Medicaid Drug Rebate Program

Last updated

The Medicaid Drug Rebate Program is a program in the United States that was created by the Omnibus Budget Reconciliation Act of 1990 (OBRA'90).

Contents

The program establishes mandatory rebates that drug manufacturers must pay state Medicaid agencies related to the dispensing of outpatient prescription drugs covered by Medicaid. To participate in the program, drug manufacturers must have a National Drug Rebate Agreement with the Secretary of the Department of Health and Human Services (HHS). As of 2020, approximately 600 pharmaceutics companies participated in the Medicaid Drug Rebate Program. [1] Rebate amounts are confidential under section 1927(b)(3)(D) of the Social Security Act.

The Medicaid Drug Rebate Program also provides for savings in other Federal health care programs. Signing the National Drug Rebate Agreement also requires drug manufacturers to enter into agreements for the 340B Drug Pricing Program as well as the Federal Supply Schedule.

Rebate Methodology

The Medicaid Drug Rebate Program provides for mandatory rebates on innovator drugs (e.g., brand drugs), blood clotting factors, drugs Food and Drug Administration-approved exclusively for pediatric indications, and non-innovator drugs (e.g., generic drugs). [1] The maximum rebate is capped at 100% of the Average Manufacturer Price (AMP).

Innovator drugs

The mandatory rebate is calculated as a base rebate plus an inflationary rebate. The base rebate is the greater of 23.1% of the AMP per unit, or the difference between the AMP and the "best price," defined as the best price given to most commercial insurers. The inflationary rebate as the difference between the AMP on the launch date compared with the current quarter and the United States Consumer Price Index-Urban.

Blood clotting factors and drugs FDA-approved exclusively for pediatric indications

The mandatory rebate is calculated as a base rebate plus an inflationary rebate. The base rebate is the greater of 17.1% of the AMP, or the difference between the AMP and the best price. The inflationary rebate, when applicable, is calculated with the same methodology as for innovator drugs.

Non-innovator drugs

The mandatory rebate is calculated as a base rebate plus an inflationary rebate. The base rebate is defined as 13% of the AMP. The inflationary rebate, when applicable, is calculated with the same methodology as for innovator drugs.

Historical Changes

The Medicaid Drug Rebate Program has undergone a number of changes since its inception. For example, Section 606 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA) amended Section 1927(a)(1) allowing states to have the option of different rebate effective dates. This section states that agreements to the rebate program that have been entered on or after November 29, 1999 may go into effect that day, and states option, any date after up to the first day of the quarter. [2]

The Medicaid Drug Rebate Program and Medicaid Managed Care

At the time the law was enacted, outpatient prescription drugs covered by Medicaid managed care organizations were excluded from access to the drug rebate program. In 1990, only 2.8 million people were enrolled in Medicaid managed care and so the savings lost by the exemption were relatively small. However, enrollment in Medicaid managed care plans has grown significantly. [3]

The Drug Rebate Equalization Act of 2009 (DRE), introduced in the 111th United States Congress by Representative Bart Stupak as H.R. 904, and in the Senate by Senator Jeff Bingaman as S. 547, sought to equalize the treatment of prescription drug discounts between Medicaid managed care and Medicaid fee-for-service. In offering states access to rebates for drugs covered by Medicaid managed care plans, this policy was seen as a way to provide relief for federal and state budgets. The Congressional Budget Office scored the DRE as saving $11 billion over ten years. [4] This proposal was also in President Barack Obama’s 2010 United States federal budget. [5] The DRE passed in both the House and Senate as part of their respective comprehensive health care reform legislation, and was signed into law on March 23, 2010 by President Obama with the Patient Protection and Affordable Care Act. The DRE became effective upon enactment.

Related Research Articles

Medicaid United States social health care program for families and individuals with limited resources

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 personal care services. The main difference between the two programs is that Medicaid covers healthcare costs for people with low incomes while Medicare provides health coverage for the elderly. There are also dual health plans for people who have both Medicaid and Medicare. The Health Insurance Association of America describes Medicaid as "a government insurance program for persons of all ages whose income and resources are insufficient to pay for health care."

Medicare (United States) United States single-payer national social insurance program

Medicare is a national health insurance program in the United States, begun in 1966 under the Social Security Administration (SSA) and now administered by the Centers for Medicare and Medicaid Services (CMS). It primarily provides health insurance for Americans aged 65 and older, but also for some younger people with disability status as determined by the SSA, and people with end stage renal disease and amyotrophic lateral sclerosis.

Prescription drug prices in the United States continually rank among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the U.S. health care reform debate of 2009, and received renewed attention in 2015. A major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the U.S. health care sector to use their bargaining power to negotiate lower prices. The Democratic Party is broadly in favor of allowing the government to negotiate drug prices, whereas the Republican Party has prevented passage of bills that would permit that.

Medicare Prescription Drug, Improvement, and Modernization Act

The Medicare Prescription Drug, Improvement, and Modernization Act, also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.

Dual-eligible beneficiaries refers to those qualifying for both Medicare and Medicaid benefits. In the United States, approximately 9.2 million people are eligible for "dual" status. Dual-eligibles make up 14% of Medicaid enrollment, yet they are responsible for approximately 36% of Medicaid expenditures. Similarly, duals total 20% of Medicare enrollment, and spend 31% of Medicare dollars. Dual-eligibles are often in poorer health and require more care compared with other Medicare and Medicaid beneficiaries.

Omnibus Budget Reconciliation Act of 1990

The Omnibus Budget Reconciliation Act of 1990 is a United States statute enacted pursuant to the budget reconciliation process to reduce the United States federal budget deficit. The Act included the Budget Enforcement Act of 1990 which established the "pay-as-you-go" or "PAYGO" process for discretionary spending and taxes.

