US Administration and Medtech Industry: A US Focus New Democratic Senate Poised To Approve More Generous COVID-19 Relief Bills, Biden Cabinet Chiefs

Executive Summary Also, because Democrats have a history of Elections guaranteeing a Democratic Senate backing tougher health and safety standards for mean President-Elect Joe Biden can push for medical products than Republicans, high-ranking $2,000 COVID-19 relief checks and get his Cabinet committee members like Sen. Patty Murray, D-WA, choices. who serves on the Health, Education, Labor and Pensions (HELP) and has pushed for stronger duodenoscope and diagnostic testing standards and Ron Wyden, D-OR, who favors more COVID-19 Industry should expect to see much stronger protections for seniors, will have more latitude Democratic leadership on medtech regulations, to carry out their agendas. (Also see “Olympus, approvals and reimbursements now that Pentax Working On Responses To Sen. Murray Congress has accepted the 2020 presidential Duodenoscope Contamination Concerns” - electoral college results affirming Joe Biden Medtech Insight, 15 May, 2019.) as President and the Senate has cemented its changeover to Democratic control following Wins By Georgia Dems Warnock And Ossoff Aid election of Democrats for two contested Georgia Biden Senate seats. “I congratulate Reverend Raphael Warnock on his groundbreaking win last night and I am hopeful Most immediately, Congress is expected to that when the count is complete, Jon Ossoff will approve larger and more generous COVID-19- also be victorious in the Georgia Senate run- relief testing and tracing packages than those off elections,” Biden stated on 6 January. The put forward when the Senate was steered by Associated Press ultimately certified that Ossoff Republican Majority Leader Mitch McConnell from also won his Georgia Senate election on Thursday, Kentucky. For example, in September, McConnell 7 January. backed a so-called “skinny” coronavirus relief bill. (Also see “US Congress Roundup: Senators Reject “I will try to work with people in both Republican COVID-19 Relief Plan; Lawmakers Fault Verma and Democratic parties to get big things done for Promos” - Medtech Insight, 11 Sep, 2020.) our nation, and I have long said that the bipartisan COVID-relief bill passed in December was just a In addition, a Democratic-controlled Senate down payment,” Biden added. should quickly give its blessing and support to more liberal Cabinet chiefs – such as Biden’s In addition, Democratic Sen. Chuck Schumer of proposed leader for the Department of Health New York, who now serves as Senate minority and Human Services, Democrat Xavier Becerra – leader but will be sworn in as Senate Majority than a Republican-led Senate would. In turn, these Leader on 20 January, also said in a 6 January Cabinet-level officials are expected to oversee press briefing that one of his priorities will be to tightened standards for product approvals at pass legislation that would send $2,000 stimulus the US Food and Drug Administration and more checks to US taxpayers and provide more funding generous reimbursements from the Centers for for testing and tracing. The previous coronavirus Medicare and Medicaid Services. relief package, passed by Congress and signed by President Trump last week alongside an

2 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) omnibus agency funding bill, directed only $600 Nonetheless, Biden pledged to get a coronavirus in payments to Americans. (Also see “Radiologists, relief package including $2,000 stimulus checks Other Out-Of-Network Providers See Partial Win out. “We need urgent relief action on what comes In ‘Surprise Billing’ Law, Attorney Says” - Medtech next, because the COVID-19 crisis hits red states Insight, 5 Jan, 2021.) and blue states alike,” Biden said on 6 January. Approval Of Becerra To Lead HHS, Garland As The incoming Biden team has also pledged to A.G., Will Be Eased double the rate of coronavirus vaccinations in the first 100 days of his administration, going from A Democratic-controlled Senate should also 500,000 vaccinations per day, to 1 million per make it easier for Biden get his cabinet choices day, said James Capretta, American Enterprise approved. Among these selections are California’s Institute Fellow. Both Capretta and Joe Antos, Becerra to lead HHS, and D.C. Circuit Court of another conservative and AEI fellow, pointed Appeals Judge Merrick Garland for Attorney out that Biden would need to avoid issues General, who was previously President Barack where Democrats in the Senate are not solidly Obama’s choice to become a Supreme Court behind him, because of the narrow margin (50 Justice. Democrats, 50 GOP members, with incoming Democratic VP Kamala Harris serving as a tie- Becerra served as California Attorney General breaker) between the two parties in that chamber. between 2017 and 2020, and was a 12-term Representative in the US Congress prior to that.

