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A Win for the Hospitals: An Update on the Latest 340B Lawsuit

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.

Primary Care Practice Officially Defined in Florida for APRNs Practicing Autonomously

As many providers in Florida are aware, House Bill 607 (the “Bill”), which was passed in February of last year, gives certain APRNs in Florida the ability to practice autonomously. The only catch is that they must work in primary practice. When the Bill was initially passed, there was question as to what was exactly considered primary care, absent a definition from the Florida Board of Nursing. However, as of February 25, 2021, “primary care practice” has officially been defined.

Part II of the No Surprises Act

The Department of Health and Human Services (“HHS”) published Part II of the No Surprises Act on September 30, 2021, which will take effect on January 1, 2022. The new guidance, in large part, focuses on the independent dispute resolution process that was briefly mentioned in Part I of the Act. In addition, there is now guidance on good faith estimate requirements, the patient-provider dispute resolution processes, and added external review provisions.

No Surprises Act – Notice Requirements

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.[1]

Healthcare Provisions in the Ohio FY 22-23 Budget

Governor Mike DeWine signed Ohio’s Fiscal Year 2022-2023 budget bill (HB 110) into law on July 1, 2021. At almost 1,000 pages and 74.1 billion dollars, the budget lays out the State’s spending for the next two years. Below are a few highlighted provisions from the budget that will be important for the healthcare industry in Ohio

Interim Final Rule for Surprise Billing

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

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.

EKRA Updates: COVID-19 Testing, Employment Agreements, and More

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.

Medicaid Announces Next Generation of Managed Care Organizations

For the first time since 2005, the Ohio Department of Medicaid (“ODM”) made significant changes to the structure of the Medicaid program by finalizing the Medicaid Managed Care Procurement process. The Procurement process began in 2019 at the behest of Governor Mike DeWine who had a goal to make Medicaid managed care more focused on the health and well-being of individuals.

Vaccinating Against Design and Construction Risk: A COGENCE Alliance Momentum Recap

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.

Healthcare Provisions of the American Rescue Plan

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:

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:

Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Important Updates Every Provider Should Know: Information Blocking

In December 2016, Congress passed the 21st Century Cures Act (“Cures Act”) which: (1) authorized funding for the National Institutes of Health to promote medical research and drug development, (2) implemented provisions aimed at addressing the prevention and treatment of mental illness and substance abuse, and (3) reformed certain standards of the Medicare program and federal tax laws to foster healthcare access and quality improvement.

Lessons Learned: Five Tips for Buying or Selling a Practice

If you are anticipating buying or selling a practice during the coming months, you are not alone. The healthcare industry is experiencing a wave of integration. In fact, it has been occurring for several years. Many transactional healthcare attorneys have negotiated and closed dozens of these transactions for clients. They have negotiated on behalf of the sellers in some cases and the buyers in others.

CARES Act Offers Additional Funds to Healthcare Providers Offering Care, Diagnoses, or Testing Related to COVID-19

In order to help prevent, prepare for, and respond to the COVID-19 pandemic, a $100 billion fund, run through the Public Health and Social Services Emergency Fund (PHSSEF), has been made available to cover non-reimbursable costs attributable to COVID-19 under the CARES Act. This fund has been designed to get money into the health care system as quickly as possible. As such, applications will be reviewed, and payments will be made, on a rolling basis. HHS has been given significant flexibility in determining how the funds are to be allocated, as opposed to operating under a mandated formula or process for awarding the funds. While the Secretary of HHS has not yet released guidance on the application process, this is expected in the near future. BMD will provide updates as soon as this information becomes available.