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30 posts from June 2013

June 26, 2013

Physician Payment Sunshine Act: AMA House of Delegates Voice Concern over Accuracy and Potential Inclusion of CME Meals

Last week, we reported that the American Medical Association (AMA) would be discussing at its annual meeting in Chicago a number of important topics including the Physician Payments Sunshine Act

Modern Healthcare (subscription required) noted that officials from the Center for Medicare & Medicaid Services (CMS) attempted to reassure physicians at the meeting that "the burdens of reporting their connections to drug and devicemakers under the Physician Payment Sunshine Act would fall almost entirely on industry.

Bloomberg BNA quoted Anita Griner, CMS's deputy director for the Data Sharing & Partnership Group, who spoke to physicians at the meeting. She stated that "Data accuracy is the number one goal of our program." "We want the data put on the public website to be complete and accurate. We do not want it to be disputed. We do not want it to be inaccurate. We do not want to perpetuate any false information about a physician or teaching hospital. So data accuracy is key. And that will come from you tracking your own transfers and checking the website before it goes public.''

However, doctors at the AMA meeting expressed concern about "protecting their reputations after details of their business relationships get publicized."

"The media can really sensationalize this," said Dr. Lynda Young, a pediatrician from Worcester, Mass., and the former president of the Massachusetts Medical Society. Massachusetts is already posting information on physician relationships with pharmaceutical and medical-device manufacturers. When the information becomes public, "the media jumps on it," Young said during the Chicago meeting. 

Outgoing AMA president Dr. Jeremy A. Lazarus, said that AMA supports efforts that provide the public with additional transparency over financial relationships between the medical profession and players in the health industry. At the same time, Lazarus said data accuracy is paramount. "We want the law implemented appropriately and physician rights to challenge false or misleading reports protected,'' Lazarus said in his June 15 address before the House of Delegates. He also pointed to the AMA Sunshine Act resource page we previously covered.

Dr. Nancy Nielsen, former president of the AMA, asked whether the law would be triggered when industry sources pay for coffee and pastries at accredited continuing medical education (CME) events.

 "We're trying to be pragmatic," replied Dr. Shantanu Agrawal, director of the CMS data-sharing and partnership group, explaining that the agency would not get too preoccupied with "who picked up what" at a large buffet. Whether this is CMS' official position about meals at CME events, however, is uncertain. CMS still has left questions about CME related issues unanswered on its FAQ webpage as we come up to a little over 5 weeks before Sunshine tracking begins.
"We hope that you keep track of your own transfers of value," said Anita Griner, deputy director of the CMS data-sharing and partnership group. Griner said physicians' records would help resolve disputes. The CMS, though, will not mediate them, she said. If industry and doctors cannot agree on the figure, the CMS will post the industry-supplied number and mark it as under dispute.  "The CMS will audit some of the reports supplied by manufactures and GPOs, and disputes could trigger an audit," the article noted.

While Agrawal acknowledged that relationships between physicians and manufacturers contribute to important innovations, he emphasized the concerns raised by conflicts of interest. Those conflicts, he said, become "far more magnified" because 60% of physicians reporting an industry relationship are involved in medical education and 40% are involved in creating clinical practice guidelines. It's unclear where Argawal got such numbers from. Irrespective, physicians who participate in accredited CME must comply with all disclosure and conflict of interest standards set by the ACCME Standards for Commercial Support.

Griner reviewed with the audience how the business relationships of physicians, teaching hospitals, podiatrists and chiropractors would be subject to reporting. When she asked if physician assistants and nurse practitioners would be subject to sunshine reports, the audience replied in unison: "No, but they should be."

In related Sunshine Act news, the Financial Times reported that manufacturers are "scrambling to create data collection systems by 1 August that comply with a template the federal government revised as recently as last month," citing comments from Michaeline Daboul, CEO and president, MMIS.

According to the article, "Some physicians are not familiar with the details of the new rules, added a Senate aide involved in crafting the sunshine law. A significant minority of physicians are also not aware of the fact that a company might be reporting their income in a publicly listed manner, the aide said."


