Tag Archives: Federal Trade Commission (FTC)

FTC announces inquiry into PBM practices and orders PBMs to provide information

On June 7, 2022, the Federal Trade Commission (FTC) announced that it would conduct an inquiry into the competitive impact of contracting and other business practices of pharmacy benefit managers (PBMs), including their effects on access to and affordability of prescription drugs.  As part of the inquiry, which is similar to FTC inquiries into other … Continue Reading

Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading marketing … Continue Reading

Congressional Committees Advance Multiple Bills Addressing Surprise Medical Billing, Prescription Drug Policy, and Other Health Policy Issues

Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including:  surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others.  The following are highlights of recent action.  Note that none of the bills … Continue Reading

FTC/DOJ Workshop on Health Care Competition (Feb. 24).

On February 24, 2015, the Federal Trade Commission and the Department of Justice Antitrust Division will hold a public workshop on health care provider organization and payment model developments that may affect competition in the provision of health care services. Topics for discussion include: accountable care organizations; alternatives to traditional fee-for-service payment models; trends in … Continue Reading

Obama Administration Warns Consumers about Potential “Obamacare” Fraud

The OIG has issued a consumer alert warning consumers about potential fraud related to enrollment in ACA Health Insurance Marketplaces. Among other things, the OIG cautions individuals about people asking for money to enroll the individual in the Marketplace or “Obamacare”; high-pressure solicitations; or requests for personal information.  Likewise, HHS, the Department of Justice, and … Continue Reading

GAO Summarizes Stakeholder Views on Health Care Provider Antitrust Policy

The Government Accountability Office (GAO) has issued a report entitled “Federal Antitrust Policy: Stakeholders’ Perspectives Differed on the Adequacy of Guidance for Collaboration among Health Care Providers.” In response to a Congressional request, the GAO examined the perspectives of health care industry groups and antitrust law experts on how federal antitrust guidance may affect the … Continue Reading

December Congressional Health Policy Hearings

A number of Congressional committees have held hearings recently on a variety of health policy issues, including the following: The Senate Judiciary Antitrust Subcommittee held a hearing to examine the proposed Express Scripts/Medco merger; The Senate Finance Committee examined “Drug Shortages: Why They Happen and What They Mean”; The House Oversight and Government Reform Committee … Continue Reading

Reed Smith Analysis and Overview of the Medicare Shared Savings Program for Accountable Care Organizations

The Centers for Medicare & Medicaid Services’ (“CMS”) Medicare Shared Savings Program final rule offers potential opportunities as well as risks to health care providers and suppliers interested in forming accountable care organizations (“ACOs”). While the core principle of the Medicare Shared Savings Program is simple—reward improvements in quality and cost containment through a share of … Continue Reading

CMS Releases Final Medicare Shared Savings Program/ACO Rule

Today the Centers for Medicare & Medicaid Services (CMS) released its long-awaited final rule to implement the Medicare Shared Savings Program as authorized by Section 3022 of the Affordable Care Act (ACA). The Shared Savings Program is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs) to provide cost-effective, coordinated care to Medicare beneficiaries. Under the final rule, an ACO that meets established quality and performance standards and surpasses a minimum savings target will be able to share a percentage of savings (in addition to traditional fee-for-service payments under Medicare Parts A and B).… Continue Reading

FTC Workshop on ACO Policy Scheduled for May 9

On May 9, 2011, the FTC is hosting a workshop to seek input on its "Proposed Statement of Antitrust Enforcement Policy," which discusses how the federal antitrust agencies will enforce U.S. antitrust laws when competing health care providers create new Accountable Care Organizations (ACOs) under the Affordable Care Act.  Note that attendees will be admitted on … Continue Reading

CMS Proposes Long-Awaited Accountable Care Organization (ACO) Regulations

On March 31, 2011, the Centers for Medicare & Medicaid Services ("CMS") proposed highly anticipated regulations setting forth the details of the implementation of new "accountable care organizations" under Section 3022 of the Affordable Care Act ("ACA"). Specifically, the proposed rule would establish a "Shared Savings Program" intended to encourage physicians, hospitals, and other providers and suppliers to ACOs to create accountable care organizations ("ACOs") to provide cost-effective, coordinated patient care. The proposed rule will appear in the April 7, 2011 issue of the Federal Register. CMS will accept comments on the proposed rule until June 6, 2011, and will respond to comments and issue a final rule later this year. CMS anticipates that the Shared Savings Program will begin operating on January 1, 2012, as mandated by the ACA.… Continue Reading

