FDA Closes EUA Program to Lab-Developed Tests

The question of whether the FDA has the authority to regulate lab-developed tests (LDTs) boiled into plain view in August when the Department of Health and Human Services directed the agency to stand down on its regulation of LDTs. The predicament took another turn Oct. 7 when the FDA announced it would no longer review LDTs under the emergency use authorization (EUA) program, a change that was not well received in some quarters.

The HHS order to the FDA arrived with a reference to two executive orders from the Trump administration, but the notice also stated that developers of LDTs could voluntarily file for an EUA or a conventional premarket review. One of the more significant drawbacks described in the rescission order was that any LDTs that did not go through the FDA would not enjoy immunity from litigation under the Public Readiness and Emergency Preparedness (PREP) Act. At the time of the HHS announcement, however, there was no signal from the FDA that it would refuse to review LDT filings under the EUA program.

The FAQ page for testing stated, “we are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs.” The update states that the agency is prioritizing review of EUA requests for considerations such as public health need and availability of the product.

Among the priorities cited by the FDA are testing that would increase accessibility, such as point-of-care tests and home collection test kits, and tests that consume relatively few supplies. The statement said the FDA was declining to review EUA requests for LDTs “at this time,” suggesting the policy can be reversed if circumstances dictate.

Three members of the House of Representatives took the news as a negative, casting the FDA’s decision as “a grave mistake” that was prompted by officials at HHS. The letter described the change as reckless and as increasing the risk of false negative test results. Another concern voiced by Reps. Anna Eshoo (D-Calif.), Frank Pallone (D-N.J.) and Diana DeGette (D-Colo.) was the abruptness of the announcement, which did not allow the FDA to make changes to previously posted policy announcements.

The American Clinical Laboratory Association (ACLA) provided a brief Oct. 7 statement, making the argument that many of the LDTs that have been granted EUAs are known for reducing the reliance on supplies and for increasing testing capacity. ACLA President Julie Khani said these “are exactly the kinds of tests the FDA has stated it wants to prioritize,” adding that the FDA should continue to review LDTs under the EUA program. Khani also said the announcement “creates unnecessary confusion.”

CMS Cracking Down on CLIA Certification

Two days after the FDA announced its change in policy for LDTs, the Centers for Medicare & Medicaid Services announced it is targeting clinical laboratories that have lapsed certifications or are conducting tests not included in their certifications. The agency directed these labs to immediately cease any violative testing, although no enforcement action was spelled out in the statement.

The CMS said it has issued 171 cease and desist letters to labs since Aug. 12, 66% of which were for labs that were conducting tests that fell outside their certifications under the Clinical Laboratory Improvement Amendments (CLIA) Act. The other 34% were conducting tests with no CLIA certification at all, and recipients of the CMS letters were required to certify that they had desisted from the violative testing activity. The agency indicated that it had offered labs an expedited review process early in the COVID-19 pandemic, but said there is concern that these labs’ operations could lead to errant tests that would worsen the pandemic. However, the letters were sent with instructions on how to amend the oversights, assuming the recipient lab is interested in resuming the violative testing protocols.

FDA Revisits Intended Use Rule

The FDA’s policy for determining a manufacturer’s intended use has strained relations between the agency and industry in the past, but the agency said in a press release that the latest version clarifies that simple knowledge of off-label use does not suffice to infer intended use. The press release highlights this as a significant change despite that essentially the same language appears in the version of the rule published five years ago.

A previous version of the intended use rule was released in September 2015, and led with a discussion of the agency’s regulation of tobacco, only belatedly discussing pharmaceutical products and medical devices. The 2015 edition states that the FDA can consider any objective evidence to determine intended use, including direct and circumstantial evidence.

The text of the 2015 rule states that circumstantial evidence is often sufficient to determine a manufacturer’s intent even in the absence of express claims about off-label use. However, this portion of the 2015 rule states also that the agency would not infer intention “based solely on the firm’s knowledge” of off-label use.

