An America-First Healthcare Plan, 62179-62186 [2020-21914]
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62179
Presidential Documents
Federal Register
Vol. 85, No. 191
Thursday, October 1, 2020
Title 3—
Executive Order 13951 of September 24, 2020
The President
An America-First Healthcare Plan
By the authority vested in me as President by the Constitution and the
laws of the United States of America, it is hereby ordered as follows:
Section 1. Purpose. Since January 20, 2017, my Administration has been
committed to the goal of bringing great healthcare to the American people
and putting patients first. To that end, my Administration has taken monumental steps to improve the efficiency and quality of healthcare in the
United States.
(a) My Administration has been committed to restoring choice and control
to the American patient.
On December 22, 2017, I signed into law the repeal of the burdensome
individual-mandate penalty, liberating millions of low-income Americans
from a tax that penalized them for not purchasing health-insurance coverage
they did not want or could not afford. Through Executive Order 13813
of October 12, 2017 (Promoting Healthcare Choice and Competition Across
the United States), my Administration has expanded coverage options for
millions of Americans in several ways. My Administration increased the
availability of renewable short-term, limited-duration healthcare plans, providing options that are up to 60 percent cheaper than the least expensive
alternatives under the Patient Protection and Affordable Care Act (ACA)
and are projected to cover 500,000 individuals who would otherwise be
uninsured. My Administration expanded health reimbursement arrangements,
which have been projected by the Department of the Treasury to reach
800,000 businesses and over 11 million employees and to expand coverage
to more than 800,000 individuals who would otherwise be uninsured. My
Administration also issued a rule to increase the availability of association
health plans for small businesses, which, upon implementation of the rule,
are projected to cover up to 400,000 previously uninsured individuals for
on average 30 percent less cost.
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As set forth in the Economic Report of the President (February 2020), my
Administration’s expansion of health savings accounts will further help
millions of Americans pay for health expenditures by allowing them to
save more of their own money free from Federal taxation, and will especially
help Americans with chronic conditions who now have more flexibility
to enroll in plans that fit their complicated care needs and can be paired
with a tax-advantaged account.
At the beginning of the current COVID–19 pandemic, my Administration
acted to dramatically increase the accessibility and availability of telehealth
services for Medicare beneficiaries, enabling millions of individuals to use
these services. Pursuant to Executive Order 13941 of August 3, 2020 (Improving Rural Health and Telehealth Access), the Secretary of Health and Human
Services will make permanent many of the new policies that improve the
accessibility and availability of telehealth services. In addition, pursuant
to that order, the Secretary of Health and Human Services and the Secretary
of Agriculture will develop and implement a strategy to improve the physical
and communications healthcare infrastructure available to rural Americans.
Through our State Relief and Empowerment Waivers, my Administration
has given States additional health-insurance flexibility, which has expanded
health-insurance coverage options for consumers and lowered costs for patients. These waivers allow States to move away from the ACA’s rigid
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structure and are estimated to have lowered premiums by approximately
11 percent in Wisconsin, 20 percent in Minnesota, and 43 percent in Maryland. Due to actions my Administration took, like the State Relief and
Empowerment Waivers, after years of dwindling choices and escalating
prices, plan options for consumers increased and for 2019, for the first
time ever, benchmark premiums actually decreased on Healthcare.gov. For
2020, the average benchmark premium dropped by nearly 4 percent.
After the prior Administration spent tens of billions of dollars creating
electronic health records systems unable to accurately or effectively record
and communicate patient data, my Administration has paved the way for
a new wave of innovation to allow patients to safely send their own medical
records to care providers of their choosing. My Patients over Paperwork
initiative has cut red tape for doctors and nurses so they can spend more
time with their patients, which the Centers for Medicare and Medicaid
Services (CMS) within the Department of Health and Human Services (HHS)
has estimated to save over 40 million hours of wasted time for providers
and suppliers between 2017 and 2021.
(b) My Administration has been ceaseless in its efforts to lower costs
to make healthcare more affordable for American patients.
Under my tenure, prescription drugs saw their largest annual price decrease
in nearly half a century. For three consecutive years, we have approved
a record number of generic drugs. The Council of Economic Advisers has
estimated that these approvals saved patients $26 billion in the first 18
months of my Administration alone. As part of the Further Consolidated
Appropriations Act, 2020, I signed into law the Creating and Restoring
Equal Access to Equivalent Samples Act, which will pave the way for
even more generic drugs and is projected to save taxpayers $3.3 billion
from 2019 to 2029.
CMS has acted to offer Medicare beneficiaries prescription drug plans with
the option of insulin capped at $35 in out-of-pocket expenses for a 30day supply. We are also reducing Government payments to overcharging
hospitals participating in the 340B Drug Pricing Program by instead paying
rates that more accurately reflect the hospitals’ acquisition costs, which
CMS estimated would save Medicare beneficiaries $320 million on copayments for drugs alone.
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As a result of Executive Order 13937 of July 24, 2020 (Access to Affordable
Life-Saving Medications), low-income Americans who receive care from a
federally qualified health center will have access to insulin and injectable
epinephrine at prices lower than ever before. Under Executive Order 13938
of July 24, 2020 (Increasing Drug Importation to Lower Prices for American
Patients), my Administration will be the first to complete a rulemaking
to authorize the safe importation of certain lower-cost prescription drugs
from Canada. Pursuant to Executive Order 13939 of July 24, 2020 (Lowering
Prices for Patients by Eliminating Kickbacks to Middlemen), my Administration is taking action to eliminate wasteful payments to middlemen by passing
drug discounts through to patients at the pharmacy counter without increasing premiums for beneficiaries or cost to Federal taxpayers. And my Administration is taking action to ensure that Medicare patients receive the lowest
price that drug companies offer comparable foreign nations through Executive
Order 13948 of September 13, 2020 (Lowering Drug Prices by Putting America
First).