In addition, the Financial Times quoted an official from HHS-OIG, who noted that either DOJ or OIG could flag certain payments that raise concerns about possible kickbacks or other fraud violations. "Either agency can take the lead in pursuing suspected violations of the antikickback statute, agreed the OIG spokesperson." "As far as whether payments will be viewed as kickbacks, that is evidently a possibility," he said.


Information posted to the CMS site "would not be sufficient in and of itself to bring any kind of legal case," the OIG spokesperson told the Financial Times, but the data could be cause for further investigation. It is "certainly fair to assume that DoJ and the OIG will be taking a look" at the information, noted Andrew Van Haute, associate counsel, Advanced Medical Technology Association (AdvaMed), a medical technology trade group. However, he added, the sheer act of disclosure does not mean investigations are warranted.


Interestingly, former Chief Counsel to HHS-OIG Lew Morris was also quoted in the article. Manufacturers and healthcare providers could face multiple sources of scrutiny, countered Lewis Morris, former OIG chief counsel. The published data will likely be of interest to "whistleblowers and investigative reporters and law enforcement," among other groups, he said.


This attention could be unjustified for those "outliers that really aren't outliers and are just a matter of information being put into the wrong category," pointed out Morris, who is now an attorney at Adelman, Sheff & Smith.

Additionally, Morris told Financial Times that "there is broad understanding that Sunshine implementation will involve some complications." Based on his conversations with the DoJ and the OIG, he said it is unlikely that enforcers "are going to be handing out traffic tickets the first day that the rule goes into effect." Morris also cautioned government officials, industry attorneys and other interested parties against making snap judgments immediately after the CMS posts the data. "There are some extremely well-reimbursed physicians and experts who earn every penny of it," Morris said.


CMS Proposes Increased Incentives for Information on Misuse

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would increase incentives for people to report information that leads to a recovery of funds from individuals and entities that have or are engaged in Medicare fraud and abuse. The proposed rule would also improve CMS' ability to detect new fraud schemes, and help ensure that fraudulent entities and individuals do not enroll in or stay enrolled in Medicare. 

"President Obama has made the elimination of fraud, waste and abuse, particularly in health care, a top priority for the administration," said Secretary Sebelius.  "Today's announcement is a signal to Medicare beneficiaries and caregivers, who are on the frontlines of this fight, that they are critical partners in helping protect taxpayer dollars." Over the last three years, the administration has recovered over $14.9 billion in fraud, some of which resulted from fraud reporting by individuals – a proven tool in helping the government detect fraud, waste and abuse in the Medicare program.

Comments should reference file code CMS-6045-P and are due by June 28, 2013.

CMS issued a fact sheet summarizing its proposed changes for the Medicare Incentive Reward Program as well as new provider enrollment provisions outlined in the proposed rule.

 CMS propsed to increase the potential reward amount for information that leads to a recovery of Medicare funds from 10 percent to 15 percent of the final amount collected. The current program caps the reward at $1,000, meaning CMS pays a reward on the first $10,000 it collects as a result of a tip.

CMS is also proposing to increase the portion of the recovery on which CMS will pay a reward up to the first $66 million recovered – this means an individual could receive a reward of $9.9 million if CMS recovers $66 million or more.

In 1998, CMS began paying rewards to individuals who reported tips that led to the recovery of funds, as part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, codified at 42 U.S.C. 1395b-5. Since 1997, more than 3.5 million beneficiaries have learned how to recognize and fight fraud and abuse, and more than 7,000 referrals have been made to the CMS and the Office of the Inspector General for investigation.

To date, CMS has recovered approximately $3.5 million as a result of this program and paid just $16,000 for 18 rewards. The proposed changes are similar to the IRS whistleblower program that has resulted in recoveries of over $2 billion since 2003.   

"Public involvement in our anti-fraud efforts is critical because alert and vigilant providers, beneficiaries, family members, and caregivers are able to detect and prevent fraud as it occurs," the proposed rule states. "Information from beneficiaries and other parties helps us to quickly identify fraudulent practices, stop payment to suspect providers and suppliers for inappropriate services or items, and prevent further abuses in the program. However, many people do not report suspected fraud because they are not monitoring claims submitted to Medicare for their care, or noticed a suspicious claim but were not motivated to report. Every fraudulent claim submitted contains a beneficiary's Medicare number. Therefore, we believe that each complaint we receive may represent hundreds of other individuals that did not spot a fraudulent activity or did not report their suspicions to us."