Interestingly, the agency’s press release for the Sept. 22, 2020, rule states that a firm’s knowledge of an unapproved use of a medical device or pharmaceutical, “standing alone, is not sufficient to establish the product’s intended use.” The FDA said this update should provide a greater degree of certainty and predictability for regulated industry.

The statement contends that the new rule does not reflect a change in the agency’s policies, but is intended to reemphasize the FDA’s long-standing approach to the question. The preamble to this latest version provides some examples of evidence that would not be deemed adequate to infer the manufacturer’s intent. The new rule would replace the version issued in 2017, which carried its own controversies.

The Jan. 9, 2017, final rule states that the agency would rely on the totality of the evidence to determine a manufacturer’s intent, a provision that was not well received. One commenter stated that the totality of the evidence standard had not previously been discussed in connection with the intended use rule, and that this standard was not a logical outgrowth of any prior communications on the FDA’s part. Because this standard was not discussed in a draft version, its introduction in the final rule violated the Administrative Procedures Act, said Richard Samp and Mark Chenoweth of the Washington Legal Foundation. The FDA is taking comment on the draft rule through Oct. 23.

DOJ Revisits APA a Second Time

The U.S. Department of Justice expressed its views of the current understanding and use of the Administrative Procedures Act in early August, but the matter wasn’t closed as of the date of that Aug. 11 statement. This was followed quickly by an Aug. 26 statement that provided details on two executive orders that are intended to provide guidance on adherence to the terms of the APA, a question that has arisen in the context of FDA guidance and rulemaking on several occasions.

Attached to the Aug. 11 statement was a report on a summit regarding the APA, which provided some insights into the concerns held by a number of parties about the evolution of the act. One source of concern was that compliance with federal regulation adds $2 trillion in costs to the economy each year, perhaps not surprising given the staggering volume of guidance and rulemaking across the federal government.

There is also some legislative interest in bringing independent federal agencies under the umbrella of the APA, such as the Securities and Exchange Commission. However, the larger point of interest for the DOJ consists in part of thwarting the use of guidance to create novel liabilities for the private sector without going through the normal notice-and-comment process required of rulemaking. The underlying theme in this regard is the 2017 Sessions memo, and Executive Order 13891 is intended to codify that principle.

Another consideration expands on the 2018 Brand memo, which pushed back on the use of agency guidance in affirmative civil enforcement. The second Executive Order announced Aug. 26 likewise codifies the Brand memo, but also provides a set of procedures for DOJ staff regarding the review and clearance of department guidance. Going forward, DOJ will be required to post all guidance documents on a web portal set up specifically for that purpose, but also creates a process by which the public can petition for withdrawal of a guidance.

Deputy Attorney General Jeffrey Rosen said guidance broadly is helpful to regulated parties, but observed that “backdoor regulation by guidance document is improper.” Rosen stated further that the Executive Orders will ensure “that guidance documents will not be used to impose novel legal requirements as a shortcut around the rulemaking process.”

CMS Floats Coverage Policy for Breakthrough Devices

The Centers for Medicare & Medicaid Services recently unveiled a new plan to offer four years of Medicare coverage for any medical devices cleared or approved through the FDA’s breakthrough devices program. The news won raves from medical device associations, but the offer comes with a postmarket study requirement that may exceed the demands usually imposed by the FDA for breakthrough devices.

The CMS announcement describes the terms of the Medicare Coverage of Innovative Technology (MCIT) pathway as providing coverage on the same date as the FDA marketing authorization. This coverage would last four years, an offer that assumes, but does not mandate, that the sponsor of the device continues to collect data in the postmarket realm.

Following the four years of MCIT coverage, that device would have to be covered by one of the conventional Medicare coverage mechanisms. In addition to national and local coverage determinations, the CMS press release cites claim-by-claim decisions as one of the post-MCIT alternatives. However, the agency advised that a coverage with evidence development outcome may follow the fourth year of MCIT coverage, adding that participants may be incentivized to gather postmarket data.

CMS said the MCIT program is available only to breakthrough devices that fit within an existing Medicare benefit category, while coverage is limited to on-label use. Device makers are encouraged to communicate with the CMS during the four-year coverage period, but the agency also suggested that sponsors of MCIT devices communicate their interest in an NCD or LCD before the four years are up.

