FTC asks Missouri lawmakers to reconsider APRN safety and competition

The Federal Trade Commission (FTC) submitted written comments on a proposed Missouri law that would modify the collaborative practice arrangements imposed on Advanced Practice Registered Nurses (APRNs) and limit the authority of APRNs to provide services. The FTC comments urge Missouri lawmakers to make certain that the stricter APRN requirements are warranted in light of alleged patient safety concerns. The agency comments assert that unnecessary legislative burdens on APRNs run the risk of increasing health care costs while decreasing competition and access to care.

Bill 633

Under current Missouri law, APRNs are required to enter into a collaborative practice arrangement with a specific physician in order to assess and diagnose patients. APRNs also need a collaborative practice arrangement to order diagnostic and therapeutic tests and procedures. The proposed law, Missouri House Bill 633, would remove some constraints on the collaborative practice arrangements between physicians and APRNS, while imposing some additional constraints. Specifically, the law would impose additional recordkeeping, consultation, and chart review responsibilities for APRNs. The FTC comments acknowledge that, as currently drafted, HB633 “may lower the costs of these arrangements by facilitating electronic collaboration.”

Practice structure

The primary focus of the FTC comments is the collaborative practice arrangement itself and the agency’s concern that it raises possible competitive issues. Through its comments, the FTC reiterated a position that it established in a March 2014 Policy Perspective (see FTC offers state legislatures some principles for evaluating APRN scope of practice restrictions, Health Law Daily, March 10, 2014). The agency cautioned that, although the state asserted health and safety concerns as the basis for the collaborative practice arrangement, the arrangements may be unnecessarily burdensome because APRNs have been demonstrated to be “safe and effective as independent providers of many health care services within the scope of their training, licensure, certification and current practice.” As a result, the FTC comments asked Missouri legislature to “scrutinize claimed health and safety justifications” for the current requirements so that a determination can be made as to “whether the collaboration requirements are warranted.”


Despite several concerns, the FTC praised a provision of the Missouri proposal that would decrease the length of an APRN’s supervision period prior to the authorization of independent practice. The comments also were supportive of a provision allowing supervising physicians to conduct off-site review of APRN documentation of patient charts. The FTC was cautious about the potential effects of other provisions, including one provision that would impose additional record keeping obligations on APRNs for certain patient conditions and circumstances.

Using connectivity to expand telehealth to rural and remote areas

On April 21, 2015, the U.S. Senate Subcommittee on Communications, Technology, Innovation, and the Internet, heard from witnesses on the progress made by the private sector and government entities to expand the benefits of telehealth nationwide, particularly in rural areas. The hearing also explored the connectivity challenges facing many health-care providers and patients attempting to take advantage of innovative telehealth applications.


Globally, the number of patients using telehealth services is predicted to grow from 350,000 in 2013 to 7 million by 2018. Last Congress, the Senate passed a resolution (S. Res. 588) recognizing that access to hospitals and health-care providers for patients in rural areas is “essential to the survival and success of communities in the United States.” The resolution further stated that Congress must address the unique health-care needs of rural areas, in order to ensure that those communities continue to thrive.


The subcommittee heard testimony from four witness: (1) Dr. Kristi Henderson, Chief Telehealth and Innovation Officer, University of Mississippi Medical Center; (2) Jonathan D. Linkous, Chief Executive Officer, American Telemedicine Association; (3) Dr. M. Chris Gibbons, Distinguished Scholar in Residence, Connect2Health Task Force, Federal Communications Commission; and (4) Todd Rytting, Chief Technology Officer, Panasonic Corporation of North America.


Henderson’s testimony focused on the use of telehealth in Mississippi, which leads the nation in prevalence of multiple chronic diseases and has the lowest number of doctors per capita of any state in the nation. According to Henderson, the greatest challenge is winning federal level reimbursement parity that will make telehealth attractive in the marketplace and securing the reliable, high quality connectivity.