As part of the Further Consolidated Appropriations Act, 2020, I also signed
into law the repeal of the medical device tax, the annual fee on healthinsurance providers, and the ‘‘Cadillac’’ tax on certain employer-sponsored
health insurance, which threatened to dramatically increase the cost of
healthcare for working families.
My Administration is transforming the black-box hospital and insurance
pricing systems to be transparent about price and quality. Regardless of
health-insurance coverage, two-thirds of adults in America still worry about
the threat of unexpected medical bills. This fear is the result of a system
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under which individuals and employers are unable to see how insurance
companies, pharmacy benefit managers, insurance brokers, and providers
are or will be paid. One major culprit is the practice of ‘‘surprise billing,’’
in which a patient receives unexpected bills at highly inflated prices from
providers who are not part of the patient’s insurance network, even if
the patient was treated at a hospital that was part of the patient’s network.
Patients can receive these bills despite having no opportunity to select
around an out-of-network provider in advance.
On May 9, 2019, I announced four principles to guide congressional efforts
to prohibit exorbitant bills resulting from patients’ accidentally or unknowingly receiving services from out-of-network physicians. Unfortunately, the
Congress has failed to act, and patients remain vulnerable to surprise billing.
In the absence of congressional action, my Administration has already taken
strong and decisive action to make healthcare prices more transparent. On
June 24, 2019, I signed Executive Order 13877 (Improving Price and Quality
Transparency in American Healthcare to Put Patients First), directing certain
agencies—for the first time ever—to make sure patients have access to meaningful price and quality information prior to the delivery of care. Beginning
January 1, 2021, hospitals will be required to publish their real price for
every service, and publicly display in a consumer-friendly, easy-to-understand format the prices of at least 300 different common services that are
able to be shopped for in advance.
We have also taken some concrete steps to eliminate surprise out-of-network
bills. For example, on April 10, 2020, my Administration required providers
to certify, as a condition of receiving supplemental COVID–19 funding,
that they would not seek to collect out-of-pocket expenses from a patient
for treatment related to COVID–19 in an amount greater than what the
patient would have otherwise been required to pay for care by an innetwork provider. These initiatives have made important progress, although
additional efforts are necessary.
Not all hospitals allow for surprise bills. But many do. Unfortunately, surprise
billing has become sufficiently pervasive that the fear of receiving a surprise
bill may dissuade patients from seeking appropriate care. And research
suggests a correlation between hospitals that frequently allow surprise billing
and increases in hospital admissions and imaging procedures, putting patients at risk of receiving unnecessary services, which can lead to physical
harm and threatens the long-term financial sustainability of Medicare.
Efforts to limit surprise billing and increase the number of providers participating in the same insurance network as the hospital in which they work
would correspondingly streamline the ability of patients to receive care
and reduce time spent on billing disputes.
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On May 15, 2020, HHS released the Health Quality Roadmap to empower
patients to make fully informed decisions about their healthcare by facilitating the availability of appropriate and meaningful price and quality information. These transformative actions will arm patients with the tools to
be active and effective shoppers for healthcare services, enabling them to
identify high-value providers and services, and ultimately place downward
pressure on prices.
My Administration has cracked down on waste, fraud, and abuse that direct
valuable taxpayer resources away from those who need them most. My
Administration implemented a ‘‘site neutral’’ payment system between hospital outpatient departments and physicians’ offices, to ensure Medicare
beneficiaries are charged the same price for the same service regardless
of where it takes place, which CMS estimates will save them approximately
$160 million in co-payments for 2020. We also changed the rules to enable
Government watchdogs to proactively identify and stop perpetrators of fraud
before money goes out the door.
(c) My Administration has been dedicated to providing better care for
all Americans.
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This includes a steadfast commitment to always protecting individuals with
pre-existing conditions and ensuring they have access to the high-quality
healthcare they deserve. No American should have to risk going without
health insurance based on a health history that he or she cannot change.
In an attempt to justify the ACA, the previous Administration claimed
that, absent action by the Congress, up to 129 million (later updated to
133 million) non-elderly people with what it described as pre-existing conditions were in danger of being denied health-insurance coverage. According
to the previous Administration, however, only 2.7 percent of such individuals
actually gained access to health insurance through the ACA, given existing
laws and programs already in place to cover them. For example, the Health
Insurance Portability and Accountability Act of 1996 has long protected
individuals with pre-existing conditions, including individuals covered by
group health plans and individuals who had such coverage but lost it.
The ACA produced multiple other failures. The average insurance premium
in the individual market more than doubled from 2013 to 2017, and those
who have not received generous Federal subsidies have struggled to maintain
coverage. For those who have managed to maintain coverage, many have
experienced a substantial rise in deductibles, limited choice of insurers,
and limited provider networks that exclude their doctors and the facilities
best suited to care for them.
Additionally, approximately 30 million Americans remain uninsured, notwithstanding the previous Administration’s promises that the ACA would
address this intractable problem. On top of these disappointing results,
Federal taxpayers and, unfortunately, future generations of American workers,
have been left with an enormous bill. The ACA’s Medicaid expansion and
subsidies for the individual market are projected by the Congressional Budget
Office to cost more than $1.8 trillion over the next decade.
The ACA is neither the best nor the only way to ensure that Americans
who suffer from pre-existing conditions have access to health-insurance
coverage. I have agreed with the States challenging the ACA, who have
won in the Federal district court and court of appeals, that the ACA, as
amended, exceeds the power of the Congress. The ACA was flawed from
its inception and should be struck down. However, access to health insurance
despite underlying health conditions should be maintained, even if the
Supreme Court invalidates the unconstitutional, and largely harmful, ACA.