‘Reasonable and Necessary’ Defined

CMS also offered a definition for the term “reasonable and necessary,” which would eventually be codified in the regulation. This definition would address all coverage decisions, rather than being limited to the scope of the MCIT program.

As described in the regulatory notification, the first prong of the three-part test for whether a device or service meets the definition of reasonable and necessary is whether the device is safe and effective. The second prong stipulates that the device must not be strictly experimental or under investigation for the use in question, but the third prong is more complex and asks whether the device or service is appropriate for Medicare patients.

The process for determining appropriateness can be fairly complicated, starting with determining whether the device’s use is consistent with accepted standards of medical practice. The device or service must also be “at least as beneficial as an existing and medically appropriate alternative,” and must not exceed the patient’s need.

However, CMS is offering an alternative mechanism by which appropriateness can be determined. This approach hinges on whether private payers are covering the item or service, although the sponsor would have to demonstrate that the commercially insured individuals are more or less clinically homogenous with Medicare beneficiaries. Sponsors could entirely eliminate the other standards for appropriateness if they can meet this requirement for commercial payer coverage.

The proposal was met with enthusiasm by the trade associations, including the Advanced Medical Technology Association (AdvaMed). Scott Whitaker, AdvaMed’s president/CEO, said in an Aug. 31 press release that the proposed rule would “help ensure the patients who need these innovative technologies have access to them.” Executives from several major device makers also lent their support in the AdvaMed statement, including Mike Mussallem, CEO of Edwards Lifesciences, and John Liddicoat, executive VP for the Americas for Medtronic.

Mark Leahey, president/CEO of the Medical Device Manufacturers Association (MDMA), also supported the proposed rule, something Leahey said MDMA “has long advocated.” He said the association would continue to work with the White House, Congress and other stakeholders to “narrow the gap between regulatory and reimbursement decisions that will bolster patient care.”

HHS Orders FDA to Stand Down on LDTs

The Department of Health and Human Services issued an Aug. 19 rescission order to the FDA directing the agency to cease requiring any premarket reviews for lab-developed tests (LDTs), a change the administration said is consistent with two executive orders (EOs). The order mentions the COVID-19 pandemic, but seems intended to endure beyond the existing declaration of public health emergency.

The question of the FDA’s statutory authority to regulate LDTs has dated back at least as far as the early 1990s. In 2006, the Washington Legal Foundation (WLF) resurrected the question in a citizen’s petition that makes reference to a similar petition filed in 1992. According to the 2006 petition, the FDA waited six years to respond to the earlier petition, and WLF cited “an urgent need for FDA to comply with the Administrative Procedures Act (APA). The APA is also a timely theme, given the Department of Justice’s recent public pronouncement about whether the underlying statute is in need of a legislative update.

The HHS announcement states that the FDA is not authorized to require premarket review of any sort for LDTs absent the use of the rulemaking process. This would supplant the FDA’s use of guidances, immediately-in-effect policy declarations, and any other informal mechanisms. The notice advises, however, that LDTs practiced for testing for the COVID-19 pandemic will not enjoy immunity from product liability under the Public Readiness and Emergency Preparedness (PREP) Act without an emergency use authorization or submission of a regulatory filing under a conventional premarket review path.

At present, there are two competing legislative responses to the impasse making the rounds on Capitol Hill, such as H.R. 6102, the Verifying Leading-edge IVCT Development (VALID) Act of 2020, which has a companion bill in the Senate. While previous iterations of the VALID Act included language directed toward a pre-certification program that seemed to parallel the precert program for software as a medical device, this latest version describes a technology certification process that would ease the demands ordinarily imposed by FDA premarket review. Neither the House nor the Senate version has come up for a vote in committee, however.

