Medical Device Daily Washington Editor

The Dartmouth Atlas is famous for offering a fairly clear depiction of disparate Medicare spending levels in the U.S., but the Office of Inspector General (OIG) at the Department of Health and Human Services also has a decidedly vital interest in those disparities, and recently published a report on the topic. In a December 2010 report on outpatient therapy for Medicare beneficiaries under Part B, OIG says that per-person expenditures in the Miami-Dade County area in Florida is home to such spending at three times the national average last year.

The report points out that spending on outpatient therapy services jumped by 133% between 2000 and 2009, from $2.1 billion to $4.9 billion, although the number of beneficiaries rose by only by about a quarter, from 3.6 million to 4.5 million. Still, the numbers in the county of 2.5 million are conspicuous.

As the saying might sometimes go in dire circumstances, there was bad news and then there was worse news. The bad news was that the OIG report states that per-beneficiary spending in the Miami-Dade area “was three times the national average in 2009,“ running to a total of slightly more than $3,400 per beneficiary, compared to a national average of a bit less than $1,100. These tabs were generated by similar proportions for the average number of services received last year. OIG says that the typical beneficiary in the area in question “received an average of 158 services during 2009, while the national average was 49 services per beneficiary.“ Providers earned at an even more highly disproportional rate according to OIG, earning nearly $84,000 each, a sum the report states is “eight times the average amount“ paid to providers on average, whose average earnings last year came to slightly more than $10,000. That eightfold increase in provider earnings is matched by the increased number of services, said in the report to be “an average of 3,828 outpatient therapy services, eight times the average number of services by providers that served beneficiaries in other counties nationally.“

The worse news is that providers in Miami-Dade are also turning up more suspicious billings as well. OIG says that providers in the state's most populous county also “had at least three times the national level for five of the six questionable billing characteristics“ for Medicare outpatient work.

For instance, providers in the Miami-Dade area evidently “indicated that outpatient therapy services would exceed an annual cap four times as often as providers nationally,“ and the claims those providers filed evidently would have exceeded the annual cap for such services at a rate four times greater than the national average.

Just as damning is that the average Medicare payment for “outpatient therapy from multiple providers“ was triple the national average, and beneficiaries in Miami-Dade “were three times as likely to receive outpatient therapy throughout the year as beneficiaries nationally.“ They also were three times more likely to “exceed an annual cap as beneficiaries nationally.“

Rosatom starts shipping isotopes to Nordion

A subsidiary of Rosatom (Moscow), Russian's state-owned energy utility, has commenced shipments of molybdenum-99 (Mo-99) to Nordion (Ottawa), which has entered into an agreement for supplies of the crucial radioactive compound for processing into technetium-99 for medical procedures.

According to a Dec. 23 statement by Nordion, the Rosatom subsidiary, dubbed Isotope (Moscow), shipped a sample of the Mo-99 for evaluation as part of an agreement the entities drafted in September. The agreement calls for Isotope to supply Nordion with Mo-99 until 2020. Nordion has to qualify the sample as part of the product registration and regulatory approval by Canadian authorities before the firm can start taking orders for processing and distribution to healthcare providers.

Jill Chitra, senior VP for quality and regulatory affairs at Nordion, said in the statement that the shipment “marks a key milestone in our supply agreement with Isotope.“ She stated further that Nordion expects “to receive supply for shipment in the first half of fiscal 2011, which is anticipated to arrive in time to help alleviate the impact of the planned National Research Universal (NRU) reactor shutdown currently intended for mid-May 2011.“

Andrey Silkin, general director of Isotope, said, “ the combination of modern radiochemical production with several reactors at one site should provide an uninterrupted supply of isotopes for the future.“ He also noted, “with the aging population and growing demand for diagnostics, the timing of our supply to the market is well matched to global needs.“

The problem of availability of Tc-99 has been the source of constant headaches for providers over the past couple of years, but the crunch has driven prices of Mo-99's precursor materials up, hence sparking interest in production. The government of the People's Republic of China recently announced that it would take a closer look at its exports of molybdenum as part of an overall plan of holding onto more domestic production of strategic raw materials, including petroleum (Medical Device Daily, Dec. 8, 2010). Relatively few nations are net exporters of molybdenum, and the news helped to spark an uptick in prices. According to a Dec. 22 report at the website for energy news publisher Platts, spot prices for molybdenum have hit $17 per pound.

Another driver of prices is the news that Atomic Energy Canada Limited (AECL; Ottawa) will shut down the Chalk River reactor in February as part of a series of planned upgrades after restarting the reactor this past summer (MDD, Aug. 20, 2010). Both AECL and the Nuclear Research and Consultancy Group (NRG; Petten, the Netherlands) have suspended operations at their aging reactors due to pressing maintenance needs for reactor vessels that are showing their age.

FDA reports two-day panel meeting in January

FDA said yesterday that it will hold a two-day meeting of the circulatory systems advisory committee next month in pursuit of counsel on two separate issues. One of these is the reclassification of automated external defibrillators, but the agency also will seek the panel's feedback on an application as well.

The two meeting days are Jan. 25 and 26, and will take place at the Holiday Inn in Gaithersburg, Maryland. On the first day, the meeting, which is scheduled to run from 8 a.m.-6 p.m., the agency will take up the reclassification of automated external defibrillators, a move the agency reported last month (Medical Device Daily, Nov. 16, 2010).

The second day, Jan. 26, also is expected to run 8 a.m.-6 p.m. and will address the PMA for the RX Acculink carotid artery stent, made by Abbott Vascular (Redwood City, California). This PMA, the agency says, includes that the indication for the stent would be for patients “at high and standard risk for adverse events from carotid endarterectomy“ and who are neurologically symptomatic with 50% stenosis or asymptomatic with 70% stenosis of one of the carotid arteries. The vessel diameter at the lesion site would have to fall between 4 and 9 millimeters.

Mark McCarty, 703-268-5690

mark.mccarty@ahcmedia.com