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My Administration has always been committed to ensuring that patients
with pre-existing conditions can obtain affordable healthcare, to lowering
healthcare costs, to improving quality of care, and to enabling individuals
to choose the healthcare that meets their needs. For example, when the
COVID–19 pandemic hit, my Administration implemented a program to
provide any individual without health-insurance coverage access to necessary
COVID–19-related testing and treatment.
My commitment to improving care across our country expands vastly beyond
the rules governing health insurance. On July 10, 2019, I signed Executive
Order 13879 (Advancing American Kidney Health) to improve care for the
hundreds of thousands of Americans suffering from end-stage renal disease.
Pursuant to that order, my Administration launched a program to encourage
home dialysis and promote transplants for patients, and expects to enroll
approximately 120,000 Medicare beneficiaries with end-stage renal disease
in the program. We also have removed financial barriers to living organ
donation by adding additional financial support for living donors, such
as by reimbursing expenses for lost wages, child care, and elder care. HHS,
together with the American Society of Nephrology, issued two phases of
awards through KidneyX’s Redesign Dialysis Price Competition to work
toward the creation of an artificial kidney.
My Administration has taken unprecedented action to improve the quality
of and access to care for individuals with HIV, as part of our goal of
ending the epidemic of HIV in the United States by 2030. HHS has awarded
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at least $226 million to expand access to HIV care, treatment, medication,
and prevention services, focused on 48 counties, Washington, DC, and San
Juan, Puerto Rico, where more than 50 percent of new HIV diagnoses occurred
in 2016 and 2017, as well as seven States with a substantial rural HIV
rate. We secured a historic donation of a groundbreaking HIV preventive
medication that is available at no cost to eligible patients.
My Administration has started a transformation in healthcare in rural America. This includes a new effort, pursuant to my directive in Executive Order
13941, to support small hospitals and health clinics in rural communities
in transitioning from volume-based Medicare and Medicaid reimbursement,
which has failed rural communities that struggle with a lack of patient
volume, and toward value-based payment mechanisms that are tailored to
meet the needs of their communities. We updated Medicare payment policies
to address a problem in the program’s payment calculation that has historically disadvantaged rural hospitals, and released a Rural Action Plan to
incorporate recommendations from experts and leaders across the Federal
Government. We have also dedicated a special focus on improving care
offered through the Indian Health Service (IHS) within HHS, including by
creating the Office of Quality, implementing an increase in annual funding
for IHS by $243 million from 2019 to 2020, and expanding nationwide
IHS’s successful Alaska Community Health Aide Program.
My Administration has additionally demonstrated an incredible dedication
to protecting and improving care for those most in need, including senior
citizens, those with substance use disorders, and those to whom our Nation
owes the greatest debt: our veterans.
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I have protected the viability of the Medicare program. For example, on
February 9, 2018, I signed into law the repeal of the Independent Payment
Advisory Board, which would have been a group of unelected bureaucrats
created by the ACA, designed to be insulated from the will of America’s
elected leaders for the purpose of cutting the spending of this important
program. On October 3, 2019, I signed Executive Order 13890 (Protecting
and Improving Medicare for Our Nation’s Seniors), to modernize the Medicare
program and continue its viability. According to CMS estimates, seniors
have saved $2.65 billion in lower Medicare premiums under my Administration while benefiting from more choices. For example, the average monthly
Medicare Advantage premium has declined an estimated 28 percent since
2017, and Medicare Advantage has included about 1,200 more plan options
since 2018. New Medicare Advantage supplemental benefits have helped
seniors stay safe in their homes, improved respite care for caregivers, and
provided transportation, more in-home support services and assistance, and
non-opioid pain management alternatives like therapeutic massages. Medicare
Part D premiums are at their lowest level in their history, with the average
basic premium declining 13.5 percent since 2016.
My Administration has directed unprecedented attention on the substance
use disorder epidemic, with a focus on reducing overdose deaths from
prescription opioids and the deadly synthetic opioid fentanyl. On October
24, 2018, I signed the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities Act, enabling
the expenditure of billions of dollars of funding for important programs
to support prevention and recovery. My Administration has provided approximately $22.5 billion from 2017 to 2020 to address the opioid crisis
and improve access to prevention, treatment, and recovery services. We
saw a 34 percent decrease in total opioids dispensed monthly by pharmacies
between 2017 and 2019, an approximate increase of 64 percent in the
number of Americans who receive medication-assisted treatment for opioid
use disorder since 2016, and a 484 percent increase in naloxone prescriptions
since 2017. Data show that drug overdose deaths fell nationwide for the
first time in decades between 2017 and 2018, with many of the hardesthit States leading the way.
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Improving care for our Nation’s veterans has been a priority since the beginning of my Administration. On June 6, 2018, I signed the VA Maintaining
Internal Systems and Strengthening Integrated Outside Networks (MISSION)
Act of 2018, which authorized billions of dollars to improve options for
veterans to receive care outside of Department of Veterans Affairs (VA)
healthcare providers. Since taking effect, the VA estimates that more than
2.4 million veterans have benefited from more than 6.5 million referrals
to the 725,000 private healthcare providers with which the VA is now
working. On June 23, 2017, I signed the Department of Veterans Affairs
Accountability and Whistleblower Protection Act of 2017 to hold our civil
servants accountable for maintaining the best quality of care possible for
our Nation’s veterans by giving the Secretary of Veterans Affairs more power
to discipline employees and shorten an appeals process that can last years.
On March 5, 2019, I signed Executive Order 13861 (National Roadmap
to Empower Veterans and End Suicide) to ensure that the Federal Government
leads a collective effort to prevent suicide among our veterans.