Conversely, the Verified Innovation Testing in American Laboratories (VITAL) Act of 2020, sponsored by Sen. Rand Paul (R-Ky.), would place sole authority for LDT regulation under the Centers for Medicare & Medicaid Services. S. 3512 keys on laboratory staffing qualifications to ensure that tests are appropriately developed and conducted, but also has provisions related to the pandemic, such as a requirement that CMS update the related CLIA regulations to address future pandemics. This bill, too, has failed to gain enough traction to merit a vote in the committee of jurisdiction.

PTO Revisiting IPR Rules of Practice

The U.S. Patent and Trademark Office is considering an amendment to the rules of practice for several patent procedures as indicated by an entry at the electronic dashboard for the Office of Information and Regulatory Affairs at OMB. The entry is titled to reflect an examination of the rules of practice in trials before the Patent Trial and Appeal Board, the entity charged with handling inter partes reviews (IPRs). There is little additional information as to the nature of the proposed changes, however.

The IPR process has come under fairly constant fire in the years since passage of the America Invents Act, including in a 2017 article describing the process as “a patent killing field.” The authors of the article claimed that despite the numbers posted by the PTO, the IPR process proved substantially more hostile toward claims than litigation conducted in Article III courts.

The docket for this proposal lists four meetings, the first of which took place Aug. 4 with members of the Computer & Communications Industry Association. Included in the documents for that Aug. 4 meeting is a file by PTO suggesting that IPR institution rates have dropped from 87% in fiscal year 2013 to 56% to date in fiscal 2020. However, the sheer volume of petitions for IPRs rose from 220 in that first year to more than 1,500 three fiscal years later. The current total for FY 2020 is 854 petitions, 478 of which have been instituted.

FDA Releases Final Guidance for Multiple Function Devices

After a wait of two years, the FDA has concluded the draft guidance for multiple function devices with a final version that makes several substantive changes. Among these is that the list of participating centers now includes the Center for Drug Evaluation and Research (CDER), which was excluded from the draft.

One of the clear indications that the FDA took to heart some of the recommended changes is that the draft covered 18 pages while the final version spans 27 pages. The draft explicitly stated that the scope includes device constituents of combination products, a factor that prompted at least one trade group to recommend that the final version include CDER.

Conversely, the draft and final guidances both state that the FDA will offer no insight as to which functions do and do not meet the definition of a device. Both versions apply the same approach regarding the device types for which the agency currently exercises enforcement discretion regarding compliance activities.

One of the more substantial changes to the policy appears in Section V., specifically the paragraphs for separation of the device and non-device functions in design and implementation. The draft guidance makes several overarching recommendations without providing much in the way of detail. However, the final guidance offers much more insight into the agency’s thinking, such as the suggestion that documentation of a risk analysis of the impact of the non-device function may aid the agency’s understanding of the device function under review.

The final guidance briefly discusses design architecture in the context of maximizing functional separation and segregation as a means of managing risk, content that is not seen in the draft. Also missing from the draft is a recommendation that the sponsor take cybersecurity issues under consideration when considering functional separation.

One of the major changes seen in the final guidance is the addition of a flowchart depicting assessments of the impact of non-device functions on the device function under review. One element of the flowchart states that any beneficial effect the non-device function might have on device performance should be included in the premarket filing, assuming the sponsor intends to include such information in product labeling.

In the absence of a determination that there will be any impact, positive or negative, the device maker should document the rationale for such a determination per the company’s standard operating procedures.

FDA Posts New Template for COVID-19 Testing

The FDA’s Center for Devices and Radiological Health has pressed forward with more policy changes to deal with the COVID-19 pandemic in the final days of July 2020, including publication of a template for non-clinical diagnostic testing in the home and other settings. FDA commissioner Stephen Hahn praised the publication of the template as a game changer, although limited supplies might continue to crimp the volume of testing.

The FDA’s July 29 statement explains that the new template will assist test developers in drafting their emergency use authorization applications for tests that can be performed outside a clinical lab setting, such as the home, the workplace, and in educational settings. This test would be available without a prescription, and Hahn said the objective is to ensure there are tests available that would be no more complicated to use than a pregnancy test.

“These types of tests will be a game changer in our fight against COVID-19, and will be crucial as the nation looks toward reopening,” Hahn said.

