New law stops potential criminalization of EMS ‘standing orders’ for timely controlled-substance use

A new bipartisan law, the Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, signed by President Trump on November 17, 2017, amends the Controlled Substances Act (CSA) (P.L. 91-513) to clarify that emergency medical services (EMS) professionals (including nurses, paramedics, and emergency medical technicians) are able to continue administering controlled substances (contained in schedules II, II, IV, or V) to critical patients, such as pain narcotics and anti-seizure medications, pursuant to standing (written medical protocol) or verbal (oral directive) orders when authorized by state law (Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, enacted November 17, 2017).

It has been a long-standing practice for medical directors of EMS agencies to write standing orders for the administration of controlled substances by EMS professionals. As reported by Emergency Physicians Monthly, in a January 2015 meeting with the National Association of EMS Physicians (NAEMSP) Executive Committee to discuss possible EMS regulations, the Drug Enforcement Administration (DEA) stated its position that the CSA only allows for patient-specific orders for controlled substances and that it is illegal for EMS agencies to deliver any controlled substances under written medical protocols or standing orders. Therefore, absent this new legislation, it was the position of the DEA that any regulations concerning EMS agencies would be required to prohibit the continued use of standing orders for EMS professionals.

The law also allows EMS agencies the option of having a single DEA registration in each state where the EMS agency administers controlled substances, in lieu of requiring a separate registration for each location of the EMS agency within the state, as long as certain transportation, storage, re-stocking, and recordkeeping rules for controlled substances are followed by the EMS agency. The act further provides that a hospital-based EMS agency may use the DEA registration of the hospital to administer controlled substances without an additional registration of its EMS agency.

The law was introduced as H.R. 304 in the House of Representatives by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC). The Senate version, S. 916, was introduced by Sens. Bill Cassidy (R-La) and Michael Bennet (D-Colo). H.R. 304 initially passed the House by a vote of 404-0 on January 9, 2017. It passed the Senate, as amended, by unanimous consent, on October 24, 2017.

HELP committee advances public health bills

Among a series of bills voted on by the Senate Health, Education, Labor and Pensions (HELP) committee on April 26, 2017 were bills focused on access to medications in emergency situations (Protecting Patient Access to Emergency Medications Act of 2017 (S. 916)) and hearing loss screening for children (Early Hearing Detection and Intervention Act (S. 652)). Also sent to the Senate floor were two other public health bills which would create a national commission on clinical care (S. 920) and better prepare the public health community for Zika and other mosquito-borne diseases (S. 849).

S. 916

The Protecting Patient Access to Emergency Medications Act seeks to amend the Controlled Substances Act to make it easier for first responders and those providing emergency medical services to have access to “time-sensitive and life-saving treatments.” The bill is sponsored by Sen. Bill Cassidy (R-La) and co-sponsored by Sens. Michael F. Bennet (D-Colo), Roy Blunt (R-Mo), and Al Franken (D-Minn).

S. 652

The Early Hearing Detection and Intervention Act is sponsored by Sen. Rob Portman (R-Ohio) and co-sponsored by Sens. Tim Kaine (D-Va), Sheldon Whitehouse (D-RI), John Cornyn (R-Texas, Sherrod Brown (D-Ohio), and Richard Blumenthal (D-Conn). The bill aims to improve state-based efforts to screen newborns, infants, and young children with hearing loss screening and link them to follow-up care if needed by amending sec. 399M of the Public Health Service Act. The Health Resources and Services Administration (HRSA), the Centers for Disease Control and Preventions, and the National Institutes of Health would need to coordinate and collaborate these efforts with those administering such programs as the Medicaid Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program, for example.

Insurance antitrust exemption reform clears House

The House passed on March 22, 2017, H.R. 372, The Competitive Health Insurance Reform Act of 2017, with a bipartisan vote of 416 to 7. The Act repeals in part the McCarran-Ferguson Act antitrust exemption for insurers, including price fixing, bid rigging, and market allocation, and retains the exemption for certain collaborative activities. A CBO report projected that the Act would have no significant net effect on the premiums that private insurers would charge for health or dental insurance and that any effect on federal revenue would be negligible.

