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Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

Client Alert

Senate Bill 269 (SB 269), introduced on May 14, 2024, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

What is the Federal 340B Drug Pricing Program?
Under the 340B Program, Federal law permits covered entities to buy outpatient prescription drugs from drug manufacturers at a discount. In exchange for committing to serve historically marginalized and underserved patients, payors reimburse covered entities at retail rates, allowing the covered entity to realize a savings. Covered entities reinvest that savings into their services and programs; the savings covered entities achieve through the 340B Program helps them stretch scarce federal resources. Without the 340B Program, covered entities will not be able to provide care to vulnerable populations.

What Does SB 269 Do?
Prohibits Restrictive Practices: SB 269 prohibits drug manufacturers, re-packagers, third-party logistics providers, and wholesale distributors (and their agents or affiliates) from denying, prohibiting, restricting, discriminating against, or otherwise limiting the acquisition or delivery of 340B drugs to covered entities, unless required by Federal law. The law would prohibit drug manufacturers and others from limiting covered entities’ use of contract pharmacies, a practice that interferes with the ability of patients who rely on covered entities to access needed health care services and affordable prescription drugs. Under the bill, these parties also cannot require 340B covered entities to submit claims or utilization data as a condition for acquiring or delivering 340B drugs, unless such data sharing is mandated by Federal law.

Enforcement and Penalties: Under the bill, violations of these provisions may result in a civil penalty of $50,000 per violation, as well as referral to the Ohio Board of Pharmacy for further action.

Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com with any questions about SB 269 or the 340B drug pricing program, or to weigh in with your lawmaker about the bill.


HHS Delays Quarterly Reporting for Provider Relief Funds

There is good news for providers that received either (1) General Distributions from the HHS Provider Relief Funds [link to my article], or (2) Targeted Distributions from the HHS Provider Relief Funds [link to Ashley’s article]. HHS reversed its stance requiring quarterly reports for providers that received Provider Relief Funds and PPP loan monies. The initial quarterly reports would have been due by July 10, 2020. However, on June 13, 2020, HHS delayed the quarterly reporting requirement.

July 20 is Important Deadline for HHS Fund Distributions to Medicaid and CHIP Providers

On June 10, 2020, the U.S. Department of Health and Human Services (“HHS”) released details on the distribution of more CARES Act Provider Relief Fund payments. After allocating $50 billion to Medicare providers through its General Distribution fund, HHS has now announced that it will distribute $15 billion to eligible Medicaid and CHIP providers who apply by the deadline through a Targeted Distribution. Applicants must apply through the Enhanced Provider Relief Fund Payment Portal. The application form itself can be found on the HHS website and is due by July 20, 2020.

DOJ Updates Corporate Compliance Plan Guidance

With the passage of the Affordable Care Act in 2010, all healthcare providers were required to adopt and implement a corporate compliance plan. Historically, having an effective corporate compliance plan in place has been key to defending healthcare providers in fraud and abuse actions by Medicare, Medicaid, and commercial payers. Over the past couple of years, the U.S. Department of Justice’s (DOJ) Criminal Division has increased the number of prosecutions against U.S. corporations, including healthcare providers. Earlier this month, the DOJ’s Criminal Division updated its “Evaluation of Corporate Compliance Programs” guidance to educate prosecutors on how a corporate compliance program will be evaluated going forward.

IRS Responds - Economic Impact Payments Do Not Belong to Nursing Homes or Care Facilities

In response to the concerns that some nursing homes and care facilities have been taking patients economic impact payments (“EIP”) and claiming the EIP belongs to the facility, the IRS issued a reminder that the EIP does not belong to a nursing home or care facility even if that facility receives the individual’s payments, either directly or indirectly. The EIP does not count as income or a resource in determining an individual’s eligibility for Medicaid or other federal programs for a period of 12 months from when the EIP is received. What this means: an individual’s EIP does not have to be turned over by the benefit recipient.

Title VII to Protect LGBTQ Community

It is not every day that the United States Supreme Court issues a decision that dramatically changes the workplace, but it happened this week. In a landmark decision captioned as Bostock v. Clayton County, issued by the Court on June 15th, the Court ruled that federal law prohibiting discrimination on the basis of “sex” will now include protections for individuals on the basis of sexual orientation, transgender, and gender identity.