New Medicare Equipment Program

(from: Steve Fogarty | The Chronicle-Telegram)

Invacare is among the companies that oppose a new Medicare program aimed to lower Medicare payments on long-term medical equipment and supplies.

The program, to begin July 1, will use a competitive bidding process by which Medicare will set and pay lower prices to qualified suppliers of equipment such as hospital beds, power wheelchairs and oxygen.

The U.S. Department of Health and Human Services estimates the program will save taxpayers about $1 billion a year, but an official of Invacare Corp., the Elyria-based maker of medial equipment ranging from sophisticated power wheelchairs to canes and walkers, begs to differ.

The program, said Cara Bachenheimer, the company’s vice president of government relations, said the program is “ill-conceived and heavy-handed” and seriously will impact “consumers’ ability to access quality home medical items.”

“They’re touting cost savings, but there’s a lot to be said that you get what you pay for,” Bachenheimer said.

The Washington-based official spoke by phone early Thursday, prior to meetings concerning a proposed measure that would delay the program’s launch.

“We’re aggressively working on legislative efforts to delay implementation by 18 to 24 months, with the ultimate goal of getting rid of it altogether,” she said.

Bachenheimer hopes the program is replaced by something fairer.

“We’re on the path to that now. Both the House and Senate have put out documents in the last two days indicating support for such a bill,” she said.

Employing about 6,200 workers globally, of which some 1,500 are in Lorain County, Invacare eliminated 225 jobs at its Taylor Street plant while sending production of low-end products such as canes, crutches, walkers and standard wheelchairs to China and Mexico in 2006.

Company officials said the changes were needed in the face of tougher competition from low-cost imports coupled with ongoing cuts in Medicare and Medicaid reimbursements.

If the program isn’t derailed, the plan calls for medical equipment and supply firms to submit bids, which Medicare will use to set a uniform price for items based on economics in each of the 10 regions.

A 2007 Centers for Medicare and Medicaid Services study indicated that Medicare is paying from two to five times — or $1,000 to nearly $2,000 more — than the average price available on the Internet for items including oxygen concentrators, standard power wheelchairs, hospital beds and devices that aid people with breathing problems caused by such conditions as sleep apnea.

Bids are not submitted by manufacturers such as Invacare, but by equipment and supply companies that are Invacare’s customers, Bachenheimer said.

Northeast Ohio is among 10 regions nationally chosen to get the program first, based in part on population and numbers of medical equipment and supply providers. The Ohio region encompasses Lorain, Cuyahoga, Medina, Lake and Geauga counties, as well as portions of Erie, -Huron, Ashland and Wayne counties.

“The goal here is to have competition to drive down costs,” said Peter Leonis of the Chicago offices of the Department of Health and Human Services’ Centers for Medicare and Medicaid Services. “It’s hard to justify the way the program used to operate when you could go to the Internet and get wheelchairs or beds for one-third the price.”

“If a wheelchair costs $1,000 now, you pay $200, but if the price is driven down to $800, you’ll see the savings from that,” Leonis said.

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When the cure becomes the killer

Posted in: Sports, Health & Lifestyle
Written By: Thuria Ghaleb
Article Date: Jun 3, 2008 - 2:35:35 PM

Hanin and her Eyes
Three year-old Hanin was born with cataracts in both eyes. Her parents did not realize this until she was three months old. The little girl underwent routine cataracts-removal surgery at a local hospital when she was six months old. The operation was deemed a success.

As a follow up, her ophthalmologist wrote her prescriptions for different kinds of eye drops. Unfortunately, when Hanin’s parents went to have her prescriptions filled, the pharmacy gave them the wrong prescribed medicines.

It was later that the parents realized that it was counterfeit medicine that had been illegally smuggled into the country. The medicines were not merely unregulated imitations, they were simply ineffective. Also, they were dangerous and proved to be quite harmful, especially in the case of the Hanin’s disinfectant eye drops.

The medicine proved to be highly caustic, leaving her with painful ulcers on the surface of her eye. As a result the child had to undergo an emergency surgery to try to clean out the chemicals.

“Instead of treating our child’s eyes, that ‘medicine’ may have permanently damaged them,” Hanin’s mother said. “The date that was printed on the bottle was valid. and the box and bottle look just like the original. We really could not tell the difference between the two. Later, it was explained to us that the local agent’s seal was not on the box, which means it was smuggled.”

As if that weren’t enough, some time later, after artificial lenses had been transplanted in both of Hanin’s eyes, she was prescribed a special post-surgery eye ointment. When getting that prescription filled, a different pharmacist mistakenly gave her mother a skin ointment instead, which would have badly damaged Hanin’s eyes if her mother had not been vigilant and immediately pointed out the pharmacist’s mistake.

Pharmaceutical smuggling
The smuggling of narcotics and pharmaceuticals is considered a new phenomenon in Yemen, which has emerged only in the past 20 years.

It began on just an individual scale in 1984, according to reports, and now, many local and imported medicines, drugs, and medical compounds – including smuggled and counterfeit ones- are tossed into one big basket called Yemen.

