Medical Device Daily Washington Editor

WASHINGTON — The Centers for Medicare & Medicaid Services (CMS; Baltimore) has had a busy start to 2005. Amid all the recent movement toward Medicare reform, including the Bush administration's hype surrounding the prescription drug card, the agency also has announced a series of new coverage decisions.

One such decision that stirred the med-tech industry last week was the expanded coverage for implantable cardioverter defibrillators (Medical Device Daily, Jan. 30, 2005).

Late Friday, CMS also announced cancer-focused expanded coverage decisions for positron emission tomography (PET) scans and additional “off-label“ uses in selected clinical studies for new cancer drugs that already have been approved.

The agency gave the nod to cover PET scans for certain uses in evaluation of patients with brain, cervical, ovarian, pancreatic, ovarian and testicular cancers, in addition to other cancers.

The expansion of PET scan benefits makes the test available to patients when the patient and doctor participate in certain clinical studies or submit information to a PET database, CMS said. The agency said that the data collected as part of this policy would ensure that the PET information is used accurately and appropriately in patient management and also help doctors and Medicare beneficiaries make better choices about their healthcare.

The PET database is being developed by a working group that includes representatives from clinical oncologists, imaging organizations, academic institutions and industry. Medicare coverage will become effective when the database is fully established within the next several months, according to CMS.

In addition, the CMS Council on Technology and Innovation will begin to develop a draft guidance document on this policy approach. An open-door forum on this topic will be held on Feb. 14 to obtain public input on linking coverage to practical trials and databases.

PET images the biology of diseases at the molecular level, often before changes are visible by anatomical imaging or, in some cases, before symptoms appear.

“Medicare reimbursement of PET imaging for cancer will give hope to thousands of Americans and their families,“ said Ronald Nutt, PhD, president of CTI Molecular Imaging (Knoxville, Tennessee). “Now patients will get the best treatment available as a result of this important decision. Approximately 70% of all cancers have some coverage for PET scans.“

The Academy of Molecular Imaging (AMI; Los Angeles) called the CMS decision “a major step forward.“

AMI president Ed Coleman said, “The decision builds on years of experience with PET for presently covered indications and will provide valuable data on the accuracy of PET and its impact on physician management of patients.“

Quality-based pay for providers

CMS also announced new initiatives to pay healthcare providers for the quality of the care they provide to seniors and people with a disability. The plan is part of an ongoing pay-for-quality push frequently touted by McClellan.

“Better care should be rewarded, and thanks to growing support from healthcare providers and other stakeholders, we have better approaches to doing so than ever before,“ he said. “It is time that we pay for the quality of the healthcare provided to our beneficiaries, not simply the amount. We are working to apply this in every setting in which Medicare and Medicaid pays for care.“

In addition, CMS said that 10 large physician groups across the U.S. would participate in the first pay-for-performance initiative for physicians under the Medicare program. The Physician Group Practice demonstration gives physician groups an opportunity to demonstrate that improving care in a proactive and coordinated manner also saves money, the agency said.

Currently, Medicare reimburses physicians and other healthcare providers on the number and complexity of the services provided to patients. CMS said there is good evidence to show that by anticipating patient needs, especially for patients with chronic diseases, healthcare providers that partner with patients can intervene before expensive procedures and hospitalizations are required.

During the three-year project, CMS will reward 10 physician groups nationwide that improve patient outcomes by coordinating care for chronically ill and high-cost beneficiaries in what the agency termed “an efficient manner.“

CMS will assess both quality performance and quality improvement. The quality measures that will be used focus on common chronic illnesses in the Medicare population, including congestive heart failure, coronary artery disease, diabetes mellitus and hypertension, as well as preventive services, such as influenza and pneumonia vaccines and breast cancer and colorectal cancer screenings.

Under the demonstration, physician groups will continue to be paid on a fee-for-service basis. The groups will implement care management strategies designed to anticipate patient needs, prevent chronic disease complications and avoidable hospitalizations, and improve quality of care. Depending on how well these strategies work in improving quality and avoiding costly complications, physician groups will be eligible for performance payments.

Groups were selected based on technical review panel findings, organizational structure, operational feasibility, geographic location, and implementation plan.

New rules for end-stage renal disease

On Friday, CMS also released a proposed rule that would modernize the Medicare end-stage renal disease conditions for coverage by promoting higher quality care from dialysis facilities that want to participate in the Medicare program.

The proposed regulation is applicable to more than 4,700 Medicare-approved renal dialysis facilities and more than 325,000 patients with chronic kidney disease. In addition, the proposed regulation reflects important advances in dialysis technology and standard care practices because these requirements have not been revised in their entirety since 1976.

McClellan said the new rule brings CMS “up to date.“

The proposed rule lessens prescriptive and burdensome requirements for dialysis facilities and provides flexibility regarding the use of their resources to meet the needs of individual patients and achieve better outcomes of care.

This rule also reflects current clinical and scientific advances in dialysis technology and standard care practices, including clinical practice guidelines developed by the National Kidney Foundation (New York).

Some of the proposed changes include:

  • Incorporating current Centers for Disease Control and Prevention (Atlanta) infection control guidelines.
  • Additional patient safety protections such as defibrillators in the emergency equipment list and updated fire safety code provisions.
  • Additional patient rights, such as advance directives, a 30-day notice prior to involuntary discharge, posting of external grievance mechanisms and an internal patient grievance process.
  • A more comprehensive patient assessment, including a patient's suitability for a transplantation referral and criteria to identify unstable patients.
  • A separate condition for coverage addressing the special needs of home dialysis patients, including a provision to ensure that services are at least equivalent to services provided in dialysis facilities.
  • Minimum federal qualifications for patient care technicians (PCT) such as professionally supervised on-the-job training and a written PCT training program with specified criteria, including patient sensitivity training.
  • Electronic data reporting and collection of CMS clinical performance measures project data for improved facility-level quality of care accountability.

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