2005 California Proposition 79

California Proposition 79 (2005) was an initiative in the November 8, 2005 elections that covers the areas of Prescription Drug Discounts and State-Negotiated Rebates.

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 through prescription drug insurance premiums. Part D was originally proposed by President Bill Clinton in 1999, then by both political parties and Houses of Congress and President Bush during 2002 and 2003. The final bill was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. The various proposals were substantially alike in that Part D was optional, it was separated from the other three Parts of Medicare in most proposals, and it used private pharmacy benefit managers on a regional basis to negotiate drug prices. The differences included consistent benefits nationwide in the Clinton/Democratic proposals and a wide array of deductibles and co-pays ; Bush's initial proposal included true catastrophic coverage for middle income seniors, but it was not in the final version and is a feature still not available in Part D.

The Balanced Budget Act of 1997,, was an omnibus legislative package enacted by the United States Congress, using the budget reconciliation process, and designed to balance the federal budget by 2002. This act was enacted during Bill Clinton's second term as president.

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, and state government employee plans. According to the American Pharmacists Association, "PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims." PBMs operate inside of integrated healthcare systems, as part of retail pharmacies, and as part of insurance companies.

The Medicare Part D coverage gap is a period of consumer payment for prescription medication costs which lies between the initial coverage limit and the catastrophic-coverage threshold, when the consumer is a member of a Medicare Part D prescription-drug program administered by the United States federal government. The gap is reached after shared insurer payment - consumer payment for all covered prescription drugs reaches a government-set amount, and is left only after the consumer has paid full, unshared costs of an additional amount for the same prescriptions. Upon entering the gap, the prescription payments to date are re-set to $0 and continue until the maximum amount of the gap is reached OR the current annual period lapses. In calculating whether the maximum amount of gap has been reached, the "True-out-of-pocket" costs (TROOP) are added together. "TrOOP includes the amount of your Initial Deductible and your co-payments or co-insurance during the Initial Coverage stage. While in the Donut Hole, it includes what you pay when you fill a prescription and of the 75% Donut Hole discount on brand-name drugs, it includes the 70% Donut Hole Discount paid by the drug manufacturer. The additional 5% Donut Hole discount on brand-name drugs and the 75% Donut Hole discount on generics do not count toward TrOOP as they are paid by your Medicare Part D plan."

Mandatory spending

The United States federal budget is divided into three categories: mandatory spending, discretionary spending, and interest on debt. Also known as entitlement spending, in US fiscal policy, mandatory spending is government spending on certain programs that are required by law. Congress established mandatory programs under authorization laws. Congress legislates spending for mandatory programs outside of the annual appropriations bill process. Congress can only reduce the funding for programs by changing the authorization law itself. This requires a 60-vote majority in the Senate to pass. Discretionary spending on the other hand will not occur unless Congress acts each year to provide the funding through an appropriations bill.

Pharmaceutical lobby

The pharmaceutical lobby refers to the representatives of pharmaceutical drug and biomedicine companies who engage in lobbying in favour of the pharmaceutical industry and its products.

In the United States, Medicare fraud is the claiming of Medicare health care reimbursement to which the claimant is not entitled. There are many different types of Medicare fraud, all of which have the same goal: to collect money from the Medicare program illegitimately.

Healthcare reform in the United States has a long history. Reforms have often been proposed but have rarely been accomplished. In 2010, landmark reform was passed through two federal statutes enacted in 2010: the Patient Protection and Affordable Care Act (PPACA), signed March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, which amended the PPACA and became law on March 30, 2010.

The Pennsylvania Department of Aging is a cabinet-level agency charged with providing aid to Pennsylvania's approximately 3 million individuals age 60 and older. Although the bureau operates some services directly, such as the Pharmaceutical Contact for the Elderly (PACE) prescription drug program, it generally serves as a clearinghouse of funding and information for county-level Area Agencies on Aging. The department was formed under the governorship of Milton Shapp.

The Path to Prosperity

The Path to Prosperity: Restoring America's Promise was the Republican Party's budget proposal for the Federal government of the United States in the fiscal year 2012. It was succeeded in March 2012 by "The Path to Prosperity: A Blueprint for American Renewal", the Republican budget proposal for 2013. Representative Paul Ryan, Chairman of the House Budget Committee, played a prominent public role in drafting and promoting both The Path to Prosperity proposals, and they are therefore often referred to as the Ryan budget, Ryan plan or Ryan proposal.

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "[s]tretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services." Maintaining services and lowering medication costs for patients is consistent with the purpose of the program, which is named for the section authorizing it in the Public Health Service Act (PHSA) It was enacted by Congress as part of a larger bill signed into law by President George H. W. Bush.

The Affordable Care Act (ACA) is divided into 10 titles and contains provisions that became effective immediately, 90 days after enactment, and six months after enactment, as well as provisions phased in through to 2020. Below are some of the key provisions of the ACA. For simplicity, the amendments in the Health Care and Education Reconciliation Act of 2010 are integrated into this timeline.

References

  1. 1 2 "Medicaid Drug Rebate Program". Medicaid.gov. Centers for Medicare & Medicaid Services. Archived from the original on 11 September 2020. Retrieved 27 September 2020.
  2. History of the Medicaid Drug Rebate Program Archived 2006-09-27 at the Wayback Machine , U.S. Department of Health & Human Services.
  3. "Exploring the Growth of Medicaid Managed Care". Congressional Budget Office. Congressional Budget Office. Retrieved 27 September 2020.
  4. Health Care Budget Options, Volume 1 (December 2008), Congressional Budget Office
  5. President's Budget for FY2010 Office of Management and Budget