Health and Biosciences: The Lowdown on the Showdown

As the shutdown of the federal government continues and hopes for a near-term resolution diminish, clients — particularly those in the health and life sciences sectors — may begin to feel the pinch. The work of multiple agencies affects the interests and needs of our clients in academia, industry and nonprofit organizations. We will examine the effects of the shutdown on the operations of several agencies within the Department of Health and Human Services (HHS) and provide information available today that may affect your business interests and strategies.

HHS. All total, HHS has furloughed about half of its employees, though furlough rates vary depending upon the agency. Many of the most important activities discharged by HHS agencies will continue during a shutdown. For example:

• The Centers for Medicare & Medicaid Services (CMS) will continue processing Medicare claims through Medicare Administrative Contractors (MACs), and the agency will continue to implement significant components of the Affordable Care Act. This is because Medicare is a "mandatory" or entitlement program not subject to annual appropriations and because many components of the ACA were funded in the law itself.

• The National Institutes of Health (NIH) will continue caring for patients enrolled in clinical trials at the NIH Clinical Center and will provide minimal staffing levels to maintain research protocols and equipment and care for animals.

• The Centers for Disease Control and Prevention (CDC) will continue operating the emergency operations center, though the agency will have reduced staff should there be a need to respond to outbreaks and process laboratory samples.

• The Food and Drug Administration (FDA) will continue conducting reviews of drug and device applications since substantial funding for such activities comes from industry user fees, though this is subject to change as FY 2013 user fees are consumed and FY 2014 user fees are not able to be accepted.

Funding. As of the date of publication, entities receiving HHS funding for projects that have already been authorized and appropriated can continue to draw down funding as long as no changes are requested. However, entities anticipating funding that would be provided in Fiscal Year 2014 and that has not already been appropriated will not be able to access funds since Congress has yet to appropriate funding for the new fiscal year.

For those entities that have a grant or other funding application pending at NIH, the Agency for Healthcare Research and Quality (AHRQ) or other HHS agencies, no action would likely be taken during the shutdown, meaning the announcement of new awards and allocation of funds would likely be delayed.

FDA. At the FDA, actions like routine facility inspection, import monitoring and laboratory research will be suspended. The agency will also not be reviewing or accepting regulatory submissions that require an FY 2014 user fee payment during the shutdown. However, of the near 700 FDA staff working during the shutdown under the "safety of human life exception," nearly 580 are product and manufacturer inspectors. The remaining 120 staff will be conducting and overseeing adverse event reporting and lot release protocol reviews as well as providing support with surveillance, product incidents, compliance, recalls and emergencies. Overall, nearly 55 percent of the FDA workforce will continue to work. To summarize:

• Already filed INDs/IDEs will (at least for the time being) continue to be processed.
• Already filed NDAs, PMAs, 510(s) will continue to be processed as long as user fee money is available.
• No new submissions are being accepted.
• Routine enforcement and inspections are on hold.
• Public health critical inspections and enforcements will continue.

Following is a more detailed Q&A as well as a breakdown of various programs at HHS that are exempted and thus remain fully or largely operational:

Please contact us with any questions you have that we may not have addressed or that are specific to your business interests. We will be pleased to provide greater detail for you as required.  

Questions & Answers

Can I still access information through the Health and Human Services (HHS) website?
Health and Human Services is reporting that only websites supporting "excepted functions" will be updated unless otherwise funded. As a result, the information on the HHS, or related agency's websites, may not be up to date, the transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

Will Grants.gov still be operational?
HHS will maintain Grants.gov system in an operational status, but with reduced federal support staff presence. In addition, the Grants.gov Contact Center will remain available and provide assistance to callers.

Am I still able to post comments on Regulations.gov?
The Regulations.gov website is still receiving comments, but due to the shutdown, the information on the website may not be up to date.

Will I still be able to contact my Agency contact?
If your Agency contact has been deemed an "excepted or exempted" employee, you should still be able to carry out normal communication. However, "non-excepted or non-exempted" employees' cell phone and email use has been suspended until further notice.  

What determines if a government employee is furloughed?
Staff who would not be furloughed is broken into the two broad categories of "authorized by law" and "safety of human life and protection of property," consistent with Department of Justice legal opinions.

"Authorized by law" includes:

• Employees who are "exempt" from furlough because they are not affected by a lapse in appropriations — staff working in a pay status, as funding would continue to be available to pay their salaries.
• Officers appointed by the President.
• Staff performing activities authorized by necessary implication.

