Mar 6, 2017
Washington Healthcare Update
This Week: Congress returned from recess…Preparing for ACA repeal and replacement…President addresses a joint session of Congress.
Heath Reform Takeaways
- House Energy and Commerce Committee prepares for a markup this
week—although nothing has been announced officially.
- Another senator questions repealing Medicaid expansion.
3. State Activities
4. Regulations Open for Comment
House Energy and Commerce Committee Reviews Bill to Incentivize Generic Drug Development
On March 2, the House Energy and Commerce Committee
the “Lower Drug Costs through Competition Act,” a bill aimed at
incentivizing generic development. The bill, sponsored by Reps. Kurt
Schrader (D-OR) and Gus Bilirakis (R-FL), aims to tackle drug pricing by
increasing generic drug availability through the creation of a new generic
priority review voucher.
During the hearing, FDA drug center chief Janet Woodcock told congressmen
that more than 180 off-patent drugs are currently without generic
competition. She did caution, however, that the review times mandated by
the bill—H.R. 749—could be impossible for the FDA to meet. Stakeholders
also criticized the bill for mandating a study on the abuses of the Risk
Evaluation and Mitigation Strategies (REMS) system, which they say could
discourage more sweeping reforms of the system.
Woodcock also cautioned at the hearing that there are a number of drugs for
which a generic is the sole source, because the brand drug has been
withdrawn from the market. “There may well be other generics that are sole
source where the innovator has withdrawn. Because right now there are 546
drugs where the brand name has withdrawn from the market and some of those
may only have one generic,” Woodcock said.
Energy & Commerce Committee Chairman Greg Walden (R-OR) praised the
bill at the hearing, which he previously tried to push through without a
Theatrics Highlight Lack of Transparency Regarding ACA Bill
On March 2, Sen. Rand Paul (R-KY) demanded to be shown the House GOP’s
updated draft bill to repeal and replace parts of the Affordable Care Act.
Paul criticized the earlier leaked draft because of its inclusion of
refundable tax credits. House Energy & Commerce ranking Democrat Frank
Pallone (NJ) also tried to find the updated draft and slammed the GOP for
lack of transparency, but House Energy and Commerce Committee Chair Greg
Walden (R-OR) said committee Republicans and staff were continuing to
refine the draft and it wasn’t ready to be distributed.
While standing outside a room where the bill allegedly was being kept, Paul
held an impromptu press conference in which he slammed House Republicans
for not letting him see the updated draft and said he would continue
pressing to see it. He also expressed frustration about the prospect of the
Senate having to accept the House version.
Pallone also attempted to find the bill at a room in the Capitol and then
went to Walden’s office looking for it. He complained about the lack of
transparency while searching for the bill and stressed that Democrats gave
Republicans 30 days to review the Affordable Care Act while it was under
Rep. Paul Tonko (D-NY) also attempted to enter the room where the draft
bill reportedly was housed and was told the bill was not in there. He said
a markup is expected to be held March 8 where the bill would be read, but
said there has been no official notice. Tonko specifically stressed that he
wanted to see the Medicaid reform portion of the bill.
Walden issued a statement saying the process wasn’t irregular. “Reports
that the Energy and Commerce Committee is doing anything other than the
regular process of keeping its members up to speed on latest developments
in its jurisdictions are false,” Walden said.
“We are continuing to work on drafting and refining legislative language to
provide relief from a failing law. Part of that process is giving committee
members and staff the opportunity to work closely together to draft a bill
that reflects the concerns of our constituents and reflects our mandate
from voters to repeal and replace Obamacare. Simply put, Energy and
Commerce majority members and staff are continuing to discuss and refine
draft legislative language on issues under our committee’s jurisdiction,”
Senate Finance Committee Approves Verma’s Nomination for CMS Administrator
On March 2, the Senate Finance Committee advanced Seema Verma’s nomination
to lead CMS in a 13-12 vote along party lines.
Verma will play a key role in shaping Republicans’ Obamacare replacement
plan and overhauling Medicaid. Verma has worked with several Republican
governors to adopt conservative reforms in their Medicaid programs,
including cost-sharing and work incentives.
The committee originally convened on March 1 to vote on the nomination but
had delayed a final vote because there weren’t enough Republicans present.