The Advanced Medical Technology Association said in a July 28 statement that the daily volume of molecular diagnostic tests for COVID-19 reached one million for the week ending July 24. That number is based on a report from a registry operated by AdvaMed and several diagnostics companies, which also states that 80 million total molecular tests have been shipped in the U.S. as of July 18.

Despite the increase in molecular testing, a number of stakeholders are pressing Congress for dedicated funding and clear coverage guidelines for testing. The letter was signed by several each of medical societies, trade associations and non-profit patient organizations, but the House and Senate are at a standstill over their respective economic relief bills, which include the much-needed taxpayer funding for testing.

FDA to Resume Domestic Device Inspections

The FDA was forced to announce in March 2020 that it would suspend inspections of drug and medical device manufacturing sites because of the COVID-19 pandemic, but the agency has partially reversed that decision in a July 10 statement. FDA commissioner Stephen Hahn said the pause that had been applied to inspections did not prevent the agency from conducting mission-critical inspections, although routine surveillance inspections had been shuttered for four months.

The FDA has been tracking state and local conditions with the aid of a rating system designed to establish which locations are reasonably safe for a site inspection. This COVID-19 advisory rating system makes use of real-time data to provide a qualitative assessment of the number of cases in an area. These data are shared with the agency’s partners on the state level who handle some inspectional activities, presumably including inspections of mammography facilities.

The rating system is broken down into three levels of risk on a county-by-county basis, starting with the category of counties where inspections will only take place when those inspections are deemed mission-critical. The second tier of inspections takes into account whether the agency can send field investigators who have not identified themselves as vulnerable to poor outcomes for infection with the SARS-CoV-2 virus. The last tier is for counties that are open to a resumption of normal activities. The agency’s objective is to resume surveillance inspections the week of July 20, although the FDA said that conditions on the ground would continue to drive the level of inspectional activity.

FDA Posts Two Draft Updates

Regulatory science has not completely stagnated in the COVID-19 pandemic, a fact of life demonstrated by two draft guidances the FDA published for updates to existing guidances. One of these is a July 13 update for 510(k) submissions for devices that provide atherectomy for the peripheral vasculature, comments for which are due Sept. 11.

The scope of the draft is limited to intraluminal artery strippers that fall under the MCW product code, which includes four technologies, including rotational atherectomy devices. Sponsors can use ISO 10993 to test for biocompatibility, and ISO 14971 for risk evaluation and management. Devices that are packaged with a pre-installed internal battery will have to fulfill several performance testing recommendations, including shelf life, and the sponsor will have to determine the impact of sterilization on the battery when the battery will be left in the device during sterilization procedures.

The FDA states that it has no intention of imposing changes to the existing guidance that are not specified in this latest draft. Interestingly, the existing final guidance was issued in February 2020, less than two years after the previous draft had been published.

The second updates draft published in the month of July is the July 14 draft for clinical and non-clinical investigations into devices for treatment of benign prostatic hyperplasia (BPH), which will also limit updates to the existing to the contents of the draft. This draft will update the recommendations for devices that are covered by four product codes (KNS, PEW, PZP and NOY), and includes updates to recommended approaches to animal studies.

Among the draft recommendations is that animal studies should include both gross and histological examinations of the treated area by a pathologist who is blinded to the treatment. The draft states that animal studies of thermotherapy devices should include evaluations of how well the device limits the volume of affected tissue by checking parameters such as blood flow and tissue heterogeneity. There are also recommendations for animal studies of stents used for BPH.

Also included in the updates draft for BPH devices are recommendations for pilot and pivotal studies, including a recommendation that the sponsor make use of a randomized, controlled study design for the pivotal study. While the standard of care for the population under investigation might be the most appropriate control treatment, the FDA said the risk-benefit ratio of the investigational device should be comparable to that of the control treatment. The comment period for this draft closes Sept. 14.

