/PRNewswire/ — Nielsen BioSciences announced today that the Centers for Medicare & Medicaid Services (CMS) updated the payment rate for the coccidioidomycosis skin test to recognize the cost of SPHERUSOL® (Coccidioides immitis Spherule-Derived Skin Test Antigen). The skin test is used in patients with Valley Fever.
“CMS’ decision to update the reimbursement rate for the coccidioidomycosis skin test will support access to the critical information SPHERUSOL provides to help manage this devastating disease, Valley Fever,” said Tom Carpenter, DVM, Ph.D., president and chief operating officer of Nielsen BioSciences. “SPHERUSOL can aid physician assessments about how the patient’s immune system is fighting the disease, information that they otherwise would not be able to attain from other commercially available tests for Valley Fever. We are pleased to see the decision by CMS, which will enable physicians to get appropriate reimbursement when testing patients impacted by this serious disease.”
Valley Fever is a serious infection that usually affects the lungs and is caused by inhaling airborne spores of the Coccidioides fungus, which grows in dry desert soil of the western United States. According to the Centers for Disease Control and Prevention, of the estimated 150,000 people per year who become infected with the Valley Fever fungus, 40 percent will develop symptoms, including fever, cough, chest pain, headaches, weight loss, night sweats, lethargy, and/or rashes. In severe cases, the fungal infection spreads from the lungs to other parts of the body, such as the central nervous system (brain and spinal cord infection), skin, bones and joints, can have life-long consequences and be life-threatening.
CMS’ updated reimbursement rate for the coccidioidomycosis skin test is $70.58 per test under the CMS Medicare Physician Fee Schedule for 2016. The updated reimbursement rate went into effect at the beginning of January. The Medicare reimbursement rate is also an importance source of information that may be used by private insurers and state health care plans to determine their own rate of reimbursement.
The CMS Medicare Physician Fee Schedule for 2016 can be found here: https://www.gpo.gov/fdsys/pkg/FR-2015-11-16/html/2015-28005.htm
SPHERUSOL is a skin test antigen administered by heath care professionals and is indicated for the detection of delayed-type hypersensitivity to Coccidioides in individuals with a history of pulmonary coccidioidomycosis. SPHERUSOL is a commercially available test specifically designed to see if a patient’s cellular immune system is responding to the fungus (Coccidioides) that causes Valley Fever.
The safety and effectiveness of SPHERUSOL have not been established in pregnant and nursing women, the pediatric population, or individuals > 65 years of age. The use of SPHERUSOL to detect delayed-type hypersensitivity response in a general population with unknown exposure to Coccidioides has not been evaluated. Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL. Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL.
The expected response to SPHERUSOL is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication. Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test. SPHERUSOL should never be given intravenously.
Additional Safety Information
The most common side effects in clinical studies were itching, swelling, pain and ulceration at the site. Certain drugs that suppress the immune system, such as corticosteroids, can prevent a delayed-type hypersensitivity response to SPHERUSOL.
See www.nielsenbiosciences.com for full prescribing information.
About Nielsen BioSciences
Nielsen BioSciences develops products to help in the evaluation, treatment, or prevention of immune-mediated diseases that can be missed by narrowly targeted diagnostic strategies. In addition to SPHERUSOL, Nielsen markets CANDIN® (Candida albicans skin test antigen for cellular immunity.) FDA-approved for detecting delayed-type hypersensitivity, CANDIN is also a drug candidate in ongoing investigational studies evaluating its use in the treatment of human papilloma virus (HPV) lesions. For more information, visit www.nielsenbiosciences.com.