To promote the importance of reporting fraud, CMS conducts national campaigns to train Medicare beneficiaries and caregivers to detect and prevent health care fraud. On March 7, 2012, CMS released new explanations of benefits (Medicare Summary Notices (MSNs)) that are easier to read and provide instructions on how to spot fraud available online, and starting in 2013, the new MSNs will be mailed out quarterly to beneficiaries.

At § 420.405(e)(3), CMS proposes to limit eligibility for a reward to the first individual who provides CMS with specific information on a provider or supplier that is engaging in, or has engaged in, acts or omissions that constitute grounds for the imposition of a sanction under section 1128, section 1128A or section 1128B of the Act or that has otherwise engaged in sanctionable fraud and abuse that leads to a review or investigation by CMS or law enforcement or other actions that result in the imposition of a sanction. Once CMS receives information on a specific provider or supplier for a specific time period of the alleged sanctionable conduct, CMS will consider the provider or supplier to be subject to a review or investigation by CMS, its contractors, or its law enforcement partners.

In new paragraph (f)(3), CMS proposed to add a requirement that upon notification of eligibility, or when otherwise required by CMS, an individual must complete an attestation stating that

  • he or she is not participating and has not participated in the sanctionable conduct,
  • he or she is not otherwise ineligible to receive a reward,
  • that the information he or she has furnished is accurate and truthful to the best of their knowledge, and that
  • he or she acknowledges that knowingly failing to provide truthful information could subject him or her to potential civil and criminal liability.

Section 203(b) of HIPAA directs CMS to discourage the provision of, and to not consider, information that is frivolous or irrelevant to the imposition of a sanction. An attestation may discourage individuals from furnishing baseless reports of sanctionable conduct. CMS is soliciting comments on whether it should adopt the proposed approach of requiring the completion of an attestation, the timing of the attestation, and on the content of any attestation.

CMS proposed clarifying that an individual is not eligible for an IRP reward if he or she has filed a qui tam lawsuit under the federal or any state False Claims Act. CMS is also proposing not to give a reward for the same or substantially similar information that is the basis of a payment of a share of the amounts collected under the False Claims Act or any state False Claims Act, or if the same or substantially similar information is the subject of a pending False Claim Act case.

In new paragraph (c)(2)(v), CMS proposed to clarify that an individual is not eligible for a reward under the IRP if he or she is eligible for a reward for furnishing the same or substantially similar information to the federal government under any other federal reward program or payment under federal law.

CMS Provider Enrollment 

"Provider enrollment is the gateway to Medicare." CMS routinely evaluates its provider enrollment policies, and has implemented new safeguards as a result of the Affordable Care Act. In the February 2011 final screening rule (72 FR 5862), CMS identified additional changes in enrollment policy that would increase the integrity of the Medicare program. Now, CMS is proposing include the following provisions:

  • Add the ability to deny the enrollment of providers, suppliers and owners affiliated with an entity that has unpaid Medicare debt. This proposal would prevent individuals and entities from being able to incur substantial debt to Medicare, leave the Medicare program and then re-enroll as a new business to avoid repayment of the outstanding
  • Medicare debt. CMS is proposing that it would only enroll individuals or entities if they repay the debt or enter into a repayment plan, if they are otherwise eligible for the program.
  • Deny enrollment or revoke the billing privileges of a provider or supplier if a managing employee has been convicted of certain felony offenses within the preceding 10 years. This provision ensures that CMS can block or remove bad actors from the Medicare program to protect beneficiaries and safeguard the Medicare Trust Fund. 
  • Permit CMS to revoke billing privileges of providers and suppliers that have a pattern or practice of billing for services that do not meet Medicare requirements. This proposal is intended to address providers and suppliers that regularly submit inaccurate claims in such a way that it poses a risk to the Medicare program.
  • Make the effective date of billing privileges consistent across certain provider and supplier types. Most practitioners and practitioner groups may only submit bills as of the filing date of their enrollment application. CMS is proposing to eliminate ambulance suppliers' current ability to bill for up to a year prior to enrollment in the Medicare program. CMS is also proposing to require that ambulance providers and other provider and supplier types submit any claims within 60 days of revocation of billing privileges, consistent with the requirements for practitioners and practitioner groups.

