Trade groups representing the medical device and imaging industries want CMS and other federal agencies to protect patient access to advanced medical technologies as they craft regulations on accountable care organizations.

ACOs as described under the health care reform law would offer integrated care for patients and allow for potential cost savings to the Medicare program. Providers that participate in ACOs could share in the cost savings if they meet certain quality performance measures.

The Medical Imaging and Technology Alliance, the Medical Device Manufacturers Association and AdvaMed were among those who submitted comments on how antitrust, physician self-referral, anti-kickback and civil monetary penalty rules should be modified to support ACOs.

Access To Medtech Must Be Protected - AdvaMed

AdvaMed wants CMS to include patient safeguards in its rules, such as explicit protections for Medicare beneficiary access to medically appropriate care, including advances in medical technology. Such provisions could include "adjustments in spending targets to avoid discouraging adoption of new treatments and technologies," AdvaMed writes in Sept. 27 comments.

Patients should also be notified before being treated by providers participating in an ACO, AdvaMed says. "Such beneficiary notification should include possible adverse effects on his or her care resulting from incentives to limit the items or services available to him or her," AdvaMed writes.

The trade group also calls for the development of robust quality measures "to offset financial incentives to reduce the volume and intensity of care."

In written comments, MITA argues against using utilization as a performance measure for ACOs.

"The measure needs to be focused on whether or not the patient received the appropriate imaging test for their condition, not how many of a specific imaging test were rendered," MITA writes.

MITA Warns Against Concentrated Market Power

The imaging trade group wants CMS to encourage competition among ACOs within a given geographic area.

"Allowing the formation of a single ACO would create an imbalance in market power between the providers and purchasers of health care," MITA says in Sept. 27 comments.

The group is "particularly concerned that a single ACO also would have little incentive to invest in technologies that improve the quality of care over the longer term but have increased costs in the near term."

MDMA wants CMS to wait until it completes and evaluates its current hospital-physician gainsharing demonstration projects before creating any new exceptions to physician self-referral laws (¹ Also see "Medicare Gainsharing Demos Still Have A Pulse, CMS Release Confirms" - Medtech Insight, 24 August, 2009.).

If exceptions are made, MDMA writes, CMS should require ACO programs to measure cost savings over at least one year.

"To show that savings have not resulted in adverse effects on quality, the program must measure savings over a long enough period to capture all of the costs of care provided under the program," MDMA writes Sept. 27.

"Programs that encourage physicians to select medical devices based on cost rather than clinical appropriateness for the patient are likely to result in higher rates of medical complications, malpractice liability, and hospital re-admittance."

If CMS creates a shared savings exception to the physician self-referral prohibition or if the HHS Office of Inspector General drafts safe harbors for ACOs, MDMA wants them to "clearly state that programs that satisfy the exception could implicate other state and federal laws."

CMS, OIG and the Federal Trade Commission will continue taking comments through Oct. 19.

- Monica Hogan ( ² m.hogan@elsevier.com )

Device Groups Voice Key Concerns With Accountable Care Organizations

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