For safety of human life, the numbers needed to continue medical services that HHS provides are separately identified. For protection of property, the HHS plan provides separate information on the number of staff excepted to protect on-going medical experiments, to maintain computer data, and to maintain animals and protect inanimate government property.

What if I have a meeting scheduled at an HHS agency with an Agency employee?
The occurrence of meetings scheduled during the funding lapse will depend on the HHS agency.  If your meeting is within one of the cabinet level exemptions below, or with an exempt employee, your meeting should occur as scheduled, though we would advise you to contact the meeting organizer in order to confirm. If your meeting is related to the NIH's initial peer review meetings, review panels and/or advisory council for extramural research, please see below for additional details.

What would happen with federal contracts?
According to the Congressional Research Service, effects of a shutdown on federal contractors would "depend upon the facts and circumstances of individual contracts, such as the funding source(s) for the contract, the type and terms of the contract, and where and how the contract is being performed. However, as a general matter, in the event of a shutdown, the Anti-Deficiency Act would greatly restrict agencies' ability to enter new contracts, or to allot additional funds to existing contracts. Contractors with contracts that are fully funded are also likely to experience delays in performance and/or payment."

Will deadlines for federal grants be extended?
Depending on the agency, deadlines for federal grants will be extended. The NIH states that adjustments to grant application submission dates that occur during the funding lapse will be announced once operations resume and the safest course is to wait to submit any application until NIH operations resume. However, it is important to note that NIH also states Grants.gov will be able to accept electronic grant applications, though those applications will not be processed by NIH until the eRA Systems are back online.

What if my company currently has a drug or device being reviewed by the FDA?
Because the FDA receives a substantial amount of funding for drug reviews from user fees provided by the pharmaceutical industry, the review process is scheduled to remain operational, though possibly at a slower pace due to a smaller number of employees.

Will the FDA still be accepting regulatory submissions?
The FDA has stated that it is not accepting regulatory submissions that require an FY 2014 user fee payment during the shutdown. The FDA does not have legal authority to accept user fees assessed for fiscal year 2014 until an appropriation for the year is enacted. However, we would advise clients to file submissions even though they may not be accepted, as timing of filing can be important. In addition to that, we advise that you document your filing, and then re-file when the government is once again operational.

Will the FDA still conduct food safety operations?
FDA will be unable to support the majority of its food safety, nutrition and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making. However, the U.S. Department of Agriculture will still maintain thousands of inspectors to check out meat and poultry facilities, and the Food Safety and Inspection Service is still allowed to recall workers in the event of an emergency.

Will funding be secure for active NIH grants?
All work and activities performed under currently active NIH grant awards may continue. However, there will be limits on performing many of the reporting requirements associated with NIH grant funding. Additionally, grantees are likely to experience delays in payments.

Will the NIH issue any new grants?
No NIH grant awards will be processed for the duration of the funding lapse. For any awards processed before the funding lapse that have an issue date during the funding lapse, the awards will not be sent to the grantee on the issue date. Once operations resume, all pending NoAs will be sent. This will not affect the start date nor the issue date of these awards; it just affects the date the award document is actually sent to the grantee and available for access in the eRA Commons. In the absence of actually receiving the NoA, institutions may use pre-award costs authority at their own risk.

Will NIH peer review meetings still take place?
The NIH will not be able to conduct initial peer review meetings — whether in-person or through teleconferences or other electronic media. Also during this time, the NIH staff will not be able to send or receive email messages or update website information, and NIH computer systems that support review functions will not be operational. Additionally, individuals who had agreed to serve on NIH review panels ("study sections") that were scheduled to meet during the funding lapse will not be able to access the Internet Assisted Review (IAR) site or other NIH web-based systems during that time.

Will NIH Advisory Council meetings still take place?
The NIH will not be able to conduct Advisory Council review meetings — whether in-person or through teleconferences or other electronic media — during the funding lapse. Also during this time, the NIH staff will not be able to send or receive email messages or update website information, and NIH computer systems that support review functions will not be operational. Therefore, no applications will be processed for council review or be taken to council meetings during that time. When operations resume, those pending applications will be processed, and meetings will be re-scheduled as soon as possible.