CMS said that current regulations do not adequately articulate the distinction between enrolling in Medicare: (1) To obtain Medicare billing privileges; and (2) solely to order or certify items or services for Medicare beneficiaries. Thus, CMS proposes to clarify the definition of enroll/enrollment to include the later situation.

CMS is proposing to modify the list of felonies to deny a provider or supplier's Medicare billing privileges such that any felony conviction—including guilty pleas and adjudicated pretrial diversions—that CMS has determined to be detrimental to the best interests of the Medicare program and its beneficiaries would constitute a basis for denial or revocation. This would give CMS the discretion to deny or revoke enrollment based on any felony conviction that it believes to be detrimental to the best interests of Medicare and its beneficiaries. CMS said it is expanding this list because it is "unwise" to restrict its authorities to only certain felonies, particularly since the types of felony offenses often vary from state to state.

"Any felony conviction, regardless of the type, raises real questions as to whether the provider or supplier can be relied upon to be a trustworthy partner in the Medicare program, and it is important to do everything possible to prevent unnecessary risks to Medicare beneficiaries and the Medicare Trust Fund," CMS explained. Thus, CMS would remove the enumerated list of felonies and instead provide that enrollment may be denied or revoked based upon any such felony conviction.

CMS also would expand its authority to include felony convictions against a provider or supplier's "managing employee," as that term is defined in § 424.502. CMS said it has "found numerous instances in which a particular managing employee of a provider or supplier has as much, if not more, control of and involvement with the entity as does the owner." Thus, CMS said "that managing employees should be held to the same standard as owners in this regard. Clearly, having a managing employee with a felony conviction raises questions about whether the provider or supplier can be a responsible participant in the Medicare program."

Section 424.535(a)(8) states that a provider or supplier's Medicare billing privileges may be revoked if the provider or supplier submits a claim or claims for services that could not have been furnished to a specific individual on the date of service. These instances include, but are not limited to, situations where the beneficiary is deceased, the directing physician or beneficiary is not in the state or country when services were furnished, or when the equipment necessary for testing is not present where the testing is said to have occurred.

Consequently, CMS proposed to expand this revocation reason by adding a new paragraph that would permit revocation if we determine that the provider or supplier has a pattern or practice of billing for services that do not meet Medicare requirements such as, but not limited to, the requirement that the service be reasonable and necessary. This revocation reason would differ from that in paragraph (a)(8)(i) in two ways. First, while the former deals with individual claims, paragraph (a)(8)(ii) addresses overall billing patterns. Second, paragraph (a)(8)(i) addresses situations involving claims for services that could not have been furnished. Paragraph (a)(8)(ii) would deal with cases where the services were furnished but the claims do not meet Medicare requirements.

While CMS is soliciting comment on what should qualify as a "pattern or practice" under the proposed change, CMS envisions that a common—though by no means the only—scenario in which proposed § 424.535(a)(8)(ii) could apply would be "one where a provider or supplier is placed on prepayment review and a significant number of its claims are denied for failing to meet medical necessity requirements over time."

Indeed, any situation in which an unusually or abnormally high volume of claims are denied over time because they do not meet Medicare requirements could potentially trigger § 424.535(a)(8)(ii), though much would depend, of course, on the particular facts of the situation. In each case, CMS would take into account several factors, including, but not limited to the following:

  • The percentage of submitted claims that were denied.
  • The total number of claims that were denied.
  • The reason(s) for the claim denials.
  • Whether the provider or supplier has any history of "final adverse actions" (as that term is defined under § 424.502).
  • The length of time over which the pattern has continued.
  • How long the provider or supplier has been enrolled in Medicare.

With respect to these factors, CMS solicits comment on the following:

  • Whether additional factors should be considered and, if so, what those factors should be.
  • Which, if any, of these factors should not be considered.
  • Which, if any, of these factors should be given greater or lesser weight than others.
  • Whether a minimum or maximum threshold for consideration should be established for the "percentage of claims denied" and "total number of claims denied" factors.