FDA Sets 50% Efficacy Benchmark in Vaccine Guidance

The FDA has released a guidance for development of vaccines in response to the COVID-19 pandemic, which among other things suggests the agency will push harder to ensure that any such studies enroll pregnant women and minorities. The guidance also calls for an effectiveness rate of 50%, a benchmark which exceeds those of most recent influenza vaccines used in the U.S.

The June 30 FDA press release states that the agency may use the accelerated approval pathway for licensing a vaccine for the SARS-CoV-2 virus, but that any application would have to identify an immune response or other measure “that is reasonably likely to predict clinical benefit.” The agency left open the possibility that a vaccine could be distributed under the emergency use authorization program (EUA), but the guidance seems to suggest that the FDA is reluctant to grant an EUA authorization for the first vaccine specific to this virus.

The guidance states that issuance of an EUA prior to completion of a large randomized trial could inhibit demonstrations of effectiveness, and that such a study may be needed to clarify the effect of the vaccine on vaccine-associated enhanced respiratory disease. Conversely, the FDA said an EUA may be appropriate once the study has returned sufficient data to demonstrate safety and effectiveness, even if the manufacturer has not yet submitted all the data from that study.

Patients who are at higher than average risk of severe adverse events may be excluded from early-phase studies, but those patients may have to be included in late-phase studies. Trials of all stages will have to include pregnant women and women who are not actively avoiding pregnancy, along with several other sub-groups, including racial and ethnic minorities and elderly patients. Randomized, controlled trials will have to enroll evenly between placebo and the candidate vaccine, and the FDA said an approved vaccine can be used as a control for subsequent vaccine studies.

In the discussion of statistical considerations, the guidance calls for a 50% efficacy endpoint both at the completion of the study and at any interim analysis, a superior metric to 11 out of 15 of the vaccines listed at the CDC website. The most recent influenza vaccine to exceed that mark is the 2013-14 vaccine for the H1N1 virus, which provided an effectiveness rate of 52%.

The FDA said the terms of the guidance will continue to apply after the public health emergency has been withdrawn, and that any revisions will be made within 60 days of the termination of the emergency. The guidance makes some concessions on manufacturing considerations, including the use of a virtual site inspection, depending on that manufacturing site’s compliance history.

High-throughput Testing Emphasized

The FDA’s EUA program for testing and diagnostics is still a key component in the U.S. federal government’s efforts to rein in the COVID-19 pandemic, and the agency is now focused on bringing high-throughput testing into the picture. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiology said on a June 24 town hall that the FDA is also working on an EUA template for molecular testing for the pandemic, which would also help to enable the volume of testing needed to reopen the economy.

According to the FDA’s transcript of the town hall, the agency has received a number of questions about the distinction between testing for diagnosis, screening and surveillance. Stenzel asked that test developers comb through existing guidance and templates for answers to their questions prior to contacting the agency, and said the emphasis is on point-of-care and high-throughput testing systems. The agency’s review of such systems is contingent on receipt of an EUA filing that contains sufficient data for review, including separate reporting for the various antibody isotypes stimulated by the virus.

The FDA made good on Stenzel’s promise, adding two templates for molecular testing at the template webpage. The July 2 update provides one template each for commercial manufacturers and labs, and there are provisions in the documents for asymptomatic testing for screening purposes and for testing of specimen pools.

FDA Moves on Home Sample Collection for COVID-19

The FDA has broken new ground on numerous occasions as a result of the COVID-19 pandemic, including with the release of a voluntary template for at-home sample collection kits under the emergency use authorization program. There are limitations to the use of home sample collection kits for the pandemic, however.

The agency’s May 29 press release indicated that test developers can provide a test for samples obtained by the user in their domicile only if that test is authorized under the EAU program, or when used in connection with a study overseen by an IRB. Jeff Shuren, director of the Center for Devices and Radiological Health, said home collection samples are the subject of several concerns, including whether the sample can be shipped without degradation.

The FDA template states that the sample can be drawn from the anterior nares or saliva, and that a developer that wants to manufacture a sample collection kit for other types of respiratory specimens (or non-respiratory sources) should contact the agency regarding a validation a strategy. The developer of that home collection kit should also contact the Pipeline and Hazardous Materials Safety Administration regarding compliance with regulations pertaining to hazardous materials shipping, the FDA said.