I have used scientific research to focus on areas most pressing for the
health of Americans. On September 19, 2019, I signed Executive Order
13887 (Modernizing Influenza Vaccines in the United States to Promote
National Security and Public Health), recognizing the threat that pandemic
influenza continues to represent and putting forward a plan to prepare
for future influenza pandemics. To modernize influenza vaccines and promote national security and public health, HHS issued a 6-year, $226 million
contract to retain and increase capacity to produce recombinant influenza
vaccine domestically, and the National Institute of Allergy and Infectious
Diseases, part of the National Institutes of Health within HHS, initiated
the Collaborative Influenza Vaccine Innovation Centers program.
Investments my Administration has made in scientific research will help
tackle some of our most pressing medical challenges and pay dividends
for generations to come. This includes working to increase funding for
Alzheimer’s disease research by billions of dollars since 2017 and a plan
to invest more than $500 million over the next decade to improve pediatric
cancer research. On December 18, 2018, I signed the Sickle Cell Disease
and Other Heritable Blood Disorders Research, Surveillance, Prevention,
and Treatment Act of 2018 to provide support for research into sickle
cell disease, which disproportionately impacts African Americans and Hispanics, and to authorize programs relating to sickle cell disease surveillance,
prevention, and treatment.
On May 30, 2018, I signed the Trickett Wendler, Frank Mongiello, Jordan
McLinn, and Matthew Bellina Right to Try Act of 2017, which gives terminally ill patients the right to access certain treatments without being blocked
by onerous Federal regulations.
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In response to the COVID–19 pandemic, my Administration launched Operation Warp Speed, a groundbreaking effort of the Federal Government to
engage with the private sector to quickly develop and deliver safe and
effective vaccines, therapeutics, and diagnostics for COVID–19. On August
6, 2020, I signed Executive Order 13944 (Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines,
Medical Countermeasures, and Critical Inputs Are Made in the United States),
to protect Americans through reduced dependence on foreign manufacturers
for essential medicines and other items and to strengthen the Nation’s Public
Health Industrial Base.
Taken together, these extraordinary reforms constitute an ongoing effort to
improve American healthcare by putting patients first and delivering continuous innovation. And this effort will continue to succeed because of my
Administration’s commitment to delivering great healthcare with more
choices, better care, and lower costs for all Americans.
Sec. 2. Policy. It has been and will continue to be the policy of the United
States to give Americans seeking healthcare more choice, lower costs, and
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better care and to ensure that Americans with pre-existing conditions can
obtain the insurance of their choice at affordable rates.
Sec. 3. Giving Americans More Choice in Healthcare. The Secretary of the
Treasury, the Secretary of Labor, and the Secretary of Health and Human
Services shall maintain and build upon existing actions to expand access
to and options for affordable healthcare.
Sec. 4. Lowering Healthcare Costs for Americans. (a) The Secretary of Health
and Human Services, in coordination with the Commissioner of Food and
Drugs, shall maintain and build upon existing actions to expand access
to affordable medicines, including accelerating the approvals of new generic
and biosimilar drugs and facilitating the safe importation of affordable prescription drugs from abroad.
(b) The Secretary of the Treasury, the Secretary of Labor, and the Secretary
of Health and Human Services shall maintain and build upon existing actions
to ensure consumers have access to meaningful price and quality information
prior to the delivery of care.
(i) Recognizing that both chambers of the Congress have made substantial
progress towards a solution to end surprise billing, the Secretary of Health
and Human Services shall work with the Congress to reach a legislative
solution by December 31, 2020.
(ii) In the event a legislative solution is not reached by December 31,
2020, the Secretary of Health and Human Services shall take administrative
action to prevent a patient from receiving a bill for out-of-pocket expenses
that the patient could not have reasonably foreseen.
(iii) Within 180 days of the date of this order, the Secretary of Health
and Human Services shall update the Medicare.gov Hospital Compare
website to inform beneficiaries of hospital billing quality, including:
(A) whether the hospital is in compliance with the Hospital Price Transparency Final Rule, as amended (84 Fed. Reg. 65524), effective January
1, 2021;
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(B) whether, upon discharge, the hospital provides patients with a receipt
that includes a list of itemized services received during a hospital stay;
and
(C) how often the hospital pursues legal action against patients, including
to garnish wages, to place a lien on a patient’s home, or to withdraw
money from a patient’s income tax refund.
(c) The Secretary of Health and Human Services, in coordination with
the Administrator of CMS, shall maintain and build upon existing actions
to reduce waste, fraud, and abuse in the healthcare system.
Sec. 5. Providing Better Care to Americans. (a) The Secretary of Health
and Human Services and the Secretary of Veterans Affairs shall maintain
and build upon existing actions to improve quality in the delivery of care
for veterans.
(b) The Secretary of Health and Human Services shall continue to promote
medical innovations to find novel and improved treatments for COVID–
19, Alzheimer’s disease, sickle cell disease, pediatric cancer, and other conditions threatening the well-being of Americans.
Sec. 6. General Provisions. (a) Nothing in this order shall be construed
to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency,
or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and
subject to the availability of appropriations.
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(c) This order is not intended to, and does not, create any right or benefit,
substantive or procedural, enforceable at law or in equity by any party
against the United States, its departments, agencies, or entities, its officers,
employees, or agents, or any other person.
THE WHITE HOUSE,
September 24, 2020.
