Children’s Codeine Prescriptions Remain High Despite Warnings

Despite a decline in the prescription of codeine for children in the past 10 years, and despite warnings against the use of codeine in children who have a cough or upper respiratory infection (URI), a study published in the journal Pediatrics has shown that a substantial number of codeine prescriptions are still being given to children. According to the study, titled “National Patterns of Codeine Prescriptions for Children in the Emergency Department,” more effective interventions are necessary “to prevent prescription of this potentially hazardous drug to children.”

Background

According to the study, there are serious safety concerns about the use of codeine in children because of the risk of toxicity compared to the inadequate relief the drug provides to many children. “Because of the unreliable effect of the drug and its associated risk for death,” the researchers wrote, “national and international guidelines have recommended against codeine use in children for both of its common indications, analgesia and cough suppression.” Specifically, guidelines issued by the American Academy of Pediatrics (AAP) in 2006 warned about the potential dangers of the drug, as well as its lack of efficacy in children with cough or URI.

Slight Decrease in Codeine Prescriptions

The researchers analyzed the 10 most recent years of data available from the National Hospital and Ambulatory Medical Care Survey (NHAMCS) of emergency department (ED) visits for patients aged three to 17. The sample of data showed 56,375 ED visits by children in this age group, which, when weighted, represented a total of 189,028,628 ED visits between 2001 and 2010. Over this time period, the rate of codeine prescription fell from 3.7 percent to 2.9 percent, with total prescriptions ranging from 558,805 to 876,729 per year. According to the researchers, children between eight and 12 were prescribed codeine more frequently, and there was no statistically significant change in prescription rates for this age group. For ages three to seven, the researchers did find a decline in codeine prescription, which, according to the study, “is reassuring, as these children are at greatest risk for potential toxicity. There was also a decline in prescription for non-Hispanic black children, but the researchers noted that “[d]ecreased prescribing of codeine in these children . . . may reflect general opioid prescription avoidance rather than provider knowledge that poor codeine metabolizers are more common among non-Hispanic blacks.”

Codeine for Treatment of URI

Despite guidance by the AAP warning of the risks of codeine use in children for the treatment of cough and URI, the researchers found no changes in prescription patterns. Between 69,057 and 145,857 children are being prescribed codeine every year for URI and cough. “This suggests that cough and URI prescribing may be an important focus for interventions to change provider behavior,” wrote the researchers. The researchers suggested switching from acetaminophen-codeine to acetaminophen-hydrocodone as an alternative, as hydrocodone “has demonstrated efficacy as an analgesic agent with good safety profile in children.” The removal of codeine from hospital formularies and electronic medical record-based decision support for providers was also suggested by the researchers.

Surgical Procedure Could Spread Cancer, FDA Warns

The FDA is discouraging doctors and patients from using laparoscopic power morcellation for the removal of the uterus (hysterectomy) or the removal of uterine fibroids (myomectomy) since it could spread unsuspected cancerous tissue beyond the uterus. It has released a safety communication with its recommendations for physicians and for women that warns of the risks and lists considerations for parties who will perform or undergo hysterectomies and myomectomies, including alternative treatment options. The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Device Panel to gain “input from clinical and scientific experts.”

Most women will develop uterine fibroids (leiomyomas), noncancerous tumors that arise from uterine muscular tissue, at some point during their lives. While generally not problematic, leiomyomas can become symptomatic, causing heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes growing to the size of cantaloupes, and may necessitate medical or surgical treatment. Surgical options include traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. More than 200,000 hysterectomies are performed each year for uterine fybroids. Laparoscopic power morcellation involves the use of a power morcellator to divide uterine tissue into small pieces or fragments that are removed through an incision in the abdomen. Patients sometimes choose a laparoscopic procedure because it is associated with a shorter post-operative recovery time and a reduced risk of infection.

According to William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.” The FDA has determined that one in 350 women undergoing a hysterectomy or myomectomy due to fibroids will unknowingly have uterine sarcoma, a rare form of cancer that usually develops after menopause. Laparoscopic power morcellation in these women could spread cancerous tissue from the uterus to the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival.” Previously, the threat of spread was thought to be less common, affecting anywhere from one in 500 to one in 10,000 women.

In light of this information, the FDA has instructed manufacturers of power morcellators used in laparoscopic hysterectomies and myomectomies to review their current labeling to ensure that it includes accurate risk information. It has also advised physicians not to use the procedure in patients with suspected or known cancer. Physicians who deem the procedure the best option should discuss the risks with their patients. The FDA notes that some clinicians and medical institutions advocate the use of a specimen bag during morcellation to attempt to contain the uterine tissue and minimize the risk of spreading it. Women who have previously undergone the procedure and whose tissue tested normally (at noncancerous levels) should undergo routine follow-up with their physicians.

When the FDA convenes a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee, in addition to discussing the clinical role of laparoscopic power morcellation to treat uterine fibroids, it will discuss the use of a specimen bag and other surgical techniques that could reduce risks, as well as whether a boxed warning related to the risk of cancer spread should be required for laparoscopic power morcellators.

Show Us the Money: Medicare Data Disclosure Highlights Expensive Treatments

In an unprecedented action, on April 9, 2014, CMS publicly released data disclosing Medicare payments made to physicians in 2012. CMS Principal Deputy Administrator Jonathan Blum  told the media on the morning of the release that the reasons behind the disclosure were three-fold: (1) because the public had a right to know; (2) to help understand geographic variation in spending; and (3) to aid in the identification of fraudulent activity. Yet, in the flood of responses to the release, different patterns in the data became evident and other, maybe unanticipated, discussions arose. Many have noted that oncologists and ophthalmologists make up two of the three most highly billed types of providers on the data list. Blum and other CMS representatives acknowledged this pattern and stated that these higher numbers were due to more expensive drugs. In addition, recent reports have emerged that highlight these treatments and question their necessity in the presence of less expensive alternatives.