Verma is expected to be confirmed on the Senate floor.
question and answer document from the Senate
Finance Committee, CMS Administrator-nominee Seema Verma deferred to
Congress on a vast majority of questions from members.
Verma gave longer answers to questions about Medicaid waivers compared to
most of her other responses to Senate Finance Committee members’ questions,
and she emphasized giving states the flexibility to alter their programs
more than she emphasized giving state residents the opportunity to weigh in
on those changes.
House Republicans’ designs for a Medicaid financing overhaul do not sit
well with some Senate Republicans because they do not want their states to
lose the high federal match rate for residents who are covered under
Medicaid expansions, and some Republican governors in states that expanded
Medicaid also are apprehensive about capping federal funding of their
Nevada expanded Medicaid, and Sen. Dean Heller (R-NV) asked written
questions of CMS Administrator-nominee Seema Verma about the prospect of
capping Medicaid funding, Nevadans losing exchange-plan subsidies and women
losing birth control and preventive services. Verma’s written response
states that she is open to block grants, per-beneficiary caps and “other
innovative ideas,” but she said Medicaid reform is up to Congress and that
CMS would merely offer technical assistance.
Verma helped several states obtain Medicaid waivers, and throughout her
responses to the many questions about Medicaid waivers and financing
reforms she stressed that innovation starts locally.
Verma said making the process of getting waivers transparent and consistent
would be one of her top priorities. Most Republicans, including Sen. John
Cornyn (R-TX) asked how Verma plans to make it easier for states to secure
waivers. Cornyn said some states have been operating under waivers for
decades and that one-third of Medicaid spending goes to Medicaid programs
operating under waivers.
Democrats were more concerned about public transparency and enabling input
from beneficiaries. Sen. Ron Wyden (OR), the ranking Finance Committee
Democrat, asked Verma if she supports making states disclose waiver
requests prior to submitting them to CMS and requiring that states respond
to public input. Verma said stakeholders must have a chance to provide
input, but she said states should not be mired in paperwork.
Republican Senators Concerned About Medicaid Expansion Repeal
Sen. Shelley Moore Capito (R-WV) is the latest Republican senator to
express strong resistance to repealing Obamacare’s Medicaid expansion,
putting repeal of the provision in serious doubt.
As of now, the House legislation would repeal the Medicaid expansion. But
Capito, whose home state of West Virginia expanded Medicaid, is just the
latest Republican senator to express concern with repealing it.
Sen. Lisa Murkowski (R-AK) said recently that she would not vote to
eliminate the expansion if her legislature wants it kept in place. Sen.
Susan Collins (R-ME) has expressed the same concerns. Republicans can only
afford to lose two votes to pass a bill through reconciliation in the
Insurers Write CMS to Express Support for Medicare Advantage Program
The largest insurance companies in the country are worried about the future
of the Medicare Advantage program. There are currently 19.6 million private
Medicare enrollees—nearly twice the number of individuals who signed up for
coverage through Obamacare exchange markets for this year. That translates
to roughly $200 billion in annual revenue for insurers.
Those figures have been on an upward spiral for some time. The number of
private Medicare customers increased by 7.6 percent over the last year and
has more than doubled during the past decade.
On Feb. 28, a letter expressing support for the program sent to acting CMS
Administrator Patrick Conway garnered more than 200 signatures from members
of both political parties and across the ideological spectrum.
This year’s proposed payment rule was released at the beginning of February
and it included no significant changes. However, insurers still see a cause
for concern in the rule, which is that payment levels aren’t keeping up
with expected cost increases. Thus the industry is pushing for
changes when the final payment notice is released at the beginning of
Many health plans would like to fix a problem in the cap on Medicare
Advantage payments. Under current rules, plans that qualify for quality
bonus payments under the star rating system don’t always get all of the
money that they are entitled to. This is because bonus payments are counted
against the payment cap.
For Humana alone, the cap cost $200 million in bonus payments last year.
But many smaller plans are affected financially too. Insurers stress that
beneficiaries are the ones getting shortchanged; the bonus payments cover
the cost of additional benefits insurers add to enhance the quality of
their MA plans, such as dental and vision coverage, which not all policies
Health plans are also seeking to unlink performance audits, which track
access to medical care and contract compliance, from quality star ratings.
