Elijah Cummings Lower Drug Costs Now Act
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The Elijah Cummings Lower Drug Costs Now Act
H.R. 3
is proposed legislation in the
117th United States Congress The 117th United States Congress is the current meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives. It convened in Washington, D.C., on ...
. The bill is designed to lower prescription drug costs in the United States. Notably, the law gives the federal government the power to negotiate prescription drug prices. The legislation takes the name of late
Maryland Maryland ( ) is a state in the Mid-Atlantic region of the United States. It shares borders with Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware and the Atlantic Ocean to ...
Representative
Elijah Cummings Elijah Eugene Cummings (January 18, 1951October 17, 2019) was an American politician and civil rights advocate who served in the United States House of Representatives for from 1996 until his death in 2019, when he was succeeded by his predecess ...
.


Background

The
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
spends more money on prescription drugs than any other developed nation in the world. In 2020 alone, the United States spent $358.7 Billion on prescription drugs. The United States does not guarantee
universal healthcare coverage Universal health care (also called universal health coverage, universal coverage, or universal care) is a health care system in which all residents of a particular country or region are assured access to health care. It is generally organized ar ...
to its citizens. This means that individuals that do not have
health insurance Health insurance or medical insurance (also known as medical aid in South Africa) is a type of insurance that covers the whole or a part of the risk of a person incurring medical expenses. As with other types of insurance, risk is shared among ma ...
or are underinsured will have to pay either the full price of the drugs, or a still large amount of the money. Most people who have health insurance still have to pay at least some money towards prescription drugs, and some drugs may not be covered by health insurance at all. Several polls have shown that a large share of the population has skipped filling drugs that were medically necessary because of the cost. Insurance companies generally have
pharmacy benefit managers In the United States, a pharmacy benefit manager (PBM) is a third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, ...
negotiate discounts for drug prices on their behalf. It is unknown how much of the savings (if any) are given to the patients, as the details of these deals are generally not shared with the public. Even if the savings are passed on to the insurance company patients, it is unlikely that the savings would be extended to those who do not have insurance, meaning that they would still have to pay full price. Drug companies are willing to make deals on the prices of their drug with insurance companies because the insurance companies they negotiate lower drug prices with are more likely to have their patients use the company's drugs.


Key provisions


Drug price negotiation

The bill would require the
Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
(HHS) to negotiate certain drug prices. Under current federal law, the HHS is not allowed to negotiate the drug prices for any drug covered by the Medicare prescription drug benefit, even though other government agencies like the VA and
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and pers ...
are allowed to do so. Specifically, the law would require the HHS to negotiate maximum drug prices for: # Insulin Products (which are infamous in the United States for their high and increasing cost). # At least 25 single-source brand name drugs that do not have any
generic Generic or generics may refer to: In business * Generic term, a common name used for a range or class of similar things not protected by trademark * Generic brand, a brand for a product that does not have an associated brand or trademark, other ...
version to compete with them by
fiscal year A fiscal year (or financial year, or sometimes budget year) is used in government accounting, which varies between countries, and for budget purposes. It is also used for financial reporting by businesses and other organizations. Laws in many ...
2023. The 25 drug prices that are negotiated would have to be either amongst the 125 drugs that account for the most spending nation-wide, or be amongst the 125 drugs that account for the most spending under the Medicare prescription drug benefit and
Medicare advantage Medicare Advantage (Medicare Part C, MA) is a capitated program for providing Medicare benefits in the United States. Under Part C, Medicare pays a private-sector health insurer a fixed payment. The insurer then pays for the health care expenses ...
. # Starting in fiscal year 2024, 50 drugs with the same criteria as before would need to have their price negotiated. # Any newly approved, single-source, brand name drugs that exceeds a price threshold that the HHS has set that was determined to likely to meet the spending criteria. The negotiated drug prices would have to meet the following criteria: # The negotiated drug price does not exceed than 120% of the drug's average price in Canada, the United Kingdom, Australia, Germany, France, and Japan. # If that data is not available, then the price must not exceed 85% of the United States average manufacturer price. The drug prices that are negotiated must be offered under both Medicare and
Medicare Advantage Medicare Advantage (Medicare Part C, MA) is a capitated program for providing Medicare benefits in the United States. Under Part C, Medicare pays a private-sector health insurer a fixed payment. The insurer then pays for the health care expenses ...
. The drug prices that are negotiated may also be offered by private insurance companies, but the insurance companies can choose to opt out. Any drug manufacturers that do not comply with the law's negotiation requirements may be fined or receive tax penalties.


