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340B FAQs During COVID-19
March 2020 - information provided by HRSA
HRSA has posted some general frequently asked questions (FAQs) related to COVID-19. A few topics are below;

  • We are seeing a surge in patients and need to expand our services to another site. Will any special exemptions be made for covered entities or any changes to the registration process?To the extent a covered entity has a specific concern about 340B eligibility of a new site, the covered entity should contact the 340B Prime Vendor Program (1-888-340-2787 or apexusanswers@340bpvp.com HRSA Exit Disclaimer) and we will evaluate each circumstance on a case-by-case basis.

  • Will HRSA relax its standards around the definition of a patient for purposes of providing covered outpatient drugs to all who need treatment related to COVID-19?At this time, HRSA is unable to waive 340B statutory requirements, specifically the provision related to reselling or otherwise transferring the drug to a person who is not a patient of the entity, pursuant to section 340B(a)(5)(B) of the Public Health Service Act.

  • Given the coronavirus 2019 pandemic, what flexibilities are available to entities to allow a provider to offer telehealth services? HRSA understands that the use of technology in health care delivery during this time is critical, and that telemedicine is merely a mode by which the health care service is delivered. For the 340B Program, HRSA recommends that covered entities outline the use of these modalities in their policies and procedures and continue to ensure auditable records are maintained for each eligible patient dispensed a 340B drug.
 
  • Does HRSA plan to suspend or cancel audits based on COVID-19? Based on the current COVID-19 pandemic, HRSA is moving towards conducting 340B Program covered entity audits remotely (virtually) for the next several months while we monitor and assess the impact on the covered entities. If a covered entity has specific questions regarding an audit once it has been engaged, please contact the Bizzell Group (the 340B audit contractor) at 340baudit@thebizzellgroup.com HRSA Exit Disclaimer who will coordinate with HRSA based on the specifics of the request. HRSA will continue to monitor the COVID-19 response and provide updates accordingly.

To read the full listing of FAQs and entire post please visit https://www.hrsa.gov/opa/COVID-19-resources 
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FCC's COVID-19 Telehealth Program Application Portal
April 2020 - information provided by NACHC
The COVID-19 Telehealth Program will provide $200 million in funding, appropriated by Congress as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, to help health care providers provide connected care services to patients at their homes or mobile locations in response to the COVID-19 pandemic.

The COVID-19 Telehealth Program will provide immediate support to eligible health care providers responding to the COVID-19 pandemic by fully funding their telecommunications services, information services, and devices necessary to provide critical connected care services until the program’s funds have been expended or the COVID-19 pandemic has ended.

Submit Your Application Here
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Template for Updating Your 340B Policies During COVID-19
April 2020 - information provided by 340B Health
The Health Resources & Services Administration (HRSA) has recognized that the coronavirus disease 2019 (COVID-19) pandemic “may warrant additional flexibilities” for 340B covered entities. To help 340B hospitals responding to the pandemic, 340B Health has outlined policies, procedures, and recommendations on the use of 340B drugs during the public health emergency based on the flexibilities HRSA has afforded covered entities.

We recently sent members an alert covering how hospitals can operate compliant 340B programs while the flexible policies are in place. We also have created a policies and procedures template that hospitals can use regarding maintenance of auditable records, patient definition, provision of telehealth services, and inventory management during a public health emergency. These new resources are intended to complement the information that HRSA has posted on the Office of Pharmacy Affairs (OPA) COVID-19 website.

As you consider the P&P template, please review the alert for more information about how the flexibilities extended during the public health emergency affect several aspects of the 340B program, including:
  • 340B registration
  • Patient definition
  • Telehealth
  • GPO/private label products
  • 340B audits

340B Health has expressed its appreciation to HRSA for extending operational flexibility to covered entities as they help fight the pandemic. We had requested several accommodations to help 340B hospitals respond to the public health emergency and are pleased that HRSA has relaxed some policies and issued clarifications of its guidance.