[FR Doc. 2020–21914
Filed 9–30–20; 11:15 am]
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Billing code 3295–F1–P
Agencies
[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Presidential Documents]
[Pages 62179-62186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21914]
[[Page 62177]]
Vol. 85
Thursday,
No. 191
October 1, 2020
Part VI
The President
-----------------------------------------------------------------------
Executive Order 13951--An America-First Healthcare Plan
Presidential Documents
Federal Register / Vol. 85 , No. 191 / Thursday, October 1, 2020 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 62179]]
Executive Order 13951 of September 24, 2020
An America-First Healthcare Plan
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Purpose. Since January 20, 2017, my
Administration has been committed to the goal of
bringing great healthcare to the American people and
putting patients first. To that end, my Administration
has taken monumental steps to improve the efficiency
and quality of healthcare in the United States.
(a) My Administration has been committed to
restoring choice and control to the American patient.
On December 22, 2017, I signed into law the repeal of
the burdensome individual-mandate penalty, liberating
millions of low-income Americans from a tax that
penalized them for not purchasing health-insurance
coverage they did not want or could not afford. Through
Executive Order 13813 of October 12, 2017 (Promoting
Healthcare Choice and Competition Across the United
States), my Administration has expanded coverage
options for millions of Americans in several ways. My
Administration increased the availability of renewable
short-term, limited-duration healthcare plans,
providing options that are up to 60 percent cheaper
than the least expensive alternatives under the Patient
Protection and Affordable Care Act (ACA) and are
projected to cover 500,000 individuals who would
otherwise be uninsured. My Administration expanded
health reimbursement arrangements, which have been
projected by the Department of the Treasury to reach
800,000 businesses and over 11 million employees and to
expand coverage to more than 800,000 individuals who
would otherwise be uninsured. My Administration also
issued a rule to increase the availability of
association health plans for small businesses, which,
upon implementation of the rule, are projected to cover
up to 400,000 previously uninsured individuals for on
average 30 percent less cost.
As set forth in the Economic Report of the President
(February 2020), my Administration's expansion of
health savings accounts will further help millions of
Americans pay for health expenditures by allowing them
to save more of their own money free from Federal
taxation, and will especially help Americans with
chronic conditions who now have more flexibility to
enroll in plans that fit their complicated care needs
and can be paired with a tax-advantaged account.
At the beginning of the current COVID-19 pandemic, my
Administration acted to dramatically increase the
accessibility and availability of telehealth services
for Medicare beneficiaries, enabling millions of
individuals to use these services. Pursuant to
Executive Order 13941 of August 3, 2020 (Improving
Rural Health and Telehealth Access), the Secretary of
Health and Human Services will make permanent many of
the new policies that improve the accessibility and
availability of telehealth services. In addition,
pursuant to that order, the Secretary of Health and
Human Services and the Secretary of Agriculture will
develop and implement a strategy to improve the
physical and communications healthcare infrastructure
available to rural Americans.
Through our State Relief and Empowerment Waivers, my
Administration has given States additional health-
insurance flexibility, which has expanded health-
insurance coverage options for consumers and lowered
costs for patients. These waivers allow States to move
away from the ACA's rigid
[[Page 62180]]
structure and are estimated to have lowered premiums by
approximately 11 percent in Wisconsin, 20 percent in
Minnesota, and 43 percent in Maryland. Due to actions
my Administration took, like the State Relief and
Empowerment Waivers, after years of dwindling choices
and escalating prices, plan options for consumers
increased and for 2019, for the first time ever,
benchmark premiums actually decreased on
Healthcare.gov. For 2020, the average benchmark premium
dropped by nearly 4 percent.
After the prior Administration spent tens of billions
of dollars creating electronic health records systems
unable to accurately or effectively record and
communicate patient data, my Administration has paved
the way for a new wave of innovation to allow patients
to safely send their own medical records to care
providers of their choosing. My Patients over Paperwork
initiative has cut red tape for doctors and nurses so
they can spend more time with their patients, which the
Centers for Medicare and Medicaid Services (CMS) within
the Department of Health and Human Services (HHS) has
estimated to save over 40 million hours of wasted time
for providers and suppliers between 2017 and 2021.
(b) My Administration has been ceaseless in its
efforts to lower costs to make healthcare more
affordable for American patients.
Under my tenure, prescription drugs saw their largest
annual price decrease in nearly half a century. For
three consecutive years, we have approved a record
number of generic drugs. The Council of Economic
Advisers has estimated that these approvals saved
patients $26 billion in the first 18 months of my
Administration alone. As part of the Further
Consolidated Appropriations Act, 2020, I signed into
law the Creating and Restoring Equal Access to
Equivalent Samples Act, which will pave the way for
even more generic drugs and is projected to save
taxpayers $3.3 billion from 2019 to 2029.
CMS has acted to offer Medicare beneficiaries
prescription drug plans with the option of insulin
capped at $35 in out-of-pocket expenses for a 30-day
supply. We are also reducing Government payments to
overcharging hospitals participating in the 340B Drug
Pricing Program by instead paying rates that more
accurately reflect the hospitals' acquisition costs,
which CMS estimated would save Medicare beneficiaries
$320 million on copayments for drugs alone.
As a result of Executive Order 13937 of July 24, 2020
(Access to Affordable Life-Saving Medications), low-
income Americans who receive care from a federally
qualified health center will have access to insulin and
injectable epinephrine at prices lower than ever
before. Under Executive Order 13938 of July 24, 2020
(Increasing Drug Importation to Lower Prices for
American Patients), my Administration will be the first
to complete a rulemaking to authorize the safe
importation of certain lower-cost prescription drugs
from Canada. Pursuant to Executive Order 13939 of July
24, 2020 (Lowering Prices for Patients by Eliminating
Kickbacks to Middlemen), my Administration is taking
action to eliminate wasteful payments to middlemen by
passing drug discounts through to patients at the
pharmacy counter without increasing premiums for
beneficiaries or cost to Federal taxpayers. And my
Administration is taking action to ensure that Medicare
patients receive the lowest price that drug companies
offer comparable foreign nations through Executive
Order 13948 of September 13, 2020 (Lowering Drug Prices
by Putting America First).