3 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) FDA Faces Succession Questions As Hahn’s Departure Nears

Executive Summary 2016 and the agency senior leadership has been Plan specifying the acting head of the US FDA until reorganized since then. new commissioner is confirmed references senior positions that no longer exist. Former commissioner Scott Gottlieb eliminated the deputy commissioner for foods and veterinary medicine and other directorate layer positions just before his departure in 2019. The White Commissioner Stephen Hahn plans to leave US House avoided the succession planning problem Food and Drug Administration when President- when Gottlieb left, naming National Cancer elect Joe Biden is inaugurated, but the choice of Institute director Norman Sharpless as acting a temporary replacement is not clear – in part commissioner. because agency succession plans are outdated. Biden also could appoint a temporary As is tradition, political appointments offer their commissioner upon taking office. A similar resignation when a new administration takes approach was used at the beginning of the Obama office. The incoming president can ask them to administration, when Josh Sharfstein was tapped stay in their positions, but often they are let go. to be principal deputy commissioner and acting head of the agency while Margaret Hamburg Hahn is expected to be among the many Trump awaited confirmation. administration agency heads and other officials that will depart. The agency confirmed that he Whatever approach is used, extended uncertainty plans to serve the remainder of his term, which at the top of FDA would be concerning, especially will expire at 12:01 p.m. on 20 January. as the agency continues juggling its response to the coronavirus pandemic with its many other But the FDA was not forthcoming on who will be regulatory duties. Hahn’s replacement until a new commissioner is confirmed by the Senate. An agency spokesperson Abernethy, Other FDA Officials Could Take said there was no information to share and the Over Department of Health and Human Services, the Several career and other senior leaders at the overseer of the FDA, did not respond to questions agency could take charge at the FDA until a about Hahn’s replacement. commissioner nominated and confirmed.

The FDA’s succession plan also does not appear to The agency’s second in command, principal offer much help. The agency Staff Manual Guide deputy commissioner Amy Abernethy, may be states that when a commissioner leaves office as the most obvious choice to take over. As a career described in the Vacancies Reform Act and the employee, Abernethy is planning to stay at the president does not appoint someone, the deputy FDA after the administration changes. Gottlieb commissioner for Foods and Veterinary Medicine hired Abernethy and she was thought to be a becomes the acting commissioner. potential commissioner-in-waiting.

Currently there is no one at the agency with that The position closest to the description in the title. The Staff Manual Guide was last updated in succession plan is deputy commissioner for food

4 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) policy and response, which is currently filled by time, such as because of a change in policy or loss Frank Yiannas. of confidence, without a right to appeal.

Deputy commissioner for Medical Products and After chief of staff is the deputy commissioner for Tobacco, another eliminated position, is listed in operations and chief operating officer, which is the succession plan as the second choice when currently filled by James Sigg. the commissioner is absent or otherwise unable to perform their duties and the Vacancies Reform The FDA invoked its succession plan when Act does not apply. commissioner Robert Califf resigned at the end of the Obama administration. Then deputy That is followed by the FDA chief of staff, which is commissioner for Foods and Veterinary Medicine currently filled by Keagan Lenihan. However, the Stephen Ostroff became acting commissioner position is considered a noncareer appointment, until Gottlieb was confirmed. which means Lenihan can be removed at any

5 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) One-Two Punch Of HHS Rules On Guidance Docs, Regs Will ‘Tie Hands’ Of Biden Admin: Expert