She urged the subcommittee to focus on three issues: (1) the need for continued support of the Universal Service Fund, which, through its Rural Health Care Support Mechanism, allows rural health care providers to pay rates for telecommunications services similar to those of their urban counterparts, making telehealth services affordable; (2) broader application of the Federal Communication Commission’s (FCC) E-rate program, which connects the nation’s schools and libraries to broadband; and (3) the need for a more inclusive Health Care Connect Fund, which would allow large hospitals to receive a more robust reward for serving as a consortium lead for a network of smaller rural hospitals and clinics.


Linkous gave examples of telehealth growth. He testified that, in 2015, over 125,000 patients who suffer stroke symptoms will be diagnosed by a neurologist in an emergency room using a tele-stroke network; tele-ICU will be used for 11 percent of the nation’s intensive care beds to help oversee almost 500,000 critically ill patients; and about one million patients with an implantable pacemaker or suffering from an arrhythmia will be remotely monitored.

Despite this growth, Linkous testified that certain reforms are necessary to achieve the full benefits of telehealth. These reforms include: (1) providing the infrastructure to physically enable telehealth services; (2) making sure that benefit coverage will financially enable telehealth networks; and (3) the need for Congress to direct or facilitate the development of new telehealth networks.


Gibbons described activities of the FCC’s Connect2Health Task Force. According to Gibbons, the Task Force is a senior-level, multi-disciplinary effort to move the needle on broadband and advanced health care technologies by thinking across various FCC silos, with the Task Force serving as an umbrella for the FCC’s health-related activities.

Gibbon’s assured the subcommittee that: (1) telehealth and other broadband-enabled health solutions are playing (and likely will continue to play) a significant role in helping to achieve the national objective of a healthier America; (2) the FCC is actively engaged in efforts to ensure that telehealth and other broadband-enabled health technologies are accessible in rural and remote areas, on tribal lands, and in other underserved sectors of the country; and (3) tangible progress on rural telehealth is within reach if broadband is done right and done now in rural areas, outreach and education is provided, better tools to measure progress are provided, solutions are tailored to the locality, and collaboration with public-private stakeholders occurs.


Rytting testified that Panasonic is committed to the effort to transform America’s healthcare system through the power of information technology supported by robust broadband connectivity. Panasonic believes, according to Rytting, “that a fully-connected and interoperable health information and communications technology (ICT) ecosystem will provide the foundation to improve the coordination and quality of care, better health outcomes, and reduced overall costs.”

Because a key component of this ICT ecosystem is the utilization of telehealth and remote patient monitoring services, “Panasonic…urge[s] that national policy…reflect the dynamic and transformative nature of advanced ICT solutions, and not inhibit the innovation that holds the promise to continually improve the care delivery system even as it can contain costs.”

Rytting suggested that: (1) Congress and federal agencies should ensure that their approaches utilize a technology-neutral approach, so as not to “lock in” a limited set of solutions that, while deemed adequate for today, may impede innovations; (2) well-intentioned overregulation can act as a disincentive to investment and innovation in the healthcare space, potentially short-changing or harming patients; (3) there is an ongoing need for cross-agency coordinated inquiries into opportunities for wireless broadband allocations that can be utilized by healthcare applications; (4) in the Universal Service Fund context, the FCC’s policies should constantly be re-examined for ways to foster innovation; and (5) the solutions needed for a fully connected healthcare system must be able to utilize both licensed as well as unlicensed spectrum, and be permitted to operate with appropriate sharing arrangements.

Cardinal Health pays $27M to resolve radiopharmaceutical monopoly allegations

Cardinal Health has agreed to settle allegations that the manufacturer illegally monopolized 25 local markets for the sale and distribution of low-energy radiopharmaceuticals through anti-competitive tactics. Under the terms of the proposed final order with the Federal Trade Commission (FTC), Cardinal Health will pay $26.8 million into a fund that will be used to compensate customers injured by the manufacturer’s anti-competitive conduct.


Radiopharmaceuticals are used by providers to diagnose a variety of medical conditions, including heart disease. As a result of the short half-life of the radioactive isotopes used in the drugs, “hospitals and clinics rely on radiopharmacies located nearby, resulting in highly localized markets.” According to the FTC complaint, following 2003 and 2004 acquisitions, “Cardinal became the largest operator of radiopharmacies in the United States and the sole radiopharmacy operator in 25 metropolitan areas.” With its market power, the complaint alleged that Cardinal targeted Bristol-Myers Squibb (BMS) and General Electric (GE)—the only U.S. manufacturers of the radiopharmaceuticals known as heart perfusion agents (HPAs) between 2003 and 2008. Cardinal Health allegedly coerced BMS and GE to refuse to grant distribution rights for their HPA products to new competitors in the markets where Cardinal Health had taken hold.