As part of the Further Consolidated Appropriations Act,
2020, I also signed into law the repeal of the medical
device tax, the annual fee on health-insurance
providers, and the ``Cadillac'' tax on certain
employer-sponsored health insurance, which threatened
to dramatically increase the cost of healthcare for
working families.
My Administration is transforming the black-box
hospital and insurance pricing systems to be
transparent about price and quality. Regardless of
health-insurance coverage, two-thirds of adults in
America still worry about the threat of unexpected
medical bills. This fear is the result of a system
[[Page 62181]]
under which individuals and employers are unable to see
how insurance companies, pharmacy benefit managers,
insurance brokers, and providers are or will be paid.
One major culprit is the practice of ``surprise
billing,'' in which a patient receives unexpected bills
at highly inflated prices from providers who are not
part of the patient's insurance network, even if the
patient was treated at a hospital that was part of the
patient's network. Patients can receive these bills
despite having no opportunity to select around an out-
of-network provider in advance.
On May 9, 2019, I announced four principles to guide
congressional efforts to prohibit exorbitant bills
resulting from patients' accidentally or unknowingly
receiving services from out-of-network physicians.
Unfortunately, the Congress has failed to act, and
patients remain vulnerable to surprise billing.
In the absence of congressional action, my
Administration has already taken strong and decisive
action to make healthcare prices more transparent. On
June 24, 2019, I signed Executive Order 13877
(Improving Price and Quality Transparency in American
Healthcare to Put Patients First), directing certain
agencies--for the first time ever--to make sure
patients have access to meaningful price and quality
information prior to the delivery of care. Beginning
January 1, 2021, hospitals will be required to publish
their real price for every service, and publicly
display in a consumer-friendly, easy-to-understand
format the prices of at least 300 different common
services that are able to be shopped for in advance.
We have also taken some concrete steps to eliminate
surprise out-of-network bills. For example, on April
10, 2020, my Administration required providers to
certify, as a condition of receiving supplemental
COVID-19 funding, that they would not seek to collect
out-of-pocket expenses from a patient for treatment
related to COVID-19 in an amount greater than what the
patient would have otherwise been required to pay for
care by an in-network provider. These initiatives have
made important progress, although additional efforts
are necessary.
Not all hospitals allow for surprise bills. But many
do. Unfortunately, surprise billing has become
sufficiently pervasive that the fear of receiving a
surprise bill may dissuade patients from seeking
appropriate care. And research suggests a correlation
between hospitals that frequently allow surprise
billing and increases in hospital admissions and
imaging procedures, putting patients at risk of
receiving unnecessary services, which can lead to
physical harm and threatens the long-term financial
sustainability of Medicare.
Efforts to limit surprise billing and increase the
number of providers participating in the same insurance
network as the hospital in which they work would
correspondingly streamline the ability of patients to
receive care and reduce time spent on billing disputes.
On May 15, 2020, HHS released the Health Quality
Roadmap to empower patients to make fully informed
decisions about their healthcare by facilitating the
availability of appropriate and meaningful price and
quality information. These transformative actions will
arm patients with the tools to be active and effective
shoppers for healthcare services, enabling them to
identify high-value providers and services, and
ultimately place downward pressure on prices.
My Administration has cracked down on waste, fraud, and
abuse that direct valuable taxpayer resources away from
those who need them most. My Administration implemented
a ``site neutral'' payment system between hospital
outpatient departments and physicians' offices, to
ensure Medicare beneficiaries are charged the same
price for the same service regardless of where it takes
place, which CMS estimates will save them approximately
$160 million in co-payments for 2020. We also changed
the rules to enable Government watchdogs to proactively
identify and stop perpetrators of fraud before money
goes out the door.
(c) My Administration has been dedicated to
providing better care for all Americans.
[[Page 62182]]
This includes a steadfast commitment to always
protecting individuals with pre-existing conditions and
ensuring they have access to the high-quality
healthcare they deserve. No American should have to
risk going without health insurance based on a health
history that he or she cannot change.
In an attempt to justify the ACA, the previous
Administration claimed that, absent action by the
Congress, up to 129 million (later updated to 133
million) non-elderly people with what it described as
pre-existing conditions were in danger of being denied
health-insurance coverage. According to the previous
Administration, however, only 2.7 percent of such
individuals actually gained access to health insurance
through the ACA, given existing laws and programs
already in place to cover them. For example, the Health
Insurance Portability and Accountability Act of 1996
has long protected individuals with pre-existing
conditions, including individuals covered by group
health plans and individuals who had such coverage but
lost it.
The ACA produced multiple other failures. The average
insurance premium in the individual market more than
doubled from 2013 to 2017, and those who have not
received generous Federal subsidies have struggled to
maintain coverage. For those who have managed to
maintain coverage, many have experienced a substantial
rise in deductibles, limited choice of insurers, and
limited provider networks that exclude their doctors
and the facilities best suited to care for them.
Additionally, approximately 30 million Americans remain
uninsured, notwithstanding the previous
Administration's promises that the ACA would address
this intractable problem. On top of these disappointing
results, Federal taxpayers and, unfortunately, future
generations of American workers, have been left with an
enormous bill. The ACA's Medicaid expansion and
subsidies for the individual market are projected by
the Congressional Budget Office to cost more than $1.8
trillion over the next decade.
The ACA is neither the best nor the only way to ensure
that Americans who suffer from pre-existing conditions
have access to health-insurance coverage. I have agreed
with the States challenging the ACA, who have won in
the Federal district court and court of appeals, that
the ACA, as amended, exceeds the power of the Congress.
