS also provided data on the top 500 drugs prescribed nationally and in each state.
The data includes information from 2007 through 2010 about prescribing by physicians and other providers under Medicare's drug benefit program—but only data from 2010 is searchable at this time. This is the first time Medicare has released prescribing information with provider identities. ProbPublica claims that "No patient information was disclosed." Further, "In cases where a provider wrote 10 or fewer prescriptions for a specific drug, CMS removed some information to protect patient privacy."
Prescribers include any health professional who wrote a prescription that was filled by a beneficiary in Medicare Part D. For each provider and drug, the data includes the total number of claims, including refills dispensed, the retail cost of the drug, the days of supply and the number of units (i.e. pills or ounces). In addition to doctors, nurses, physician assistants, dentists and others with prescribing authority are included in the data.
CMS provided ProPublica with two different prescribing files for each year, allowing reporters to analyze the data in different ways. One file was broken down by provider ID and drug name. The other file was grouped by the first 9 digits of a standard code, called the National Drug Code, which is used to classify medications, and indicates the dosage strength of the drugs.
After consulting with "dozens of experts" in various fields, ProPublica used First Databank, a company that sells and analyzes health information, to classify drugs by category, such as narcotics or antipsychotics. Within each category, they "identified the highest prescribers and those whose drug choices were significantly different from other providers. They also examined prescribing patterns for many individual drugs. ProPublica used National Provider Identifier numbers—the same numbers that CMS will use under the Physician Payments Sunshine Act—to match prescribers with names, addresses, and other information about the prescribers, including their primary specialty.
One cause for the focus on antipsychotics is a May 2011 HHS-OIG report, which said that Medicare has not ensured that Part D paid only for drugs prescribed for FDA-approved and widely accepted off-label indications as federal law requires. About half of the 1.4 million antipsychotic prescriptions made to nursing home patients in the first six months of 2007 "were not used for medically accepted indications," the report said.
ProPublica also obtained a database of U.S. Drug Enforcement Administration registrations from the National Technical Information Service to identify providers who did not have an NPI but did have a DEA registration number.
In addition to these methods, ProPublica "interviewed many high-volume prescribers to better understand their patients and their practices." Some told ProPublica "their numbers were high because they were credited with prescriptions by others working in the same practice. I n addition, providers who primarily work in long-term care facilities or busy clinics with many patients naturally may write more prescriptions."
Prescribers also pointed out that the prescriber's drug choice varies based on the nature of his/her practice; the more patients over 65, the more drugs that may be prescribed. ProPublica also looked at prescriptions for narcotics and antipsychotics.
Each prescriber's profile page notes the total retail price of their drugs and the average price per prescription. These prices include patients' copayments and the amount reimbursed by Part D insurance plans. But the costs do not reflect confidential rebates that drug companies negotiate with insurers. As such, the listed price is likely higher than the final price paid. A report from the inspector general of the Department of Health and Human Services calculated overall manufacturer rebates of 19 percent for the 100 brand name drugs Part D spent the most money on in 2009.
Medicare Part D Failing to Monitor Prescribers "Putting Seniors, Disabled at Risk"
In a separate piece analyzing certain information from the new database, ProPublica asserted that CMS is not monitoring providers who prescribe "large quantities of drugs that are potentially harmful, disorienting or addictive", including antipsychotics and narcotics, and federal officials "have done little to detect or deter these hazardous prescribing patterns." They claim that CMS officials believe it is "not their job to look for unsafe prescribing or weed out doctors with troubled backgrounds."
"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. ProPublica, however, maintained that there was no provision in the regulations or statute that limits CMS' oversight of prescribers—and CMS officials could not point to a provision.
For example, ProPublica noted that in 2010, nearly 340 physicians and other providers accounted for more than 1,000 antipsychotic prescriptions each for patients 65 and older. CMS's Blum said his agency deserves credit for trying to reduce antipsychotic use in nursing homes, but CMS is not focusing on the doctors who prescribe risky drugs, "at this time."
Consequently, the piece analyzes several "alarm[ing]" findings after mining the data in the new Prescriber database. For example, searches through hundreds of millions of records turned up physicians such as Miami psychiatrist Fernando Mendez-Villamil, who's prescribing habits came to light in a 2009 letter from Sen. Charles E. Grassley (R-Iowa) to HHS Secretary Kathleen Sebelius. ProPublica reported that for Florida Medicaid alone, Mendez-Villamil had written more than 96,000 prescriptions for mental-health drugs from July 2007 to March 2009, more than anyone else in the program. ProPublica said that Mendez-Villamil believed "he had no other option."