CDC Advises Caution on Serological Test Interpretation

U.S. federal government activity has been more or less constant even after omitting the FDA’s updates, such as the routinely updated antibody test guidelines posted by the Centers for Disease Control and Prevention. CDC pointed out recently that interpretation of a serological test can be hazardous if local seroprevalence is in the mid-single digits. In addition to advising that there is no clear answer as to which antibody isotype is most advantageous for COVID-19 surveillance, the update page also states that when prevalence is at 5%, a serological test with 90% sensitivity and 95% specificity might offer a positive predictive value of only 49%.

This can be improved upon by the use of a test with a specificity of 99.5% or greater, or by pre-test screening to eliminate those at a low probability of infection, while another option is to run a second test on any individuals who test positive. A repeat testing strategy based on an orthogonal algorithm would require that the second test be a different test than the first, but CDC also advised that tests for immunoglobulin A (IgA) are not seen as particularly reliable, at least until more information emerges about the dynamics of IgA in the context of the SARS-CoV-2 virus.

The Federal Communications Commission announced May 28 that it had approved another 53 funding applications for telehealth programs specifically set aside for the COVID-19 pandemic. The funding for these programs was provided by the Coronavirus Aid, Relief and Economic Security (CARES) Act, and this latest round of telehealth program awards will account for $18.22 million out of the total of more than $68 million granted to date under this program.

The FCC’s COVID-19 telehealth program has $200 million to work with under the terms of the CARES Act, although the entirety of that funding source need not be expended. This was the eight set of telehealth programs announced by the FCC, the first of which was announced April 16.

Precisely how long these telemedicine programs will be needed in such numbers is difficult to pin down, but the Advanced Medical Technology Association recently highlighted a survey suggesting that three in four Americans would not hesitate to undertake a face-to-face visit with their physician. Patients have been skipping cardiology care sessions, cancer screenings, and other essential care visits as a consequence of the pandemic, but the vast majority of the 593 respondents believe the time has come to go see the doctor. Roughly half of those surveyed in a separate poll said they or someone in their household has postponed or skipped entirely a medical visit in recent months.

FDA Issues Pandemic Policy for Supplements

The FDA’s device center has put forth a number of policy documents to handle the effects of the COVID-19 pandemic, and one of the latest takes up the filing of supplements for PMA and humanitarian device exemption devices. As is the case with a number of other guidances for the pandemic, this guidance spells out the conditions under which sponsors need not file for changes to devices in some instances, but device makers must document all those changes nonetheless.

The policy for PMA and HDE devices allows the manufacturer to make changes to the device without a 30-day notice or a supplement if a design change was motivated by a need to address a lack of components caused by supply chain disruptions. Manufacturing site changes can be undertaken without a supplementary filing if that site change was necessary to provide employees with sufficient room to practice social distancing.

Manufacturers can make changes to the materials used in the device that are necessitated by changes in manufacturing, assuming that manufacturing change was brought on by the conditions imposed by the pandemic. This holds only if the change in material does not suggest an impact on device safety or performance, however.

Conversely, the manufacturer cannot make a change to a device’s intended use under this policy, and even the changes that qualify under this pandemic policy must be documented per routine record-keeping activities, such as device history records. The sponsor must also report all changes, exempt or not from supplementary flings, in the annual report due for that device. Interestingly, the FDA had just completed its revised guidance for PMA annual reports in December 2019.

PTO Says No to AI as Inventor

The U.S. Patent and Trademark Office announced last year that it was seeking feedback on whether artificial intelligence could be an inventor, but the agency ultimately declined to go along with the concept. Underlying the decision was the fact that the statute makes specific reference to entities that would qualify as a natural person or persons, but PTO was not the only patent office to pass on the proposal.

