Regulatory Center
COVID-19 Regulatory Updates
The response to the COVID-19 pandemic by federal, state and local government agencies has attempted to stay up with the rapidity of the spread of the virus. As a result, rules and regulations are ever changing. As long as COVID-19 remains a serious issue we will provide brief regulatory updates with appropriate links to help you stay abreast of regulatory changes that impact your hospice. Because this is a monthly newsletter the information may not be as timely as you need so we suggest that you stay in close communication with your state hospice and/or national hospice organizations.
Coronavirus Aid, Relief, & Economic Security Act
(CARES Act)
This massive bill was signed into law late last week. Aspects of this bill that are most important to hospices are the following:
- Section 3706 – the use of telehealth to conduct face-to-face encounters
- The legislation will allow face-to-face encounters for recertification for hospice care to be completed by hospice physicians and nurse practitioners using telehealth technologies during the emergency period.
- The legislation will allow face-to-face encounters for recertification for hospice care to be completed by hospice physicians and nurse practitioners using telehealth technologies during the emergency period.
- Posted in the Federal Register 3/31/20
- Detailed guidance on providing the hospice face-to-face encounter through telehealth.
- Use audio and video equipment permitting two-way, real-time interactive communication between the patient (from home, or any other site permissible for receiving services under the hospice benefit) and distant site hospice physician or hospice NP.
- Use audio and video equipment permitting two-way, real-time interactive communication between the patient (from home, or any other site permissible for receiving services under the hospice benefit) and distant site hospice physician or hospice NP.
- Details on the ability of the hospice to provide routine home care through telehealth. Details must be:
- Included on the plan of care.
- Meet the requirements at § 418.56.
- Tied to the patient specific needs as identified in the comprehensive assessment.
- Plan of care must include a description of how the use of such technology will help to achieve the goals outlined on the plan of care.
- Detailed guidance on providing the hospice face-to-face encounter through telehealth.
- $100 billion Public Health and Social Services Emergency Fund – the following provisions could potentially benefit hospice and palliative care providers.
- Funding will be used to prevent, prepare for, and respond to coronavirus, domestically or internationally, and for necessary expenses to reimburse, through grants or other mechanisms, eligible health care providers for health care related expenses or lost revenues that are attributable to the coronavirus.
- Funds appropriated under this program shall be available for building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity.
To view the entire bill (S. 3548) follow this link: https://www.congress.gov/bill/116th-congress/senate-bill/3548/text
CMS Guidance for Infection Control and Prevention Concerning COVID-19 by Hospice Agencies
Background
The Centers for Medicare & Medicaid Services (CMS) is committed to the protection of patients and residents of healthcare facilities or homecare settings from the spread of infectious disease. This memorandum responds to questions we have received and provides important guidance for Hospice Agencies in addressing the COVID-19 outbreak and minimizing transmission to other individuals.
Guidance
Hospice Agencies should regularly monitor the CDC website (see links below) for information and contact their local health department when needed (https://www.cdc.gov/coronavirus/2019-ncov/whats-new-all.html). Also, hospice agencies should be monitoring the health status of patients, residents, visitors, volunteers, and staff under their care setting for signs or symptoms of COVID-19. Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposures among patients, healthcare personnel, and visitors at the facility. For exposed staff, hospice agencies should consider frequent monitoring for potential symptoms of COVID-19 as needed throughout the day.
To obtain full details you can follow this link https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html
Drug alert
FDA Requests Immediate Removal of All Ranitidine (Zantac) from the Market (4/1/20)
The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by thebrand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
Update
A Message from Wise Hospice Option's President & CEO
As a result of the COVID-19 outbreak I want to make our customers aware of the precautions Wise Hospice Options has taken to assure you of uninterrupted service, timely information in the pharmaceutical industry, and efforts to do our part in limiting the spread of the coronavirus.
- All of our staff currently work in a remote setting making us, as an organization, less susceptible to a significant staff shortage due to illness or quarantines. This helps us provide uninterrupted 24/7 service during this virus outbreak.
- We are closely monitoring drug shortages through the FDA and other pharmaceutical industry resources. When we learn of any shortage(s) we will pass that information to you as quickly as possible.
- We have instituted indefinite travel restrictions to limit the risk of our staff acquiring COVID-19 as well as not unduly exposing you or any members of your staff to possible infection.
- Our Ring Central online conferencing platform will allow us to hold remote meetings with you at any time. This will give us the opportunity for continued conversations, discussion (with video), and screen-sharing of desktops.
It is my hope that these measures allow us, as your PBM, the ability to meet your 24/7 service needs while not adding risk of exposure to COVID-19. Please let us know if you have any additional questions or need clarification about any of the items addressed above.
Respectfully,
Grant Faubion
President & CEO
An Ongoing concern
Drug Shortages
Researchers at the Center for Infectious Disease Research and Policy (CIDRAP) have raised concerns that the COVID-19 pandemic will lead to shortages of critically needed medications because of our dependence on drugs made in other countries. As we’ve noted in recent newsletters, the United States relies on foreign countries for approximately 80% of the drugs, brand and generic, we use.
CIDRAP notes that the precise risk of drug shortages is hard to assess because of “the lack of structural transparency and available supply chain data about drugs, which may be known by pharmaceutical companies, wholesalers, suppliers, and contract manufacturers, but not shared with the Food and Drug Administration or the public.”
David J. Margraf, PharmD, MS, a research project specialist with the CIDRAP team, said pharmaceutical companies are required to report some supply-chain information to the FDA, but the data can be up to 6 months old and tends to be very vague. The companies “don’t give a clear reason as to why there might be a shortage.”
According to the researchers they have directly asked the pharmaceutical companies for details on their supply chains but none of them have been willing to share that information. Currently the FDA does not have any authority to compel discloser of this information. Pharmaceutical companies report shortages on a “voluntary basis.”
As the COVID-19 pandemic evolves Wise Hospice Options will closely watch for supply chain issues. We will pass on pertinent information we learn as quickly as possible.
Updated
Drug Shortage List
These shortages are due either from 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.drugs.com/drug-shortages/
The FDA is warning that there may be an increase in drug shortages due to the effect the coronavirus is having on raw products coming out of China and India used in the manufacturing of drugs.
NOTE: Any items marked with a pill icon are new from the previous month’s newsletter
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About the Author
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
Connect
- (800) 856-9757 Ext: 203
- dbougher@wiseop.com
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