Data Disclosure

According to an analysis by the Washington Post, the Medicare data revealed that, in 2012, the highest Medicare-paid specialists were ophthalmologists, oncologists, and pathologists. While the report noted that many factors could explain that trend, including “costly overhead” that necessitate costs to be forwarded to pharmaceutical companies or medical device manufacturers, the piece focused on the role fraud might play in explaining the extremely large reimbursement amounts received by some physicians. In general, most other reports on the subject also evaluated the disclosure as a means of fraud detection. A Reuters story noted the ecstatic reaction of lawyers representing whistleblowers in Medicare fraud cases that now may have potential incriminating evidence at their fingertips. Yet, viewing these numbers in light of other recent findings with regard to and in response to allegations of overspending on certain types of treatments in the field of oncology and ophthalmology, perhaps the investigative lens should be widened to analyze these trends in treatment as well.

Treatments Questioned

Although not directly related to the Medicare data disclosure, a recent perspective published in the New England Journal of Medicine is relevant to this discussion. According to this piece, high cost cancer drugs are dominating patient and provider options. The study’s authors reference estimates that reveal that one year of treatment for cancer per patient using new drugs costs over $100,000. Further, the article indicates that this cost is both borne by the patients and other payers and that these high prices form barriers to comparative effectiveness trials that could establish the efficacy of alternative, cheaper drugs. In this light, these authors might argue that the extravagantly high Medicare payments made to oncologists evident in the 2012 data is a function of this new cancer drug market that protects itself against cheaper interlopers.

Similarly, Boston University reported on the dominance of the macular degeneration treating drug Lucentis® in the field of ophthalmology. This treatment is ranked as one of the most heavily reimbursed procedures by Medicare and many ophthalmologists have blamed their high fees on the cost of this single drug which is six times more expensive than an alternative product, Avastin® that is typically used to treat cancer but is used off-label for macular degeneration as well. The BU report described the findings of  Professor Manju Subramanian, who says that while treatment with Lucentis costs $50,000 per year, Avastin, which Subramanian claims works equally well, rings in at $650 per year. Both Lucentis and Avastin are owned by the same company, which would stand to lose millions if providers begin to prescribe the less expensive option.

Oncologists Respond

The flood of response and reactions to the Medicare data release included formal statements released by several professional associations in the oncology field, including the American Society of Clinical Oncology (ASCO), the American Society of Hematology, the American Society for Radiation Oncology, and the Association of Community Cancer Centers. While each of these groups affirmed their support for greater transparency in Medicare payments to physicians, each entity also expressed concern over the release of the data without context or explanation of the details of the payment system. For instance, the statement released by ASCO asserted that “[m]ost of the amounts shown in the Medicare database for oncologists are not, in fact, revenue to oncology practices. Instead, these Medicare payments merely cover the upfront costs of purchasing drugs for patients.” While these statements certainly may quell debate about over-the-top reimbursements as to doctors’ salaries and, perhaps, even foreclose allegations of fraud, they do not address the root of the problem, which is that expensive treatments appear to dominate certain fields, causing staggering, and perhaps, unnecessary reimbursement amounts.

Kusserow’s Corner: CMS Improperly Paid Millions of Dollars for Prescription Drugs Provided to Prisoners

The HHS Office of Inspector General (OIG) issued an audit (A-07-12-06035) to CMS, reporting that CMS inappropriately accepted prescription drug event (PDE) records submitted by Part D sponsors for prescription drugs provided to incarcerated beneficiaries and used those records to make final payment determinations. The report found that CMS accepted PDE records submitted by sponsors for prescription drugs provided to approximately half of incarcerated beneficiaries. The OIG was unable to verify the remaining half as being incarcerated on the dates in the CMS database. On the basis of its sample results, the OIG estimated the total gross drug costs were about $11.7 million for period (2006-2010) covered in the audit. The OIG explained that an individual is eligible for Medicare Part D benefits if he or she is entitled to Medicare benefits under Part A or enrolled in Part B and lives in the service area of a Part D plan. Federal regulations specify that facilities in which individuals are incarcerated are not to be regarded as being within service areas for purposes of Part D coverage. The OIG noted that during the period of the audit, the final PDE records to CMS with gross drug costs totaled $256 billion.

The OIG found that CMS had inadequate internal controls during the period of the review; and did not provide sufficient and timely information to sponsors to permit them to readily and accurately verify a beneficiary’s incarceration status and dates of incarceration. It recommended that CMS:

  1. Resolve improper Part D payments made for prescription drugs provided to incarcerated beneficiaries;
  2. Strengthen internal controls to ensure that Medicare does not pay for prescription drugs for incarcerated beneficiaries; and
  3. Identify and resolve improper payments found by the OIG auditors for prescription drugs provided to incarcerated beneficiaries, by reopening and revising final payment determination for all periods before implementation of the enhanced policies and procedures that would contribute to the strengthened internal controls.

CMS concurred with the first two recommendations but did not concur with the third recommendation. The OIG acknowledged that CMS is developing and implementing policies that would address enrollment of incarcerated beneficiaries. It agreed with the CMS approach would address the problems identified.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2014 Strategic Management Services, LLC. Published with permission.