Executive Summary The SUNSET rule, combined with the Good Two new rules put forward by the US HHS Guidance rule, is just the Trump administration’s could have a chilling effect on future guidance attempt to kick sand in the gears of HHS agencies documents and regulations drafted by the FDA before President-elect Joe Biden takes office on 20 and the 27 other agencies and offices the HHS January, Jessica Schubel charges. oversees, a policy expert says. This and other stories topped our list of most-read US regulation, “This is another example of how the Trump policy, quality control and compliance articles in administration is trying to tie the hands of the December. incoming Biden administration by gumming up the works, so to speak. You can think about these two regs as a two-pronged approach to accomplishing that goal of gumming up the Expert: ‘Good Guidance,’ ‘SUNSET’ Rules Will works,” Schubel, a senior policy analyst for the Put Biden Admin In A Bind Center on Budget and Policy Priorities, said in an Two new rules put forward by the US Department interview. of Health and Human Services in the final days of the Trump administration could have a “They waited until the 11th hour to issue both chilling effect on future guidance documents of these regulations, particularly the SUNSET and regulations drafted by the Food and Drug rule,” she said. “They turned the comment period Administration, as well as the 27 other agencies around very quickly.” and offices the HHS oversees, a policy expert says. The deadline for feedback from stakeholders Our reporting on this was of most interest to on the SUNSET reg is 4 January; more than 500 Medtech Insight readers in December. comments have already been received by the HHS. By comparison, the department received The HHS rolled out its Good Guidance Practices only 88 stakeholder comments related to its Good final rule in the Federal Register on 7 December; Guidance rule. it goes into effect on 6 January. The new reg calls for all guidance documents to be added to Meanwhile, time is ticking for the FDA and other an online repository (which has already been HHS agencies and offices to add guidance docs to populated by more than 35,000 entries), directs the new online repository. Guidances that aren’t the HHS secretary to take a more hands-on in the repository by 6 January will be considered approach to the docs, distinguishes so-called rescinded, the Good Guidance rule says. “significant” guidances from more traditional ones, and gives anyone the opportunity to petition QSR Harmonization Update the department to rescind or modify a guidance, In our No. 2 story from December, we exclusively among other actions. reported that the FDA selected February as the latest target date for releasing a draft of its And a separate draft rule from the HHS released retooled Quality System Regulation, which has in November – called Securing Updated and been undergoing a facelift since early 2018. Necessary Statutory Evaluations Timely (SUNSET) – would require the department and its agencies to This is the fifth in-house deadline the agency has review all regulations every 10 years to determine set for issuing its draft rule, which will harmonize whether they’re still necessary. the QSR with international quality systems

6 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) standard ISO 13485:2016. The FDA had previously to conduct domestic and foreign manufacturing set deadlines of April 2019, September 2019, April facility inspections and other site visits, and an 2020 and October 2020. increased potential for fraudulent devices.

CDRH Chief Wants A ‘Reset’ In 2021 An Interview With FDA’s Schwartz FDA Center for Devices and Radiological Health Our deep-dive profile of the FDA’s Suzanne director Jeff Shuren said in December’s No. 3 story Schwartz clocked in at No. 8 on December’s that the CDRH’s focus on the COVID-19 pandemic Top 10 most-read stories list. Schwartz, who’s pushed some important initiatives to the side in director of the Office of Strategic Partnerships 2020, but that they’d be picked up again in the and Technology Innovation within the CDRH, new year. talked about a broad range of issues, from device shortages to cybersecurity vulnerabilities. For example, an overhaul of the FDA’s 510(k) program for clearing devices was “put somewhat During the pandemic, Schwartz and her team on the back burner,” Shuren said on 3 December. have been instrumental in monitoring for potential shortages – in particular, products like The CDRH chief said he anticipates picking up PPE that are needed to make sure front line that initiative again in 2021, after the new Biden health care workers can continue to do their jobs. administration settles in. Shuren described a She said the agency has learned a number of possible change in the program that would allow lessons based on its response to COVID-19 that is product developers – rather than comparing their paving the way for how it responds to such crises new device to an established predicate – to show in the future. how their newly designed product works just as well or provides even better performance than a “One area that is getting a lot of attention from us device that’s already on the market. and where we are building programmatically is in the area of medical device supply chain resiliency “COVID-19 disrupted our trajectory in 2020; 2021 and shortages,” she said. “Prior to COVID, we had will be a reset,” Shuren promised. no authorities within the device shortage space. We were granted some authorities in March And in our No. 9 story, an FDAer went into detail through the CARES [Coronavirus Aid, Relief, and about other impacts the pandemic has had on Economic Security] Act. device and diagnostic regulation. “We recognize the importance of pre-positioning “This particular public health emergency has had a our effort so we have a steady state of huge impact on the medical device ecosystem as a understanding and intelligence of the medical whole, and the FDA’s medical device program has device supply chain, especially in the areas of continued to adjust and adapt,” said Erin Keith, products that we know are going to be needed, associate director for compliance and quality in were there to be different types of public health the Office of Product Evaluation and Quality within emergencies” at once, Schwartz added. “Of course, the CDRH. PPE bubbles up to the top, almost irrespective of the type of public health emergency that you’re Keith explained that the pandemic had not only dealing with.” caused widespread shortages of key medical devices such as personal protective equipment Before COVID-19 became the main public health (PPE) and ventilators, but also brought to light priority, Schwartz was probably best known for vulnerabilities in the device supply chain. She her work on the FDA’s efforts to develop policies noted that other key areas of concern have been around device cybersecurity, including publishing an urgent need for new products, the inability a number of guidance docs on the best premarket

