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Client Alert

ODM to Implement Medicaid Work Requirements: What Providers and Medicaid Expansion Recipients Need to Know

March 21, 2025The Ohio Department of Medicaid (ODM) has submitted a waiver to impose work requirements for Medicaid expansion recipients. If approved, the new eligibility criteria will take effect on January 1, 2026. A federal public comment period is open until April 7, 2025.Client Alert

Ohio Appellate Court Rules in Favor of Gender-Affirming Care

March 19, 2025On March 18, 2025, the 10th District Court of Appeals in Franklin County ruled that Ohio’s House Bill (HB) 68, which restricts puberty blockers and hormone therapy for minors seeking gender-affirming care, violates the Health Care Freedom Amendment and is therefore unenforceable. The court found that the law unlawfully interferes with parental rights and medical decision-making. The case, Moe v. Yost, has been remanded, and Ohio Attorney General Dave Yost intends to appeal.Client Alert

HHS Revokes Public Comment Requirement on Certain Policy Changes

March 5, 2025The U.S. Department of Health and Human Services (HHS) has revoked the Richardson Waiver, eliminating the requirement for public notice and comment on certain policy changes. This decision allows HHS to implement new policies more quickly, potentially affecting healthcare funding rules like Medicaid work requirements. While it speeds up policymaking, it also reduces opportunities for stakeholder input, raising concerns over transparency and unintended consequences for healthcare providers, states, and patients.Client Alert

Ohio Recovery Housing Operators Beware: House Bill 58 Seeks to Make Major Changes

February 26, 2025Ohio House Bill 58 proposes significant changes to recovery housing oversight, granting ADAMH Boards authority to inspect and investigate recovery residences. The bill also introduces a Certificate of Need (CON) program, requiring state approval for major facility changes. OMHAS will assess applications based on cost, quality, accessibility, and financial feasibility. The bill also establishes a recovery housing residence fund to support inspections. For more information, contact BMD attorneys Daphne Kackloudis or Jordan Burdick.Client Alert

January 2025 Notice of Proposed Rulemaking Brings Notable Changes to HIPAA Security Rule

February 25, 2025In January 2025, the U.S. Department of Health and Human Services proposed amendments to the HIPAA Security Rule, aiming to enhance cybersecurity for covered entities (CEs) and business associates (BAs). Key changes include mandatory compliance audits, workforce training, vulnerability scans, and risk assessments. Comments on the proposed rule are due by March 7, 2025.Client Alert

Status Update: Physician Noncompete Agreements in Ohio

February 11, 2025Noncompete agreements remain enforceable in Ohio if they meet specific legal requirements. While the AMA and FTC have challenged these restrictions, courts continue to uphold reasonable noncompete provisions for physicians. Recent cases, like MetroHealth System v. Khandelwal, highlight how courts may modify overly restrictive agreements to balance employer interests with patient care. With ongoing legal challenges to the FTC’s proposed ban, Ohio physicians should consult a healthcare attorney before signing or challenging a noncompete agreement.Client Alert

New Ohio Recovery Housing Rules Take Effect January 1, 2025

January 2, 2025Ohio’s new recovery housing rules, effective January 1, 2025, require certified community behavioral health providers to refer clients only to accredited recovery housing residences listed on the statewide registry.Client Alert

SCOTUS to Weigh In on Medicaid Beneficiaries’ Right to Choose their Provider

January 2, 2025The U.S. Supreme Court will hear arguments this spring on whether Medicaid beneficiaries have an enforceable right to choose their healthcare providers without state interference, as outlined in Section 1902(a)(23) of the Social Security Act. This case stems from a South Carolina petition challenging a Fourth Circuit ruling that blocked the state from terminating Planned Parenthood’s Medicaid provider agreement.Client Alert

Checklist of Legal Considerations for a Med Spa

December 23, 2024Checklist of key legal considerations for a med spa providing a broad overview of certain state and federal legal requirements.Client Alert

Effective December 12, 2024: Key Updates to Ohio Medicaid Rules for CPC and CMC Programs

December 12, 2024Ohio Medicaid has amended rules for the Comprehensive Primary Care (CPC) and Comprehensive Maternal Care (CMC) programs, effective December 12, 2024. Key updates include expanded provider eligibility, stricter cultural competency training timelines, new clinical quality metrics, and changes to maternal care requirements.Client Alert

Ohio Medicaid Extends Timely Filing Deadline Until 2025

December 11, 2024The Ohio Department of Medicaid (ODM) recently announced that it is extending its timely filing deadline to February 28, 2025. According to ODM, roughly 2% of providers have contract issues preventing them from meeting the previous timely filing deadline of December 1, 2024.Client Alert