If you have any questions about the new guide on 340B policies and recommendations, the template, or any of our other COVID-19 resources, please contact Steven Miller (steven.miller@340bhealth.org or 202-536-2292).
340B and Telehealth/HHS Waivers
March 2020 - information provided by Powers Pyles Sutter & Verville PC
The COVID-19 pandemic has created an increased need for the use of telehealth services, which raises the question of whether a prescription for a patient who receives services through telehealth qualifies to be filled with 340B drugs. A prescription that is written as the result of a telehealth visit may be filled with 340B drugs, provided that the three prongs of HRSA’s patient definition are met:

1) the prescriber must be employed by or under contract with the covered entity, or have received a referral from the covered entity;
2) the covered entity must have medical records of the telehealth visit; and
3) the service provided via telehealth must be within the scope of the covered entity’s grant.

The third requirement above is applicable only to grantees and not hospitals. For a telehealth visit with a prescriber who received a referral from a covered entity, the covered entity is responsible for maintaining documentation of both the referral and the telehealth visit.

For hospitals, the clinic at which the covered entity provides healthcare services must be an integral part of the hospital, listed as reimbursable on its Medicare cost report. In the case of all other covered entities, the patient must be provided healthcare services that are within the scope of the grant or other statutory basis for eligibility.

Earlier this week, HHS announced a waiver of certain restrictions related to Medicare payment for telehealth services. Significantly, the waiver allows for Medicare payment for services provided in all settings, including when the patient is at home. This waiver applies to all patients – not just those with COVID-19. FAQs on the waiver are available here.

HHS also announced that the Office of Civil Rights would not impose penalties for noncompliance with HIPAA rules in connection with the good faith provision of telehealth during the COVID-19 public emergency. The announcement is available here.

Powers has prepared a more detailed memo on these waivers that is available on their website.
Forum for finding COVID-19 Information
March 2020 - infromation provided by NACHC
With various outlets dispersing COVID-19 information, it can be difficult to find the most accurate, up-to-date news. NACHC is providing a forum for finding COVID-19 info quickly and connecting with other health centers.  

NACHC has set up a new online forum, called Noddlepod, which: 
  • Consolidates COVID-19 information from many sources - e.g, BPHC, CMS, NACHC, CDC, in a single location where you can quickly find info on a specific topic. (e.g., What did BPHC say about FTCA coverage for drive-through testing? What's a good video on fitting N95 masks?
  • Allows health centers to share info and ideas quickly - e.g., Ideas for finding PPE, draft P&Ps on telework.

We think you would find this a helpful resource. To join, send an email to shansen@nachc.org
Small Business Administration Offering Low-Interest Disaster Relief Loans
March 2020 - information provided by Powers Pyles Sutter & Verville PC
The U.S. Small Business Administration’s (SBA) Economic Injury Disaster Loan Program allows eligible small businesses and private non-profit organizations to apply for low interest loans of up to $2 million per business to cover financial losses incurred as a result of the ongoing COVID-19 emergency.

Only certain counties have been declared as disaster areas, which is dependent on whether the state’s governor has requested disaster assistance from the SBA. Small businesses and private non-profits located in these counties are eligible to apply for the loans. Eligible states and counties may be found here or here. This list of eligible counties is updated frequently.

The loans may be used to pay fixed debts, payroll, accounts payable, and other bills that cannot otherwise be paid as a result of the COVID-19 disaster. The interest rate for these loans is 3.75% for small businesses and 2.75% for private non-profits. SBA asserts that it offers long-term loans, with terms for repayment up to 30 years, to keep them affordable and that the loan terms are determined on a case-by-case basis, depending on each borrower’s ability to repay.

The deadline to apply for an Economic Injury Disaster Loan is December 16, 2020. SBA has set the “incident period” to have begun on January 31, 2020 and to continue indefinitely. Requestors must submit the completed loan application and a signed and dated IRS Form 4506-T granting the IRS permission to provide the SBA with tax information. Requestors may also apply in person at a Disaster Recovery Center. More information regarding the application process, which involves three steps, may be found here.

SBA usually makes a decision on an application within two to three weeks. If the decision is affirmative, SBA will send loan closing documents to the applicant for his or her signature. Upon receipt of the signed closing documents, SBA will normally provide the applicant with an initial disbursement of $25,000 within 5 days. To begin the online application process, follow this link.