Consumer harm

According to FTC Chairwomen Edith Ramirez, “Cardinal, by preventing other radiopharmacies from entering its markets, was able to deny customers the benefits of competition and reap monopoly profits from the sale of radiopharmaceuticals for a sustained period of years.” The FTC alleges that through its exercise of illegal market power, Cardinal Health “obtained de facto exclusive distribution rights” for HPAs in the relevant markets. As a result, the complaint alleged that Cardinal Health violated the FTC Act by blocking or delaying competitive entry into 25 local HPA markets across the country.


In addition to the $26.8 million disgorgement, Cardinal Health is also barred under the proposed final order from “entering into simultaneous exclusive deals with manufacturers of the same radiopharmaceutical product or from using coercion or retaliation to obtain de facto exclusivity.” Additionally, Cardinal Health is required to notify the FTC before entering into any further exclusivity distribution agreements or buying any radiopharmacy assets. Finally, the agreement allows for enhanced entry into some of the radiopharmaceutical markets by requiring Cardinal Health to give its customers the option to terminate their contracts with Cardinal Health for low energy radiopharmaceuticals.

Study explores the reform wilderness of Pioneer ACOs

Performance of provider organizations enrolled in the Medicare Pioneer accountable care organization (ACO) program differed significantly in 2012, the program’s first year. In order to sustain or expand the program, according to a study published in the New England Journal of Medicine, researchers believe it may be necessary to require “greater and more reliable rewards for ACOs that reduce spending than those currently in place.” Additionally, the performance differences of organizations with high pre-enrollment spending and those with low pre-enrollment spending indicate that benchmarks for ACOs should be better tailored to the efficiencies of particular organizations.


Under Section 3021, the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), authorized the creation of ACOs for Medicare in order to incentivize the formation of legal entities, compromised of multiple health care providers, who work together to coordinate care and keep costs down. Under the Pioneer model, “ACOs share in savings with Medicare if spending for an attributed patient population falls sufficiently below a financial benchmark and incur losses if spending sufficiently exceeds the benchmark.”


To evaluate the performance of ACOs in the Medicare Pioneer ACO program, the study reviewed Medicare claims data between 2009 and 2012. The study compared the performance of Medicare fee-for-service organizations with the 32 Medicare Pioneer ACOs. Specifically, for the year 2012, the study evaluated differences in spending and quality between traditional Medicare providers and the Pioneer ACO’s. Researchers also used data prior to 2012 to look into differences between the performances of organizations that had high spending prior to enrolling in the Pioneer program and organizations with relatively low spending prior to their participation in the Pioneer program.


The study estimated savings by ACOs in spending on acute inpatient care, hospital outpatient care, and post-acute care, particularly in skilled nursing facilities. However, the researchers also identified that “spending on outpatient care in office settings differentially increased in 2012 for the ACO group, partially offsetting the lower spending on hospital outpatient care.” Savings were greater for ACOs with baseline spending above local averages, while savings were lower for ACOs with pre-program spending below local averages. The study projected an “overall per-beneficiary estimate of -$29.2,” which suggests that the total Medicare spending for 2012 was approximately $118 million lower than expected as a result of the Pioneer program. According to the study, this figure “exceeds the $76 million in bonuses paid by CMS to Pioneer ACOs by $42 million.” Additionally, for the 13 ACOs that withdrew from the Pioneer program, estimated savings were comparable to those of the 19 ACOs that remained in the program.


The findings were consolidated by researchers into three issues pertinent to the future of the Pioneer ACO program: (1) a lack of a relationship between estimated savings and program participation; (2) the appropriation by CMS of savings generated by ACOs and the lack of strong incentives to participate; and (3) the need for more equitable benchmarks that do not unnecessarily favor organizations with higher pre-program spending.