7 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) and postmarket practices, and encouraging for remotely evaluating manufacturer compliance industry to develop a Total Product Life Cycle during the pandemic. approach to how it implements cybersecurity of devices. No. 6 story: The Biden administration will waste no time using the Defense Production Act to ramp Other Top Stories up the manufacture of PPE, a member of the These articles rounded out our Top 10 list in president-elect’s COVID-19 task force said. December: No. 7 story: Makers of devices deemed critical No. 4 story: The medtech industry responded during the pandemic that fail to notify the to President-elect Biden’s selection of California FDA of product shortages could find a letter of attorney general Xavier Becerra as his nominee noncompliance from the agency in their mailbox. to head the HHS. A longtime political operative, That’s one of the messages in the latest update to Becerra gained national fame for leading the agency’s device shortages guidance. his state’s efforts to stop Republicans from dismantling the Affordable Care Act. No. 10 story: The HHS now requires all its agencies to publish documents supporting their rationale No. 5 story: The number of on-site inspections whenever they propose a new rule, except in of medical device facilities performed by the situations where there may be a legal conflict to FDA between mid-July and mid-November fell by do so. 93% from the same time frame last year. That’s forced the agency to consider creative techniques, The 10 most popular US regulation and policy including records requests and the use of video, stories in December are listed in the table below.

8 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) Medtech Industry Reacts To Biden’s Nomination Of ACA Defender Becerra To Lead HHS

Executive Summary government to expand testing and masking, The president-elect on 7 December named oversee the safe, equitable, and free distribution nominees for his health team, including California of treatments and vaccines, reopen schools and attorney general Xavier Becerra for HHS secretary. businesses safely, lower prescription drug and Missing from the list is a nominee for FDA other health costs and expand affordable health commissioner. care to all Americans, and rally the country and restore the belief that there is nothing beyond America’s capacity if we do it together,” the president-elect said. Incoming US President Joe Biden has picked California attorney general Xavier Becerra as his In a tweet following the news, Becerra highlighted nominee to head the Department of Health and his work on the ACA and the need to ensure Human Services. The longtime political operative greater access to health care. has gained national fame for leading state efforts to stop Republicans from dismantling the Affordable Care Act.

A former Democratic congressman who served in the US House between 1993 and 2017, Becerra had been touted as the potential Biden pick for US attorney general given his work taking on issues such as criminal justice reform and immigration. However, after Rhode Island Gov. Gina Raimondo surprisingly turned down the HHS nomination last week, the incoming president’s transition team was left scrambling for a new candidate. Some stakeholders had hoped for an HHS secretary candidate who was either a physician or Biden announced Becerra’s pick in a 7 December had direct experience in public health. Stephanie press release that also included nominating Vivek Keenan, senior VP for federal public affairs at Murthy to reprise his role as surgeon general; McGuireWoods Consulting, noted however that Rochelle Walensky for director of the Centers for Becerra has extensive knowledge of HHS given Disease Control and Prevention; and Anthony his work as a congressional leader on the House Fauci as chief medical adviser to the president Ways and Means Committee. on COVID-19, and continuing his role as director of the National Institute of Allergy and Infectious “While he may not have worked in a specific health Diseases within the National Institutes of Health. care sector, he has other skills that are invaluable and some background knowledge already,” Biden made clear in his release that the new Kennan told Medtech Insight. “For example, he health team’s top priority will be to tackle the knows how the Hill works and many of the key coronavirus pandemic. health policy players. Those relationships will be important going forward.” “This team of world-class medical experts and public servants will be ready on day one She also says Becerra will likely attract senior to mobilize every resource of the federal advisors to the department who have more in-