Both Cigna and Humana have seen major downgrades in their star ratings for
this year stemming from problems uncovered through audits. Insurers argue
that plans are being penalized twice and that the issues uncovered through
audits do not necessarily affect quality.
Another area of concern for insurers is the use of “encounter data”—paid
claims data—used in the funding formula to determine how much insurers are
paid per beneficiary. They argue that the data does not provide an accurate
assessment of their enrollees’ medical needs and results in lower payments.
HRSA Delays Implementation of 340B Rule
The Health Resources and Services Administration (HRSA) delayed
implementation of the 340B ceiling price and manufacturer civil monetary
penalties rule until March 21, in line with the regulatory freeze President
Donald Trump implemented shortly after taking office. The regulation was
originally set to go into effect on March 6.
The rule deals with setting prices under the 340B drug discount program. It
finalized the so-called “penny-pricing policy” that drug makers oppose and
laid out a formula for drug manufacturers to use when estimating the 340B
price of new drugs.
“The temporary delay in the effective date of this final rule is necessary
to give Department officials the opportunity for further review and
consideration of new regulations, consistent with the Assistant to the
President and Chief of Staff’s memorandum,” the Federal Register notice
The notice also says that although the rule will be effective March 21,
“HHS recognizes that the effective date falls in the middle of a quarter.
As such, HHS plans to begin enforcing the requirements of this final rule
at the start of the next quarter, which begins April 1, 2017.”
The White House’s regulatory freeze put a 60-day hold on regulations that
had been finished but not implemented when Trump took office. CMS also
delayed the cardiac care bundle rule until March 21.
U.S. and EU Finalize Agreement on Pharmaceutical Inspections
On March 2, the United States and the European Union finalized an agreement
to recognize each other’s pharmaceutical good manufacturing practices
inspections—a move FDA officials say will let the agency focus its limited
foreign inspection resources on areas like China and India where drug
manufacturing has greatly increased. The effort—known as the Mutual
Reliance Initiative (MRI)—was launched in May 2014 to increase FDA’s
collaboration with Europe on drug quality efforts.
FDA said the agreement will help prevent duplication of drug inspections,
lower inspection costs and “enable regulators to devote more resources to
other parts of the world where they may be a greater risk.”
The document, “Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices
(GMPs),” explains that a joint sectoral committee will be set up to monitor
activities performed under the annex. The committee will be charged with
developing and updating a list of recognized authorities, providing a forum
to discuss issues related to the annex, considering the status and taking
decisions on inclusions products listed in the annex, and adopting
appropriate complementary technical and administrative arrangement to
effectively implement the annex.
“The Committee shall be co-chaired by a representative of the FDA for the
United States and a representative of the EU who each shall have one vote
in the Joint Sectoral Committee. The Joint Sectoral Committee shall make
its decision by unanimous consent. The Joint Sectoral Committee shall
determine its own rules and procedures,” the document says.
The annex also says that all parties should maintain an alert system so
that other parties can be made aware of defects, recalls, counterfeit or
falsified products, or shortages and other quality or non-compliance
For a related press release,
FDA Report Shows Generic Drug Approvals at Record High
According to a new FDA report out Feb. 24, generic drug approvals are at a
record high. More than 800 generic drugs were approved in 2016, up from 726
the previous year. Seventy-three of those approvals were the first generic
version of a drug to reach the U.S. market. First-time generics, in
particular, help reduce the cost of high-priced branded drugs, FDA’s
generic drug office head Kathleen Uhl wrote in an accompanying blog post.
Although 2016 was a productive year for the FDA, it was not the agency’s
most prolific with regard to first-time generic approvals—FDA signed off on
90 first generics in 2015, 17 more than in 2016.
To see the report,
Rare Disease Group Issues Statement on President Trump’s Address to
The country’s main advocacy group representing rare disease patients
contradicted President Donald Trump’s claim in his State of the Union
address that a “slow and burdensome” FDA approval process is slowing down
“We agree that FDA review processes can be improved upon to expedite the
development and review of orphan drugs,” the National Organization for Rare
Disorders (NORD) said in a
March 1 statement. “Yet we disagree with the President that restraints must be slashed, or
that the approval process at the FDA is preventing advances from reaching
those in need.”
NORD cautioned against Trump’s calls for loosening FDA requirements,
warning that lower safety and efficacy standards will just threaten the
population with unsafe, ineffective therapies.
