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.

Dem leaders push for quick Graham-Cassidy CBO assessment; hearing scheduled

Democrats in both the House and Senate reacted quickly to the Graham-Cassidy legislation in requesting a full assessment from the Congressional Budget Office (CBO). The office stated that it is working on a preliminary assessment for the week of September 25, 2017, as early as possible. However, the CBO warned that point estimates on several matters will be unavailable for at least a number of weeks.

Graham-Cassidy legislation

Offered as an amendment to the American Health Care Act (AHCA) (H.R. 1628), the proposal would give more control to states over meeting their residents’ health care needs. The legislation would repeal the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and fund a block grant program through the Children’s Health Insurance Program (CHIP) instead (see Sanders’ Medicare-for-all, Graham-Cassidy’s block grant legislation introduced in Senate, September 14, 2017).

Finance hearing

The Senate Finance Committee will conduct a hearing on the Graham-Cassidy amendment on September 25, 2017. Committee Chair Orrin Hatch (R-Utah) announced the hearing, stating that it would allow members on both sides of the issue to better understand policy. In light of the Finance Committee’s hearing announcement, Sen. Ron Johnson (R-Wis), chair of the Senate Homeland Security and Governmental Affairs Committee, has chosen to cancel his committee hearing.

CBO request and response

According to Rep. Nancy Pelosi (D-Calif), “Republicans are reportedly hoping to rush to a vote with only a scant budget assessment.” The letter to the CBO requested information on loss of coverage, premium and out-of-pocket cost increases, effect on those with pre-existing conditions, Medicaid cuts, marketplace stability, and state reform timelines. The CBO will be unable to provide estimates on the effects on the deficit, coverage, or costs in its preliminary assessment.

AMA chimes in 

Ahead of a CBO report, the American Medical Association (AMA) believes that the bill would destabilize markets and cause millions to lose coverage. The association reached out to Senate Majority Leader Mitch McConnell (R-Ky) and Minority Leader Chuck Schumer (D-NY) to oppose the amendment and all legislation that would jeopardize coverage. The AMA holds the position that any health reform proposals should ensure that those currently insured are able to maintain their coverage, and expressed its concerned that the conversion of the Medicaid program would limit federal support for needy patients.

House committee gives its approval to Medicare Advantage telehealth bill

A bill—The Increasing Telehealth Access in Medicare (ITAM)—aimed at improving access to Medicare Advantage telehealth services received approval from the House Ways and Means Committee on September 13, 2017. The unanimous approval came alongside the committee’s unanimous passage of a bill (H.R. 3726) to simply physician self-referral prohibitions and a bill (H.R. 3729) to continue Medicare add-on payments for ambulance services.

ITAM

The bipartisan bill, Increasing Telehealth Access in Medicare (ITAM) (H.R. 3727), introduced by Representatives Diane Black (R-Tenn) and Mike Thompson (D-Calif), seeks to encourage the use of telehealth by making it a basic benefit—rather than a supplemental service—for Medicare Advantage beneficiaries. Although critics of telehealth warn that the service presents a risk of overutilization in a fee-for-service reimbursement model, proponents of the new ITAM bill note that by pairing telehealth with Medicare advantage, that concern is “flipped on its head.”

Telehealth

A related bill, in the Senate, known as the Furthering Access to Stroke Telemedicine Act (S. 431), would permit any site exclusively administering acute care stroke treatment to be included in the list of eligible Medicare sites for telemedicine services, without regard for the site’s geographic location. In May of 2017, the Senate Finance Committee unanimously passed the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act (S. 870), a bill designed to expand telehealth access for Medicare beneficiaries with chronic conditions while increasing the incentives for accountable care organizations (ACOs) to provide those services.

Webinar: Delay, Deregulate, Derail — Health Care Roiled by Actions of Trump and Congress

Since January, both President Trump and Republican leaders in Congress have talked about a three-step process for repealing and replacing the Patient Protection and Affordable Care Act (ACA). While the first six months of the Trump administration has seen mixed results, its efforts to reign in or hold back regulations, combined with its delay in filling lower-level agency roles, has impacted regulatory review and issuance of new regulations. So, despite Congress’ inability to pass legislation to change parts of the ACA, there is still plenty for providers to be concerned about.

Join Associate Managing Editor Kathryn Beard, JD, on Wednesday, August 2, for this half-hour live webinar covering attempts by the Trump Administration and Congress to delay, deregulate, and derail significant parts of federal health policy. She will discuss the two “repeal and replace” bills, FDARA, and significant executive and regulatory actions taken by the Trump administration which directly impact ACA provisions.

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