Another Drug Manufacturer Pursues Rebate Program as 340B Alternative

December 11, 2024Some of the nation’s largest drug manufacturers are forging ahead to implement rebate programs for 340B drugs, even after the federal government has called these programs illegal. While it is unclear how these federal courts will rule, this could threaten the sustainability of safety net providers and their patients.Client Alert

Medicare Making Changes to Improve Behavioral Health Care Access

November 26, 2024The Centers for Medicare & Medicaid Services (CMS) has introduced changes to Medicare’s behavioral health coverage, including allowing Marriage and Family Therapists and Mental Health Counselors to enroll independently, increasing reimbursements for crisis psychotherapy and substance use treatment, and expanding services via community health workers. These updates address gaps in care and improve access to mental health services for Medicare beneficiaries.News Article

NAMAS | Insurance Discrimination - Against the Provider

November 8, 2024Insurance discrimination can go beyond protected classes, such as race, national origin, sex, or religion. It can include discrimination against certain providers. The Affordable Care Act prohibits this type of discrimination by insurers when the provider is acting within the scope of their licensure. Once a proposed rule to implement this protection is in place, there could be wide-reaching reimbursement implications.Client Alert

Permanent Injunction of “Heartbeat” Abortion Ban in Ohio

October 28, 2024Hamilton County Common Pleas Judge Christian Jenkins has ruled Ohio’s six-week abortion ban unconstitutional, citing the state’s new reproductive rights amendment. This ruling emphasizes that Ohio law must fully reflect the will of voters, offering clarity for medical providers and safeguarding women's health care rights.Client Alert

Parental Approval Mandate for Diagnosing Gender-Related Conditions in Minors under Ohio House Bill 68

September 4, 2024Ohio House Bill 68, effective August 6, 2024, introduces strict guidelines for mental health professionals diagnosing and treating minors with gender-related conditions. The law mandates parental or guardian consent before any diagnosis or treatment can proceed. Additionally, professionals must first screen for other comorbidities and assess for any history of abuse. Failure to adhere to these requirements can result in disciplinary action for unprofessional conduct.Multimedia, Blog Post

BMD Vice President Amanda Waesch Shares the Secrets to Her Success

August 8, 2024BMD Vice President and Healthcare Law Member, Amanda Waesch, recently shared the secrets to her success on the Driving Change Podcast. From managing a high-powered career to balancing family life and mentoring the next generation of lawyers, Amanda’s insights are a must-hear. Watch the full interview here!Client Alert

New Medicare Billing Rules: What MFTs, MHCs, and IOP Providers Need to Know

July 9, 2024Starting January 1, 2024, Medicare began covering services provided to Medicare beneficiaries by marriage and family therapists, mental health counselors, and Intensive Outpatient Program (IOP) services. With this change, Medicare has become the primary payer for these services.Client Alert

Chevron Doctrine No More: What the Supreme Court’s Ruling Means for Agency Authority

July 2, 2024On June 28, 2024, the Supreme Court invalidated the Chevron doctrine, nearly 40 years after it first took effect.Client Alert

Ohio Board of Pharmacy Update: Key Regulatory Changes and Proposals You Need to Know

June 26, 2024The Ohio Board of Pharmacy (BOP) has rescinded certain OAC rules (OAC 4729:5-18-01 through 4729:5-18-06), removing regulations on office-based opioid treatment (OBOT) clinics. The rescissions took effect on June 3, 2024. The BOP also published a new rule, OAC 4729:8-5-01, which sets explicit reporting guidelines for licensed dispensaries and became effective on June 7, 2024.Client Alert

LGBTQIA+ Patients and Discrimination in Healthcare

June 6, 2024In early April, the Kaiser Family Foundation released a study outlining the challenges that LGBT adults face in the United States related to healthcare. According to the study, LGBT patients are “twice as likely as non-LGBT adults to report negative experiences while receiving health care in the last three years, including being treated unfairly or with disrespect (33% v. 15%) or having at least one of several other negative experiences with a provider (61% v. 31%), including a provider assuming something about them without asking, suggesting they were personally to blame for a health problem, ignoring a direct request or question, or refusing to prescribe needed pain medication.”Client Alert

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

May 29, 2024SB 269, introduced on December 19, 2023, 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.Client Alert

Unveiling Ohio's Pharmacy Board Updates for Distributors, Mobile Clinics, and Controlled Substances