9 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) depth program knowledge. Kennan says the relationship between the HHS and the FDA will likely change for the better under While Biden’s priority will be tackling the COVID-19 a Biden HHS leadership. crisis, there are other top priorities that Becerra will have to handle, Kennan says, including shoring “I think overall the Biden administration will value up Medicare financing, working to eliminate thoughtful consideration as a way of instilling minority health disparities and expanding access confidence in the public that the FDA is on the to health care. She says there are also sector- job ensuring safety,” Kennan said. “That doesn’t specific issues such as drug pricing, controlling mean there won’t be frustrations, or suggestions health care costs and ensuring Medicare access to about how to do things differently, but the overall breakthrough products that are also high on the approach is likely to be more strategic.” list of priorities. News of Becerra’s nomination was taken well by No FDA Commissioner Pick Yet industry stakeholders including Mark Leahey, One position that was not on Biden’s list is a pick president of the Medical Device Manufacturers for FDA commissioner. There have been a number Association, who told Medtech Insight that the of names that have been floated for the position, MDMA is looking forward to working with Becerra but former FDA commissioner David Kessler and if he’s approved by the Senate. former principal deputy commissioner Joshua Sharfstein have surfaced as frontrunners. (Also “Attorney general Becerra has a long history of see “A Return Trip For Kessler At US FDA? It working with various stakeholders in the health Wouldn’t Be The First Time It’s Happened” - Pink care ecosystem to develop policies that seek to Sheet, 2 Dec, 2020.) improve patient care and support innovation,” he said. “Whoever gets the job will have to ensure that the FDA workforce feels they have someone who AdvaMed CEO Scott Whitaker also said in an will fight for them and the [regulatory] system, interview that he too is looking forward to working as well as wanting to improve FDA performance,” with Becerra, especially on issues related to the Kennan said. “It is ironic that we are coming up pandemic. to the time that the user-fee legislation has to be renewed – the change in administration is “The medical technology industry’s historic timely to ensure public confidence while working mobilization to save lives throughout this with manufacturers of products to find ways to pandemic continues, and we at AdvaMed will keep improve the system.” working in a bipartisan way with both parties and the next administration,” he said. Over the past few months there’s been some reportedly heated disagreements between HHS Similarly, Mary Grealy – president of the secretary Alex Azar and FDA commissioner Healthcare Leadership Council – said in a Stephen Hahn, especially on issues such as statement that Becerra would bring extensive whether the FDA has the authority to regulate policy experience and expertise to the position, laboratory developed tests. (Also see “‘Wrong and lauded him for his championing of the Move’: Gottlieb Blasts Azar’s Perceived Regulatory Affordable Care Act. Power Play Over FDA; HHS On Defense” - Medtech Insight, 20 Sep, 2020.)

10 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) SUNSET Draft Rule Is Trump Admin’s ‘Latest Attempt To Sabotage HHS Programs,’ Analyst Charges

Executive Summary she said. The proposed rule from the US HHS that would require its agencies to review all regulations Schubel also believes the SUNSET rule could every 10 years could distract an incoming Biden distract the incoming Biden administration at a administration from the COVID-19 pandemic and time when it needs to be focused on the COVID-19 will “wreak havoc” on Medicare, a senior policy pandemic. analyst for the Center on Budget and Policy Priorities says. The rule “would disrupt work on program operations and force the [Biden] administration to delay adopting its health care priorities because it needed to redirect staff to review existing A proposed rule released last month by the US regulations,” she said. “If HHS could not dedicate Department of Health and Human Services is the needed resources to conduct the assessments the Trump administration’s “latest attempt to and reviews, some rules might expire and cause sabotage HHS programs,” a policy expert says. major harm.”

Under the 4 November draft rule – Securing While a more pessimistic Schubel believes Updated and Necessary Statutory Evaluations the SUNSET rule will “wreak havoc on the Timely (SUNSET) – the HHS would require its administration of Medicaid, Medicare, the agencies to review all regulations every 10 years marketplaces, and other HHS programs,” to determine whether they’re still necessary. (Also an industry attorney who recently spoke see “Most Regs Would Get 10-Year Reviews Under with Medtech Insight said medical device HHS Proposal” - Medtech Insight, 5 Nov, 2020.) manufacturers could expect a lot of red tape to disappear because of the rule. (See sidebar story.) “Coupled with the ‘Good Guidance’ proposed rule, which targets HHS’ use of sub-regulatory guidance Schubel also says the rule isn’t needed because in administrating its programs, the SUNSET rule the HHS (and the agencies it oversees, including would make it harder for the Biden administration the Food and Drug Administration) already to effectively administer HHS programs and routinely reviews regulations. And implementing it respond to critical issues facing the nation,” Jessica would be pricey, she said. Schubel, a senior policy analyst for the Center on Budget and Policy Priorities, said in a blog post. “HHS estimates that it would have to assess over 2,400 rules in the first two years of “While the Biden administration could rescind implementation,” Schubel said. “The rule would the policy through new rulemaking, that would also be costly, with HHS estimating that the new take time and would also consume resources that review procedures would require 90 full-time staff, could be dedicated to more important priorities,” costing up to $26m over 10 years, to implement.”