The report noted that health insurance premiums could be lower to the extent that enacting the bill would prevent insurers from engaging in practices currently exempted from antitrust law. On the other hand, insurers could become subject to additional litigation and thus their costs and premiums might increase. The CBO estimated that both of those effects would be small.

The American Hospital Association had expressed concerns about the abuse of market power by large commercial insurers with the Departments of Justice and Health and Human Services previously.

Is the American Health Care Act a ‘critical first step’ or unsupportable?

HHS Secretary Tom Price, M.D., supports the reconciliation recommendations known as the American Health Care Act, and considers the changes a necessary and important first step in further reforming the U.S. health care system. In a letter to the chairs of the House Committees on Energy & Commerce and Ways & Means, Price explained that in his view, the proposed legislation aligns with President Donald Trump’s promise to repeal and replace the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). Two major industry groups, however, said that they could not support the current version of the bills.

American Health Care Act 

On March 6, 2017, House Speaker Paul Ryan announced the American Health Care Act, consisting of two committee “budget reconciliation legislative recommendations,” which would be passed under the provisions of S. Con. Res. 3, a resolution which developed a streamlined process for Congress to pass health reform without threat of Senate filibuster. The document from the Ways & Means Committee would alter many of the ACA’s tax provisions, including eliminating penalties related to the individual and employer mandates, while the Energy & Commerce Committee’s document focuses on changes to the Medicaid program (see Republicans present health reform that is neither repeal nor replacement, March 7, 2017). Both committees began markup on the bills less than two days after the documents were made public.

First step in Administration’s plan

According to Price, the reconciliation legislation is just the first of three planned steps in undoing the ACA’s reforms. The reconciliation process can only be used to change some ACA provisions, though not all, and also cannot be used for all of the Trump Administration’s planned reforms. To complete those changes, HHS has two more planned steps; first, taking administrative actions to provide patients with additional options and give states more flexibility in Medicaid spending, and second, to support legislation on Trump’s other priorities including sale of insurance across state lines and medical tort reform. HHS noted that the Administration has already begun work on the second step, including Trump’s Executive Order on minimizing the economic burden of the ACA (see Trump Administration previews health care plans with Executive Order, regulatory freeze, January 23, 2017) and a Proposed rule designed to stabilize the health insurance marketplace by altering enrollment periods and other rules.

AHA and AMA opposition

Two major stakeholders in the health reform debate are the American Hospital Association (AHA) and American Medical Association (AMA), both of which released statements saying that, as currently written, neither organization could support the American Health Care Act. AHA President and CEO Richard J. Pollack wrote a letter on behalf of the hospitals, health systems, health organizations, and clinician partners associated with the group, and first raised concerns about the lack of coverage estimates from the Congressional Budget Office (CBO) and asked that Congress wait until an estimate is available before proceeding with formal consideration of the Act. The letter also listed the AHA’s policy concerns, including the restructuring of Medicaid—which “already pays providers significantly less than the cost of providing care—and the elimination of funding sources while continuing the ACA”s reductions in hospital payments.

Similarly, AMA President Andrew W. Gurman, M.D., wrote that the Act would reverse the ACA’s coverage gains, with millions of Americans losing coverage, and insisted on the involvement of physicians in the health reform debate. AMA Vice President and CEO James L. Madara, M.D., wrote a letter to the Committee Chairs and Ranking Members in which he said the organization cannot support the Act as drafted “because of the expected decline in health insurance coverage and the potential harm it would cause to vulnerable patient populations.” He noted concerns that rolling back the ACA’s Medicaid expansion would limit state flexibility and urged the Committees to “do all that is possible” to prevent individuals who currently have health insurance from losing that coverage.