Months later, in April 2010, Florida Medicaid expelled Mendez-Villamil without publicly revealing its reasons. An internal memo cited concerns about "the volume of patients being seen, and the medications being prescribed." Earlier this year, the Florida medical board accused him of giving patients as young as 3 a variety of mental health drugs without properly diagnosing or monitoring them. Despite these issues, ProPublica raised concern that Mendez-Villamil has remained in good standing with Medicare, wrinting 6,100 prescriptions for antipsychotics in 2009 and 5,500 more in 2010. Senator Grassley told ProPublica that it was "kind of ridiculous" that Medicare and Medicaid take such different actions.
The piece also raised concerns about another Miami psychiatrist, Enrique Casuso, who prescribed more antipsychotics to seniors in Medicare than any other physician in the country - 50 percent more than the second-ranking doctor. Three-quarters of the prescriptions were for a single brand, Seroquel, which Casuso said is "less evil" and has less-severe side effects than other antipsychotics. He told ProPublica that such prescriptions were necessary to "avoid a catastrophic event" and noted that often his patients "are beset with dementia and have been abandoned by their families in understaffed assisted-living facilities."
ProPublica raised issue with the prescriptions because there have been warnings from geriatric experts that the drugs do little to help the elderly sleep and that the medications increase the risk of confusion, falls and bone fractures. "Casuso said the pills allow his agitated patients to sleep," and his prescribing has not triggered any intervention from Medicare. However, Florida's Medicaid network removed him from the program because according to an internal memo, he was seeing up to 81 Medicaid patients a day in addition to non-Medicaid cases, and "[i]nvestigators found cases in which he lacked 'awareness or oversight of the medication prescribed."
Despite the fact that the drug has a black box warning for use in the elderly, which Casuso is aware of from notifications from CMS, he noted that he had nothing else to use. He also maintained that Medicaid removed him because the state did not want to pay for expensive drugs, and he explained that his "prescribing numbers are high because some insurers require two prescriptions if patients need a different-strength pill in the morning than at night."
ProPublica also raised concern about doctors shown to be prescribing drugs for off-label use or for uses that may be unsafe or ineffective. For example, they cited an Oklahoma psychiatrist who 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," ProPublica wrote.
With respect to narcotics, 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. For example, ProPublica found that Half of Medicare's top 20 prescribers of OxyContin in 2010 have been criminally charged, convicted or settled fraud claims, or have been disciplined by their state medical boards, records show. Similarly, eight of the top 20 prescribers of 30-milligram oxycodone pills - the strongest dose - have been charged, convicted or barred from prescribing controlled substances, or face discipline by licensing boards. Yet ProPublica noted that only one of those doctors has been barred from Medicare - and that wasn't until nearly a year after his conviction for drug trafficking and health-care fraud.
Additionally, the data analysis also showed widespread prescribing of drugs such as carisoprodol, which was pulled from the European market in 2007. In 2010 alone, health-care professionals wrote more than 500,000 prescriptions for the drug to patients 65 and older. The muscle relaxant, also known as Soma, is on the American Geriatrics Society's list of drugs seniors should avoid.
ProPublica also profiled Gerson Sternstein, 61, a Connecticut psychiatrist, consistently ranked among Medicare's most prolific OxyContin prescribers from 2007 to 2010. (OxyContin was reformulated in late 2010 to make it less prone to abuse.) Since 2009, at least five malpractice lawsuits have been filed in Connecticut accusing him of questionable prescribing. A state medical board investigation found that his count of painkillers and other controlled substances - for the 12 months beginning July 2008 - exceeded that of Yale-New Haven Hospital.
In revoking Sternstein's license in 2011, the board cited 10 cases in which he had given out painkillers inappropriately, including two in which patients died - one from opiate toxicity, the other from a heart condition that can be associated with drug overdose. In an e-mail, Sternstein said he was a specialist in treating patients whose pain could not be managed by anyone else. "I considered it my responsibility to try and help these individuals in their suffering," he said, noting that he faced no criminal action.
The article also discussed concerns raised by ProPublica about physicians prescribing under Part D but who had various legal actions against them. For example, Michael Reinstein, a Chicago psychiatrist, who works at various nursing homes for the mentally ill. They pointed out that Reinstein had been sued more than a dozen times since 2005 for malpractice involving patients who died.
From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and a brand-name version, FazaClo, with most going to disabled patients younger than 65. Although he wrote fewer prescriptions in 2010 - 14,000 - the number was still more than double the next-highest prescriber of these drugs. Reinstein was the Part D program's top prescriber of antipsychotics to seniors and the disabled over the four-year period analyzed by ProPublica.
