Doctor on video call with disabled senior patient

Hospice Pharmacy Insights July 2021

New This Month: Telehealth Legislation to Benefit Home Health & Hospice, New OSHA Covid-19 ETS, Deprescribing: Antiplatelet & Anticoagulant Medications, FDA Approves New Drug Treatment for Alzheimer's Disease, & An Updated Drug Shortage List.
Regulatory

Telehealth Legislation to benefit home health & hospice

A new version of the CONNECT (Creating Opportunities Now for Necessary and Effective Care Technologies) Act was introduced by a group of legislators from both houses recently. The bills are S. 1512 and HR. 2903. The National Association for Home Care & Hospice (NAHC) reports that the bills have several elements that will impact home health and hospice providers.

  • The legislation, if passed, would allow the Secretary of Health and Human Services (HHS) to waive telehealth requirements related to payment for telehealth services as long as the quality of care is not adversely impacted. These waivers would need to be reassessed at least every three years, but this could be a significant change for home health and hospice providers that are not allowed, currently, to bill for telehealth services because of a statutory limitation in the Social Security Act. 
  • The legislation would remove geographic requirements related to the provision of reimbursable telehealth services. 
  • Expansion of originating sites to include a patient’s home is included in the bill. 
  • The bill includes a waiver of telehealth requirements during any public health emergency. 
  • The bill provides for the use of telehealth services recertification of hospice benefits. 
  • The bill provides for $3 million in funds for audit, investigation, and oversight activity related to telehealth services. 
  • The act also mandates that the Secretary of HHS make educational resources available for both beneficiaries and providers. 

Wellsky Newsletter June 9, 2021

Regulatory

New osha covid-19 emergency temporary standard (ets)

On June 17th OSHA issued a new Emergency Temporary Standard related to COVID-19. This ETS is specifically aimed at employers who provide healthcare services in a patient’s home must be in general compliance with these rules beginning on July 5th and will have until July 21st to implement some of the more complex components of this standard.

The ETS has four parts – the healthcare provisions, the Mini Respiratory Protection Program, severability provisions, and Incorporation by Reference, which specifically relate to other governmental agency publications that have a direct bearing on COVID-19 guidance and precautions. The OSHA website (see link below), where the standards can be found, includes several documents and tools designed to make the implementation of the new standard easier for non-exempt providers. Readers will want to take advantage of them, especially the COVID-19 plan template, readiness checklist, and training materials. In this tip sheet, we are going to cover what home-based care providers should know about the ETS and, most importantly, what needs to be done in the event of compliance gaps.

https://www.osha.gov/coronavirus/ets

Clinical

Deprescribing: antiplatelets & anticoagulant medications

As we review a patient’s medication profile we always need to ask, “How do you identify which medications are appropriate to deprescribe?”

  • Benefits no longer outweigh the risk of adverse effects
  • Time to benefit is longer than anticipated life expectancy
  • Treatment target no longer aligns with patient’s goals of care
  • Deprescribing is a trial – medications can be restarted!!!

There remains a scarcity of trials focused on deprescribing in the elderly. However, in the hospice population, it is prudent to at least consider deprescribing for the reasons above as well as improving quality of life. In addition, the risks of adverse effects increase due to pharmacokinetic and pharmacodynamic changes, polypharmacy, and multimorbidity, especially in old age.

The decision to discontinue antiplatelet and anticoagulant medications should always be an individualized approach, weighing the risks vs benefits, and the patient and family’s goals of care. Discontinuing these medications is generally considered acceptable in any patient with a life-limiting illness, especially when adverse effects are possible.

The continued use of antiplatelet and anticoagulant medications in patients of advanced age, frailty, with CHF, CVD, hypertension, liver or renal disease, diabetes, history of GI bleed, or concomitant use of NSAIDs are at increased risk for major hemorrhage or bleeding complications.

Consider deprescribing antiplatelet and anticoagulant medications if any of the following are present:

  • The patient is at risk for bleeding.
  • Meds many no longer be indicated.
  • The patient is at risk for falls.
  • The patient is at risk for drug-to-drug interactions.
  • The patient has decreased hepatic or renal function.
  • Decreased nutritional intake.
  • Difficulty swallowing.
  • Increased pill burden and monitoring.
  • Continued use is outside the goals of care.

According to NHPCO’s Deprescribing Tool Kit, clinicians need to “BUILD” trust with the patient and family in order to successfully and appropriately deprescribe.

  • Build a foundation of trust.
  • Understand what the patient and family know.
  • Inform the patient and family about the clinical evidence.
  • Listen to the patient and family’s goals and expectations.
  • Develop a plan of care in collaboration with the patient and family.
Clinical

FDA Approves New treatment for Alzheimer's Disease

Aducanumab/Aduhelm

Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. FDA 7/7/21

The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms, though some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea. Another warning for Aduhelm is for the risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.

Under the accelerated approval provisions, which provide patients suffering from the disease with earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

  • 170 mg/1.7 mL (100 mg/mL) solution in a single-dose vial (3)
  • 300 mg/3 mL (100 mg/mL) solution in a single-dose vial (3)

The recommended maintenance dosage is 10 mg/kg administered as an intravenous infusion over approximately one hour every four weeks.

Approximate cost $56,000/year ($4700/month).

updated

drug shortage list

These shortages are due either to manufacturing delays or shortage of raw ingredients. This is not an inclusive list, but the listed drugs may be used for hospice patients, especially in the inpatient setting.

For a complete list of drugs on shortage follow this link:

https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages&loginreturnUrl=SSOCheckOnly

About the author

Author

highlight

David Bougher

Senior VP of
Regulatory Affairs

David is a seasoned veteran of the hospice world and an essential member of the Wise Hospice Options clinical team. 

Education:

RN, BSN

Experience:

  • Former hospice COO
  • 20 Years of education & training experience
  • 10 Years of experience at Wise Hospice Options

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Tino Vilches

rph

senior vice president of clinical services

Deanna Rice

pharmD

vice president of clinical services

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