BNA’s Health Care Fraud Report™ is the go-to source for health care fraud reporting, with in-depth information on government and private enforcement actions and strategies designed to...
Proposed waivers of the physician self-referral law, federal anti-kickback statute, and civil monetary penalties law for qualified accountable care organizations most likely would be applied consistently across all entities, a senior adviser with the Department of Health and Human Services Office of Inspector General said during an April 28 web conference.
“We are not envisioning a case-by-case or advisory opinion approach for introducing the waivers; they would be consistent for everyone,” Vicki L. Robinson said during a Health Care Compliance Association webinar, Proposed ACO Rule: Risks & Challenges for Compliance Officers.
The Centers for Medicare & Medicaid Services and OIG in the April 7 Federal Register published a notice with comment period pertaining to proposals for waivers of fraud and abuse laws for ACOs. Comments are due June 6.
An ACO is a group of medical care providers that accepts responsibility for providing or arranging all care for a group of patients under a payment arrangement that allows it to profit by reducing costs and improving quality. CMS issued a proposed rule March 31 for implementing ACOs.
Providers have expressed concerns that without fraud and abuse law waivers, the creation of ACOs would create financial relationships that could run afoul of existing laws.
Robinson said any waivers to fraud and abuse laws would “supplement, not supplant, existing safe harbors and exceptions.”
Under the OIG/CMS notice, the Stark, anti-kickback, and CMP laws would be waived with respect to the distribution of shared savings payments to ACOs, Robinson said.
In addition, the anti-kickback and CMP laws would be waived for Stark-compliant relationships within the ACO, she said.
The Stark law prohibits referrals of Medicare and Medicaid patients to entities with which physicians or their immediate family members have a financial relationship if the referral is for the furnishing of designated health services.
“Usually, arrangements that comply with the Stark law are still subject to the [anti-kickback] and CMP laws, so this would be a departure from the norm,” Robinson said. “Our goal is to use the waiver to support ACOs while at the same time protecting patients. We want to ensure that the fraud and abuse laws do not impede beneficial ACOs.”
Robinson was joined on the web conference by Max Reynolds, deputy general counsel of health law for the University of California Office of General Counsel. Reynolds said that compliance officers will face numerous challenges associated with implementing ACOs.
For example, he said, ACO compliance officers must monitor their clinical operations to ensure that high-risk beneficiaries are not being denied service.
“It's very significant that you monitor whether you're avoiding high-risk beneficiaries and steering healthy beneficiaries into your network,” Reynolds said. “Make sure that you're not doing anything to deter the high-risk beneficiaries from getting care.”
A greater number of high-risk beneficiaries could reduce the shared savings payments for ACOs, Reynolds said.
ACOs also will need to implement and maintain a compliance plan and designate a compliance officer who is not the legal counsel, he said.
The compliance officer must have direct communication with the ACO's governing board.
Other compliance requirements include:
• ensuring that the ACO adheres to the governing board structure in the original application to CMS;
• ensuring that state licensing requirements are met;
• validating the ongoing implementation of a quality assurance and improvement process, led by a physician;
• allowing CMS to approve marketing materials before their use; and
• notifying the Federal Trade Commission if there is a material change to the ACO network that gives it a market share of more than 50 percent.
By James Swann
The ACO notice on fraud waiver proposals is at http://edocket.access.gpo.gov/2011/pdf/2011-7884.pdf.
The CMS proposed rule on ACOs is at http://edocket.access.gpo.gov/2011/pdf/2011-7880.pdf.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)