The ACA was flawed from its inception and should be
struck down. However, access to health insurance
despite underlying health conditions should be
maintained, even if the Supreme Court invalidates the
unconstitutional, and largely harmful, ACA.
My Administration has always been committed to ensuring
that patients with pre-existing conditions can obtain
affordable healthcare, to lowering healthcare costs, to
improving quality of care, and to enabling individuals
to choose the healthcare that meets their needs. For
example, when the COVID-19 pandemic hit, my
Administration implemented a program to provide any
individual without health-insurance coverage access to
necessary COVID-19-related testing and treatment.
My commitment to improving care across our country
expands vastly beyond the rules governing health
insurance. On July 10, 2019, I signed Executive Order
13879 (Advancing American Kidney Health) to improve
care for the hundreds of thousands of Americans
suffering from end-stage renal disease. Pursuant to
that order, my Administration launched a program to
encourage home dialysis and promote transplants for
patients, and expects to enroll approximately 120,000
Medicare beneficiaries with end-stage renal disease in
the program. We also have removed financial barriers to
living organ donation by adding additional financial
support for living donors, such as by reimbursing
expenses for lost wages, child care, and elder care.
HHS, together with the American Society of Nephrology,
issued two phases of awards through KidneyX's Redesign
Dialysis Price Competition to work toward the creation
of an artificial kidney.
My Administration has taken unprecedented action to
improve the quality of and access to care for
individuals with HIV, as part of our goal of ending the
epidemic of HIV in the United States by 2030. HHS has
awarded
[[Page 62183]]
at least $226 million to expand access to HIV care,
treatment, medication, and prevention services, focused
on 48 counties, Washington, DC, and San Juan, Puerto
Rico, where more than 50 percent of new HIV diagnoses
occurred in 2016 and 2017, as well as seven States with
a substantial rural HIV rate. We secured a historic
donation of a groundbreaking HIV preventive medication
that is available at no cost to eligible patients.
My Administration has started a transformation in
healthcare in rural America. This includes a new
effort, pursuant to my directive in Executive Order
13941, to support small hospitals and health clinics in
rural communities in transitioning from volume-based
Medicare and Medicaid reimbursement, which has failed
rural communities that struggle with a lack of patient
volume, and toward value-based payment mechanisms that
are tailored to meet the needs of their communities. We
updated Medicare payment policies to address a problem
in the program's payment calculation that has
historically disadvantaged rural hospitals, and
released a Rural Action Plan to incorporate
recommendations from experts and leaders across the
Federal Government. We have also dedicated a special
focus on improving care offered through the Indian
Health Service (IHS) within HHS, including by creating
the Office of Quality, implementing an increase in
annual funding for IHS by $243 million from 2019 to
2020, and expanding nationwide IHS's successful Alaska
Community Health Aide Program.
My Administration has additionally demonstrated an
incredible dedication to protecting and improving care
for those most in need, including senior citizens,
those with substance use disorders, and those to whom
our Nation owes the greatest debt: our veterans.
I have protected the viability of the Medicare program.
For example, on February 9, 2018, I signed into law the
repeal of the Independent Payment Advisory Board, which
would have been a group of unelected bureaucrats
created by the ACA, designed to be insulated from the
will of America's elected leaders for the purpose of
cutting the spending of this important program. On
October 3, 2019, I signed Executive Order 13890
(Protecting and Improving Medicare for Our Nation's
Seniors), to modernize the Medicare program and
continue its viability. According to CMS estimates,
seniors have saved $2.65 billion in lower Medicare
premiums under my Administration while benefiting from
more choices. For example, the average monthly Medicare
Advantage premium has declined an estimated 28 percent
since 2017, and Medicare Advantage has included about
1,200 more plan options since 2018. New Medicare
Advantage supplemental benefits have helped seniors
stay safe in their homes, improved respite care for
caregivers, and provided transportation, more in-home
support services and assistance, and non-opioid pain
management alternatives like therapeutic massages.
Medicare Part D premiums are at their lowest level in
their history, with the average basic premium declining
13.5 percent since 2016.
My Administration has directed unprecedented attention
on the substance use disorder epidemic, with a focus on
reducing overdose deaths from prescription opioids and
the deadly synthetic opioid fentanyl. On October 24,
2018, I signed the Substance Use-Disorder Prevention
that Promotes Opioid Recovery and Treatment for
Patients and Communities Act, enabling the expenditure
of billions of dollars of funding for important
programs to support prevention and recovery. My
Administration has provided approximately $22.5 billion
from 2017 to 2020 to address the opioid crisis and
improve access to prevention, treatment, and recovery
services. We saw a 34 percent decrease in total opioids
dispensed monthly by pharmacies between 2017 and 2019,
an approximate increase of 64 percent in the number of
Americans who receive medication-assisted treatment for
opioid use disorder since 2016, and a 484 percent
increase in naloxone prescriptions since 2017. Data
show that drug overdose deaths fell nationwide for the
first time in decades between 2017 and 2018, with many
of the hardest-hit States leading the way.
[[Page 62184]]
Improving care for our Nation's veterans has been a
priority since the beginning of my Administration. On
June 6, 2018, I signed the VA Maintaining Internal
Systems and Strengthening Integrated Outside Networks
(MISSION) Act of 2018, which authorized billions of
dollars to improve options for veterans to receive care
outside of Department of Veterans Affairs (VA)
healthcare providers. Since taking effect, the VA
estimates that more than 2.4 million veterans have
benefited from more than 6.5 million referrals to the
725,000 private healthcare providers with which the VA
is now working. On June 23, 2017, I signed the
Department of Veterans Affairs Accountability and
Whistleblower Protection Act of 2017 to hold our civil
servants accountable for maintaining the best quality
of care possible for our Nation's veterans by giving
the Secretary of Veterans Affairs more power to
discipline employees and shorten an appeals process
that can last years. On March 5, 2019, I signed
Executive Order 13861 (National Roadmap to Empower
Veterans and End Suicide) to ensure that the Federal
Government leads a collective effort to prevent suicide
among our veterans.
