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S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio

Just before the end of calendar year 2020 and at the end of its two-year legislative session, the Ohio General Assembly passed Senate Bill 263, which prohibits insurance companies and pharmacy benefit managers (“PBMs”) from imposing on 340B Covered Entities discriminatory pricing and other contract terms. This is a win for safety net providers and the people they serve, as 340B savings are crucial to their ability to provide high quality, affordable programs and services to patients.

What is the 340B program?

The 340B program provides discounts on outpatient prescription and over-the-counter drugs to certain safety net health providers, called Covered Entities (“CEs”). The program's intent is to stretch scarce federal resources by allowing CEs to increase patient services with the savings realized from participation in the 340B program. Federally Qualified Health Centers (“FQHCs”), FQHC Look-Alikes, Ryan White Clinics, and Disproportionate Share Hospitals are CEs. CEs typically save 18-50% on outpatient drug costs through participation in the program. CEs use 340B savings to provide needed services – such as behavioral health, dental, case management and enhanced pharmacy management – to the most underserved Ohioans such as those who literally cannot afford to pay for health care services.

How does the 340B program work?

Section 340B(a)(1) of the Public Health Service Act requires that the U.S. Secretary of Health and Human Services enter into a pharmaceutical pricing agreement (“PPA”) with each manufacturer of covered outpatient drugs. Through the PPA manufacturers agree to charge a price for covered outpatient drugs that will not exceed an amount determined under the statute. This is known as the 340B ceiling price. The PPA “shall require that the manufacturer offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.”[1] 

What does this mean in the context of SB 263?

SB 263 stops a practice negatively affecting 340B Covered Entities – insurance companies and PBMs diverting funding intended to care for underserved patients and communities to increase their profit margins. This happens when insurance companies and PBMs target 340B providers with discriminatory contracts – contracts that absorb all or part of the savings earned by 340B providers. They do this by reducing reimbursement and/or adding fees not applicable to non-340B providers, and then forcing CEs to either sign the contract or not be able serve patients in their network. Despite insurance companies and PBMs being aware that CEs depend on 340B savings to serve every patient who walks in its doors, regardless of ability to pay, they continue to offer discriminatory contracts to CEs. This practice isn’t just theoretical. One real-life example of a Payor/CE contract includes language that explicitly reimburses the CE more than 30 times less for a 340B brand name drug than for a retail brand name drug. In this same real-life example, not only does the Payor reimburse the CE significantly less for 340B drugs, it entirely wipes out the 340B savings intended for the Covered Entity, as provided in federal law.

The passage of SB 263 will help to end the predatory contracting practices of PBMs and insurance companies and was vital for CEs that rely on 340B savings. For questions about the 340B program or SB 263 please reach out to healthcare attorney Daphne Kackloudis at dlkackloudis@bmdllc.com.

For an update on federal actions being taken to reduce predatory practices of PBMs, see BMD Healthcare and Hospital Law Member Jeana Singleton's article HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements.

[1] https://www.hrsa.gov/opa/manufacturers/index.html

Surprise! A Cautionary Tale for Out-Of-Network Billing: The No Surprises Act and the Impact on Healthcare Providers

SURPRISE! Congress passed The No Surprises Act at the end of 2020. Providers, particularly those billing as out-of-network providers, should start thinking about strategies to comply with this new law, set to take effect on January 1, 2022. In its most basic sense, the new law prohibits providers from billing patients for more than the in-network cost-sharing amount in most situations where surprise bills happen. It specifically applies to non-government payers and the amounts will be set through a process described in the new law. In particular, the established in-network cost-sharing amount must be billed for the following services:

Ohio Enacts Substantial Changes to Employment Discrimination Laws

In January, Governor Mike DeWine signed into law the Employment Law Uniformity Act, amending the employment protections in the Ohio Civil Rights Act in several significant ways. Such changes to the state’s anti-discrimination and anti-harassment laws have been considered and debated for years and finally made their way into Ohio law. What has changed for employment claims under the amended Ohio Civil Rights Act?

OHIO ADOPTS THE SERIES LLC: Implementation of Ohio’s Revised Limited Liability Company Act is Coming

On January 7, 2021, Ohio adopted S.B. 276. The new legislation establishes the Ohio Revised Limited Liability Company Act (“ORLLCA”) which effectively replaces the current Ohio LLC Act. ORLLCA will be fully effective as of January 2022. While the new law contains numerous changes to the existing LLC landscape, below is an overview of some of the key differences under the ORLLCA.

Will Federal Legislation Open Cannabis Acquisition Floodgate?

Are potential buyers quietly lobbying at federal and state levels to kick open the door to launch a new round of strategic acquisitions? Will presently pending federal legislation, the SAFE and MORE Acts, providing safe harbor for banks and re- or de-scheduling marijuana, be sufficient to mobilize into action major non-cannabis companies that previously shunned the cannabis industry due to the unknown implications of owning businesses whose activities are illegal under federal law?

The Future of the Families First Coronavirus Response Act

Over the last year we all have had to adjust to the new normal ushered in by the coronavirus pandemic. Schools and daycares closed, businesses transitioned from in-office work to work from home, bars and restaurants have closed their doors...all to slow the spread and try to prevent this pandemic from spiraling out of control. The start of the pandemic was utter pandemonium. Working parents trying to balance both caring for their now at-home children and their livelihood. Businesses trying to decide how to implement leave policies with limited information. Employees determining if they could financially afford to take time off. We were all flying by the seat of our pants trying to adjust to our new normal.