Health Care Reform & ACA

Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:


Continue Reading OIG Sends a Special Fraud Alert on Speaker Programs

On October 29, 2020, the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) issued a final rule requiring private-sector health insurers and self-insured health plans to disclose treatment prices and cost-sharing information with consumers.  The Transparency in Coverage rule comes in response to President Trump’s executive order aiming to increase transparency in the healthcare industry. It is slated to become effective on January 11, 2021.

The final rule contains three main parts: (1) requirements for plans and issuers to disclose estimated costs associated with covered items or services furnished by a particular provider; (2) requirements for plans and issuers to publicly disclose reimbursement rates; and (3) amendments to the medical loss ratio program rules to allow issuers to receive credit for enrollees’ savings. Each part is discussed below.

Estimated Costs

First, insurers and employer-sponsored health plans will be required to provide price estimates, including in-network and out-of-network negotiated rates, for health care items and services upon request.  The regulation requires these estimates beginning in 2023 for the 500 most “shoppable” items and services on an internet-based self-service tool (and in paper form, if requested by the participant, beneficiary, or enrollee).  Among the 500 “shoppable services” are mammograms, physician visits, colonoscopies, and various blood tests, biopsies, and X-rays, and the full list is specified in the regulations.  Then, beginning in 2024, price estimates for all remaining items and services offered, including procedures, drugs, durable medical equipment, must be disclosed. The price transparency requirements include disclosure of the following:


Continue Reading HHS Finalizes Health Plan Price Transparency Rule

On July 17, 2020, in a 2-1 decision, the  U.S. Court of Appeals for the D.C. Circuit upheld a Trump Administration rule that expands the scope of short-term limited duration insurance (STLDI) plans, affirming the lower court’s opinion that STLDI plans do not violate the Affordable Care Act. Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury , D.C. Cir. App., No. 19-05212 (July 17, 2020).

The rule’s genesis can be traced to an Executive Order issued in October 2017, which aimed to expand the availability of STLDI plans, seen by the Administration as more “appealing and affordable” than plans mandated by the ACA. The order tasked the Departments of Treasury, Labor, and Health and Human Services with expanding the duration of STLDI plans from three months to twelve. The changes also provide for renewals of those plans, which can amount to continuous coverage for up to three years.


Continue Reading Appeals Court Upholds Trump Administration’s Short-term, Limited Duration Insurance Policy Rule

Potentially overlooked between the enactment of the Families First Coronavirus Response Act (the FFCRA) on March 18 and the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) on March 27, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument via teleconference on March 20 in Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury, No. 19-05212 (D.C. Cir. July 30, 2019). At issue in that case is the fate of a Trump Administration rulemaking expanding the scope of non-ACA compliant short-term limited duration insurance (STLDI) plans. Already controversial—with some arguing that STLDI plans increase access to health care, while others decry them as misleading consumers and destabilizing the individual insurance market—STLDI plans are of particular import given the COVID-19 pandemic.

As millions face unemployment, lose access to employer-sponsored health insurance coverage, and qualify to seek coverage via a special enrollment period, others may look to STLDI policies to obtain at least some coverage in the wake of COVID-19. But, as with ACA requirements such as essential health benefits and community rating, STLDI plans are not subject to the recently enacted zero-dollar cost-sharing and other coverage requirements for COVID-19 diagnostic testing.


Continue Reading Appeals Court Hears Argument on Short-term, Limited Duration Insurance Plan Rule; STLDI Plans are not Required to Provide $0 Cost-share of COVID-19 Diagnostic Testing

In part two of this two-part series on what providers should know about COVID-19, hosts Payal Nanavati and Joe Records talk with Brian McGovern about guidance from state and federal health care regulators. This episode touches on how state agencies, CMS, CDC, and other regulatory bodies have instructed providers—especially nursing homes—on how to handle this

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In part one of this two-part series on what providers should know about COVID-19, hosts Payal Nanavati and Joe Records discuss labor and employment issues with

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Xavier Baker and Kevin Kroeker to discuss medical loss ratio requirements. The first episode

The past week has seen daily action at the state and federal level that seeks to ensure that health plans and insurers are providing unrestricted access to testing for COVID-19 and for related services.  Health plans nationally have responded by adopting copayment and preauthorization waivers even where they have not been mandated.

Here are a few of the headlines:

On March 2, 2020, New York Gov. Andrew Cuomo announced he would require state health insurers to waive fees related to coronavirus testing in the state in order to avoid cost as a barrier to testing.  To implement his directive, Governor Cuomo announced that the New York State Department of Financial Services (“DFS”) will promulgate an emergency regulation that (i) prohibits health insurers from imposing cost-sharing on an in-network provider office visit or urgent care center when the purpose of the visit is to be tested for COVID-19 and (ii) prohibits health insurers from imposing cost-sharing on an emergency room visit when the purpose of the visit is to be tested for COVID-19.  In addition, DFS issued other COVID-19 guidance to New York insurers, including: (a) directing insurers to develop robust telehealth programs with their participating providers, and (b) directing insurers to verify that their provider networks are adequately prepared to handle a potential increase in the need for health care services, including offering access to out-of-network services where appropriate and required.
Continue Reading Flurry of Regulatory Activity Driven by COVID-19 Anxiety Impacts Health Plan Requirements and Permissible Actions

In early February, two federal bills targeting surprise billing in healthcare advanced out of committee.  On February 11, the House Education and Labor Committee passed the Ban Surprise Billing Act (H.R. 5800), which was introduced by Chairman Rep. Bobby Scott (D. – Virginia) and Ranking Member Rep. Virginia Foxx (R. – North Carolina).  One day later, the House Ways and Means Committee unanimously advanced the Consumer Protections Against Surprise Medical Bills Act (H.R. 5826), led by Chairman Rep. Richard Neal (D. – Massachusetts) and Ranking Member Rep. Kevin Brady (R. – Texas).  Both bills would prohibit providers from balance billing patients for surprise medical bills and would limit patients’ cost-sharing to in-network amounts.  The two competing bills must be reconciled before the full House can vote on the issue.  Leaders hope to include the final product in a spending bill that must pass Congress by May 22.

Similar scopes of coverage

The competing bills are substantively similar in several ways.  Each bill applies to out-of-network emergency claims, to post-stabilization inpatient services provided to patients who are admitted to the hospital through the emergency room, and to non-emergency services provided at in-network facilities by out-of-network providers.  The Ban Surprise Billing Act also covers air ambulance services.  Additionally, both bills apply to all individual and group health plans (both fully- and self-insured) in the group and individual markets, but do not apply to federal programs such as Medicaid or the Federal Employees Health Benefits Program.  The Ban Surprise Billing Act also extends to grandfathered health plans.

Notice requirements
Continue Reading Competing Surprise Billing Proposals Set to Collide in the U.S. House; States Test Different Solutions

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Xavier Baker and Kevin Kroeker to discuss medical loss ratio. This episode touches on