11 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) 10 Predictions On How Health Policy Could Change Under A Biden Presidency

Executive Summary will use it now,” commented Julie Rovner, chief Health policy changes that President-elect Joe Washington correspondent, Kaiser Health News. Biden will likely make during his four-year term include Medicaid expansion and a greater reliance The Trump administration did make some use of on medical science, among others, experts say. the DPA, but some say the touch was too light. “The president-elect plans to invoke the [DPA] to dramatically scale up production of personal protective equipment,” said infectious diseases At a recent post-election webinar hosted by the physician Celine Grounder, a member of the Alliance for Health Policy, conservative and liberal president-elect’s task force, on 16 November. policy experts offered 10 predictions for how (Also see “Biden Will Invoke Defense Production health policy decisions – many of which would Act On ‘Day One’ To Ramp Up PPE Manufacture” - impact device manufacturers – will be handled by Medtech Insight, 16 Nov, 2020.) the incoming Biden administration. No. 3 Predictions made during the webinar ranged “On day one after the inauguration, Biden will put from future expansion of Medicaid programs, to us back into the World Health Organization, and greater trust of medical science and investigations the head of the WHO will be sipping diet Coke into minority health disparities, to greater use with the president,” Blendon said. of the Defense Production Act and telehealth to address the COVID-19 pandemic. US federal government cooperation and membership in the WHO is likely to foster Here are some notable quotes heard during the more sharing of data and health care resources 17 November webinar, and the individual experts between the US and foreign countries about the who made the health policy predictions: latest medtech technology and diagnostics used to fight global diseases. No. 1 “If you are president, you can expand Medicaid, No. 4 and you can do some health care demonstration “Black voters put Biden over the top to win [the programs under the Affordable Care Act that election]. …This administration coming in will react can accomplish that,” said Robert Blendon, dean to those who put them in office. With or without of policy, Harvard’s T.H. Chan School of Public Congress, Biden’s going to enter into oversight Health. investigations into racial health disparities,” Blendon said. Expansion of the Centers for Medicare and Medicaid Service’s Medicaid program would result Medtech manufacturers should expect to see in more medtech equipment being used and congressional and agency hearings focused on reimbursed by the CMS. disparate treatment of minorities, and most likely, policies that support equal treatment of people of No. 2 color. “The Trump administration has been slow to use the Defense Production Act to force more No. 5 manufacturing of COVID-19-needed resources, “Biden’s immediate change for the majority that and we are still short of PPE. Perhaps Biden elected him will be limiting the spread of the

12 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) coronavirus, and limiting damage to the economy Policy Strategies. caused by COVID-19,” according to Liz Hamel, VP and director of public policy for the Kaiser Family Under the Trump administration, CMS Foundation. administrator Seema Verma proposed Medicare price transparency regulations for hospitals and The new administration says it will work even insurers, requiring them to place their negotiated harder, and dedicate even more funding, to prices for their 500 most-common medical expand testing and contact tracing for COVID-19, procedures, advanced imaging scans and lab tests as well as production of personal protective online. The Biden administration will likely carry equipment and disbursement of funds for PPE to those rules out, the experts say. (Also see “CMS state and local authorities. Sets Insurers’ Deadlines To Comply With Final Health Care Price Transparency Rule” - Medtech No. 6 Insight, 29 Oct, 2020.) “One issue the public wants to see action on is ending surprise medical bills,” Hamel said. No. 9 “States are evaluating what they’d like to see done Directors of out-of-network providers, including in a Biden administration. Telehealth, for example. advanced imaging facilities and labs affiliated Some states are looking to telehealth as a way to with hospital emergency rooms, will have less get things done,” said Rachel Nuzum, VP of state opportunity to charge higher-than-average fees and federal policy at The Commonwealth Fund. to patients for their services. (Also see “HHS Conditions Hospital COVID-19 Relief Payments The CMS has issued regulations requiring more On No Surprise Billing” - Medtech Insight, 30 Jul, reimbursement for use of telehealth, even after 2020.) the COVID-19 pandemic. And during the Biden administration, state governments – especially No. 7 those with sparse populations and with large “If the GOP wins the Senate, you will see expanses of remote rural areas – are expected Republicans rally around a COVID-19/paycheck to support the movement toward greater use protection program, and get more money to the of telehealth to connect physicians in cities with states,” commented Clay Alspach, a principal at rural populations. (Also see “US CMS Should Leavitt Partners. Delay Adjustment In Pay For E/M Services Until COVID-19 Crisis Passes: Device Firms” - Medtech If Republicans gain control of the Senate after Insight, 9 Oct, 2020.) the outcome of two Georgia races in dispute are settled, they may become more cooperative with No. 10 House Democrats in crafting a new paycheck “Republicans and Democrats differ in their trust of protection program that will get more dollars to the medical sciences. So, you’re going to be going state governments to fight the COVID-19 crisis. from President Trump expressing skepticism (Also see “Trump Admin Accused Of Diverting about the impact of COVID-19, to President Biden COVID-19 Testing, PPE Funds To Defense creating an Oval Office surrounded by white- Purposes” - Medtech Insight, 21 Jul, 2020.) coated scientists,” Blendon said.