CMS also solicits comment on whether there should be a set knowledge standard associated with our proposed provision—specifically, whether revocation is warranted only if the provider or supplier submitted the claims in question with "reckless disregard" as to their accuracy or the provider "knew or should have known" that the claims did not meet Medicare requirements. CMS clarified that the proposed addition "is not meant to be used to revoke providers and suppliers for isolated and sporadic claim denials or for innocent errors in billing." The focus is instead on situations where a provider or supplier regularly fails to submit accurate claims in such a way as to—when considering the factors previously mentioned—pose a risk to the Medicare Trust Fund.

June 25, 2013

HHS OIG Reports Small Percentage of Prescribers May be Overutilizing Part D Drugs

Recently we reported that ProPublica had launched a new effort known as "Prescriber Checkup", which allows anyone with internet access to look up on a searchable website what drugs their physician is prescribing under Medicare Part D and how much they are being reimbursed.

Consequently, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released a report raising concerns about the "Questionable" prescribing patterns of approximately 700 physicians (Less than .07%) who participate in the Part D program. In fact, the OIG report cites ProPublica's Prescriber Checkup on page 2 of its report.

OIG developed five measures to describe Part D prescribing patterns and to identify general-care physicians with questionable patterns. Those measures were (1) average number of prescriptions per beneficiary; (2) total number of pharmacies associated with each prescriber, (3) percentage of prescriptions that were for Schedule II drugs, (4) percentage of prescriptions that were for Schedule III drugs, and (5) percentage of prescriptions that were for brand-name drugs. OIG found that

  • A total of 1.1 million individual prescribers ordered over 1 billion drugs/prescriptions paid by Part D in 2009 (paying $70.7 billion). Prescribing varied widely by specialty.
  • Over 700 general-care physicians had questionable prescribing patterns. Each of these physicians prescribed extremely high amounts for at least one of the five measures we developed. For example, many of these physicians prescribed extremely high numbers of prescriptions per beneficiary, which may indicate that these prescriptions are medically unnecessary.
  • More than half of the 736 general-care physicians (which OIG called "very extreme outliers) with questionable prescribing patterns, including extremely high percentages of Schedule II or III drugs, which have potential for addiction and abuse. Although some of this prescribing may be appropriate, OIG maintained that "such questionable patterns warrant further scrutiny."

This report is a view into things to come under the Sunshine Act, as OIG relied on several of the same factors CMS will rely on including: (1) NPI #; (2) name as reported in the NPPES database; (3) National Drug Code (NDC); and (4) specialty. For example, OIG explained that it identified each prescriber's specialty based on the primary taxonomy code that he or she reported in the NPPES. The taxonomy code indicates a provider's specialty and subspecialty, if any. For example, it may indicate that a prescriber is a family-medicine physician specializing in geriatric medicine.

OIG then grouped the taxonomy codes for similar specialties. For example, it grouped all of the nurse practitioners together and all of the dentists together. It considered general-care physicians to be general practitioners, family practitioners, and internal medicine practitioners with no specialization or a specialization in adults or geriatrics. OIG calculated each group's average for the five measures listed above.

Based on these findings, discussed further below, OIG expressed a need for "increased oversight of Part D." Consequently, OIG made four recommendations, all of which CMS concurred with:

  1. Instruct the Medicare Drug Integrity Contractor (MEDIC) to expand its analysis of prescribers,
  2. Provide sponsors with additional guidance on monitoring prescribing patterns,
  3. Provide education and training for prescribers; and
  4. Follow up on prescribers with questionable prescribing patterns. CMS concurred with all four recommendations.

With respect to the first recommendation, OIG stated that that CMS should work with the MEDIC to ensure that it effectively and systematically monitors prescribers to identify those with questionable patterns. Therefore, "taking specialty into account is an important step in identifying prescribers with questionable patterns," OIG wrote. This recommendation highlights a predicted concern stemming from the Sunshine Act—that OIG and CMS will be using the reporting of a physician's specialty to raise flags or concerns about particularly payments associated with drugs/devices.

For example, if a physician's specialty does not match the particular drug he or she is receiving payment for, this may suggest to OIG or CMS one of two things. First, that the drug is being prescribed or used off-label and such use may have been induced through off-label promotion by the manufacturer, causing a violation of the FDCA for misbranding and the resulting payment by the federal government of a false claim under the False Claims Act; or such prescribing may have been induced by improper payments or kickbacks, which would violate the Anti-Kickback Statute.