The PTO opened the proposal for public comment in August 2019 at the behest of the inventors of the DABUS algorithm, Stephen Thaler of Imagitron LLC. The algorithm, which Thaler described as a creativity machine, is a general-purpose algorithm that Thaler claimed was not trained for any specific invention or field of endeavor. When Thaler first filed for a patent in 2019, the examiner returned the application for failure to identify the inventor by a legal name.

The problem for Thaler, according to the PTO, is that Title 35 of the U.S. Code defines an inventor or inventors as “the individual or … individuals who invented or discovered the subject matter of the invention.” The agency said Section 101 of Title 35 states that “whoever invents or discovers” a useful article may obtain a patent, and that other portions of Title 35 make reference to pronouns such as “himself” and “herself.”

The PTO pointed to case law in support of its position as well, including a 2013 decision by the Court of Appeals for the Federal Circuit. The PTO observed that Thaler had himself acknowledged that an AI system enjoys no property rights under current law, which the agency said “further calls into question whether the submitted assignment document satisfies the requirements” spelled out in several portions of the Code of Federal Regulations.

Thaler had no better luck in other patent offices, including the U.K. Intellectual Property Office, which came to a similar conclusion in December 2019. The U.K. IPO’s handling of the matter largely mirrored that of the PTO’s approach, initially rejecting the application because “a person must be identified” on an application. The agency’s deputy director, Huw Jones, acknowledged that there is a legitimate question as to how such issues ought to be handled, but recommended that the debate be handled legislatively and “not shoehorned arbitrarily into existing legislation.”

ONC, CMS Delay Compliance Dates for EHR Interoperability

The COVID-19 pandemic has incurred a number of regulatory casualties in recent weeks, and the final rules for electronic health records (EHRs) promulgated earlier this year are two of the latest among those. Not all aspects of these rules were on the same original compliance deadline, however, and vendors will have to delve into the details of these respective delays to keep them straight.

The Office of the National Coordinator and the Centers for Medicare & Medicaid Services posted a joint statement about the delayed implementation date. ONC director Don Rucker said his agency will offer three months of enforcement discretion to EHR vendors “at the end of … certain compliance dates,” a concession to the pandemic. In contrast, CMS administrator Seema Verma stated that hospitals will generally have an additional six months to implement the related requirements.

The ONC announcement was accompanied by a tabular presentation of revised compliance deadlines, many of which simply add three months onto the original six-month deadline. The roll-out of application programming interface (API) functionality was originally subject to a 24-month compliance date, but now enjoys 27 months of regulatory relief. Many other requirements, such as the information blocking requirement, were initially on a six-month delay from the date of the final rule, but this requirement will not be in force until the end of the year at the earliest. The ONC rule appears in the Federal Register with a date stamp of May 1 and an effective date of June 30.

The CMS stated that the requirements for the patient access API are now in force as of Jan. 1, 2021, the same date as the provider directory API. The CMS requirement for information blocking enjoys a less crisply defined compliance date of “late 2020,” while payer-to-payer data exchange functions must be up and running by Jan. 1, 2022.

FDA Posts AE Reporting Policy

Among the pandemic-related considerations undertaken by the FDA is a policy document spelling out the agency’s expectations regarding adverse event (AE) reporting. The terms of the policy apply to medical products and dietary supplements, and deals with the prospect that COVID-driven absenteeism might hamper a company’s AE reporting program.

The policy, which updates a 2012 guidance addressing influenza outbreaks, allows companies to focus their AE reporting efforts on products related to the COVID-19 pandemic. Affected companies are expected to develop a continuity of operations plan (COOP), which should spell out AE reporting and updates for any events that are stored during the pandemic. Companies should document the start and ending dates of their nations’ emergency declarations as well as the impact of absenteeism on AE reporting.

The FDA says it “does not plan to object” if a company is unable to file AE reports on time due to absenteeism caused by they pandemic, but the affect entities have to file those reports within six months of restoration of normal order of a company’s operations. Companies that can report at least some AEs in a timely fashion must do so, and firms that can file all required reports are expected to make timely reports. If the agency expresses concern about reports in connection with specific products or a particular set of circumstances, the FDA will offer no leniency on the standard reporting requirements, the guidance states.