3/25/20 - Senate Passes Stimulus Package with Some Relief for Small to Mid-Sized Laboratories
On March 25, 2020, the Senate passed a third piece of legislation to respond to the toll COVID-19 has taken on the U.S. economy. The Coronavirus Aid, Relief, and Economic Security (CARES) Act provides $2 trillion to stimulate the economy and respond to the COVID-19 pandemic. Expanded small business loans, assistance to hospitals, funding for public health agencies, and direct payments to lower and middle-income Americans are just some of the provisions included in this sweeping bill. The House is expected to consider the bill by unanimous consent on Friday morning, March 27, 2020.
Below is a summary of provisions that could affect CRB members, both as laboratories and as small to medium-sized business owners.
Small Business Provisions
Small Business Loans and Forgiveness Grants
Businesses with up to 500 full or part-time employees are eligible to receive loans from the Small Business Administration (SBA) to cover payroll, employee salaries, and certain other costs incurred between February 15 and June 30, up to a maximum of $10 million. These loans are subject to forgiveness equal to the amount spent by the borrower during an 8-week period after the origination date of the loan, subject to a reduction based on the reduction in number of employees or reduction of wages paid, in excess of 25%. The SBA will also pay the principal, interest, and any associated fees on certain existing SBA loans for 6 months.
Other Business Provisions
Economic Injury Disaster Loans (EIDLs) for Small, Medium, and Large Businesses
The bill expands eligibility for access to Economic Injury Disaster Loans (EIDLs), which can supply up to $2 million in disaster assistance for small and medium to large businesses located in a disaster declared county. The bill also creates a grant program allowing eligible entities that apply for an EIDL loan due to COVID-19 to request an advance of up to $10,000, to be distributed within 3 days, that is not required to be repaid, even if the loan is subsequently denied. Advance EIDL payments can be used to maintain payroll, meet increased costs to obtain materials, pay rent or mortgage obligations, or repay other obligations that cannot be met due to revenue losses.
Employee Retention Credit
A refundable payroll tax credit is authorized for 50% of wages paid by employers during the crisis for employers whose operations were fully or partially suspended due to a COVID-19 related shutdown or whose gross receipts declined by more than 50% when compared to the same quarter in the prior year. The credit is based on qualified wages paid to the employee. For employers with greater than 100 full-time employees, qualified wages are wages paid to employees when they are not providing services due to the COVID-19-related circumstances described above. For eligible employers with 100 or fewer full-time employees, all employee wages qualify for the credit, whether the employer is open for business or subject to a shut-down order. The credit is provided for the first $10,000 of compensation, including health benefits, paid to an eligible employee.
Assistance for Mid to Large Sized Businesses<
The Treasury Department will provide financing to banks and other lenders that make direct loans to businesses with between 500-10,000 employees with an annualized interest rate of no more than 2% and principal and interest obligations not due for at least six months. To be eligible, the business must:
- Certify that the funds will be used to retain at least 90% of its workforce at full compensation and benefits until September 30, 2020;
- Certify that the recipient intends to restore at least 90% of the recipient’s workforce that was in place on February 1, 2020;
- Restore compensation and benefits to workers no later than 4 months after the termination of the public health emergency; and
- Meet other requirements relating to stock buy backs, dividends, and job outsourcing.
Unemployment and Rebate Provisions
Pandemic Unemployment Assistance
Individuals otherwise not eligible for unemployment benefits (e.g., self-employed, independent contractors, and others) are eligible for benefits through December 31, 2020, if unable to work as a direct result of the coronavirus public health emergency. Eligible individuals will receive an additional $600/week payment for up to four months and up to an additional 13 weeks of unemployment through December 31, 2020, for those unemployed after state unemployment benefits run out.
2020 Recovery Rebates
All U.S. non-dependent residents with adjusted gross income up to $75,000 ($150,000 for joint filers) are eligible for $1,200 per individual and $500 per child, phasing out completely at adjusted gross income of $99,000 ($198,000 for joint filers).
View a copy of the complete Coronavirus Aid, Relief, and Economic Security (CARES) Act here.
2/14/20 - Important FDA Notification Regarding Coronavirus
On February 14, 2020, the Food and Drug Administration (FDA) issued the following notice for circulation to HCT/P establishments.
FDA continues to work closely with CDC and other federal and international agencies to monitor the evolving outbreak of the 2019 novel coronavirus (COVID-19) that was first identified in Wuhan, Hubei Province, China. While respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps), the potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via these products.
Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors.
FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening measures in response to the COVID-19 outbreak.
