Category: HHS

HHS launches innovative payment model for ambulance providers

Curtis Campbell, Class of 2019; Kim Harvey Looney, Partner at Waller

The United States Department of Health and Human Services (HHS) recently announced a new payment model for emergency ambulance services that will permit Medicare patients to be transported to healthcare facilities other than hospital emergency departments.

The Emergency Triage, Treat and Transport (ET3) model was announced on February 14 with the objective of allowing Medicare Fee-for-Service beneficiaries to receive the most appropriate level of care, while simultaneously reducing out-of-pocket costs. Under the model, HHS will allow ambulance suppliers and providers to transport Medicare beneficiaries to areas besides the emergency room, such as a doctor’s office or urgent-care facility, or use telemedicine, with the goal of reducing unnecessary trips to the hospital.

The ET3 model will run for five years and is expected to start in early 2020. This model was introduced to create a new set of incentives for emergency transport and care while ensuring patients get convenient and appropriate treatment in the correct setting. One concern with the existing model is that the payment system only pays ambulance providers when they take beneficiaries to the hospital emergency department, which HHS argues may lead to unnecessary emergency room visits or hospitalizations that may harm the patients.

The ET3 model will test two new payment models while still paying for emergency transport when a Medicare beneficiary is transported to a hospital emergency department or other destination covered under current regulations. The two new payment models are:

  • payment for treatment in place with a qualified healthcare practitioner, either on-the-scene or connected using telehealth; and,
  • payment for unscheduled, emergency transport of Medicare beneficiaries to alternative destinations, such as 24-hour care clinics.

The ET3 model will reward participating ambulance suppliers or providers by providing the opportunity to earn up to a 5% payment adjustment in later years of the model if they meet certain quality measures. The quality measurement strategy aims to avoid adding additional burdens to participants, while also seeking to minimize new reporting requirements. The model will be phased in with multiple application periods in order to maximize participation throughout the country. HHS anticipates it will start accepting applications from Medicare-enrolled ambulance suppliers and providers in Summer 2019.

The proposed ET3 model illustrates the willingness of HHS to develop and evaluate new cost-containment strategies while ensuring that Medicare patients receive the appropriate levels of care in the right settings.

The HHS press release announcing the program can be found here.

Trump Administration Opens Door for Broader Contraceptive Mandate Exemptions

By Matthew Byron, Class of 2019

The Affordable Care Act (ACA) does not currently mandate that insurers cover contraceptives under their respective plans. However, in 2011, the Departments of Health and Human Services, Treasury, and Labor (the Departments) issued regulations requiring non-grandfathered group health plans and health insurers to cover all FDA-approved contraceptives. Under those regulations, a few entities–mainly churches and other religious organizations–were exempt from being required to cover contraceptives, so the exemptions under these regulations were very narrow.

Since the 2011 regulations were enacted, several religious organizations sued the Department of Health and Human Services to challenge paying for or providing contraceptives due to certain religious and moral objections over contraceptives. In an effort to protect the individuals and entities with sincere religious and moral objections to providing or covering contraceptives, while still keeping the contraceptive mandate intact, on November 7, 2018, the Departments announced two final rules, available at the Federal Register, that provide certain protections for American individuals and entities that have a legitimate religious or moral objection to health insurance that covers certain contraceptive methods. While these rules do not go into effect until January 14, 2019, the rules provide for two major exemptions from the contraceptive mandate requirement.

Exemptions for Religious Beliefs

The first of the two final rules establish an exemption from the contraceptive mandate for entities and organizations that have “sincerely held religious beliefs” opposed to coverage of some or all contraceptive or sterilization methods…” An otherwise exempt entity can still choose in its plan to provide for the coverage of contraceptives, but of course, this would be a voluntary choice for that entity instead of a requirement. In addition, if an otherwise exempt entity chooses to object to one particular type of contraceptive, but chooses to allow for coverage of another type of contraceptive, the entity may do so. This exemption applies not only to religious organizations, but it can be applicable to non-profit organizations, institutions of higher learning, and certain individuals, so long as those entities have a sincerely held religious objection.

Exemptions for Moral Convictions

The second of the two final rule provides an exemption from the contraceptive mandate requirement for individuals and entities that have non-religious moral convictions opposing services covered by the mandate. These exemptions can apply to nonprofit organizations and to closely held businesses, as well as to institutions of education, health insurance issuers serving exempt entities, and individuals. Like the religious beliefs exemption, otherwise exempt individuals and entities with a moral conviction may choose to voluntarily cover contraceptives to beneficiaries in their plan. One notable exception to this exemption is that this final rule does not exempt publicly-traded businesses or governmental entities. While it can be hard to establish what a valid moral conviction looks like, the Departments clarified that, under case law, a moral conviction is one (1) that a person “deeply and sincerely holds”; (2) “that are purely ethical or moral in source and content; (3) “but that nevertheless impose…a duty”; (4) and that “certainly occupy…a place parallel to that filled by…God’ in traditionally religious persons,” such that one could say the “beliefs function as a religion.”

In sum, since these two final rules are not currently in effect, it is unclear as to how many individuals and entities will try to claim the exemption, and how many beneficiaries the exemption would otherwise affect. The Departments estimate that, at most, 200 employers with religious or moral objections would be affected by these final rules, and between 6,400 and 127,000 women’s coverage would potentially be affected. Although these rules do not replace or supersede any existing contraceptive mandate requirements, they do add protection, and possibly an additional avenue for providers of health insurance with legitimate religious or moral objections to be exempt from covering contraceptive services. While at first glance it appears, based on the Departments’ numbers, that the final rules will only have a relatively small impact on contraceptive coverage, only time will tell when these rules take effect mid-January.

