An America-First Healthcare Plan

 
CONTENT
Presidential Documents
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Vol. 85, No. 191
Thursday, October 1, 2020
Title 3—
The President
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 monu-
mental 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, pro-
viding 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 (Improv-
ing 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 pa-
tients. 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 Mary-
land. 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 copay-
ments 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 Administra-
tion is taking action to eliminate wasteful payments to middlemen by passing
drug discounts through to patients at the pharmacy counter without increas-
ing premiums for beneficiaries or cost to Federal taxpayers. And my Adminis-
tration 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
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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 unknow-
ingly 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 mean-
ingful 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-under-
stand 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 pa-
tients 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 partici-
pating 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 facili-
tating the availability of appropriate and meaningful price and quality infor-
mation. 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 hos-
pital 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 condi-
tions 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, not-
withstanding 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
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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 Amer-
ica. 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 histori-
cally 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 Administra-
tion 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 ap-
proximately $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.
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Improving care for our Nation’s veterans has been a priority since the begin-
ning 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 pro-
mote 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 His-
panics, 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 termi-
nally 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 Oper-
ation 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 Emer-
gencies 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 contin-
uous 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 pre-
scription 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 Trans-
parency 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 condi-
tions 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]
Billing code 3295–F1–P
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