May 24, 2024The Ohio Board of Pharmacy will hold a public hearing on May 28, 2024, to discuss several proposed changes and additions to Ohio Administrative Code (OAC). These changes pertain to terminal distributors of dangerous drugs (TDDDs), mobile clinics or medication units, and the classification of controlled substances.Client Alert

House Bill 249: Key Updates to Involuntary Hospitalization Law for Mental Health Providers

May 23, 2024House Bill 249 (HB 249) proposes changes to Ohio Revised Code (ORC) Sections 5122.01 and 5122.10 to expand the conditions under which a person with a mental illness can be involuntarily hospitalized.Client Alert

Starting an Advanced Practice Provider Practice

May 13, 2024Advanced practice providers (APPs), which includes non-physician providers such as nurse practitioners, physician assistants, and nurse anesthetists, commonly start their own healthcare practices. Practices may provide, for example, service offerings such as primary care, anesthesiology, mental health, and aesthetics (medical spas). However, there are a number of considerations and steps that must be taken for APPs to compliantly function independently.Client Alert

New Federal Medical Conscience Rule and Its Implications

May 13, 2024The Department of Health and Human Services Office for Civil Rights issued a Final Rule to clarify protections for healthcare providers who refuse services based on religious or moral beliefs. This includes protection against discrimination for refusing procedures like assisted suicide or abortion. The OCR can receive complaints, conduct investigations, and enforce these protections. Entities are encouraged to update policies accordingly and display a model notice provided by the OCR.Client Alert

Marijuana Reclassification and APRN/PA Prescribing

May 7, 2024Marijuana is expected to be reclassified by the Drug Enforcement Administration (DEA) from a Schedule I controlled substance to a Schedule III controlled substance as a result of efforts by the Biden administration.Client Alert

Board of Pharmacy Rule Changes

April 1, 2024Board of Pharmacy made changes to rules effective on March 4, 2024Client Alert

Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board Rule Changes

March 29, 2024The Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board has proposed changes to the Ohio Administrative Code rules discussed below. The rules are scheduled for a public hearing on April 23, 2024, and public comments are due by this date. Please reach out to BMD Member Daphne Kackloudis for help preparing comments on these rules or for additional information.Client Alert

Latest Batch of Ohio Chemical Dependency Professionals Board Rules: What Providers Should Know

March 25, 2024The Ohio Chemical Dependency Professionals Board recently released several new rules and proposed amendments to existing rules over the past few months. A hearing for the new rules was held on February 16, 2024, but the Board has not yet finalized them.Client Alert

The Ohio State University Launches Its Accelerated Bachelor of Science in Nursing Program

February 27, 2024In response to Ohio’s nursing shortage, The Ohio State University College of Nursing is accepting applications for its new Accelerated Bachelor of Science in Nursing program (aBSN). Created for students with a bachelor’s degree in non-nursing fields, the aBSN allows such students to obtain their nursing degree within 18 months. All aBSN students will participate in high-quality coursework and gain valuable clinical experience. Upon completion of the program, graduates will be eligible to take the State Board, National Council of Licensure Exam for Registered Nursing (NCLEX-RN).Client Alert

Enhancing Privacy Protections for Substance Use Disorder Patient Records

February 16, 2024On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) finalized updated rules to 42 CFR Part 2 (“Part 2”) for the protection of Substance Use Disorder (“SUD”) patient records. The updated rules reflect the requirement that the Part 2 rules be more closely aligned with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) privacy, breach notification, and enforcement rules as mandated by the Coronavirus Aid, Relief, and Economic Security Act of 2020.Client Alert

The Ohio Chemical Dependency Professionals Board’s Latest Batch of Rules: What Providers Should Know

January 26, 2024The Ohio Chemical Dependency Professionals Board has introduced new rules and amendments, covering various aspects such as CDCA certificate requirements, expanded services for LCDCs and CDCAs, remote supervision, and reciprocity application requirements. Notable changes include revised criteria for obtaining a CDCA certification, expanded services for LCDCs and CDCAs, and updated ethical obligations for licensees and certificate holders, including non-discrimination, confidentiality, and anti-sexual harassment measures.Client Alert

Governor Mike DeWine and The Ohio State University Introduce the SOAR Study on Ohio Mental Illness

January 22, 2024On January 19, Ohio Gov. Mike DeWine and The Ohio State University announced a new research initiative, the State of Ohio Adversity and Resilience (“SOAR”) study, which will investigate all factors influencing Ohio’s mental illness and addiction epidemic.Client Alert

