Stark II rules still need fine-tuning, doctor groups say

Round two: Physicians offer their suggestions on how to further refine the latest version of the self-referral regulations.

By Tanya Albert, amednews staff. June 18, 2001.

For the most part, physician self-referral regulations that the government issued in January will be less disruptive to everyday practice than expected. But physicians say there are still a few problem areas in the 600-page regulation.

From in-office ancillary exemptions to indirect compensation, some parts of the regulation will need to be fine-tuned for doctors to provide the best patient care possible as they apply the rules in real-world situations, physician groups said.

Trouble spots
Links

"There is a tremendous effort for people to work together and provide care, and these rules seem to discourage that," said Bruce Bagley, MD, American Academy of Family Physicians chair. "It tries to keep everyone at arm's length."

Physicians and others had until June 4 to let the Health Care Financing Administration know about the problems they still had with the physician self-referral regulations, known as Stark II. About two weeks before the deadline for comments, HHS had received 81 responses on the regulations. That's a mere fraction of the nearly 13,000 comments the agency received after it asked for feedback on the 1998 proposed regulations that preceded the final rules.

"The clients we represent and the lawyers are pleased HCFA tried to clarify rules and add flexibility," said health care lawyer Patricia Meador, chair of the American Bar Assn.'s health law section. "There are some issues that are unresolved and unclear because the statute is unclear."

Physicians say they want the regulation to be more forward-thinking because it doesn't accommodate medical advances.

"It's a little behind the time," Dr. Bagley said.

The American Society for Therapeutic Radiology and Oncology is concerned that the rules restrict the CPT codes that radiation oncologists would be allowed to bill for and that they don't include codes for emerging treatments. For example, a radiation oncologist might use a CT scan to evaluate a cancer patient's tumor, but the regulation wouldn't allow that doctor to provide the scan.

"The current Stark regulation isn't aware of the next generation of systems," said Michael L. Steinberg, MD, co-chair of the joint economic committee for ASTRO and the American College of Radiology. "It would have an extremely negative effect on the technological development in freestanding clinics."

Some definitions in the regulation are also causing concern.

In its comment letter, the AMA asks HCFA to change the definition of durable medical equipment so that when new equipment becomes available, physicians would be able to provide it to their patients without breaking the law.

The rule allows physicians to sell canes, crutches, walkers, folding manual wheelchairs and blood glucose monitors to their patients, but the language the regulation uses doesn't account for new devices that could become available, the Association said.

Patient care worries

Physicians also are concerned that the rules won't allow patients to get the best and most convenient care.

The regulations say a physician group that owns or leases mobile vehicles, vans or trailers must use them on a 24-hour-a-day, seven-day-a-week basis for at least six months. The AAFP says that rule needs to be relaxed so that doctors would be allowed to share the vehicle if they could show that each participating group used the service exclusively for its patients for the contracted period of time.

"The rule effectively eliminates common practices whereby physicians lease services for a day or a block of time for the exclusive use of the patients," the AAFP said in its letter to HCFA.

Patient care also would be hurt by a portion of the rule that requires physicians who are providing a designated health service to treat a patient only for the "primary reason" for which the patient was referred.

For example, Dr. Steinberg said, there is concern that some radiation oncologists would have to send a cancer patient they are treating to another physician if the patient comes down with a cold and might need fluids or other treatment.

"It's not conducive with total patient care," he said. "It would be inhumane to run sick patients around town."

The self-referral law covers 10 services: physical therapy; occupational therapy; radiology; home health services; outpatient prescription drugs; radiation therapy services and supplies; durable medical equipment and supplies; inpatient and outpatient services; parenteral and enteral nutrients; and prosthetics, orthotics, and prosthetic devices and supplies.

Among some of the other issues in the regulation that medical and legal groups said need to be addressed are:

The group practice definition. If an existing group practice admits a new physician, 75% of the total patient care services of the group practice members has to be furnished through the group and billed under a group billing number. That's a difficult standard to meet, and the group practice could lose its designation because it sometimes takes up to nine months for a new physician to get a Medicare billing number.
Physician education. The AMA wants HCFA to create a Web site with a tutorial that would ask physicians a series of questions about self-referrals that would signal potential problems or for HCFA to create other educational tools.
The definition of self-referral. Services that a physician's employee performs should be considered personally performed services, without triggering a referral, doctor groups said.

The regulations issued in January were just the first part of the final regulations and are the ones that will most affect physicians. They are scheduled to take effect in January 2002. The second part of the final regulations are yet to be unveiled and don't have a set release date. They will primarily affect hospitals.

ADDITIONAL INFORMATION:

Trouble spots

Physician groups and health lawyers say the Stark II self-referral regulations have some problem areas, including:

In-office ancillary exception: A new "primary reason" criterion could stop some physicians who are seeing a patient on a designated health service referral, such as oncologists and orthopedists, from treating patient concerns unrelated to the referral. In order to provide the service without breaking the self-referral regulation, a physician would need to be a member of a group big enough to have a centralized building for services.
Indirect compensation: The standards are complex, particularly where the "volume or value" of referrals standard is concerned. It appears that the definitions are contradictory.
Academic medical center arrangements: A large portion of faculty practice plans base at least part of physicians' compensation on their percentage of professional fee revenues, which wouldn't be allowed under the new rules.

Weblink

HCFA files, "Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships" (http://www.hcfa.gov/regs/physicianreferral/default.htm)

American Health Lawyers Assn. (http://www.healthlawyers.org/)