US Administration and Medtech Industry: A US Focus - Pharma Intelligence
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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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