FTC Issues FAQs on Medical Identity Theft

The FTC recently released "Medical Identity Theft FAQs for Health Care Providers and Health Plans". The publication addresses how providers and insurers can minimize the risk of medical identity theft and help patients if they are victimized.… Continue Reading

President Signs into Law Physician Fee Schedule Fix/Extenders Bill, Red Flag Rule Relief, Health Policy Bills

On December 15, 2010, President Obama signed into law H.R. 4994, the “Medicare and Medicaid Extenders Act of 2010.” The new law averts a 25% Medicare physician fee schedule cut previously scheduled to take effect January 1, 2011 under the statutory “sustainable growth rate” formula. The law also continues a variety of expiring Medicare provisions and makes … Continue Reading

Congress Clears Legislation to Exempt Health Care Providers from “Red Flags” Rule

The House and Senate have approved legislation intended to clarify that health care providers and other non-financial businesses are not subject to the Federal Trade Commission’s (FTC) “Red Flag” identity theft rule simply because they extend credit to patients who do not pay for all services at the time services are received. Specifically, S. 3987 … Continue Reading

Congressional Hearings

On December 9, 2010, the House Energy and Commerce Committee held a hearing on “Alzheimer’s Disease: The Ongoing Challenges.” On December 1, the House Judiciary Subcommittee on Courts and Competition Policy held a hearing on “Antitrust Laws and Their Effects on Healthcare Providers, Insurers and Patients.”… Continue Reading

FTC/CMS/OIG Workshop on Accountable Care Organizations (Oct. 5, 2010)

On October 5, 2010, the FTC, CMS, and the OIG are holding a workshop on accountable care organizations (ACOs). These organizations, authorized by the ACA, are designed to deliver high-quality and efficient health care services to consumers. The workshop is intended to assess how the variety of possible ACO structures in different health care markets … Continue Reading

FTC Again Delays Red Flags Rule Enforcement

On May 28, 2010, just shy of the June 1st compliance deadline, the Federal Trade Commission (FTC) announced that it would again be postponing enforcement of the Red Flags Identity Theft Prevention Rule through December 31, 2010. This delay comes at the request of Congress, which has been considering legislation that would affect the scope of entities … Continue Reading

FTC Report on Drug Company “Pay-for-Delay” Agreements

The Federal Trade Commission has released a “staff study” entitled “Pay for Delay: How Drug Company Pay-Offs Cost Consumers Billions.” The report examines agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. According to the study, over the past six years, such agreements delayed … Continue Reading

Red Flag Rule Enforcement Extended Until June 1, 2010

The Federal Trade Commission (FTC) has announced it is extending its enforcement date for its Red Flag identity theft rules from November 1, 2009 until June 1, 2010. This extension, which was made at the request of members of Congress, will provide affected industries – including certain health care providers and suppliers — with additional time … Continue Reading

House Passes Bill to Exclude Small Health Practices from Identity Theft “Red Flags” Rule

On October 20, 2009, the House of Representatives passed H.R. 3763, which would amend the Fair Credit Reporting Act to exclude certain businesses from the “Red Flag” identity theft guidelines, including health care practices with 20 or fewer employees. The bill also would require the Federal Trade Commission to establish a process to allow businesses to … Continue Reading

FTC Further Postpones Identity Theft Red Flags Rule

The Federal Trade Commission (FTC) has announced that it is delaying until November 1, 2009 enforcement of its Identify Theft Red Flags Rule. According to the FTC, this three-month delay will “give creditors and financial institutions more time to review this guidance and develop and implement written Identity Theft Prevention Programs.” The FTC staff also … Continue Reading

FTC Report on “Authorized Generic” Drugs

The Federal Trade Commission (FTC) has issued an interim report on the impact of authorized generic drugs on competition in the prescription drug marketplace. Authorized generics are drugs sold by a pharmaceutical manufacturer under both a brand-name and generic label. In short, the FTC found that retail drug prices average 4.2% lower when authorized generics are marketed … Continue Reading

FTC Issues Report on Follow-On Biological Drug Competition

A lengthy new FTC report on “Follow-on Biologic Drug Competition" issued June 10, 2009 concludes that: Competition between a biologic drug and a follow-on biological (FOB) is much more likely to resemble brand-to-brand competition than the dynamics of brand-generic competition under Hatch-Waxman. Existing incentives that support brand-to-brand competition among biologic drugs – patent protection and market-based pricing … Continue Reading