This is particularly relevant because OIG acknowledged in the report that while some prescriptions or prescribing patterns (above average) may have been necessary, "prescribing high amounts on any of these measures may indicate that a physician is prescribing drugs which are not medically necessary or that he or she has an inappropriate incentive, such as a kickback, to order certain drugs."

Second, the reporting or analysis of a physician's specialty and prescribing patterns may raise concerns about the reimbursement and medical necessity of the prescribed drug. The CMS reimbursement standard for drugs is medically necessary, which is different from FDA's safe and effective use. If an off-label use of a drug is listed in one of CMS' three (3) recognized compendia, then CMS typically pays for such off-label use. However, there have been recent settlements and allegations that some companies have fraudulently had their drugs listed in such compendia either by false or inaccurate data or improperly drafted or created research articles.

Either way, OIG's suggestion and already present use of physician specialty, coupled with the Sunshine Act publication and aggregation of NPI# and specialty may create challenges for physicians and manufacturers moving forward. This report clearly confirms the predictions of many in the industry that OIG, CMS and other federal and state healthcare enforcement agents will be looking at the upcoming Sunshine Act database to question large or unusual payments, such as those discussed in the OIG report as well as the previously written story on ProPublica's "Prescriber Checkup." In fact, ProPublica wrote a piece discussing OIG's report, noting that it "echo[ed]" and "mirror[ed]" ProPublica's investigation.

OIG Report

CMS relies on sponsors to help safeguard Part D from fraud and abuse. CMS requires sponsors to have compliance plans that contain measures to detect, prevent, and correct fraud, waste, and abuse. CMS recommends that sponsors use data analysis as a part of these plans. Specifically, it recommends that sponsors develop indicators and establish baseline data so that they can recognize abnormalities and changes in prescribing patterns.

CMS recently issued guidance recommending that sponsors use data analysis as part of their Drug Utilization Review programs to identify beneficiaries who may be over utilizing opioids. Opioids include Schedule II controlled substances, such as oxycodone, morphine, and fentanyl. CMS also recommended that sponsors communicate with prescribers to ascertain the medical necessity of these drugs.

Last year, the government spent $62 billion subsidizing the drugs of 32 million people.

Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. OIG said it conducted the study because in recent years, prescription drug abuse has emerged as a serious and growing problem (7 million people in the U.S. were misusing prescription drugs in 2010) and with the rise in prescription drug abuse, "concerns about Medicare fraud, particularly prescriber fraud, have increased."

OIG based its analysis on Prescription Drug Event records. Sponsors submit these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record contains information about the pharmacy, prescriber, beneficiary, and drug. OIG analyzed all of the records for drugs billed in 2009, which covered nearly 87,000 general-care physicians.

While OIG raised concerns about Schedule II and III drugs, on average, only 4% of the prescriptions from each prescriber were for Schedule II drugs, and only 7% on average for Schedule III. The breakdown for Schedule II was:

  • 14% ordered by physical medicine and rehabilitation specialists; and
  • 11% for both surgeons and anesthesiologists
  • 2% was for general-care physicians
  • ~0.3% for cardiologists and endocrinologists

The breakdown for Schedule III drugs:

  • Surgeons, emergency medicine specialists, and dentists, on average, ordered >14%
  • 3% were ordered by general-care
  • Cardiologists and gastroenterologists rarely prescribed these

While there was concern about the use of brand-name drugs, the OIG report found that on average, only "about a quarter of prescriptions were for brand-name drugs;" the national average was 27% for brand-name drugs. This is consistent with numerous reports that doctors prescribe or patients receive over 75% generic drugs. 16 % of prescribers did not order any brand-name drugs, while 10 percent of prescribers ordered 60% or more of their prescriptions as brand-name.

Ophthalmologists, pulmonologists, and endocrinologists commonly ordered brand-name drugs. More than half the prescriptions ordered by prescribers in these specialties were for brand-name drugs, on average. In contrast, 28 percent of the prescriptions ordered by general-care physicians were for brand-name drugs. Dentists prescribed only an average of 9 percent brand-name drugs. However, OIG recognized that these differences may be due to the availability of generic equivalents for the drugs commonly used by these specialties.

