Industry cites safety concerns.
Home health suppliers should keep news about inhalation drugs on their radar screens.
Sen. Charles Grassley (R-IA) is praising the Centers for Medicare & Medicaid Services' proposal to alter the way Medicare reimburses for compounded inhalation drugs.
Representatives for compounding pharmacies are stepping lightly around the issue, reports the FDA Weekly. Industry representatives say they hope CMS will field industry concerns as the new payment system is finalized.
The comments follow CMS' announcement on Aug. 22 that beginning next year, it will make drastic cuts in reimbursements to pharmacies and home health suppliers who concoct their own versions of inhalation drugs.
Though not finalized, the agency says the new system will result in payments for such drugs "at significantly lower payment rates" than under current rules.
In a statement released Aug. 24, Grassley, the Senate Finance Committee chairman, praised the changes as a good first step toward understanding the scope of the dangers posed by compounded respiratory drugs in the wake of recent concerns that they are more likely than manufactured pharmaceuticals to be contaminated or served up in incorrect dosages.
"Tightening up the payment system will help program administrators get a handle on the magnitude of compounding when it comes to inhalation drugs," said Grassley. "That information will help make it clearer what policy changes need to be made to better ensure what we pay for drugs that are safe and meet legitimate medical needs."
"We hope [CMS] consults with the pharmacy profession and that it considers the impact its policies have on patients who need compounded medicines," said a source with the International Academy of Compounding Pharmacists. "There are millions of patients out there for whom manufactured drugs are inappropriate."
Compounded drugs are often prescribed when a brand name drug is unsuitable, such as when the patient is allergic to one of the secondary ingredients in the brand. But they are also controversial because, unlike brand name and generic pharmaceuticals, they do not require FDA approval.
• Arcadia Resources will lease space inside a Wal-Mart, aiming to reach consumers directly with its line of durable medical and respiratory equipment.
The Arcadia-branded store will sell its full line of DME and respiratory equipment, including sleep apnea equipment, nebulizers, and other in-home healthcare products, in addition to more than 1,000 patient safety items and mobility devices ranging from wheelchairs, scooters, stairway lifts and walkers, to orthopedic support, bathroom safety items and adjustable beds, according to a news release from the company.
"We expect to continue to expand our direct-to-the-consumer sales of DME through retail channels and the establishment of walk-in medical clinics," said the Arcadia CEO John Elliott in a statement.
• New York Gov. George Pataki recently signed into law three measures designed to enhance access to home health care for New Yorkers.
The first measure would authorize designated nursing homes to provide medical care to patients in their homes. A second makes permanent the Access to Home Program, which provides financial assistance to homeowners and renters to adapt their homes or apartments to better meet the needs of persons with disabilities. The third initiative would create a comprehensive, at-home hospice program for children.
"We are committed to advancing initiatives to allow New Yorkers to receive the treatment and support they need in the most comfortable and loving environment possible," Gov. Pataki said. "Important reforms to the health care system I have advanced along with the legislature are beginning to reshape the delivery of care in New York State."
• A South Florida physician was sentenced Aug. 28 to nearly four years in prison for her role in a $2.3 million DME-related Medicaid kickback scheme, prosecutors in Florida announced.
In addition to the 46-month term, defendant Zabdy Westerburger also was ordered to pay restitution of more than $2.3 million, said R. Alexander Acosta, U.S. attorney for the Southern District of Florida, in a written statement.
According to the statement, Westerburger provided bogus prescriptions in return for cash kickbacks from owners of durable medical equipment companies who would bring individuals to her office and specify medical equipment and medications to prescribe, the statement said. To date, at least 30 people have been convicted in connection with the scheme, the federal prosecutor's statement.
• CMS has changed the time for the next Home Health, Hospice & DME Open Door Forum, scheduled for Sept. 26, 2006. Instead of commencing at the normal 2 p.m. Eastern Time, the call will run from 1 p.m. until 2 p.m. The time was adjusted so that home health, hospice and DME providers can participate in CMS' NPI Roundtable Meeting at 2 p.m.
To participate by phone, call 800-837-1935 and enter conference ID number 8269910.
• Home health agencies that work with their Medicare quality improvement organizations (QIOs) generally show greater improvements in clinic quality measures than providers who don't work with QIOs, according to a study released Aug. 15 in the online edition of the Annals of Internal Medicine.
The study looked at the impact of the quality improvement organization program on the quality of health care in nursing homes, home health agencies, physician offices and hospitals in the United States, Puerto Rico, and the U.S. Virgin Islands. The study reported on 11 home health quality measures.