Requesting EMTALA waivers during a natural disaster

By Seth Carver, Class of 2020; Andrew F. Solinger, Associate at Waller

With the start of hurricane season, and the recent destruction caused by Hurricane Florence on the Carolinas and beyond, hospitals must review and update their policies and procedures to ensure that proper care can be provided to patients following surges caused by natural disasters and emergencies.

Following large natural disasters such as Hurricane Florence, and other mass casualty events such as terrorist attacks or public health emergencies, hospitals are likely to experience significant surges of patients that will test and push the limits of hospitals’ capacities.  In the face of these mass casualty events, hospitals must quickly and effectively choose which patients will be treated and which will not.

This decision is likely to cause friction with a hospital’s obligations under The Emergency Medical Treatment and Active Labor Act (“EMTALA”), which requires hospitals to properly screen and stabilize all patients that present to an emergency department for care.  Because of this tension between a hospital’s ethical and legal obligations to treat patients and the realities of responding to natural disasters and other mass casualty events, hospitals must understand the requisite responsibilities under EMTALA during such disasters as well as ways in which they can protect themselves from liability for potential, but unavoidable, violations of EMTALA.

EMTALA prohibits all Medicare-participating hospitals from denying emergency medical service to individuals, regardless of ability to pay.  It also requires hospitals to provide an appropriate medical screening to determine if a medical condition exists.  If such a condition exists, the hospital is required to provide stabilizing treatment before transferring or discharging the patient.

Natural disasters do not by themselves absolve hospitals of this requirement under EMTALA.  However, it is foreseeable that hospitals in the path of a natural disaster will need to transfer patients to other facilities without conducting medical screening exams or stabilizing treatment.  An option which has been used in the past to transfer these patients without violating the requirements under EMTALA is a Section 1135 waiver. These waivers are short-term releases from the normal EMTALA requirements in the wake of declared natural disasters.  HHS has issued these waivers in previous natural disasters, including Hurricanes Katrina, Rita, Gustav, Ike and Dean, the Iowa floods of 2008, and the Minnesota floods of 2009.

When utilizing Section 1135 waivers, in order to lawfully transfer patients without conducting such medical screening exams, or if needed stabilizing treatments, all of the following conditions must apply:

  • The President declares an emergency or disaster under the Stafford Act or the National Emergencies Act;
  • The Secretary of HHS declares that a public health emergency (PHE) exists;
  • The Secretary of HHS authorizes EMTALA waivers under Section 1135 of the Social Security Act;
  • Unless EMTALA waivers are granted for an entire geographic area, the hospital in question applies for a waiver from HHS;
  • The hospital has actually activated its emergency operations plan; and
  • The state has activated its emergency operations plan or pandemic plan for the area that covers the hospital.

Once the Secretary of HHS authorizes § 1135 waivers a hospital may submit a request to operate under that authority by sending an email to the CMS regional office in their service area.

The request should contain the following:[i]

  • Provider Name/Type;
  • Full Address (including county/city/town/state) CCN (Medicare provider number);
  • Contact person and his or her contact information for follow-up questions;
  • A brief summary of why the waiver is needed.  For example: “Critical Access Hospital (CAH) is the sole community provider without reasonable transfer options at this point during the specified emergent event (e.g. flooding, tornado, fires, or flu outbreak)” or “CAH needs a waiver to exceed its bed limit by X number of beds for Y days/weeks” (be specific);
  • Consideration – Type of relief you are seeking or regulatory requirements or regulatory reference that the requestor is seeking to be waived;
  • There is no specific form or format that is required to submit the information but it is helpful to clearly state the scope of the issue and the impact;
  • If a waiver is requested, the information should come directly from the impacted provider to the appropriate Regional Office mailbox with a copy to the appropriate State Agency for Health Care Administration to make sure the waiver request does not conflict with any State requirements and all concerns are addressed timely.

The waiver request is then reviewed by a cross-regional waiver validation team.  In reviewing waiver requests CMS makes the following inquiries: [ii]

  • Is the hospital within the defined emergency area?
  • Is there an actual need?
  • What is the expected duration?
  • Can this be resolved within current regulations?
  • Will regulatory relief requested actually address stated need?
  • Should we consider an individual or blanket waiver?

If granted, Section 1135 waivers generally last for up to 72 hours after both the emergency is declared and the hospital’s emergency plan is activated.  In some instances, the waiver will terminate prior to 72 hours if the HHS Secretary determines that the waiver is no longer necessary. It is important to note that this waiver does not allow for hospitals to selectively only treat patients with insurance and to transfer away all uninsured or underinsured patients.  If utilizing the waiver to transfer such patients, hospitals must not discriminate on

In order for hospitals to remain compliant with all EMTLA regulations during natural disasters and emergencies, it is important to review and revise EMTLA policies so that they reflect the proper steps in utilizing Section 1135 waivers.  Natural disasters and other mass casualty events impose large challenges for hospitals regarding treatment requirements. However, with active preparation and well-written emergency policies hospitals can limit violations of government regulations and ease the decision making of hospital personnel.