I have used scientific research to focus on areas most
pressing for the health of Americans. On September 19,
2019, I signed Executive Order 13887 (Modernizing
Influenza Vaccines in the United States to Promote
National Security and Public Health), recognizing the
threat that pandemic influenza continues to represent
and putting forward a plan to prepare for future
influenza pandemics. To modernize influenza vaccines
and promote national security and public health, HHS
issued a 6-year, $226 million contract to retain and
increase capacity to produce recombinant influenza
vaccine domestically, and the National Institute of
Allergy and Infectious Diseases, part of the National
Institutes of Health within HHS, initiated the
Collaborative Influenza Vaccine Innovation Centers
program.
Investments my Administration has made in scientific
research will help tackle some of our most pressing
medical challenges and pay dividends for generations to
come. This includes working to increase funding for
Alzheimer's disease research by billions of dollars
since 2017 and a plan to invest more than $500 million
over the next decade to improve pediatric cancer
research. On December 18, 2018, I signed the Sickle
Cell Disease and Other Heritable Blood Disorders
Research, Surveillance, Prevention, and Treatment Act
of 2018 to provide support for research into sickle
cell disease, which disproportionately impacts African
Americans and Hispanics, and to authorize programs
relating to sickle cell disease surveillance,
prevention, and treatment.
On May 30, 2018, I signed the Trickett Wendler, Frank
Mongiello, Jordan McLinn, and Matthew Bellina Right to
Try Act of 2017, which gives terminally ill patients
the right to access certain treatments without being
blocked by onerous Federal regulations.
In response to the COVID-19 pandemic, my Administration
launched Operation Warp Speed, a groundbreaking effort
of the Federal Government to engage with the private
sector to quickly develop and deliver safe and
effective vaccines, therapeutics, and diagnostics for
COVID-19. On August 6, 2020, I signed Executive Order
13944 (Combating Public Health Emergencies and
Strengthening National Security by Ensuring Essential
Medicines, Medical Countermeasures, and Critical Inputs
Are Made in the United States), to protect Americans
through reduced dependence on foreign manufacturers for
essential medicines and other items and to strengthen
the Nation's Public Health Industrial Base.
Taken together, these extraordinary reforms constitute
an ongoing effort to improve American healthcare by
putting patients first and delivering continuous
innovation. And this effort will continue to succeed
because of my Administration's commitment to delivering
great healthcare with more choices, better care, and
lower costs for all Americans.
Sec. 2. Policy. It has been and will continue to be the
policy of the United States to give Americans seeking
healthcare more choice, lower costs, and
[[Page 62185]]
better care and to ensure that Americans with pre-
existing conditions can obtain the insurance of their
choice at affordable rates.
Sec. 3. Giving Americans More Choice in Healthcare. The
Secretary of the Treasury, the Secretary of Labor, and
the Secretary of Health and Human Services shall
maintain and build upon existing actions to expand
access to and options for affordable healthcare.
Sec. 4. Lowering Healthcare Costs for Americans. (a)
The Secretary of Health and Human Services, in
coordination with the Commissioner of Food and Drugs,
shall maintain and build upon existing actions to
expand access to affordable medicines, including
accelerating the approvals of new generic and
biosimilar drugs and facilitating the safe importation
of affordable prescription drugs from abroad.
(b) The Secretary of the Treasury, the Secretary of
Labor, and the Secretary of Health and Human Services
shall maintain and build upon existing actions to
ensure consumers have access to meaningful price and
quality information prior to the delivery of care.
(i) Recognizing that both chambers of the Congress have made substantial
progress towards a solution to end surprise billing, the Secretary of
Health and Human Services shall work with the Congress to reach a
legislative solution by December 31, 2020.
(ii) In the event a legislative solution is not reached by December 31,
2020, the Secretary of Health and Human Services shall take administrative
action to prevent a patient from receiving a bill for out-of-pocket
expenses that the patient could not have reasonably foreseen.
(iii) Within 180 days of the date of this order, the Secretary of Health
and Human Services shall update the Medicare.gov Hospital Compare website
to inform beneficiaries of hospital billing quality, including:
(A) whether the hospital is in compliance with the Hospital Price
Transparency Final Rule, as amended (84 Fed. Reg. 65524), effective January
1, 2021;
(B) whether, upon discharge, the hospital provides patients with a
receipt that includes a list of itemized services received during a
hospital stay; and
(C) how often the hospital pursues legal action against patients,
including to garnish wages, to place a lien on a patient's home, or to
withdraw money from a patient's income tax refund.
(c) The Secretary of Health and Human Services, in
coordination with the Administrator of CMS, shall
maintain and build upon existing actions to reduce
waste, fraud, and abuse in the healthcare system.
Sec. 5. Providing Better Care to Americans. (a) The
Secretary of Health and Human Services and the
Secretary of Veterans Affairs shall maintain and build
upon existing actions to improve quality in the
delivery of care for veterans.
(b) The Secretary of Health and Human Services
shall continue to promote medical innovations to find
novel and improved treatments for COVID-19, Alzheimer's
disease, sickle cell disease, pediatric cancer, and
other conditions threatening the well-being of
Americans.
Sec. 6. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
[[Page 62186]]
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
(Presidential Sig.)
THE WHITE HOUSE,
September 24, 2020.
[FR Doc. 2020-21914
Filed 9-30-20; 11:15 am]
Billing code 3295-F1-P