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A Win for the Hospitals: An Update on the Latest 340B Lawsuit
June 16, 2022
On Wednesday, the Supreme Court unanimously rejected massive payment cuts to hospitals under the 340B drug discount program. Now, the Department of Health and Human Services no longer has the discretion to change 340B reimbursement rates without gathering data on what hospitals actually pay for outpatient drugs. This “straightforward” ruling was based on the text and structure of the statute, per the Supreme Court. Simply put, because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.
Jeana Singleton and Jordan Burdick
No Surprises Act – Notice Requirements
September 22, 2021
On July 1, 2021, the Biden Administration passed an interim final rule: Part 1 of the “Requirements Related to Surprise Billing Act,” in an attempt to curb excessive costs patients are required to pay in relation to surprise billing. The rule is set to take affect January 1, 2022, and will only affect those who are enrolled in insurance via their employers, as federal healthcare programs already prohibit this type of billing.
Amanda Waesch with Rachel Stermer
Interim Final Rule for Surprise Billing
July 12, 2021
In an effort to implement the new bipartisan No Surprises Act, on July 1, 2021, the Department of Health and Human Services (HHS), along with the Departments of Labor and Treasury, issued an interim final rule to safeguard patients against unforeseen medical bills arising from out-of-network care.
COVID, Privacy and More! New Challenges for Physicians in 2021
May 12, 2021
While hopefully we are coming out of the pandemic, the legal repercussions related to legislative initiatives and other actions during that time continue to apply to businesses in general and healthcare practices. It is a helpful reminder that practices make certain that they maintain accurate records in order to satisfy the reporting requirements under the various COVID-related bills and protect yourself from future employment claims.
Scott P. Sandrock
EKRA Updates: COVID-19 Testing, Employment Agreements, and More
May 7, 2021
Ever since the Eliminating Kickbacks in Recovery Act (“EKRA”) was passed by Congress in 2018, we have been waiting to see how the law is interpreted and ultimately enforced. As a reminder, EKRA seeks to eliminate kickbacks in return for patient referrals to facilities that treat those overcoming addiction, such as recovery homes, clinical treatment centers, and laboratories. (NOTE: EKRA applies to all laboratories, not just those related to addiction treatment.) It is essentially an expansion of the Anti-Kickback Statute, which only applies to those services that are reimbursable through federal healthcare programs such as Medicare and Medicaid, to now also cover services reimbursable through private insurers.
Jeana Singleton with Rachel Stermer
Vaccinating Against Design and Construction Risk: A COGENCE Alliance Momentum Recap
March 18, 2021
Last month, COGENCE Alliance hosted a four-day conference, attended by owners, affiliates, construction managers, trades, engineers, and architects. David Scott presented and other BMD team members hosted breakout discussions on how to “vaccinate against design and construction risk.” Groups discussed new and developing risks, how to mitigate those risks, and qualities of those who best adjusted to the new and developing risks.
Krista D. Warren
Healthcare Provisions of the American Rescue Plan
March 17, 2021
On March 11, 2021, President Joe Biden signed into law H.R. 1319, the American Rescue Plan Act of 2021 (the “ARP”). In addition to the widely reported additional stimulus paychecks, the ARP includes many provisions related to the healthcare industry and marketplace that seek to improve access and affordability. The major provisions of the ARP that affect the healthcare sector are summarized below:
Ashley B. Watson
Surprise! A Cautionary Tale for Out-Of-Network Billing: The No Surprises Act and the Impact on Healthcare Providers
February 25, 2021
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 S.B. 310 Loosens Practice Barrier for Advanced Practice Providers
January 14, 2021
S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.
Jeana Singleton and Ashley Watson
S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio
January 14, 2021
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.
UPDATE - Vaccine Policy Considerations for Employers
January 4, 2021
If you read our post from November, you’re already an informed employer. This first post of 2021 is to share good news, give a few updates, and answer some other common questions. Q: What’s the Good News? First, the EEOC confirmed that employers may require employees receive the COVID-19 vaccine. Second, polling indicates that the number of Americans who said they will receive a vaccine has increased from around 63% to over 71%. The number of Americans who are strongly opposed to a vaccine is about 27%. Third, initial returns show that the efficacy rate for certain vaccines is as high as 95% for some at-risk recipients.
Jeffrey C. Miller
Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes
December 11, 2020
The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.
Jeana Singleton and Ashley Watson
Defining Concierge and Boutique Medicine
September 21, 2016
Amanda L. Waesch, Partner at Brennan, Manna & Diamond, LLC, Akron, Ohio, shared with the Stark County Medical Society Membership alternative physician practice structures, pros and cons of each structure, and the differences between Institutional Providers and Concierge Medicine.
Brennan Manna Diamond
HIPAA Compliance Update
January 20, 2016
HIPAA compliance has been a part of the regulatory landscape of healthcare since the privacy rules became effective in 2003. Since that time, most providers have taken steps to develop their compliance plans, including distributing notices of privacy practices, obtaining authorizations for release of information as needed, and obtaining business associate agreements from third parties.
Scott P. Sandrock