Know the rules: 5 legal developments every radiologist should understand

Radiologists are responsible for knowing the ins and outs of so many laws, proposals and government organizations that trying to keep track of them all can be downright daunting.

A presentation at this week’s AHRA Annual Meeting in Las Vegas aimed to guide attendees through a variety of these hot topics, helping prepare them for the years ahead.

Adrienne Dresevic and Clinton Mikel, two partners at The Health Law Partners, P.C. in Southfield, Mich., presented the information. They both spoke with RadiologyBusiness.com afterwards to go over some key points in greater detail.

1. A potential update to the Stark Law

The Ethics in Patient Referrals Act (H.R. 939), commonly referred to as the “Stark Law,” places certain limitations on physician referrals. Advanced imaging currently falls under the in-office ancillary services exception, which allows medical practices to provide certain services without violating the Stark Law.

Dresevic and Mikel explained that there have been numerous attempts to remove advanced imaging from this exception altogether, including the Promoting Integrity in Medicare Act of 2013 (H.R. 2914).

“For the past three years, they’ve introduced legislation trying to get rid of the in-office ancillary services exception for certain services, primarily high-end imaging,” Mikel said. “They’ve been beating this drum for a while, and we continue to see publications out of MedPAC continually questioning the medical necessity and whether in-office imaging through the in-office ancillary services exception leads to overutilization and all the costs associated with it.”

So far, none of these attempts have built up enough momentum to move forward, and there are passionate voices on both sides of the argument. But legislators keep introducing these bills, and Dresevic thinks that may be an indication that changes could eventually take place.

“I think we’re seeing a signal that this is something that will go through in the near future,” Dresevic said. “Where as in the past, we saw those kind of proposals, but they were dismissed pretty fast.”

2. Proposed updates to the Anti-Kickback Statute

The federal Anti-Kickback Statute (AKS) protects patients and federal health programs, such as Medicare and Medicaid, from fraud, prohibiting the exchange of anything of value for the referral of a federal program patient. Over time, the Office of the Inspector General (OIG) has introduced various “safe harbors” that are protected from prosecution under the AKS. And in a proposed rule from October 2014, the OIG suggested one safe harbor that stands out to Dresevic and Mikel: free or discounted local transportation.

“Free or discounted transportation has been an area that’s been looked at for a long time,” Dresevic said. “The government has recognized in several favorable OIG advisory opinions that, sometimes, if structured appropriately, it can lead to access of care and there are good reasons you may want to have, for example, transportation offered for certain beneficiaries if they can’t get to their treatment.”

Technically, the AKS does presently allow for a very limited amount of local transportation, but it’s such a small amount ($10 per item or service, $50 over the course of a year) that the OIG felt a separate safe harbor was still required.

There would be strict limitations on the proposed safe harbor, Dresevic explained, so imaging centers may still want to hold off on leasing a stretch limousine for now. For instance, transportation could only be provided to obtain “medically necessary items or services” within 25 miles. And the service would only be available for established patients, keeping it from being used as a bargaining chip to induce referrals of new patients. Transportation by air or a luxury vehicle would also not be protected under the safe harbor.

The proposed rule included other safe harbors and updates as well, and can be read on OIG’s website.

3. The crackdown on commission-based marketing arrangements

“A real hot area that comes up time and time again and is being focused on right now by the government ... is the commission-based sales arrangements,”  Dresevic said.

Commission-based marketing arrangements refer to an organization using an independent contractor to market its services and then paying that contractor on a commission. Dresevic explained that many people believe this to be a violation of the AKS, and imaging providers should pay close attention to their marketing staff at all times.

In addition, Dresevic said, it’s important to make sure your marketing staff understands all applicable laws.

“Make sure there’s compliance education,” she said. “Make sure they understand the ‘rules of the game,’ so they’re not out there putting all of the parties at risk. They can’t use cash or cash equivalents, they shouldn’t be giving gift cards to referral sources, all the different things in the industry.”

The OIG is intentionally treating independent contractors with much more scrutiny than employed marketers. True employees are protected by the AKS’s safe harbor if they’re in charge of marketing and get paid on a commission, Mikel explained, but if you’re an independent contractor, it’s not allowed.

“They don’t want absolute protection for independent contractors,” Mikel said. “It doesn’t mean independent contractors are illegal, but it’s certainly much higher risk, and it’s an area that is under scrutiny right now.”

4. Sunshine Act data is available for physicians in advance

The Physician Payments Sunshine Act, also known as Open Payments, was designed to make relationships between physicians, teaching hospitals and manufacturers more transparent. Manufacturers of pharmaceutical drugs and medical devices are required to report direct payments, indirect payments and other transfers of value to physicians. CMS then takes those reported payments and publishes the data on a public, searchable website.

Mikel said that radiologists, like all physicians, should make sure they are proactive and sign up for the Sunshine Act data review process. The government receives this information and sits on it for some time before it is released to the public.

“If you have signed up for the free publication data review, it dings you and says, ‘Hey, physician, someone submitted open payments about you. Come in and look at it,’” Mikel said. “So you get a preview.”

Mikel explained that this step is especially important because the Open Payments data is currently a bit of a mess.

“Inaccurate data is being reported, data is being reported sloppily, and some stuff is being reported that doesn’t have to,” Mikel said.

There are clear benefits to reviewing this data. If the data is flat-out wrong, a physician can contact the company reporting the payment and figure out what happened. And if the data is correct, Mikel explained, at least the physician has a head start and can frame the issue.

5. The significant increase in OCR investigations

The Office of Civil Rights (OCR) is responsible for enforcing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and it’s been extra busy in recent years. These OCR investigations begin in one of three ways, Mikel explained:

• You reported a data breach to the OCR
• You were reported to the OCR
• A ‘random’ audit

Dresevic and Mikel’s presentation included a step-by-step explanation of how to handle possible OCR investigations, but it can be summarized fairly easily: fix your overall HIPAA compliance, and respond to what the OCR is specifically asking about. It’s important to do both of these things at the same time, Mikel said, because it shows the OCR that you are trying to fix the problem and improve your practice. Demonstrating that you are trying can go a long way with these investigations.

“The OCR isn’t typically in the game of playing ‘gotcha,’” Mikel said. “They can fine for a lot more things than they do. Right now ... they really want people to just comply.”