Medicare prescription drug inflation rebates

The law would require all drug manufacturers to give rebates to the
CMS CMS may refer to: Computing * Call management system * CMS-2 (programming language), used by the United States Navy * Code Morphing Software, a technology used by Transmeta * Collection management system for a museum collection * Color manag ...
for drugs covered by Medicare for any drugs that cost $100 or more (average charge for one person to use the drug for a year), or for any drug that has an average manufacturer price that increasing faster than the rate of inflation. Companies that do not comply can be fined or receive tax penalties.


Caps for out-of-pocket expenses

The bill would reduce the cap on
out-of-pocket expense An out-of-pocket expense (or out-of-pocket cost, OOP) is the direct payment of money that may or may not be later reimbursed from a third-party source. For example, when operating a vehicle, gasoline, parking fees and tolls are considered out-of ...
s that a person enrolled in certain Medicare programs would have to pay. The traditional Medicare plan does not have any limit on out-of-pocket expenses. However, the
Affordable Care Act The Affordable Care Act (ACA), formally known as the Patient Protection and Affordable Care Act and colloquially known as Obamacare, is a landmark U.S. federal statute enacted by the 111th United States Congress and signed into law by Presid ...
required out-of-pocket expense caps for Medicare Advantage health plans, and such plans would have the cap reduced. The bill extends these caps to
Medicare Part D Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medica ...
, which currently have no caps at all. Under Part D, when the costs of drugs rise, the person enrolled in Medicare must pay more in out-of-pocket expenses. This is known as cost-sharing. All organizations that are contracted with the federal government to offer certain Medicare plans (known as Drug Plan Sponsors) must allow certain people who are enrolled in Medicare to make
co-insurance In insurance, co-insurance or coinsurance is the splitting or spreading of risk among multiple parties. In the United States In the U.S. insurance market, co-insurance is the joint assumption of risk between the insurer and the insured. In title i ...
payments in installments.


Drug price transparency

Drug companies would be required to report certain pieces of information on drugs that cost more than $100 and covered by Medicare or
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and pers ...
based on the rate of price and spending increases, or face
civil penalties A civil penalty or civil fine is a financial penalty imposed by a government agency as restitution for wrongdoing. The wrongdoing is typically defined by a Codification (law), codification of legislation, regulations, and decrees. The civil fine ...
. One provision of which would require that drug companies report certain drug price increases at least 30 days before the price increase takes effect. The HHS would then have to publish the information about the price increase on its website the day that the price is increased.


Improvements for low-income people on Medicare

The bill increases the number of people eligible to receive
subsidies A subsidy or government incentive is a form of financial aid or support extended to an economic sector (business, or individual) generally with the aim of promoting economic and social policy. Although commonly extended from the government, the ter ...
for premiums and other medical expenses for people with a
Medicare Part D Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medica ...
plan. The two main expansions of edibility are: # Allows people on Medicare to have higher incomes and still qualify for the subsidies. # Makes it do that certain people who are in U.S. Territories will automatically qualify for the subsidies.


Making Medicare cover dental, vision, and hearing

The bill would make the Medicare program also cover costs for # Certain dental costs; specifically
dentures Dentures (also known as false teeth) are prosthetic devices constructed to replace missing teeth, and are supported by the surrounding soft and hard tissues of the oral cavity. Conventional dentures are removable (removable partial denture or ...
and other basic and major treatments that the CMS deems necessary, and certain preventative-screenings. # Certain hearing costs; specifically hearing aids and other treatments. # Certain vision costs; specifically
glasses Glasses, also known as eyeglasses or spectacles, are vision eyewear, with lenses (clear or tinted) mounted in a frame that holds them in front of a person's eyes, typically utilizing a bridge over the nose and hinged arms (known as temples or ...
,
contacts Contact lenses, or simply contacts, are thin lenses placed directly on the surface of the eyes. Contact lenses are ocular prosthetic devices used by over 150 million people worldwide, and they can be worn to correct vision or for cosmetic ...
(and the fitting of them), and eye-exams.


