A Medical Device Daily

The Centers for Medicare & Medicaid Services (CMS) released a final rule that it says will modernize the Medicare conditions for coverage for the nation's dialysis centers and promote higher quality of care for patients receiving dialysis.

The final regulation will enhance the quality of care available to more than 336,000 Medicare beneficiaries with end-stage renal disease (ESRD) who receive dialysis treatment from more than 4,700 Medicare-approved renal dialysis facilities across the U.S. The regulation reflects important clinical and scientific advances in dialysis technology and standards of care practices, according to CMS, updating requirements that were first published in 1976.

"By bringing the standards of care for dialysis patients up to date, we are improving the health and quality of life for thousands of Medicare beneficiaries," said CMS Acting Administrator Kerry Weems. "With the new rules, people living with ESRD can be assured that they are getting the best care possible."

The final rule went on display this week at the Office of the Federal Register and was scheduled to be published today.

These regulations will serve as minimum standards that dialysis facilities must meet in order to meet to be certified under the Medicare program. These conditions for coverage are part of the Medicare survey and certification process.

The rule focuses on the importance of patient rights, patient safety and the patient's participation in the development of his or her own plan of care. Each facility is required to develop a quality assessment and performance improvement (QAPI) program that would track the facility's performance in patient health outcomes. This regulation also reduces the detailed and burdensome requirements that dialysis facilities had to meet previously and provides flexibility for facilities to use their resources to meet the needs of individual patients and achieve better outcomes of care.

CMS establishes e-prescribing standards

People who are eligible to enroll in Medicare's prescription drug program are expected to experience greater safety, increased use of lower-cost generic equivalents, and more efficient communication between their doctor and pharmacy as a result of a new regulation issued Wednesday by CMS, the organization said.

The final rule establishes Part D e-prescribing standards for four types of information: formulary and benefits, medication history, fill status notification, and identification of individual healthcare providers.

"Establishing standards for e-prescribing under Medicare's prescription drug program will help pave the way for widespread adoption of e-prescribing throughout the medical community. Broader use of e-prescribing offers beneficiaries safer and more efficient care at lower costs," Health and Human Services Secretary Mike Leavitt said.

Prescribers, dispensers and other providers are not required to implement e-prescribing, but those who do must comply with the new Medicare standards when using e-prescribing to send prescriptions and prescription related information for covered drugs prescribed for Part D eligible individuals.

"The Part D e-prescribing standards final rule moves us closer to achieving interoperable health information technology, one of the cornerstones of the Administration's Value-Driven HealthCare Initiative," said CMS's Weems. "Converting from a paper-based system to e-prescribing promises improvements that will help prescribers, pharmacies, and all who are eligible for Medicare's prescription drug benefit. Most importantly, e-prescribing can help reduce the number of adverse drug events, which have been estimated at 530,000 a year for Medicare beneficiaries."

The standards adopted under the rule will apply to all Part D sponsors, as well as to prescribers and dispensers that electronically transmit prescriptions and prescription-related information about Part D covered drugs prescribed for Part D eligible individuals. Part D sponsors include freestanding Prescription Drug Plan sponsors, Medicare Advantage-Prescription Drug Plans, and other Part D sponsors. The new e-prescribing standards will be effective on April 1, 2009.

Medicare recipients may now receive home care

Thousands of Medicaid beneficiaries who were previously limited to receiving care in an institutional setting may now be given the option to receive that care in their homes and communities, under a proposed rule published by CMS.

The Deficit Reduction Act of 2005 (DRA) gave states a new option to provide home-and-community-based services (HCBS) to Medicaid beneficiaries without applying for a demonstration waiver. The proposed rule provides guidance to states on how to implement this provision of the DRA.

Under this option, states will now be able to set their own eligibility or needs-based criteria for providing HCBS. Previously, to qualify for assistance with personal care, home health care or other services in the home or community setting, beneficiaries were required to be at imminent risk of institutionalization. The DRA provision eliminates this requirement and allows states to cover Medicaid recipients who have incomes no greater than 150% of the federal poverty level, or $15,600 per individual in 2008, and who satisfy the needs-based criteria.