A Medical Device Daily
The Centers for Medicare & Medicaid Services (CMS) reported a pilot program to test options for beneficiaries with original Medicare to maintain their health records electronically. Under this pilot in Arizona and Utah, a beneficiary may choose one of the selected commercial personal health record (PHR) tools, and Medicare will transfer up to two years of the individual's claims data into the individual's PHR.
Medicare's administrative contractor, Noridian Administrative Services (NAS), released a solicitation to potential PHR vendors yesterday. The program is scheduled to begin in January 2009 and is expected to offer Medicare beneficiaries in the two states a choice of several PHR options.
"This exciting pilot will be a major step forward for Medicare. We believe that it will provide information and tools that will empower consumers to manage their health," said HHS Secretary Mike Leavitt. "Importantly, we intend for the pilot to provide beneficiaries with a choice of products that will make it possible for beneficiaries to meet their individual needs."
PHRs are tools that can help consumers manage their health and health care services. A PHR is a record of health information that is under the control of the consumer or patient. Sometimes it only contains data entered by the individual or his or her provider, but it also can include information from a health plan as is the case in this pilot, where Medicare provides health information from its claims data base. A PHR is different than an electronic health record (EHR), which is owned by and under the control of the physician.
Beneficiaries who select one of the participating PHR vendors also can add other personal health information if they choose. Depending on the specific product, they may be able to authorize links to other personal electronic information such as pharmacy data. PHRs can offer links to tools that help consumers manage their health such as wellness programs for tracking diet and exercise, medical devices, health education information, and applications to detect potential medication interactions.
Beneficiaries can elect to allow family members to have access to their PHR. They can also provide access to the PHR to their health care providers.
"At Medicare, we strive to find innovative ways to better serve our beneficiaries," said CMS Acting Administrator Kerry Weems. "This pilot is designed to evaluate how well PHRs meet the needs of our beneficiaries and whether PHRs can improve health outcomes and lower costs."
The PHR vendors will have until Sept. 8 to submit their applications to participate in this pilot with CMS.
CMS offers e-prescribing conference
CMS reported a conference to educate physicians and other stakeholders about a newly enacted federal program of incentive payments to encourage the use of electronic prescribing. It is requesting interested public and private sector organizations to join the agency as cosponsors of the conference, which will be held Oct. 6 7 in Boston.
"The new incentive program will help spread adoption of e-prescribing throughout the healthcare community," said Weems. "E-prescribing has many benefits for patients, providers, health plans, and pharmacies. Not only is e-prescribing more efficient than paper prescriptions, it is also safer. E-prescribing can help reduce the number of adverse drug events, which for Medicare beneficiaries alone is estimated at 530,000 a year."
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) established a five-year program of incentive payments to eligible professionals who are "successful electronic prescribers." Successful prescribers are those who either report applicable electronic prescribing measures established under the Physician Quality Reporting Initiative (PQRI) or who electronically submit prescriptions under Medicare Part D at a level determined by CMS.
The incentive payment program begins on Jan.1, 2009. The conference will serve to educate affected constituencies on the MIPPA program and CMS' plans for implementation.
CMS will invite selected organizations that meet the evaluation criteria to enter into formal, nonfiduciary cosponsor agreements to consult on the conference program content, speaker selection, and outreach strategies, in addition to other tasks as described in individual cosponsor agreements. Potential cosponsors must understand that cosponsor agreements will clearly indicate that there will be no federal endorsement of the cosponsor or endorsement of any policies, activities, products, or services resulting from cosponsorship of the conference.
Proposals to cosponsor the educational conference must be submitted by 5:00 p.m. EDT on Aug. 15.
Watson recalls lot of fentanyl patches
Watson Pharmaceuticals (Corona, California) reported that one lot of 75 mcg/hr fentanyl transdermal system patches sold in the U.S. is being voluntarily recalled from wholesalers and pharmacies.
A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
The recalled patches are from Lot Number 92461850, have expiration dates of Aug. 31, 2009, and were manufactured by Watson.
The affected lot of patches was shipped to customers between Jan. 30 and March 19 of this year. No other strengths or lots were affected and the company said it does not anticipate any product shortages as a result of this recall.
The company has notified FDA of the recall.
Fentanyl Transdermal System CII is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.