What if my institution is conducting NIH funded research?
As noted above, NIH-funded research at universities will continue, although researchers could face payment delays, and some government-run databases may have problems as support staff is furloughed. However, NIH staff will not be available to provide routine administrative support services.

Will extramural research still continue at the NIH?
For the duration of the funding lapse, NIH extramural employees will be prohibited from working (remotely or in the office). Consequently, there will be no access to voice mail, email, fax or postal mail during this period. Mail requiring someone to sign/accept may not be received. All other postal mail, fax and voice mail communications will not be acted upon until after operations resume. It is recommended that you delay sending such communications until after operations resume.

Can I still submit an NIH grant application during the government shutdown?
The NIH has strongly encouraged applicants to not submit paper or electronic grant applications to NIH during the period of the lapse. Adjustments to application submission dates that occur during the funding lapse will be announced once operations resume. For any applications submitted immediately prior to or during the funding lapse, here is what will happen.

• For electronic submissions through Grants.gov: Grants.gov will be open and can accept electronic applications. However, applications will not be processed by NIH until the eRA Systems are back online. NIH will ensure that all applications submitted within the two business days before or during the funding lapse will receive the full viewing window once the systems are back online.
• For electronic submission of multi-project applications through NIH's ASSIST system: The ASSIST system will not be available until NIH systems are back online.
• Paper Submissions: Staff will not be available to receive paper applications during a funding lapse.

NIH states that the safest course is to wait to submit any application until after operations resume and a Notice in the NIH Guide concerning adjusted submission dates is posted. However, we would advise clients to file submissions even though they may not be accepted, as timing of filing can be important. In addition to that, we advise that you document your filing, and then re-file when the government is once again operational.

Will recertification and initial surveys for Medicare and Medicaid providers be affected?
Because of the decrease in staff, it is possible that fewer recertification and initial surveys for Medicare and Medicaid providers would be completed.

Specific Exemptions for the Department of Health and Human Services

Health Resources and Services Administration (HRSA)

• Community Health Centers
• National Health Service Corps
• Maternal, Infant and Child Health Home Visiting Program
• National Practitioner Databanks
• Hansen's Disease Program

National Institutes of Health (NIH)

• Patient care for current NIH Clinical Center patients
• Animal care services to protect the health of NIH animals
• Minimal staff to support ongoing protocols and safeguard infrastructure

Centers for Disease Control and Prevention (CDC)

• Minimal support to protect the health and well-being of U.S. citizens here and abroad through a significantly reduced capacity to respond to outbreak investigations, processing of laboratory samples and maintaining the agency's 24/7 emergency operations center.
• The Strategic National Stockpile
• World Trade Center Health Program
• International Malaria
• Haiti cholera response
• U.S. President's Emergency Plan for AIDS Relief (PEPFAR)
• CDC's Global AIDS Program
• Energy Employees Occupational Illness Compensation Program Act (EEOICPA)
• Vaccines for Children (VFC) Program
• Certain childhood obesity activities and asbestos exposure in Libby, Montana

Agency for Healthcare Research and Quality (AHRQ)

• Patient-Centered Outcomes Research Trust Fund (PCORTF)
• CMS-funded work related to measure development for the Children's Health Insurance Program Reauthorization Act

Food and Drug Administration (FDA)

• Limited activities related to its user fee funded programs, including the activities in the Center for Tobacco Products
• Select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues
• Conducting and overseeing adverse event reporting and lot release protocol reviews as well as providing support with surveillance, product incidents, compliance, recalls and emergencies

Centers for Medicare & Medicaid Services (CMS)

• Large portions of ACA activities, including coordination between Medicaid and the Marketplace, as well as insurance rate reviews and assessment of a portion of insurance premiums that are used on medical services
• State Grants and Demos
• American Recovery and Reinvestment Act Mandatory Program Management
• Center for Medicare and Medicaid Innovation
• Medicare Program
• Medicaid and CHIP

Assistant Secretary for Preparedness and Response (ASPR)

• Minimal readiness and limited staffing for all-hazards preparedness and response operations, including the Secretary's Operations Center, the National Disaster Medical System and specialized medical countermeasure response.

Sources:

• Information for the NIH Extramural Grantee Community During the Lapse of Federal Government Funding
• Nature: Government Shuts Down
• House Republican Conference
• The Washington Post: The nine most painful impacts of a government shutdown
• Office of Management Budget: Agency Contingency Plans