NORD added that FDA already shows “an incredible amount of flexibility” in
approving treatments for rare diseases. Between 2008 and 2013, 87 percent
of applications for rare disease treatments received an expedited FDA
review compared to only 35 percent of treatments for common diseases.
The group also emphasized that fully staffing and funding the FDA would
allow the agency to get drugs to patients faster. It is still unclear how
Trump’s executive order calling for a hiring freeze will affect the agency,
which has hundreds of vacant positions. Trump’s budget proposal would also
require substantial cuts to most domestic programs like FDA.
3. State Activities
Arkansas: Arkansas House Approves Bill to Freeze Enrollment in Medicaid Expansion
The Arkansas House has approved legislation that would freeze enrollment in
the state’s Medicaid expansion program. Under
the bill, Arkansas would not approve any new enrollment after July 1. However, it
is not likely to become law because Gov. Asa Hutchinson opposes it.
Enrollment in Arkansas’s Medicaid expansion has gone beyond initial
estimates, causing concerns from Arkansas Republicans that the state
will not be able to cover its share of costs starting this year.
Florida: Safety Net Hospitals Ask for Increase in Supplemental Medicaid Money
Florida’s safety net hospitals are pushing for a $1 billion increase in
supplemental Medicaid money the state receives from the federal government
to cover the health care costs of low-income and uninsured residents. Tony
Carvalho, president of the Safety Net Hospital Alliance of Florida,
recently said that Florida should receive at minimum $1.6 billion in
supplemental payments, known as low income pool (LIP) funding, up from the
$608 million that Florida now receives. The association met with the
Florida congressional delegation earlier this week to express their support
as the state negotiates a new Medicaid 1115 waiver with the Trump
administration. The current waiver, which includes LIP funding, expires
Montana: Bill to Make “Death With Dignity” Practice Illegal Dies in the House
A bill that would have made it illegal for terminally ill patients to
obtain life-ending medication from a physician didn’t clear final passage
in the Montana House. The legislation said the “death with dignity”
practice goes against public policy, and physicians who help terminally ill
patients end their lives with medication wouldn’t have been protected from
homicide charges. The Montana Supreme Court ruled in 2009 that allowing
terminally ill patients to receive life-ending medications was not against
public policy and it protected physicians from prosecution.
New Jersey: Gov. Christie Wants Health Insurer to Help Pay for Drug Addiction Reform Plan
New Jersey Gov. Chris Christie made an odd request during his annual budget
address last week: singling out Horizon Blue Cross Blue Shield of New
Jersey, Christie attempted to pressure the state’s largest insurer into
establishing a “permanent fund” from its surplus to support health care for
the state’s poorest residents. The governor did not specify a funding
amount. However, he said the fund, which he wants set up by June 30, could
help pay for his drug addiction reform plan, including inpatient and
outpatient rehab for both uninsured residents and low-income Medicaid
North Carolina: Gov. Cooper Includes Medicaid Expansion Funding in
North Carolina Gov. Roy Cooper’s first budget plan includes Medicaid
expansion funding, although Republicans who control the state Legislature
are unlikely to support the proposal. One of Cooper’s first actions as
governor was to try to expand Medicaid, but statehouse Republicans sued the
Democratic governor to block it. Federal officials agreed to not act on
Cooper’s request for roughly another two months.
4. Regulations Open for Comment
CMS Proposes Rule for Prosthetics and Orthotics Suppliers
On Jan. 11, CMS issued a proposed rule that would implement statutory
requirements and specify: the qualifications needed for practitioners to
furnish and fabricate prosthetics and custom-fabricated orthotics, and for
qualified suppliers to fabricate prosthetics and custom-fabricated
orthotics; accreditation requirements that qualified suppliers must meet in
order to bill for prosthetics and custom‑fabricated orthotics; requirements
that an organization must meet in order to accredit qualified suppliers to
bill for prosthetics and custom-fabricated orthotics; and a timeframe by
which qualified practitioners and qualified suppliers must meet the
applicable licensure, certification and accreditation requirements. This
rule would also remove the exemption from quality standards and
accreditation that is currently in place in accordance with Section
1834(a)(20) of the Act for certain practitioners and suppliers who furnish
or fabricate prosthetics and custom‑fabricated orthotics. In addition, this
rule also includes authority for the Centers for Medicare & Medicaid
Services (CMS) to revoke the Medicare enrollment of Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) suppliers that submit claims for items that do
not meet the requirements of the statute and this proposed rule.
