By Adrienne Dresevic, Esq., and Clinton Mikel, Esq., of The Health Law Partners, P.C.
The Office of Inspector General (OIG) released its 2017 Work Plan, which contains provisions affecting the imaging community. The 2017 Work Plan is available for review here: https://oig.hhs.gov/reports-and-publications/archives/workplan/2017/HHS%20OIG%20Work%20Plan%202017.pdf.
The 2017 Work Plan explains audits and evaluations that are underway or planned, and certain legal and investigative initiatives that are ongoing. It also notes items that have been complied, postponed, revised, or canceled and includes new items that have been started or planned since April 2016. This year, the OIG highlighted the following issues affecting the imaging community.
Intensity-Modulated Radiation Therapy (IMRT)
The OIG had a Work Plan in 2016 related to IMRT, which it has revised for 2017. Prior OIG reviews identified hospitals that incorrectly billed for IMRT services. The OIG will now review Medicare outpatient payments for IMRT to determine whether the payments were made in accordance with Federal requirements
Portable X-Ray Equipment – Supplier Compliance with Transportation and Setup Fee Requirements
Medicare generally reimburses for portable x-ray services if the conditions for coverage are met. However, previous OIG work found that Medicare may have improperly paid portable x-ray suppliers for return trips to nursing facilities (ie, multiple trips to a facility in one day). The OIG will review Medicare payments for portable x-ray equipment services to determine whether payments were correct and were supported by documentation. The OIG will also assess the qualifications of the technologists who performed the services.
Collection Status of ZPIC and PSC – Identified Medicare Overpayments
The OIG issued several reports regarding the tracking and collection of overpayments that Medicare’s contractors have made to providers. In response, CMS stated that it added reporting requirements to improve overpayment tracking among the claims processors and Zone Program Integrity Contractors (ZPICs) and Program Safeguard Contractors (PSCs). ZPICs and PSCs are required to detect and deter fraud and abuse in Medicare Part A and Part B in their jurisdictions. They conduct investigations, refer cases to law enforcement, and take administrative actions such as referring overpayments to claims processors for collection and return to Medicare. The OIG will determine the total amount of overpayments that ZPICs and PSCs identified and referred to claims processors in 2014 and the amount of these overpayments that claims processors collected. The OIG also review the procedures for tracking collections of overpayments identified by ZPICs and PSCs.
The OIG investigates allegations of fraud, waste, and abuse in all of HHS’s programs. The OIG’s largest body of work involves investigating matters related to Medicare and Medicaid. This can include billing for services not rendered, medically unnecessary and misrepresented services, and patient harm. The OIG’s work also includes the illegal billing, sale, diversion, and off-label marketing of prescription drugs, as well as solicitation and receipt of kickbacks, including illegal payments to patients for involvement in the fraud scheme and illegal referral arrangements between physicians and medical companies. Specific case types include healthcare fraud schemes related to:
- Controlled and noncontrolled prescription drugs;
- Home health agencies, personal care, and home- and community-based services;
- Ambulance transportation;
- Durable medical equipment; and
- Diagnostic radiology and laboratory testing.
FDA Response Planning for a Networked Medical Device Compromise
The OIG revised the FDA Response Planning for a Networked Medical Device Compromise Networked medical devices from the 2016 Work Plan that reviewed whether the FDA’S oversight of hospital networked medical devices was sufficient to protect electronic protected health information on those specific devices.
The OIG specifically names “radiology systems” as one of the computerized medical devices that pose a security and privacy risk. The OIG further discusses that computerized medical devices “use hardware, software, and networks to monitor a patient’s medical status and transmit and receive related data using wireless communications.”
For the abovementioned reasons, hospital imaging departments should take the assessing of the security of these devices listed and networks used to transmit information seriously.
The OIG states in the Work Plan that the complexity of tasks performed by networked devices has increased exponentially over time. To meet the new demands within networked device functionality, wireless, Internet, and network connectivity has been introduced along with new cybersecurity vulnerabilities. The FDA is responsible for ensuring and monitoring the safety and effectiveness of networked medical devices. The OIG will examine the FDA’s plans and processes for timely communicating and addressing a networked medical device cybersecurity compromise.
Imaging providers and suppliers should review the new OIG Work Plan when assessing and updating their current compliance programs.
Adrienne Dresevic, Esq. is a Founding Shareholder of The Health Law Partners, P.C., a nationally recognized healthcare law firm with offices in Michigan and New York. Practicing in all areas of healthcare law, she devotes a substantial portion of her practice to providing clients with counsel and analysis regarding compliance, Stark Law, Anti-Kickback Statute, and compliance related issues. Ms. Dresevic serves on the American Bar Association Health Law Section’s Council, which serves as the voice of the national health law bar within the ABA. Ms. Dresevic also serves as the ABA Health Law Section’s Co-Chair of the Physicians Legal Issues Conference Committee, Vice Chair of the Programs Committee (Executive Leadership), and Vice Chair of the Sponsorship Committee. She is licensed to practice law in Michigan and New York, and can be contacted at firstname.lastname@example.org.
Clinton Mikel, Esq. graduated from the University of Michigan Law School. Practicing healthcare law, he concentrates in Stark, fraud/abuse, telehealth/telemedicine, compliance, and the corporate and financial aspects of healthcare practice.
The authors are members of The Health Law Partners, P.C. and may be reached at (248) 996-8510 or (212) 734-0128, or at www.thehlp.com.