Opioid and other funding

The bill provides funds for several programs related to
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
, such as: # Innovation projects at the
NIH The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
through
fiscal year A fiscal year (or financial year, or sometimes budget year) is used in government accounting, which varies between countries, and for budget purposes. It is also used for financial reporting by businesses and other organizations. Laws in many ...
2030. # Innovation projects at the
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
through fiscal year 2029. # Established an "
Opioid Epidemic The opioid epidemic, also referred to as the opioid crisis, is the rapid increase in the overuse, misuse/abuse, and overdose deaths attributed either in part or in whole to the class of drugs opiates/opioids since the 1990s. It includes the sign ...
Response Fund" that supports HHS programs and initiatives to prevent
opioid abuse Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. O ...
. The bill also mandates the HHS to cut administrative costs related to healthcare in half over a 10-year period, including costs in Medicare,
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and pers ...
, and
private insurance Insurance is a means of protection from financial loss in which, in exchange for a fee, a party agrees to compensate another party in the event of a certain loss, damage, or injury. It is a form of risk management, primarily used to hedge ...
. The HHS would be required to start a grant program so states can establish commissions to target unnecessary administrative costs as well.


Other healthcare program revisions

The bill makes some other changes to certain healthcare programs, and provides funds for other certain programs, such as: # Expands issue rights on certain
Medigap Medigap (also called Medicare supplement insurance or Medicare supplemental insurance) refers to various private health insurance plans sold to supplement Medicare in the United States. Medigap insurance provides coverage for many of the co-pays a ...
policies. # Gives money for certain things to the Community Health Centers Fund through fiscal year 2025. # Creates grant programs for trauma and mental health services in schools. # Would require pricing models for Medicaid to be one that does not include profit or administrative expenses (known as a pass-through pricing model). It would ban the use of the spread-pricing model, which includes profits and administrative expenses.


Drug advertising

The CMS would be directed to make a regulation that requires drug ads that air on television include information about how much a 30-day supply of the medication or a typical course of the treatment will cost. The CMS had planned to establish a similar rule, but a federal court had struck it down on the basis that they did not have the power to do so.


Cost

The
Congressional Budget Office The Congressional Budget Office (CBO) is a federal agency within the legislative branch of the United States government that provides budget and economic information to Congress. Inspired by California's Legislative Analyst's Office that manages ...
has estimated that the bill will save $345 Billion in federal spending over the course of 7 years, and the CMS found it could reduce out-of-pocket costs by $158 Billion over a decade.


Legislative history


Summary

As of July 14, 2022


116th Congress

The bill was introduced into the
House of Representatives House of Representatives is the name of legislative bodies in many countries and sub-national entitles. In many countries, the House of Representatives is the lower house of a bicameral legislature, with the corresponding upper house often c ...
on September 19, 2019 during the
116th Congress The 116th United States Congress was a meeting of the legislative branch of the United States federal government, composed of the Senate and the House of Representatives. It convened in Washington, D.C., on January 3, 2019, and ended on Janua ...
by Rep. Frank Pallone ( D- NJ). The bill received 106 co-sponsors. It passed the House on December 12, 2019 by a vote of
230-192
. All Democrats voted for the measure, and all but 2 Republicans voted against it. The bill was then sent to the
Senate A senate is a deliberative assembly, often the upper house or chamber of a bicameral legislature. The name comes from the ancient Roman Senate (Latin: ''Senatus''), so-called as an assembly of the senior (Latin: ''senex'' meaning "the el ...
. The Senate, having been controlled by Republicans, did not bring the bill up to a vote.


See also

*
Healthcare in the United States The United States far outspends any other nation on health care, measured both in ''per capita'' spending and as a percentage of GDP. Despite this, the country has significantly worse healthcare outcomes when compared to peer nations. The Uni ...
* Prescription Drug Costs * Single Payer Healthcare Proposal


References

{{reflist Healthcare reform in the United States Proposed legislation of the 117th United States Congress