Counterfeit drugs
Counterfeit drugs may contain too much, too little, or even none of the active ingredients. They may also contain high levels of impurities, contaminants and even toxic substances. They could also be legitimate medicines, but medicines that are past their expiration date. Although expired medicines are taken off the market, if obtained by counterfeiters they can be relabeled and re-introduced into circulation.

Shocking statistics
About 178 pharmacies were recently raided in the Capital Secretariat, Aden, Ibb, Hodeidah and al-Baidha governorates. In the country’s capital was the highest number of counterfeiting facilities- 73, according to the Ministry of Public Health and Population.

During the raids, huge quantities of smuggled medicines were seized from 111 pharmacies, and about 30 other facilities were found to be in possession of counterfeit medicines. The ministry also found that the smuggled medicines found in 57 of the inspected pharmacies were taken from governmental medical facilities. Expired medicines were being sold in some 38 of the stores.

A total of more than 932 kinds of illegal and counterfeit medicine were seized, in addition to 9,000 ready-made labels for masking expired medicines. One small counterfeiting factory was also discovered in the city of Sana’a, according to the ministry.

Medicines in Yemen
According to the Supreme Board for Drugs and Medical Appliances, about 9,345 of the 11,395 different kinds of medicine found in the Yemeni pharmacies are registered with the board. The number of new medicines presented to the board for approval has reached 13,327, of which some 1,800 are still pending. In Yemen, there are a total of 1,717 pharmaceutical manufacturing companies.

Who is responsible?
Drugs are unlike other consumer goods in that they are crucial to public health and as such they cannot simply not be treated in the same way as other commodities with respect to regulation. Their development, manufacture, import, distribution and use require specialized knowledge and skills. Consequently, they need to conform to prescribed standards and quality should be rigorously controlled. However, such regulation would require strong government will and commitment to establish and maintain a strong national drug regulatory authority.

“The Ministry of Public Health and Population and the Supreme Board do not make periodic campaigns for pharmacies in the different governorates,” said a local pharmacist in Sana’a, who wished to remain anonymous. “So many kinds of banned medicines are seen in many pharmacies. Moreover, some expired medicines are not confiscated and are still sold to patients. As pharmacists, we do not know many essential details on such counterfeit kinds of medicine; the Ministry and Supreme Board are responsible for warning the different pharmacies of such dealings and for providing them with specific names and types.”

A recent scientific study performed by researchers in the Faculty of Medicine and Health Sciences at Sana’a University shows that 22 percent of the 1,026 people surveyed are unaware of the dangerous medical, economic, social, and environmental effects of smuggled drugs. The study also found that the majority of people were unable to distinguish between smuggled and original drugs.

Massive scale
A recent study conducted by Dr. Ali al-Dooah, a pharmacist and sales manager with a local pharmaceutical company, confirmed that there are huge quantities of expired or ineffective drugs being illegally imported into Yemen. In fact, the study indicated that between 37 and 50 percent of all medicines sold in Yemen are the result of smuggling activities. Such drugs are often smuggled from the Horn of Africa, India and China, says Mohammed al-Asali, a member of the Parliament Committee on Health. According to the Yemeni Pharmacists Syndicate, influx such unregulated medicines badly affects the nation’s economy, resulting in annual losses estimated at YR 5 billion.

Counterfeit medicines cause sterility
In a particularly disturbing recent find, about 4,000 local women were about to take capsules for treating fertility issues. These capsules not only did not contain the actual medicine prescribed, but also contained ingredients which could have potentially serious side effects for the mother’s health and her ability to bear children. “When the counterfeit capsules of this medicine were examined, it was found that they did not contain the actual composition. It was just an antibiotic. Using such a counterfeit medicine would cause the woman to miscarry and possibly to be sterile in the future,” said Dr. Mosleh Abasah, director of Pharmacy and Medical Supply at the ministry.

Decreasing sales, increasing imports
According to the 2006 Annual Statistical Report issued recently by the Supreme Board, sales by local pharmaceutical manufacturers decreased 11 percent in 2006, down from $14,8 million in 2005 to $13.2 million (YR 2.6 billion). This represents 6.85 percent of total supplied drugs to the market, locally produced plus the imported. All seven local drug factories produced 108 substances during 2006.

Pharmaceutical imports, however, increased in comparison to 2005. 2006 imports were up 16 percent, totaling $179 million (YR 35 billion). According to the report, the total number of local importers reached 136. Imports of both medicines and medical supplies came from about 321 exporters located in 53 countries, nearly 60 percent of which were supplied by Arab and Asian manufacturers.

Many obstacles
A complex web of factors contributes to the proliferation of smuggling and counterfeit drugs and poses serious challenges to overcoming the problem in the future. In order for the government to be able detect smuggling and counterfeiting activities and to introduce effective programs which would eradicate the phenomenon, these factors must first be clearly identified and defined.

Among the key factors recognized are the lack of legalization, the absence of a strong national drug regulatory authority, the poor enforcement of existing legislation, corruption and conflicts of interests among legislators, the use of intermediaries to dilute transactions, the heavy demand and high prices of legitimate medicines, the sophistication of the illegal drug manufacturing industry, and the lack of regulation and cooperation from the major exporting countries.

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