No. 8 Biden will be more likely to trust scientists “Joe Biden will evaluate each rule from the Trump and medical officers at the Food and Drug administration of its own. Regarding the CMS Administration, Centers for Disease Control and price transparency rule, Biden will find is hard Prevention, and the National Institutes of Health, to be against transparency,” remarked Chris the experts say. Jennings, president of consulting firm Jennings

13 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) Biden Signs COVID-19 Relief EO To Expand And Accelerate Testing, Fill PPE Shortages

Executive Summary COVID-19 Testing Plan, US House Says In ‘Failure Under an extensive COVID-19 plan and executive To Lead’ Report” - Medtech Insight, 11 Aug, 2020.) order signed on 21 January, the US president explained how he’ll beef up testing and Strategic Plan Calls For Expanding State Lab manufacturing of medtech to fight the virus. Capacity The EO was bolstered by Biden’s COVID-19 strategy plan, which would pump $50bn into lab-testing efforts in states and nationally, and On his second day in office, US President Joe included a pledge by the president to invoke the Biden signed an executive order and 200-page Defense Product Act to instruct all government strategy for rapidly expanding COVID-19 testing departments and agencies to fill COVID-19 supply and laboratory capacity. The EO also aims to spur shortfalls immediately. greater production by device makers of personal protective equipment such as masks, medtech The Biden plan includes seven overarching goals: equipment and supplies needed to battle the coronavirus. • Mitigating spread of the virus through expanding masking, testing, data, treatment, The president revealed in the EO that his overall workforce, and clear public-health standards; plan will include establishment of a COVID-19 Pandemic Testing Board led by former manager • Immediately expanding emergency relief and consultant Jeff Zients, that will identify barriers to exercising the Defense Production Act; access and use of testing and how to overcome them; increasing testing in at-risk settings, • Safely reopening schools, businesses and travel including correctional facilities, schools and while protecting workers; manufacturing facilities; and identifying options for the federal government to maximize testing • Restoring US leadership globally, and building capacity of commercial and academic labs. better preparedness for future threats;

The board will also coordinate federal government • Restoring the public’s trust in the government; efforts to promote COVID-19 diagnostic, screening and surveillance testing. • Mounting a safe and effective vaccination campaign; and “It is the policy of my administration to control the coronavirus disease 2019 (COVID-19) by using a • Protecting those most at risk by advancing Government-wide, unified approach,” Biden wrote equity in testing and treatments. in his 21 January executive order. “Beating this pandemic will be one of the most The Biden strategy contrasts sharply with former difficult operational challenges we have ever faced President Donald Trump’s approach, which was as a nation, but I believe we are ready,” Biden said slow to start, and left individual states and cities in a “Letter from the President” to Americans in to fend for themselves in rounding up enough his plan. COVID-19 tests, supplies and other coronavirus- fighting equipment to tackle the pandemic. (Also In announcing both his central coronavirus EO see “Trump Should Have Focused On National and strategy plan, Biden acknowledged that