The HCT/P establishment’s responsible person must evaluate a prospective donor and determine eligibility (21 CFR 1271.50).Based on the limited information available at this time, establishments may wish to consider the following donor history in the 28 days prior to HCT/P recovery for persons who have:
- traveled to areas with COVID-19 outbreaks, as defined by CDC
- lived with individuals diagnosed with or suspected of having COVID-19 infection; or
- been diagnosed with or suspected of having COVID-19 infection.
CRB will continue to monitor the situation and will issue updates as information becomes available.
- Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak | FDA
- CDC 2019 Novel Coronavirus web page
11/5/19 - CDC Publishes Clarifications, Corrections for Reporting of Pregnancy Success Rates from ART Programs
The anticipated changes to data that ART clinics are required to report to the Centers for Disease Control and Prevention (CDC) have been published in the November 5, 2019, Federal Register (click here for full article). This includes clarifications for and corrections to certain data collection fields.
These changes become effective January 1, 2020, and will change the way data must be submitted at that time. Clinics should thoroughly review the changes to ensure that they are entering the data correctly.
Contact the CRB office if you have any questions.
12/27/18 - Schiavoni Bill to Regulate Cryostorage Facility Operations Introduced in Ohio on 12/10/18
S.B. No. 344, legislation that would regulate fertility treatment cryopreservation facilities in the state of Ohio, was introduced by Ohio State Senator Joe Schiavoni (D-33rd District) in the Ohio State General Assembly on December 10, 2018. While the bill was introduced, it was not assigned to committee, and was introduced in the 2017-2018 legislative session, which ends on December 28, 2018.
Therefore, the bill will have to be reintroduced during the 2019-2020 General Assembly for further action.
Key provisions of the bill, as introduced, include:
- A requirement that at least one qualified member of the cryostorage facility’s personnel must reside at a location from which that individual is able to arrive at the cryostorage facility in not more than twenty-five (25) minutes. [CRB was able to convince Senator Schiavoni to drop his original requirement that facilities be staffed with qualified onsite personnel 24/7.]
- Alarms and function checks of alarms are required of all facilities. In addition, there are requirements for system validations and recordkeeping requirements.
- A requirement to maintain at least one of the following: at least one cryostorage tank with capacity equal to the largest tank in use at the facility; or, available space in other tanks at least equal to the space used by all samples stored in the largest tank in use at the facility.
- A requirement to maintain a contract with another entity for the provision of a backup cryostorage tank to be delivered to the facility no later than 48 hours after a tank in use at the facility ceases to function properly.
- Requirements for how and when client depositors will be notified of an issue involving their stored reproductive tissue(s).
- Provisions for various fines for violations involving failure of the facility to meet required elements of the legislation.
CRB’s Legislative Committee was actively engaged with Senator Schiavoni’s staff as the legislation was drafted. Although the bill, as introduced, does not include all of CRB’s suggestions, it does include many of CRB’s recommendations.
While this is state legislation, its effects may go well beyond Ohio, as other state and federal regulators are closely monitoring the content and status of the bill.
To view S.B. No. 344, click here.
7/12/2018 - Ohio State Senator Joe Schiavoni Proposes Bill Regulating Fertility Clinics
In the wake of the March 2018 cryotank failure at University Hospitals’ fertility clinic at Ahuja Medical Center, Beachwood, Ohio, State Senator Joe Schiavoni (D-33rd District) is drafting legislation that would create guidelines and establish penalties for fertility clinics to prevent future incidents like the March 2018 freezer failure.
The University Hospitals cryotank failure resulted in irreversible damage to 4,000 frozen eggs and embryos and affected 950 patients.
According to recent news reports, the proposed bill could require oversight of fertility clinics by the state or an organization such as CAP and the establishment of emergency procedures. The proposed bill would also require:
- Onsite, around-the-clock tank monitoring
- Splitting up samples from one person across different tanks
- Training all employees to handle liquid nitrogen
- Clinic reporting if tissues or cells are moved, including emergency relocations
- Patient notification within 24 hours if damage occurs
- Clinics to notify their accreditation agency regarding any storage compromises
Violations would result in fines, and clinics with multiple issues could be forced to close.
The bill has not yet been introduced, but Senator Schiavoni is meeting with stakeholders with plans to include recommendations from the College of American Pathologists (CAP), American Society of Reproductive Medicine (ASRM), RESOLVE, University Hospitals and other interested parties. The CRB Board considers the CRB an "interested party."
While the legislation is at the state level and in the early stages of drafting, it could easily have an impact on a national level. CRB is following this issue closely and will keep you updated as developments occur.