by Admin | March 10, 2009 4:58 pm
By Karin Rives[1]
In the Merriam-Webster dictionary, a patient is defined simply as “an individual awaiting or under medical care and treatment.” In the complex world of federal healthcare policy, the definition of a single noun can determine whether or not patients get critical care, or whether safety-net pharmacies lose or save millions of dollars – as 340B providers are well aware.
In January 2007, the Health Resources and Services Administration (HRSA) set off a storm of protests when it proposed to tweak and narrow the meaning of the word “patient” under the 340B drug discount program.
Safety-net hospitals, community health centers and other stakeholders filed more than 100 comments in response to the proposal, warning that the proposed guidelines would severely curtail discount prescriptions and dramatically increase pharmacy costs.
There were also those who welcomed HRSA’s efforts, and some who said they didn’t go far enough. PhRMA, the trade organization representing the nation’s largest brand-name manufacturers, praised the proposed guidelines which it said would minimize the risk of drug diversion. But PhRMA also submitted a proposal to further identify and reduce “ambiguities in the patient guidelines,” and make them more stringent. (See Monitor, Jan. 2007.)
To this day, however, the patient definition matter remains unresolved. HRSA never issued final guidelines before President Bush left office in January. And with a new administration in Washington and a stronger Democratic majority in Congress, it’s unclear whether the guidelines will be kept in perpetual limbo, whether a compromise may be worked out, or perhaps the idea of a new patient definition be thrown out altogether.
Waiting for Ax to Fall
Nobody likes to live with uncertainty. For now, though, no news is good news to people such as Michael Glomb, legal counsel for the National Association of Community Health Centers in Bethesda, Md.
“It’s now two years later and nothing has happened. The [patient definition] matter is still out there, and I guess we’re still waiting for the ax to fall,” Glomb said. “But status quo is good.”
Any health policy decisions will likely be on hold until President Obama nominates and Congress confirms a new health secretary. It may also help to have new ears in Congress that are willing to tune into 340B issues, Glomb added. “Time is on our side,” he said.
While the specific reason for the delay is unclear, the Monitor has learned that the guidelines were, in fact, cleared by former U.S. Health and Human Services Secretary Mike Leavitt and sent to the White House’s Office of Management and Budget (OMB) for publication.
The guidelines were to be packaged with two other pending 340B-related notices – one that would expand the use of contract pharmacies (see story on p. 6) and another that would have provided final instructions for children’s hospitals on how to enroll in the 340B program.
There’s speculation that the Bush administration chose not to move on patient definition because of the 340B community’s effective pressure on OMB not go forward with publication, coupled with stiff opposition from drug makers against the other two guidelines.
Build Instead of Tearing Down
While the Obama administration has indicated that it will support safety-net providers, there’s no guarantee that the patient definition issue won’t resurface, cautioned Marcia Daigle, director of government relations for Louisiana State University’s Health Care Services Division in Baton Rouge.
“Patient definition needs to be institutionalized, preferably in legislation, so that the patients that the 340B program serves continue to receive services and providers can continue their safety-net mission,” Daigle said. “HRSA’s three-pronged test…should continue to serve as a basis for patient definition. These points can be further clarified. But to completely throw them out, start over, and make them more complicated is a gross injustice to providers – and most importantly, to vulnerable patients who seek access to needed services.”
Aliquippa—Bad Apple of Proof of Systemic Problem?
HRSA said when proposing the new guidelines that the definition of patient had to be tightened because some covered entities “may have interpreted the definition too broadly.” This had resulted in the potential for diversion of medications purchased under the 340B program, the agency said. Under the new definition, for example, a person would only be a patient if he or she has “an established relationship” with the 340B hospital, and the hospital maintains records of the patient’s healthcare.
This was a clear allusion to the high-profile Aliquippa Community Hospital drug diversion case that shook the 340B community at the time. Government prosecutors had accused a physician of setting up a discount drug distribution service under the auspices of the Pittsburgh-area 340B hospital. (See Monitor, June 2006.)
| Current Patient Definition Guidelines
Covered entity must maintain records of healthcare services for the patient. Patient must receive care from health professional employed by, or under contract or other arrangement with, covered entity. Patient must receive healthcare services from covered entity that is consistent with the scope of services paid for by the federal grant that qualifies entity for 340B. Proposed Guidelines Added to Original Three Covered entity must own, control, and possess records of healthcare services provided to the patient. Records must document all healthcare services resulting in the use or prescription of 340B drugs. Healthcare provider writing prescription must be employed by, or under contract with, the covered entity (not through another arrangement). * The prescriber must order and provide diagnostic and treatment services of which the 340B prescription is a part. * Additional requirements apply if prescription is written by person not employed by, or under contract with, covered entity. A formal referral to the prescriber and assurance that the patient will return in 12 months is required, for example. Source: Safety Net Hospitals for Pharmaceutical Access |
The physician allegedly procured and sold 340B discounted drugs to oncology patients nationwide with minimal ties to Aliquippa. The hospital was eventually kicked out of the 340B program and the physician settled criminal charges. Depending on whom you talk to, Aliquippa was evidence of compliance problems within the 340B program, or a shining example of enforcement that worked.
Such gray areas have contributed to the problem of product diversion, the Biotechnology Industry Organization (BIO), the largest trade organization for biotechnology companies, noted in its 2007 comments to HRSA. The possibility that 340B-discounted drugs land in the hands of individuals who are not patients of a 340B hospital “has become an acute concern for manufacturers,” BIO wrote.
Patients Draw Short Straw
Critics of the guidelines countered that HRSA’s redefinition of patient, while perhaps well-intended, would make it too cumbersome and difficult for providers to qualify patients for 340B-discounted drugs. This, they said, would kick previously eligible uninsured and indigent patients out of the program.
340B providers that lack their own outpatient clinics “will probably see their ambulatory models gutted,” warned Donna Evans, a pharmacist at an Alabama hospital, in her 2007 comments to HRSA. Her institution’s ambulatory drug costs would soar 50 percent, or by $500,000, which, in turn would contribute to a 50-percent drop in the number of patients who would be helped, Evans projected.
“This change, if implemented, will hurt the very patient population that the 340B program was created to help,” Evans wrote. “The drug companies, however, will pocket increased profits.”
Source URL: https://340binformed.org/2009/03/patient-definition-still-stands-but-for-how-long/
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