What raised concerns for ProPublica was that the U.S. Department of Justice also filed suit against Reinstein last November, alleging that he prescribed certain medicines in exchange for speaking or consulting payments from their makers, Novartis, Teva Pharmaceuticals and Ivax Pharmaceuticals, which Teva acquired in 2006. The suit also accused him of submitting false claims to Medicare and Medicaid. The next day, the state medical board filed a complaint against Reinstein, and Illinois Medicaid suspended payments to him. But he remains able to prescribe in Medicare. That same month, Reinstein defended his prescribing to the Chicago Tribune, saying his use of clozapine was "the best choice" for his severely mentally ill patients. "I am confident that I will be vindicated," he said.
As a result, doctors barred by State Medicaid programs for questionable prescribing and practitioners charged or convicted for problem prescribing, or have been disciplined by state medical boards, remain able to prescribe drugs under Medicare. One problem ProPublica pointed out is that HHS-OIG has not been able to exclude these providers from participating in Medicare. "Criminal charges alone are not enough to bar a practitioner, said Don White, a spokesman for the inspector general. The office must exclude providers convicted of certain offenses, including fraud, and has discretion to do so if they have lost licenses. But White said his office relies on other agencies to flag these cases."
OIG and the Government Accountability Office (GAO) have both raised concerns that the Part D program lacks adequate oversight. ProPublica pointed to several reports showing Part D is vulnerable to fraud, such as insurers paying for prescriptions from doctors who were barred by Medicare. Separately, in 2007 alone, the program covered $1.2 billion worth of drugs prescribed by providers whose identities were unknown to insurers or Medicare, according to a June 2010 report.
Recommendations
One issue raised by ProPublica that is causing the lack of prescribing oversight is that Part D is different from other government funded health programs. Patients get their drugs through stand-alone drug plans, which cover only drugs, or through Medicare HMOs that also cover medical services.
Medicare pays private insurers a set amount per enrollee to run the program and pay for the drugs. "All the insurance plans are supposed to alert pharmacies to potentially harmful drug interactions, query doctors who prescribe high levels of narcotics to individual patients and be on the lookout for fraud, among other things." Medicare also expects the insurers to prevent inappropriate prescribing for individual patients. But it doesn't give them enough information or the tools to do that.
However, Medicare rarely allows insurers to reject drug claims and it "does not give the stand-alone plans access to their members' medical claims, making it nearly impossible for them to discern if patients have been given the wrong drug for their conditions." According to ProPublica, insurers "must pay for prescriptions from all providers - even those they believe are acting improperly - unless they have been formally excluded from the program. They are asked to refer questionable cases to Medicare's fraud contractor."
Based on ProPublica's reporting and consultation with various experts, the journalist group made the following recommendations:
- Regularly analyze data to identify high prescribers of drugs that are frequently abused, misused or particularly risky for the elderly. Search for those who prescribe drugs for patients outside the intended population, such as children and younger adults receiving Alzheimer's medications.
- Compare prescriptions with patient diagnoses kept by Medicare's separate hospital and physician programs. Check whether drugs are appropriate for patients' conditions and whether doctors are prescribing without actually seeing the patients.
- Require private insurers in Part D to report suspected fraud, waste and abuse to the contractor Medicare hires to look for fraud, a step recommended by the inspector general of the Department of Health and Human Services. Such sharing is now voluntary.
- Seek congressional authority to suspend prescribers from Part D if they have been indicted or arrested on prescription drug charges or if they present an imminent risk to patients.
- Require health providers to enroll in Medicare to have prescriptions covered by Part D. Enrollment requires providers to disclose past license sanctions and criminal convictions. Under the Affordable Care Act, Medicare can require enrollment in order to prescribe but it hasn't done so.
- Routinely get prescribing records from state Medicaid programs, as well as the names of providers whom those programs have terminated — especially for improper drug choices.
- Require diagnosis codes on prescriptions, at least for commonly abused or misused drugs, as some Medicaid programs now do and as recommended by the inspector general.
- Share prescribing information with state medical boards, which license and discipline doctors.
With respect to the requirement that prescriptions include a patient's diagnosis to allow Part D to monitor how drugs are being used, Medicare officials told HHS-OIG that it could not require this because neither state boards of pharmacy nor private industry requires this practice. Interestingly, however, some state Medicaid programs already have these safeguards in place. For example, Louisiana requires that doctors include diagnosis codes when they write prescriptions for painkillers and antipsychotics. Florida found that antipsychotics given to children younger than 6 dropped when specialists reviewed prescriptions.
Ultimately, ProPublica's new Prescriber Checkup program is just a glimpse of what is to come when CMS begins to post required payment information under the Sunshine Act. While it may be difficult for other media organizations to post such payments, ProPublica has already demonstrated in the path its willingness to reach out to other news outlets, and it is likely that government agencies may already begin using this data as a way to begin flagging suspect providers.
For now, physicians, hospitals and manufacturers should start applying the sunscreen.
