A Medical Device Daily

Medicare coverage for chiropractic care currently is limited to what chiropractors are most known for: manual manipulation of the spine. But should they be reimbursed for broader services, those more often provided by MDs?

That is one of the key questions to be answered by a two-year demonstration project unveiled last week by the Centers for Medicare & Medicaid Services (CMS; Baltimore). The project, CMS said, is intended to determine the "feasibility and advisability" of reimbursements for a broader range of chiropractic services, looking specifically at beneficiary satisfaction, use of services and costs.

The demonstration expands Medicare coverage to include medical, diagnostic and therapy services to treat neuromusculoskeletal conditions. Chiropractors will be allowed to order MRI and computed tomography scans, X-rays, clinical lab services, and also make referrals for physical therapy.

"Medicare currently only pays for a limited number of services from doctors of chiropractic, even though chiropractic services may be less costly alternatives to other types of medical care," CMS Administrator Mark McClellan said in a statement.

McClellan said expanding chiropractic coverage would reduce out-of-pocket costs for seniors and allow CMS to evaluate whether paying chiropractors for additional services would improve health outcomes and reduce Medicare costs.

CMS said it would hire an independent evaluator to assess the cost impact, utilization and beneficiary satisfaction.

Donald Krippendorf, president of the American Chiropractic Association (Arlington, Virginia), called the decision "a win-win situation" for seniors, Medicare, and the chiropractic profession.

"The ultimate beneficiaries of the demonstration project are the 1.6 million Medicare recipients who will now have greater access to a broader scope of chiropractic services," Krippendorf said. "Not only do we believe patient satisfaction will be high among seniors – who typically do very well with chiropractic treatment – but also that outcomes will be improved and Medicare costs will be lowered because chiropractic care will help seniors avoid costly and unnecessary medications, hospital stays and back surgeries.

As of April 1, chiropractors in Maine and New Mexico, the northern Illinois area, and 17 counties in Virginia were able to offer Medicare Part B patients expanded services previously not covered by Medicare.

The demonstration project was mandated as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

CED guidance for coverage issued

CMS also issued draft guidance intended to improve the process for making Medicare coverage decisions involving additional evidence development. The goal is to provide better access and greater health benefits from certain medical technologies, the agency said. This policy approach is called coverage with evidence development (CED).

The purpose of the guidance is to describe and get input from interested stakeholders on the factors that CMS may consider in deciding to extend national coverage for certain items and services "in the context of protocol-specified prospective data collection, and how such coverage expansions can be undertaken as effectively as possible."

Where coverage with evidence development is appropriate, CMS, it said, will be able to provide faster and broader access to an item or service while providing support for doctors and patients to use the technology effectively in individual cases, it said.

Coverage would be granted to "cutting-edge technology, based on less extensive effectiveness data" upfront, while requiring collection of additional effectiveness data post-coverage.

"As healthcare becomes more personalized, better evidence can help doctors and patients use the treatments that Medicare covers more effectively," McClellan said. "That means faster coverage expansions, greater access to beneficial treatments, and better health outcomes."

According to CMS, the goal of the evidence-based review is to make an informed decision about whether the item or service is "reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member."

The draft guidance gives examples of two types of circumstances when the CED initiative may be used.

  • First, when a particular medical intervention has been demonstrated to improve outcomes in a broad population, but the assurance that individual patients are receiving medically necessary care would be significantly more likely to occur when specific data is collected.
  • Secondly, when a particular medical intervention has yet to conclusively demonstrate outcomes improvement, but existing information clearly suggests the intervention may provide a benefit.

A recent decision involving CED under the first circumstance is the recent coverage decision for implantable cardioverter defibrillators (ICDs). That decision provided for access to a potentially life-saving new treatment, with data collection through systems now being widely used in hospitals. The registry, developed through a collaborative process involving medical experts, clinical specialists, and product developers, will help provide evidence on the use and course of disease in particular types of Medicare beneficiaries who receive ICDs, CMS said.

In a statement issued Friday, the Advanced Medical Technology Association (AdvaMed; Washington) said it welcomes the draft guidance and will provide feedback based on "key principles" agreed to at its March board meeting. Issues that AdvaMed said need to be addressed include:

  • that CMS post-coverage data requirements should not impede the adoption of new technologies;
  • that data collection should be specific, limited to well-defined questions and developed "in a transparent manner with stakeholder input;"
  • that the structure of the program should move toward reliance on health information technology as the primary source of post-coverage data;
  • and that CED should not undermine Medicare's local coverage process.