This Act, referred to in subsec. (c)(2)(C)(i), is Pub. L. 111–148,
The date on which such amendments take effect, referred to in subsec. (c)(2)(C)(i), is the date on which the amendments by Pub. L. 111–148 to section 300gg of this title take effect, which is
Pub. L. 113–235, div. M, § 1,
Pub. L. 111–148, § 1(a),
Ex. Ord. No. 13765,
Ex. Ord. No. 13813,
Ex. Ord. No. 13877,
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:
Pursuant to Executive Order 13813 of
Shoppable services make up a significant share of the healthcare market, which means that increasing transparency among these services will have a broad effect on increasing competition in the healthcare system as a whole. One study, cited by the Council of Economic Advisers in its 2019 Annual Report, examined a sample of the highest-spending categories of medical cases requiring inpatient and outpatient care. Of the categories of medical cases requiring inpatient care, 73 percent of the 100 highest-spending categories were shoppable. Among the categories of medical cases requiring outpatient care, 90 percent of the 300 highest-spending categories were shoppable. Another study demonstrated that the ability of patients to price-shop imaging services, a particularly fungible and shoppable set of healthcare services, was associated with a per-service savings of up to approximately 19 percent.
Improving transparency in healthcare will also further protect patients from harmful practices such as surprise billing, which occurs when patients receive unexpected bills at highly inflated prices from out-of-network providers they had no opportunity to select in advance. On
Making meaningful price and quality information more broadly available to more Americans will protect patients and increase competition, innovation, and value in the healthcare system.
(b) Within 90 days of the date of this order, the Secretaries of Health and Human Services, the Treasury, and Labor shall issue an advance notice of proposed rulemaking, consistent with applicable law, soliciting comment on a proposal to require healthcare providers, health insurance issuers, and self-insured group health plans to provide or facilitate access to information about expected out-of-pocket costs for items or services to patients before they receive care.
(c) Within 180 days of the date of this order, the Secretary of Health and Human Services, in consultation with the Attorney General and the Federal Trade Commission, shall issue a report describing the manners in which the Federal Government or the private sector are impeding healthcare price and quality transparency for patients, and providing recommendations for eliminating these impediments in a way that promotes competition. The report should describe why, under current conditions, lower-cost providers generally avoid healthcare advertising.
(b) Within 180 days of the date of this order, the Secretary of the Treasury, to the extent consistent with law, shall propose regulations to treat expenses related to certain types of arrangements, potentially including direct primary care arrangements and healthcare sharing ministries, as eligible medical expenses under section 213(d) of title 26, United States Code.
(c) Within 180 days of the date of this order, the Secretary of the Treasury, to the extent consistent with law, shall issue guidance to increase the amount of funds that can carry over without penalty at the end of the year for flexible spending arrangements.
(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.
(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.
Ex. Ord. No. 13951,
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:
(a) My Administration has been committed to restoring choice and control to the American patient.
On
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
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 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 [Pub. L. 116–94], I signed into law the Creating and Restoring Equal Access to Equivalent Samples Act [see 21 U.S.C. 355–2], 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
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 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.
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In the absence of congressional action, my Administration has already taken strong and decisive action to make healthcare prices more transparent. On
We have also taken some concrete steps to eliminate surprise out-of-network bills. For example, on
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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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.
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 [Pub. L. 104–191] 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
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 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
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
Improving care for our Nation’s veterans has been a priority since the beginning of my Administration. On
I have used scientific research to focus on areas most pressing for the health of Americans. On
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
On
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
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.
(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
(ii) In the event a legislative solution is not reached by
(iii) Within 180 days of the date of this order [
(A) whether the hospital is in compliance with the Hospital Price Transparency Final Rule, as amended (84 Fed. Reg. 65524), effective
(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.
(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.
(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.
(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.
Ex. Ord. No. 14009,
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:
(i) policies or practices that may undermine protections for people with pre-existing conditions, including complications related to COVID–19, under the ACA;
(ii) demonstrations and waivers, as well as demonstration and waiver policies, that may reduce coverage under or otherwise undermine Medicaid or the ACA;
(iii) policies or practices that may undermine the Health Insurance Marketplace or the individual, small group, or large group markets for health insurance in the United States;
(iv) policies or practices that may present unnecessary barriers to individuals and families attempting to access Medicaid or ACA coverage, including for mid-year enrollment; and
(v) policies or practices that may reduce the affordability of coverage or financial assistance for coverage, including for dependents.
