The Centers for Medicare & Medicaid Services (CMS; Baltimore) last month rolled out long-expected revised guidelines for reimbursement of power mobility equipment, a move intended to diffuse recent and ongoing controversy concerning which Medicare beneficiaries should or should not get the equipment, such as powered wheelchairs and scooters. The new national coverage determination (NCD) focuses on what CMS termed "a function-based determination of medical necessity."
But the new guidelines go beyond the reimbursement for the powered wheelchair sector. Rather, according to the agency, it is a "three-pronged" approach that will cover reimbursement for products ranging from the powered and manual wheelchairs to canes and crutches, and total 13 product categories.
For the power mobility equipment, the new criteria are the most significant fall-out from the "Wheeler-Dealer" effort launched by the Department of Health and Human Services (HHS; Washington) in 2003. That program was designed to cut down the ballooning reimbursements for the power devices, which HHS said have been driven by fraudulent reimbur-sement billing. As just one example of the soaring costs, one estimate indicates that in 2001 Medicare paid for 3,000 wheelchairs in Harris County, Texas, alone (primarily the Houston area), with that number jumping to 31,000 in 2002, or more than 900%. At roughly $5,500 a chair, that was an increase from about $16.5 million to more than $170 million.
In cracking down on fraudulent reimbursements, however, the agency raised the ire of makers of power wheelchair and mobility products, who said that the traditional guidelines which set a patient "bed- or chair-confined" standard were too narrow and needed to be revised using clinically based standards that would benefit those in need of the mobility equipment.
Among those criticizing the Wheeler Dealer effort as overly restrictive and preventing appropriate beneficiaries from receiving the equipment was Restore Access to Mobility Partnership (RAMP; Washington), a group of suppliers and manufacturers of power wheelchair and scooters. RAMP praised the intent of the revised guidelines but called for clarification and changes. In a statement, it urged CMS to issue interim guidance "as soon as possible" to the durable medical equipment regional carriers (DMERC) the organizations that process Medicare claims to eliminate the possibility that the new coverage policy will produce "severe problems" before additional companion regulations are released. While RAMP said that the policy outlined in the NCD represents progress such as decisions by CMS to eliminate its "bed- or chair-confined" requirement and to establish more function-based coverage criteria, it said that "more work needs to be done."
CMS said the new coverage criteria also would come with new billing codes that will take effect next Jan. 1. It said the new codes will "reflect the variety of wheelchairs now on the market." Additionally, it will issue "new quality standards" for suppliers in 2006.
Barry Straube, MD, acting chief medical officer and acting director of the Office of Clinical Standards and Quality, said that the new policy "ensures that a beneficiary's functional status and individual circumstances are considered so that the most appropriate technology for each beneficiary's personal needs is covered." He also emphasized a consistency between "documentation of the functional needs of the patient" and the appropriate medical records.
In order to help practitioners understand the new criteria and the methods of documenting the needs of beneficiaries in their medical records, the agency said it will be issuing additional guidances. In general, this will make the power mobility coverage process "more straightforward."
Pulse oximeters: heading for OTC status?
Medical devices most frequently, point-of-care diagnostic systems are increasingly moving into the hands of customers over-the-counter (OTC). And the list of OTC-offered products was importantly expanded last year with the approval of the sale of automated external defibrillators (AEDs) without a prescription. Next on the list? Perhaps pulse oximeters, but probably only if adhering to an off-heard FDA mantra of: "more data needed."
The Anesthesiology and Respiratory Therapy Devices panel of the FDA's Center for Devices and Radiological Health met last month to discuss issues raised by the proposed OTC sales of pulse oximetry devices. Overall, panel members appeared to favor such an approval, with the usual differences of opinion among panelists regarding whether there is enough data available to make a more solid recommendation, for or against.
For a company to obtain approval for OTC marketing, it would have to submit a premarket approval application to the FDA, thus going beyond 510(k) requirements.
At present, there are already a small number of consumer products available that function somewhat like pulse oximeters. Nonin Medical (Plymouth, Minnesota), for example, manufactures devices for sports enthusiasts. The company's FlightStat product is a finger-mounted monitor for pilots to check for in-flight hypoxia. And Nonin's SportStat is marketed to mountain climbers, hikers, skiers and other athletes interested in measuring their blood oxygen saturation and pulse rate. Both are available without a prescription.
