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.”

Provisions

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.

Background

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.

Witnesses

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

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

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

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

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.

Highlight on Oklahoma: Precautions and maintenance of programs vital to protecting health

Oklahoma is currently focused on maintaining the health of its citizens (and their pets) in several different areas. From closing an ice cream plant, to keeping an eye out for bird flu, to maintaining mental health programs, the state has its hands full.

Blue Bell plant closed following listeria scare

In March 2015, a cup of ice cream traced back to a Blue Bell facility in Oklahoma was found to be contaminated with listeriosis. On April 3, Blue Bell announced the suspension of operations at its Broken Arrow plant to allow the company to determine the cause of the contamination. The now-recalled contaminated ice cream cups were shipped to institutions, such as hospitals. Listeria infections are prone to affecting people with weakened immune systems, like hospital patients. The outbreak was first identified when five patients who had been hospitalized in Kansas between December 2013 to January 2015 became infected. Three of those patients died. Blue Bell intends to reopen the plant once the investigation is complete.

Department of Agriculture warns of bird flu cases

According to the Oklahoma Department of Agriculture, Food and Forestry, those who have birds and poultry as pets should keep an eye on their health, as two new strains of avian influenza have been identified. Although the disease has not been identified in Oklahoma yet, cases have popped up in surrounding states in the last month. Humans are not in danger of contracting the disease from eating poultry products. However, those who come in contact with ill or dead poultry or wildlife should take precautions before interacting with domestic birds. Any signs of unusual bird sickness or death should be reported to officials.

Positive news for cancer patients

On a more positive note, a bill involving insurance standards for proton radiation cancer treatment has been passed by both the state House and Senate and is under review by Governor Mary Fallin (R). The bill would prevent insurers from holding this type of treatment to higher effectiveness standards than other radiation treatments. Proton radiation was approved by the FDA as a cancer treatment in 1988. However, some insurance companies still regard it as an experimental therapy. Utilizing a proton beam allows the radiation to be more effectively focused on the cancer cells, hopefully sparing damage to surrounding organs. According to the National Association for Proton Therapy, this treatment is painless and patients may have fewer side effects following proton radiation as opposed to traditional radiation.  This legislation does not contain a mandate requiring provision of coverage, but guides insurers on making coverage decision.

Making the case for mental health care

Oklahoma’s budget for the next fiscal year has been reduced by $611 million from the previous year. State agencies are expecting budget cuts. The director of the Oklahoma Department of Mental Health and Substance Abuse Services, Terri White, hopes hers will not be one of the agencies forced to make do with less. In fact, she has requested an additional $10.2 million over last year’s funding to combat decreases in Medicaid reimbursement and maintain important programs.

White has collected data and statistics showing the effectiveness of the department’s services to support her requests. The Systems of Care program, operating in 72 counties, helps school-aged children up to 18 years old with serious behavioral and emotional problems. These children are now at reduced risks for arrest and out-of-home placements. The mental health courts, drug courts, and family drug court have all worked to reduce arrests and the burden on the court system overall. The family drug court saved the Department of Human Services approximately $5 million over three years by allowing faster reunification of participating families in cases where children were removed due to substance abuse in the home.

The number of people in the state needing mental health or substance abuse treatment is somewhere between 700,000 and 950,000, but Oklahoma is only able to help about 190,000 each year. White maintains that the additional amount requested is absolutely necessary to maintain the current state of the program and avoid cutting services provided to at least 5,000 citizens.

Highlight on Oregon: House passes “right to try” measure

As detailed earlier this year, legislators in numerous states will introduce “right to try” bills in 2015 that give critically ill patients access to medications that have not been approved by the FDA. Kansas, Tennessee, Utah, and Wyoming have already filed bills or announced intentions to do so. These “right to try” laws have already been approved in five states: Arizona, Colorado, Louisiana, Missouri, and Michigan.

On April 7, 2015, the Oregon state House became the latest legislative body to pass a bill that would nullify in practice some of the FDA rules that prevent terminally ill patients from accessing treatments. In a unanimous 59-0 vote, House Bill 2300 (HB2300)  would give terminally ill patients access to medicines that have not been approved by the FDA.

Currently the federal Food, Drug, and Cosmetic Act (FDC Act) prohibits general access to experimental drugs. Under the expanded access exception of the FDC Act (21 U.S.C. § 360bbb), however, patients with serious or immediately life-threatening diseases are allowed access to experimental drugs after receiving express FDA approval. All human test subjects using the exemption must be informed that the drug is being used for investigational purposes and the consent of the subjects or their representatives must be obtained, except when an investigator deems it not feasible or contrary to the best interest of the subject. The Oregon bill would bypass this expanded access program. Insurance companies would not be required to cover the drug or complications that arise from using it under “right to try.”

Highlights of HB2300:

  • Only patients with a prognosis of one year to live would be eligible for the “right to try.”
  • Children under 15 would be denied the right to try in all circumstances.
  • Investigational product must have passed Phase I clinical trials and be currently active in subsequent phases.
  • No civil or criminal liability exists for acts or omissions of acts related to administering a treatment.
  • Licensing boards, health care facilities, or professional organizations/associations cannot impose discipline or sanctions for administering treatment.

Other states’ “right to try” bills have passed without the eligible patient and age restrictions above. For patients and providers wanting the “right to try,” the wait is on for the Oregon state Senate to approve the bill and submit it to the governor.