Only qualified practitioners who furnish or fabricate prosthetics and
custom‑fabricated orthotics and qualified suppliers that fabricate or bill
for prosthetics and custom‑fabricated orthotics would be subject to these
CMS will accept comments on the proposed rule until March 13, 2017, and
will respond to comments in a final rule.
To see the proposed rule,
FDA Releases Draft Guidance for Interchangeable Biosimilars
On Jan. 17, FDA outlined the criteria companies must meet to get a copycat
biologic deemed interchangeable with its branded counterpart, a
certification that paves the way for the cheaper products to be
automatically substituted at the pharmacy level under state laws.
To get this designation, a biosimilar sponsor must show that its product
can be expected to produce the same clinical result as the branded biologic
in any given patient, for all of the drug’s approved uses, and that there
are no risks if a patient is switched back and forth between the
interchangeable biosimilar and the branded biologic,
per draft guidance
released by FDA.
Interchangeable biosimilars are expected to offer greater savings to the
health system than biosimilars that lack this designation. Without the
interchangeability designation a doctor must proactively write a
prescription for the biosimilar.
The guidance outlines the types of studies and scientific data that
companies will need to submit to FDA to get an interchangeable designation.
When companies seek that designation, FDA recommends they seek approval for
all of the branded biologic approved uses.
FDA is requesting comments on the draft guidance as well as a number of
questions outlined in a
Federal Register notice. FDA wants to know how it should regulate manufacturing changes of
interchangeable products that occur after approval. The agency also wants
to know how it should handle interchangeable designations if a branded
biologic gets another use approved for the drug, after the interchangeable
biosimilar is cleared by FDA.
FDA Releases Draft Guidance on Off-Label Drug Communication
On Jan. 17, FDA
issued draft guidance
that gives drug and device companies more flexibility to communicate
off-label information about their products and avoid charges of
misbranding. The new policy allows companies to promote a drug or device
with information not on the agency-approved label as long as that
information is truthful and non-misleading and is consistent with
Companies have asked FDA for clarity on marketing policies after a 2012
U.S. Court of Appeals decision ruled that under the First Amendment the
government could not prohibit and criminalize the truthful off-label
promotion of FDA-approved drugs.
The guidance outlines how FDA will determine whether a company's
communication is consistent with FDA's required labeling. For example,
companies will not be permitted to communicate information about the drug
or device related to a use that has not yet been approved by FDA. They also
can't promote a patient population for the drug or device that has not been
cleared by the agency.
The agency offers some examples of information companies could communicate
that could be consistent with its FDA-required labels. For example, FDA
said companies can promote testimony of patients who used the drug for its
FDA-approved uses, such as the product's effect on patients' daily
activities. Companies could also communicate long-term safety and efficacy
information about products that were approved for chronic use based on a
six-month trial, if the company now has data on the drug lasting a couple
of years, FDA added.
The guidance also outlines the type of scientific data companies need to
support their off-label claims. Comments on the draft are due in 60 days.
CMS Proposes Average 0.25 Percent Hike for Medicare Advantage Plans
On Feb. 1, the Trump administration issued guidance that proposes updates
to the methodologies used to pay Medicare Advantage plans and Part D
sponsors. The guidance calls for raising Medicare Advantage payments an
average of 0.25 percent.
Health plans take in roughly $200 billion a year from the government to
provide care for seniors enrolled in private Medicare plans. There are
currently more than 18 million people enrolled in Medicare Advantage,
accounting for roughly a third of all of the program's beneficiaries. More
than 1 million seniors have been added to private Medicare plans in the
past year, continuing a trend of robust growth that goes back a decade.
"These proposals will continue to keep Medicare Advantage strong and stable
and provide high quality, affordable care to seniors and people living with
disabilities," said Patrick Conway, acting administrator of the Centers for
Medicare and Medicaid Services.
Obamacare included major cuts to Medicare Advantage—America's Health
Insurance Plans puts the total figure at $200 billion—that were designed to
bring payments more in line with traditional government-run Medicare. Last
year, the federal government paid private plans an average of 102 percent
of traditional fee-for-service costs per member.