The difference, according to the FDA representatives at the panel meeting, is that no medical claims are made for these consumer products and that athletes would use these devices in much the same as they would a treadmill or other exercise equipment. At the same time, however, the devices the company manufactures for medical use are "mostly identical" to those marketing for consumer use, Phil Isaacson, founder and managing director of Nonin, told the panel.
For most panel members, the main issue is not the traditional endpoints of efficacy or safety, since the devices pose little safety risk to those using them. The issue for them appeared to be how potential OTC users would interpret the data that these devices provide.
"I think we need to see a trial population to see how these people use the data," said panel member David Birnbach, MD, professor of anesthesiology, obstetrics and gynecology at the University of Miami School of Medicine (Miami, Florida). "Do these devices raise a red flag when they shouldn't? Or do they lead patients to a false sense of security? Clearly more data is needed, but I think it should move forward. I see more positives than negatives." Birnbach also suggested that if people are able to use an AED available over the counter, a pulse oximeter would be a "natural combination" with that device.
Jacqueline Leung, MD, professor of anesthesiology at the University of California, San Francisco, agreed that more studies are needed, but she said that pulse oximeters if accuracy data were provided could provide a helpful diagnostic tool to patients who need it, much like a digital thermometer or a blood pressure monitor. "On the other hand, if someone is sick enough to need a PO [pulse oximeter] at home, it should be made under the director of a physician," argued Charles Cote, MD, vice chairman and professor of research in the department of pediatric anesthesiology at Children's Memorial Hospital (Chicago).
OTC availability of the devices "just feels like the right thing to do, but I am reluctant without further studies," said Alan Lisbon, MD, panel chairman and vice chair for critical care at Beth Israel Deaconess Medical Center (Boston).
On average, the FDA reports reviewing more than 20 510(k) submissions annually for pulse oximeters.
'Mass casualty' guidelines offered
An expert panel convened by the Healthcare Research and Quality organization and the Office of Public Health Emergency Preparedness (both Washington) last month presented guidelines outlining the delivery of medical care in the event of a "mass casualty" event. The report, "Altered Standards of Care in Mass Casualty Events," offers a framework for what is described as "optimal care during a potential bioterrorism or other public health emergency involving thousands, or even tens of thousands, of victims." For example, planners at federal, state, regional, community, and health systems levels are encouraged to develop or revise triage guidelines for specific kinds of events, as well as guidelines for allocating scarce resources such as ventilators, burn beds or surgical suites.
The report includes the recommendations of a 39-member panel of experts in bioethics, emergency medicine, emergency management, health administration, health law and policy, and public health convened last August. "Providing optimal care in a mass casualty event requires that we identify, plan, and prepare for the circumstances of available providers, facilities, equipment, and transportation of casualties," said Carolyn Clancy, MD, director of AHRQ. AHRQ says it has funded more than 50 emergency preparedness-related studies and other activities.
In related news, Mike Leavitt, secretary of Health and Human Services, also last month said that the department "has made available" another $1.3 billion to the states, territories and four metropolitan areas to strengthen their capacity to respond to terrorism and other public health emergencies. The funds, he said, will be used to upgrade infectious disease surveillance, "improve the ability of hospitals and the healthcare system to deal with large numbers of casualties, expand public health laboratory and communications capacities and improve connectivity between hospitals, and city, local and state health departments to enhance disease reporting."
Groups hit proposed health plan bill
A diverse group of organizations in mid-June voiced their opposition to upcoming legislation that they said would harm consumer and employee access to quality healthcare. The legislation, called the "Small Business Health Fairness Act" (HR 525/ S 406) would create association health plans (AHPs), which are certified group health plans sponsored by a business or professional association. Supporters of AHPs argue that these plans will allow small business owners to join similar employers in order to offer employees health insurance coverage at lower cost.
During a meeting at the National Press Club, representatives from the American Diabetes Association (ADA; Alexandria, Virginia), the American Cancer Society (Atlanta), the American Nurses Association (Silver Springs, Maryland), Blue Cross and Blue Shield Association (Washington), and the National Partnership for Women and Families (Washington), argued that the legislation would be exempt from state regulation and oversight and would negatively affect millions.
"This is an issue that device manufacturers should be very interested in, especially with conditions related to diabetes," Mary Nell Lehnhard, senior vice president in the office of policy and representation at the Blue Cross and Blue Shield Association, told The BBI Newsletter's sister publication, Medical Device Daily.
