经济篇之N(第三节): Government Pricing Regulations in the U.S. Pharmaceu

In China, centralized drug purchasing greatly affects drug prices. The U.S. government has also taken some measures to limit drug prices. Government pricing regulations in the U.S. pharmaceutical industry are designed to ensure that drugs are sold at fair prices, especially to government programs like Medicaid, Medicare, and the Veterans Health Administration (VHA). These regulations aim to protect consumers, ensure that government programs have access to pharmaceuticals at reasonable prices, and manage overall healthcare costs. Here are some key aspects of government pricing regulations in the U.S. pharmaceutical industry:

Medicaid Drug Rebate Program (MDRP): This program requires drug manufacturers to provide rebates to states in order for their drugs to be covered by Medicaid. The rebate amount is determined by a formula that considers the Average Manufacturer Price (AMP) and the Best Price (BP) offered by the manufacturer. The goal is to ensure that Medicaid pays the lowest possible prices for drugs.

Medicare Part B Drugs: Pricing for drugs covered under Medicare Part B is based on the Average Sales Price (ASP) plus a markup. The ASP is calculated from sales data submitted by manufacturers, including discounts and rebates. This model aims to reflect the market prices of drugs and ensure Medicare pays prices that are aligned with what providers pay to acquire these drugs.

Medicare Part D: Unlike Parts A and B, Medicare Part D, which covers prescription drugs, is administered by private plans that negotiate drug prices with manufacturers. However, the government has established certain rules and protections, like ensuring a broad coverage of drug types and classes, to maintain reasonable drug costs.

PHS / 340B Drug Pricing Program: This program requires drug manufacturers to sell outpatient drugs at reduced prices to healthcare organizations that serve uninsured or vulnerable patients, such as hospitals in low-income areas, cancer hospitals, and HIV/AIDS clinics. The goal is to allow these healthcare providers to stretch scarce federal resources as far as possible.

Veterans Health Administration (VHA): The VHA negotiates directly with drug manufacturers to obtain discounts on drug prices for veterans. The prices paid by the VHA are often among the lowest in the U.S.

TRICARE: This program serves uniformed service members, retirees, and their families worldwide. It acts as a critical component of the Military Health System, which provides health care to active duty and retired U.S. military personnel and their dependents. TRICARE integrates civilian health care providers, military hospitals and clinics, and the TRICARE network to deliver high-quality, accessible health care services.

Penalties: Certain programs, including Medicaid, impose penalties on manufacturers if the price of a drug increases faster than inflation. This provision aims to prevent excessive price increases for drugs purchased through government programs.

Recent legislative efforts and proposals such as the Inflation Reduction Act (IRA) aim to further regulate drug prices, including allowing Medicare to negotiate directly with manufacturers for certain high-cost drugs and implementing price increase caps tied to inflation for drugs covered under Medicare. These regulations and programs are subject to ongoing debates and changes, reflecting the dynamic nature of the U.S. healthcare system and the pharmaceutical industry's role within it. The overall goal of these policies is to balance innovation and access to new therapies with the need to control healthcare costs and ensure affordability for patients and government programs.

Summary of Government Programs:

Program	Medicaid	Medicare Part B	Medicare Part D	PHS / 340B	VA-FSS	TRICARE
Agency	CMS	CMS	CMS & TPA	HRSA	VA	DOD
Population	State administered program providing outpatient drug benefits to the poor	Over 65 or the disabled; Physician administered	Over 65 or the disabled	Covered outpatient drugs at reduced priceing to eligible 340B entities	Federal government	Rx benefit for military personnel, retirees & dependents
Calculation and Reporting	Monthly AMP due 30 days after perioid-end; Quaterly AMP, BP, URA	Quarterly ASP	N/A	Quarterly 340B price due 30 days before start of quarter; 2 quarter lag	Quarterly Non-FAMP; Annual Non-FAMP; FCP, Contract Mods	N/A
Certification required	Yes	Yes
Financial Obiligation	Medicaid Rebates paid quauterly	Government reimburses physicians based on ASP	Quarterly rebates paid based on negotiated contracts with insurance	Sales at 340B Price to covered entities; subject to Penny Pricing	FSS price to eligible entities; Subject to Penny Pricing	Refund payments to match FSS pricing
Method of Discount	Rebate	N/A for manufacturer	Rebate	Chargeback	Chargeback	Rebate
Penalty for Non-compliance	$10,000 per day / per NDC; Forced CIA; Exclusion from program	$10,000 per day / per NDC; Forced CIA; Exclusion from program	Late payment penalty is 25% of total rebate liability	Up to $5,000 civil monetary panalty per incidence of overcharging	Exlusion from program	Exlusion from program

Acronyms:

340B - Public Health Service (aka PHS)

AMP - Average Manufacturer Price

ASP - Average Sale Price

BP - Best Price

CMS - Center for Medicare and Medicaid Services

DOD - Department of Defense

DRA - Deficit Reduction Act

FCP - Federal Ceiling Price

FDA - Food and Drug Administration

FSS - Federal Supply Schedule

HRSA - Health Resources & Services Administration

IRA - Inflation Reduction Act

NDA - New Drug Application

Non-FAMP / NFAMP - Non-Federal Average Manufacturer Price

PHS - Public Health Service (aka 340B)

UPPS - Unit Per Package Size

URA - Unit Rebate Amount (aka RPU)

VA - Department of Veterans Affairs

VHCA - Veterans Health Care Act

WAC - Wholesale Acquisition Cost