UnitedHealth Group and Humana are the biggest national players, accounting
for roughly 40 percent of the Medicare Advantage market in 2015.
CMS will accept comments until March 3 and the final notice will be posted
on April 3.
To read a fact sheet on the rate proposal,
CMS Announces RFI for Input on Improving Pediatric Care
CMS announced Feb. 27 a Request for Information (RFI) seeking input on
approaches to improve pediatric care, specifically to improve the quality
and reduce the cost of care for children and youth enrolled in Medicaid and
the Children’s Health Insurance Program (CHIP). CMS is also exploring
concepts that encourage pediatric providers to collaborate with
health-related social service providers at the state, tribal and local
levels and share accountability for health outcomes for children and youth
enrolled in Medicaid and CHIP.
CMS is asking stakeholders to submit comments via email to
by 11:59 p.m. on March 28, 2017.
For more information about the RFI, visit the
CMS Innovation Center website.
Express Scripts Report Finds Drug Spending in Obamacare Markets
Outpaced Employer Plans
According to a
new report, drug spending growth in Obamacare’s health insurance marketplaces greatly
outpaced employer plans Medicare and Medicaid last year.
Drug spending in the exchanges rose 14 percent in 2016 after accounting for
rebates and discounts provided by drug companies, according to new data
released by Express Scripts on Feb. 28. That increase was mostly due to a
7.8 percent increase in drug costs, while utilization rose 6.2 percent, the
country’s largest pharmacy benefits manager said.
By comparison, there was just a 5.5 percent increase in per-member drug
spending in Medicaid, a 4.1 percent increase in Medicare and a 3.8 percent
increase in employer plans. Medicare last year spent about three times more
per patient for drugs than any other health program, or nearly $3,700 per
Seniors enrolled in private Medicare plans had lower drug spending on
average than those enrolled in the prescription drug program. The average
Medicare Advantage patient spent just over $2,600 on drugs, while Part D
plan members spent more than double that, or nearly $5,500.
Express Scripts argues Medicare’s protected classes of drugs, which require
health plans to cover all medicines for certain diseases like cancer and
HIV, make it difficult for insurers to drive down costs. For example, they
say cancer drugs for Medicare beneficiaries cost on average $875 more per
prescription than those for commercial health plans.
GAO Finds Drug Companies Need More Guidance for Developing Antibiotics
released a report
finding that drug companies need more information on how to use incentives
to develop new antibiotics. Each year, more than 2 million Americans get
sick from bacterial infections that are resistant to antibiotics, and at
least 23,000 die as a result. There has also been a steady decline in the
development of new antibiotics since the 1980s—raising concerns that there
may not be enough new antibiotics to replace those that have become
In response, FDA has encouraged drug companies to develop new antibiotics,
through incentives such as expediting its review of these drug
applications. However, GAO found that FDA needs to clarify the role of
draft guidance and develop qualified infectious disease product guidance,
and recommended that the agency provide it.
GAO Recommends Improvements to Information Exchange in Post-Acute Care
In a new report, GAO recommended that HHS comprehensively plan its efforts
to increase the electronic exchange of health information in post-acute
care settings, and evaluate these efforts.
Many patients who leave hospitals receive continuing care from places like
rehab facilities (called post-acute care settings). When patients leave the
hospitals and move to post-acute care settings, electronic health records
can help providers know what the patient needs and better coordinate care.
However, GAO found that issues like increased costs and a lack of access to
technology deter the use of electronic health records in these settings.
To see the report,
GAO Recommends Actions to Ensure VHA Facilities Follow Inspection
new testimony, GAO recounts how it found that some Veterans Health Administration (VHA)
facilities did not conduct all monthly inspections or follow all required
inspection procedures. GAO recommended in its report (on which this
testimony is based) that VHA ensure that its inspection programs are in
line with its policy, and establish procedures to prevent missed
VHA requires that each of its medical facilities have an inspection program
to monitor how staff dispenses controlled substances. Inspectors check, for
example, that opioids that are dispensed from machines have a valid
doctor’s order and are administered to patients.
If you have any questions, contact the following individuals at
Kennan, Senior Vice President
Charlie Iovino, Vice
Caroline Perrin, Research Assistant
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