14 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) the national effort he is pushing for will have essential role testing serves in America’s response to include “Congress providing the necessary to the pandemic. (See sidebar story.) funding,” and the federal government working with states, cities and private industry to increase “The need for testing will remain a core supply, and administer testing and vaccines. component of our nation’s response, and we look forward to working with President Biden and Industry Pledges Its Support To Expand Testing Congress … to extend the reach of testing and The plans to ramp up the nation’s coronavirus leveraging quality tests,” they wrote. testing efforts were applauded by industry, including AdvaMed CEO Scott Whitaker and Van Meter added that AdvaMedDx members AdvaMedDx executive director Susan Van Meter, are shipping roughly 11 million new molecular who issued a joint statement on 22 January COVID-19 tests every week to states where they’re saying they welcomed Biden’s recognition of the needed most.

15 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) AdvaMed: Medtech Industry Wants Seat At Biden’s Coronavirus Response Table

Executive Summary the group was worried that the government could The largest medical device lobby group in the potentially overreach its authority and end up US says it’s open to the administration’s decision taking control of manufacturing capabilities, to to invoke the Defense Production Act to boost the detriment of industry. (Also see “AdvaMed testing and PPE production, but wants to be CEO Says Some Top Agenda Items For the Year consulted on how to implement it. Are ‘Taking A Back Seat’ To Address COVID-19” - Medtech Insight, 17 Apr, 2020.)

Since then, however, AdvaMed seems to have US President Joe Biden has invoked the Defense relaxed its position, as its fears have not come Production Act to ramp up COVID-19 tests and to fruition. Now the group is much more open personal protective equipment (PPE). While to the idea of using the act to help manage the AdvaMed has raised concerns about invoking the pandemic but wants to be a player at the table DPA in the past, the industry group says it’s open as the administration uses its executive powers to it as long as it’s consulted by the White House to implement the DPA. (Also see “Industry Lobby on the best way to use the act. Group Supports Use Of DPA To Ramp Up PPE Production” - Medtech Insight, 17 Jul, 2020.) In a 22 January letter to Biden, AdvaMed CEO Scott Whitaker asked that the device industry be A key component of Biden’s plan is to establish included in the administration’s decision-making a National Testing Board that will help guide the process to use the DPA to increase production administration’s plans to ramp up and implement and distribution of COVID-19 diagnostic tests testing, something Whitaker notes was proposed and PPE. He argues that the industry has first- by AdvaMed at the start of the pandemic. hand experience with the DPA under the Trump administration and due to the breadth of products “Last spring we established a national testing it manufactures that are critical in the battle registry – the AdvaMed COVID Testing Supply against the coronavirus, it should be consulted on Registry – and called for closing coverage gaps how to implement the act. in COVID-19 testing, and recommended the establishment of a public-private National Testing “We have learned that some of the most pressing Board to leverage the real-time data collected by supply-chain challenges throughout the pandemic the registry to ensure tests were being sent where were less about overall capacity and more about they were needed most,” Whitaker wrote. allocation, distribution and ‘last mile’ road blocks,” Whitaker wrote. “Whether it is providing enough He went on: “We believed then and continue to PPE, administering tests to all who need them, or believe today that a public-private board – chaired getting vaccines into Americans’ arms, it is critical by a National Coordinator for Diagnostic Testing that we work together to understand the true and comprised of leaders from the private sector picture of demand and the various obstacles to (diagnostics manufacturers, hospitals and health delivering these products to those who need them systems, public health laboratories, distributors, the most.” clinical labs, and retail pharmacies), HHS agencies, and FEMA – would provide critical help overseeing The tone of the letter contrasts with how implementation of a national testing plan AdvaMed initially was concerned when the Trump informed by a private-public registry/dashboard administration first invoked the DPA. At the time modeled after the AdvaMed Registry.”

16 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) HHS is the Department of Health and Human prove counterproductive,” he wrote. “That’s Services, and FEMA is the Federal Emergency why successful implementation of the Defense Management Agency. Production Act has always started with early, open communication and coordination between the Whitaker argues that defeating COVID-19 isn’t companies themselves and our federal partners. something the medtech industry or the federal government can do alone. Instead, as with past “We encourage the administration to work directly experience, he says it’s important for them to with AdvaMed as the primary convener for this partner up. global industry, but even more importantly, we encourage them to communicate and coordinate “We are deeply familiar with what works, what directly with the medical technology companies in doesn’t, and which actions would ultimately question before any invocation of the DPA.”

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17 / February 2021 © Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)