According to the ADA, the legislation, if enacted, would severely limit healthcare coverage and access to supplies for people with diabetes. "It's neither fair nor accurate for AHP proponents to say that some coverage is better than no coverage," said Jim Schlicht, ADA's chief government affairs and advocacy officer. "For the 18.2 million Americans who have diabetes, being under-insured with respect to their diabetes education and supplies is as problematic as having no coverage at all."
Schlicht said inadequate coverage would lead to poor disease management, which raises the risk of diabetes-related complications, including heart disease, blindness, kidney failure and amputations.
IOL sector gets CMS reimbursement boost
The Centers for Medicare & Medicaid Services last month saw its way clear to changing the reimbursement rules for presbyopia-correcting intraocular lenses (IOLs). Under previous guidelines, CMS covered IOLs during standard cataract surgery but did not give beneficiaries the option of choosing to pay for the more expensive presbyopia-correcting lenses out of pocket. Out-of-pocket payment would have to cover both the surgery and the lens, outside Medicare coverage. Under the new rule, beneficiaries would pay for the more advanced lenses, in addition to "associated services that exceed the charge for insertion of a conventional IOL following cataract sur-gery," the agency said.
The new ruling is also a boon for device companies with products in this rapidly growing sector. "Medicare patients will now have access to technology only available previously to non-Medicare patients," Andy Corley, CEO of Eyeonics (Aliso Viejo, California), told The BBI Newsletter. But he added the downside: "This is a typical case of Medicare reimbursement rules not keeping pace with technological innovation,"
Corley said his company, along with various others in the sector, had lobbied for roughly five years to get CMS to change its rule.
Presbyopia is an age-related condition in which the crystalline lens of the eye loses its flexibility and becomes cloudy, making it harder to see items up close. It is usually the first sign of a cataract. Physicians usually prescribe reading glasses, bifocals, trifocals, or contact lenses to treat the condition. Presbyopia-correcting IOLs such as Eyeonics' Crystalens not only replace lenses clouded by cataracts but allow the eye to focus on near, intermediate, and far vision, minimizing the need for corrective lenses.
Corley said the news will "greatly expand" his products penetration of a market where he estimated roughly 2.2 million cataract surgeries performed annually.
According to Joanne Wuensch, a device analyst for Harris Nesbitt (New York), the number of cataract procedures performed each year in the U.S. is closer to 3 million, and prior to Tuesday's decision only 10% to 20% would have been private-pay candidates for presbyopic lenses.
Other companies currently vying for a share of the pie include Advanced Medical Optics (AMO, Santa Ana, California), Alcon (Fort Worth, Texas) and Bausch & Lomb (Rochester, New York).
Program provides uninsured reimbursement
CMS also unveiled a new program to provide $1 billion over the next four years to help hospitals, certain physicians and ambulance providers recoup the costs of providing care to qualified individuals who are uninsured or cannot afford emergency care.
The funding comes from a section of the Medicare Modernization Act specifically focusing on undocumented aliens in the U.S. Each state will receive funding based formulas established in the law, and payments will be made directly to hospitals, physicians, and ambulance providers, including Indian Health Service facilities and Indian tribes and tribal organizations, "as long as they did not receive payment from any other source such as the person treated or an insurance company," CMS said.
The agency will make payments to eligible providers for some or all of their unreimbursed costs of providing emergency healthcare care services required under Emergency Medical Treatment and Labor Act (EMTALA) and related hospital inpatient, outpatient and ambulance services.
Under EMTALA, hospitals with emergency department are required to treat and stabilize patients who present with medical needs, regardless of their ability to pay. The cost of this care often strains hospital budgets and can threaten a facility's ability to keep its emergency department open. The majority of the funding nearly 70% will be distributed among healthcare providers based on a state's percentage of undocumented aliens. Remaining funds will go to providers in the six states with the largest number of arrests of undocumented aliens. Payments will be adjusted if the bills exceed a state's allocated funding.
States receiving the highest amounts in the current fiscal year are California, $70.8 million; Texas, $46 million; Arizona, $45 million; and New York, $12.25 million.
According to the American Hospital Association (Chicago), the move not only protects patients without health insurance such as illegal immigrants but also helps to keep facilities in those communities in business to treat patients who can pay.