The review found more than 2,200 doctors whose records stood out in one of several areas: prescriptions per patient, brand name drugs, painkillers and other addictive drugs or the number of pharmacies that dispensed their orders. From this 2,200, the 736 "very extreme outlier" physicians received $352 million in Part D drugs. Los Angeles and New York had greatest numbers 34 and 32 physicians respectively. Philadelphia (22), Tampa (19), and Detroit (15) had the next-largest numbers.

While on average, each prescriber ordered prescriptions for 80 beneficiaries and averaged 6 prescriptions per beneficiary, more than half of the prescribers ordered fewer than 100 Part D prescriptions each during the year.

  • General-care physicians accounted for 20 percent of all prescribers in 2009 and ordered two-thirds of all of Part D prescriptions in 2009.
  • Dentists were the second most common type of prescriber, but were responsible for just 1 percent of Part D prescriptions overall.
  • Nurse practitioners and physicians' assistants were also common prescribers; together they represented 11 percent of prescribers and were responsible for a little less than 6 percent of the Part D prescriptions.
  • Interestingly, psychiatrists accounted for only 3% of all prescriptions; surgeons were less than 1%, and cardiology was only 5%.
  • Infectious disease specialists ordered an average of 11 prescriptions per beneficiary and nephrologists ordered an average of 10.
  • Emergency medicine specialists ordered an average of two prescriptions per beneficiary

Further, on average, prescribers ordered drugs that were dispensed at 32 pharmacies. Half the prescribers ordered drugs that were dispensed at 17 or fewer pharmacies. Cardiologists, endocrinologists, and rheumatologists had the highest number of pharmacies that filled the drugs they ordered; each had an average of more than 80 pharmacies per prescriber. An average of 52 pharmacies filled the drugs ordered by each general-care physician.

But this number makes sense because specialists are often in high demand and patients are willing to travel much further, sometimes even across state lines to see a specialist, hence the additional number of pharmacies. Dentists and nurse practitioners had fewer pharmacies that filled their prescriptions, averaging 12 and 23, respectively.

Nevertheless, ProPublica chose to point out the "extreme outliers, for instance, 24 doctors who wrote more than 400 prescriptions for at least one patient, including refills dispensed; and one Ohio physician who did so more than a dozen times. However, the average doctor wrote 13 per patient. In another case, an Illinois doctor had prescriptions filled by 872 pharmacies in 47 states and Guam. General-care doctors, on average, had prescriptions for all their Medicare patients filled by 52 pharmacies.

Medicare paid $9.7 million for the prescriptions of one California doctor alone – that is 151 times more than the cost of an average doctor's tally, the report says. Most of this physician's drugs were supplied by just two pharmacies, both of which had previously been identified by the inspector general as having questionable billing practices.

Sen. Tom Coburn of Oklahoma, a physician, said no one wants Medicare to tell doctors which drugs to prescribe. But the government does have a responsibility in preventing fraud and abuse, he said to ProPublica.

OIG Recommendations

OIG's second recommendation echoes the points made above. OIG wants CMS to "emphasize the importance of using data analysis to identify prescribers with questionable patterns" and specifically, wants "sponsors compare physicians with similar specialties when conducting such analysis."

With respect to education and training, OIG recommended that CMS provide prescribers with reports comparing their prescribing patterns to their peers.' Similar to the Comparable Billing Reports issued for other services, such as Part B, these reports would provide prescribers with important educational information and insight about their prescribing patterns. OIG also said that CMS should conduct a communication and educational campaign for prescribers about the overutilization of prescription drugs. Specifically, the campaign should

  • Raise awareness about prescription drug abuse and to remind prescribers that Part D only covers drugs that are used for medically indicated purposes; and
  • Educate prescribers about what constitutes Medicare fraud and the potential consequences of committing it.

Given the high number of primary care physicians prescribing opioids, it will be interesting to see if OIG, and CMS reach out to FDA to incorporate their concerns into the recently finalized class wide REMS for opioids, and if all three agencies will welcome stakeholders from the continuing medical education (CME) industry to the table to help address these concerns and assist with the educational and training comments (as is already required under FDA's REMS).


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