Tag Archives: Drug Pricing

Congressional Hearings Focus on Health Policy Issues

A number of recent Congressional hearings have focused on health policy issues, including:  Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics. A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” … Continue Reading

Recent Congressional Health Policy Hearings and Markups

A number of Congressional committees have recently considered legislation and/or held hearings on various health policy proposals.  The Ways and Means Committee approved seven bills related to health care coverage and tax policy, including various bills to: expand access to health reimbursement arrangements and health savings accounts; ease employer insurance coverage mandates for students and … Continue Reading

Recent Congressional Health Policy Hearings

A number of recent Congressional hearings have focused on health policy topics, including the following: A House Energy and Commerce Subcommittee on Health hearing on “Medicare Access and CHIP Reauthorization Act of 2015: Examining Physician Efforts to Prepare for Medicare Payment Reforms.” A House Judiciary Constitution and Civil Justice Subcommittee hearing on oversight of the False … Continue Reading

Congressional Health Policy Hearings

The Senate Special Committee on Aging recently held a hearing on the status of efforts to find a cure for Alzheimer’s disease, and the panel plans an April 27, 2016 hearing to examine prescription drug price increases. In addition, the House Education and Workforce Subcommittee on Health plans an April 14 hearing entitled “Innovations in … Continue Reading

March Congressional Health Policy Hearings

Congressional committees have held hearings recently on various health policy issues, including: Energy and Commerce Committee hearings on CMS implementation of the Medicare physician fee schedule reform provisions included in the Medicare Access and CHIP Reauthorization Act (MACRA), financing and delivery of long-term care, and the public health response to the Zika virus. A Ways … Continue Reading

Donald Trump Proposes Prescription Drug Importation as Element of Health Reform Plan

Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes should be enacted in connection with repealing and replacing “ObamaCare.” Specifically, the plan states that Congress must: Remove barriers to … Continue Reading

Congressional Health Policy Hearings

The Senate HELP Committee is holding a January 28, 2016 hearing on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.”  Separately, on February 4, the House Committee on Oversight and Government Reform has scheduled a hearing on “Developments in the Prescription Drug Market: Oversight.”  Other recent Congressional health policy hearings have included … Continue Reading

Recent Congressional Hearings on Health Policy Issues

A number of recent Congressional hearings have focused on health policy issues, including the following: A Senate Special Committee on Aging hearing titled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines.”  A Senate Health, Education, Labor & Pensions Committee hearing on “Opioid Abuse in America: Facing the Epidemic and Examining Solutions.” A … Continue Reading

Upcoming Health Policy Hearings

Several Congressional hearings are scheduled next week and into December on health policy issues, including: A November 17 Senate Finance Committee hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” A November 17 House Judiciary Subcommittee on Regulatory Reform hearing on “The State of Competition in the Pharmacy Benefit Manager and Pharmacy … Continue Reading

HHS Schedules November 20 Pharmaceutical Forum on Innovation, Access, Affordability and Better Health

On November 20, 2015, the Department of Health and Human Services (HHS) is hosting a public forum in Washington DC to explore pharmaceutical innovation, access, affordability and better health. While attendance is by invitation only, an invitation can be requested by contacting hhspharmforum@mitre.org. There will also be a live webcast of the event.… Continue Reading

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading

Congressional Health Policy Hearings

Recent Congressional health policy hearings have addressed the following issues: The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on generic drug pricing; The House Oversight and Government Reform Committee focused on its concerns associated with transparency in passage and implementation of the Affordable Care Act in a hearing featuring CMS Administrator Marilyn … Continue Reading

HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 … Continue Reading

GAO Highlights Differences in Federal Program Drug Prices

The Government Accountability Office (GAO) has released data comparing retail prescription drug prices paid by the Department of Defense (DOD), Medicaid, and Medicare Part D for a sample of 78 high-utilization/high-expenditure drugs. In general, the GAO determined that Medicaid paid the lowest average net prices for both brand-name and generic drugs in the sample based … Continue Reading

OIG Highlights Inconsistencies in State Reporting of the Federal Share of Medicaid Drug Rebates

The OIG issued a report today entitled “Inconsistencies in States’ Reporting of the Federal Share of Medicaid Drug Rebates.”  States are eligible for higher federal financial participation (FFP) rates for certain Medical Assistance services, such as those related to family planning, Indian Health Services, and breast and cervical cancer care. Based on prior work, the … Continue Reading

CMS Abandons Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

In an email today to stakeholders, CMS announced that it will not be finalizing the ACA Medicaid federal upper payment limits (FUL) for multiple source drugs in July 2014, as previously intended. CMS attributes the change to a delay in providing detailed guidance to the states in preparation for implementation. CMS expects to announce a … Continue Reading

OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG's expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted. Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG's proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.… Continue Reading

OIG Recommends Expansion of CMS’s Medicare Part B Drug Pricing Substitution Policy

The OIG has issued a report, “Comparing Average Sales Prices and Average Manufacturer Prices for Medicare Part B Drugs: An Overview of 2012,” which assesses CMS’s use of its authority to lower reimbursement for Medicare Part B drugs when a drug’s average sales prices (ASP) exceeds its average manufacturer prices (AMP) or widely available market price … Continue Reading

OIG Examines 340B Program Contract Pharmacy Arrangements in Advance of HRSA Rules

A recent OIG report examined potential problems associated with the growing use of contract pharmacies under the 340B discount drug program. The OIG describes these arrangements as when a 340B covered entity, such as a community health center or disproportionate share hospital, contracts with a pharmacy to dispense drugs purchased through the 340B program on … Continue Reading
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