(b) Heads of agencies shall, as soon as practicable and as appropriate and consistent with applicable law, consider whether to suspend, revise, or rescind—and, as applicable, publish for notice and comment proposed rules suspending, revising, or rescinding—those agency actions identified as inconsistent with the policy set forth in section 1 of this order.
(c) Heads of agencies shall, as soon as practicable and as appropriate and consistent with applicable law, consider whether to take any additional agency actions to more fully enforce the policy set forth in section 1 of this order.
(b) As part of the review required under section 3 of this order, heads of agencies shall identify existing agency actions related to or arising from Executive Orders 13765 and 13813. Heads of agencies shall, as soon as practicable, consider whether to suspend, revise, or rescind—and, as applicable, publish for notice and comment proposed rules suspending, revising, or rescinding—any such agency actions, as appropriate and consistent with applicable law and the policy set forth in section 1 of this order.
(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.
(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.
Ex. Ord. No. 14070,
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:
Consistent with Executive Order 14009, agencies have taken numerous actions to protect and strengthen Medicaid and the ACA, including:
(a) facilitating the expansion of Medicaid in Missouri and Oklahoma to individuals below 138 percent of the Federal poverty level, which is projected to cover nearly half a million people;
(b) extending Medicaid eligibility to new populations in order to allow pregnant individuals to retain their Medicaid coverage for up to 1 year postpartum, including through initiatives in Illinois, New Jersey, Virginia, and Louisiana;
(c) operating a Special Enrollment Period during 2021 that allowed 2.8 million Americans to newly enroll in coverage under the ACA;
(d) extending the length of the HealthCare.gov Open Enrollment Period by 1 month and operating the most successful Open Enrollment Period ever, with a historic 14.5 million Americans enrolling in coverage through the ACA Marketplaces and an additional 1 million people enrolling in Basic Health Program coverage, resulting in a 20 percent increase over the prior year across both programs combined;
(e) increasing outreach and enrollment funding for organizations that help Americans apply for ACA and Medicaid coverage, including quadrupling the number of trained Navigators to more than 1,500 people in States using HealthCare.gov;
(f) lowering maximum out-of-pocket costs for consumers with employer and ACA coverage by $400 in 2022;
(g) reducing paperwork burdens for people enrolling in Medicaid and the ACA by eliminating unnecessary documentation requirements;
(h) allowing low-income Americans to enroll in affordable ACA coverage year-round;
(i) strengthening Medicaid and ACA section 1332 [42 U.S.C. 18052] waiver policies to partner with States to develop innovative coverage options, strengthen benefits, and lower costs;
(j) proposing rules that would better ensure comprehensive and standardized coverage and improve the adequacy of ACA provider networks; and
(k) making efforts to improve the affordability of ACA coverage for families by proposing rules to correct a regulatory gap that prevents family members from accessing ACA subsidies despite very high premiums for coverage through an employer.
On
My Administration has made significant progress in making healthcare more affordable and accessible to millions of Americans. From the end of 2020 to September 2021, one in seven uninsured Americans gained coverage, leaving the uninsured rate at nearly an all-time low. Despite this progress, nearly 4 million Americans continue to be locked out of Medicaid expansion because they reside in 1 of the 12 States that have failed to adopt the ACA’s Medicaid expansion. In addition, millions more continue to struggle to obtain the care they need, to go without health coverage, or to be enrolled in coverage that is insufficient to meet their needs. The effects of being uninsured or underinsured can be devastating financially, as families without access to affordable coverage may accrue high levels of medical debt.
It remains the policy of my Administration to protect and strengthen Medicaid and the ACA and to make high-quality healthcare accessible and affordable for every American. Agencies with authorities and responsibilities related to Medicaid and the ACA are continuing their review of existing agency actions under Executive Order 14009.
(a) policies or practices that make it easier for all consumers to enroll in and retain coverage, understand their coverage options, and select appropriate coverage;
(b) policies or practices that strengthen benefits and improve access to healthcare providers;
(c) policies or practices that improve the comprehensiveness of coverage and protect consumers from low-quality coverage;
(d) policies or practices that expand eligibility and lower costs for coverage in the ACA Marketplaces, Medicaid, Medicare, and other programs;
(e) policies or practices that help improve linkages between the healthcare system and other stakeholders to address health-related needs; and
(f) policies or practices that help reduce the burden of medical debt on households.
(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.
(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.