The Ohio Board of Pharmacy’s Latest Batch of Rules: What Providers Should Know

January 15, 2024The Ohio Board of Pharmacy released several new rules and proposed amendments to existing rules over the past month that will significantly impact pharmacy operations. Topics range from updates to the Terminal Distributor of Dangerous Drugs license to mobile clinics to mandatory rest breaks for pharmacists of outpatient pharmacies. A summary of the proposed changes is below, along with instructions for commenting on the rules. Your BMD healthcare attorney can help write comment letters and submit the comments on your behalf as well.Client Alert

The Second Wave of UnitedHealthcare's Prior Authorization Cuts Started in November

December 11, 2023In August 2023, UnitedHealthcare released its plan to eliminate roughly one-fifth of its then-current prior authorization requirements. The first round of prior authorization cuts took effect on September 1, 2023. In that round, UnitedHealthcare eliminated the necessity for some prior authorizations for UnitedHealthcare Medicare Advantage, UnitedHealthcare commercial, UnitedHealthcare Oxford and UnitedHealthcare Individual Exchange plan members. The second and final round of prior authorization cuts began on November 1, 2023. The November 2023 Prior Authorization Cuts apply to the same plans as well as community plans (i.e., Medicaid managed care plans).Client Alert

Proposed Laboratory Arrangement Draws Heightened Scrutiny from the OIG

October 18, 2023On September 25, 2023, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO). The Opinion involved a proposed arrangement between an independent laboratory and other physician laboratories for the purchase of the technical component of anatomic pathology services. The OIG ultimately concluded that the arrangement at issue, if it was entered into with the requisite intent, would implicate the Federal Anti-Kickback Statute (AKS) and constitute grounds for sanctions.Client Alert

Health Care Inclusivity for the LGBTQIA+ Community

October 5, 2023Healthcare providers, regardless of practice setting, should be aware of the healthcare disparities for LGBTQIA+ individuals, and ways in which they can be more inclusive of these individuals by making modifications to their practices.Client Alert

Obtaining Patient Consent

October 4, 2023Patients have autonomy to choose what can and cannot be done to their bodies. Therefore, informed consent is required before any treatments or procedures commence. This is a stark contrast to the previously recognized paternalistic approach, which relies solely on the decision-making of the provider. However, in order for patients to really choose whether or not to submit themselves to a particular healthcare service, they must actually understand what the service is. Therefore, patient consent should help the patient understand the risks and benefits, as well as any alternative treatment options.Client Alert

Over-the-Counter Contraceptive Pills Are Coming, But Will Insurance Cover Them?

September 20, 2023Client Spotlight

BMD Client Spotlight: Brigid's Path

August 10, 2023Client Alert

Push for Parity: Mental Health Coverage Fifteen Years in the Making

August 7, 2023Client Alert

Recent HIPAA Breach Settlements - Lessons Learned

June 19, 2023According to the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), the consequences for providers may include settlements of $30,000 to $240,000. OCR recently released two settlements for improper breaches of protected health information (PHI) that are good examples of the major monetary penalties that can result from common HIPAA mistakes.Client Alert

Supreme Court Issues Major False Claims Act Decision

June 5, 2023Client Alert

Important Update: New Advanced Beneficiary Notice in Effect for Medicare on June 30, 2023

April 19, 2023On April 4, 2023, the Office of Management and Budget (OBM) approved an updated Advance Beneficiary Notice of Non-coverage (ABN) form CMS-R-131.[1] Providers can continue using the current ABN form with an expiration date of June 30, 2023.[2] However, all providers are mandated to use the new ABN starting on June 30, 2023, which has an expiration date of January 31, 2026.Client Alert

Ohio Medical Board Releases New Telehealth Rules

February 23, 2023On Tuesday, February 21, 2023, the State Medical Board of Ohio released its final telehealth rules to implement Ohio’s telehealth statute (O.R.C. 4743.09) for physicians, physician assistants, dieticians, respiratory care professionals and genetic counselors. Ohio’s advanced practice registered nurses (“APRNs”) should also take note of these rules. While the Medical Board does not govern APRNs directly, those APRNs who are required to have a collaborating physician and standard care arrangement (namely nurse practitioners, certified nurse midwives, and clinical nurse specialists) are still affected by the rules. Generally, if an APRN’s collaborating physician is limited in their practice, then the APRN will also be limited.Client Alert

Five Opportunities for Operations and Compliance Excellence in 2023

February 17, 2023With the holidays behind us and the rest of the year ahead, now is the perfect time to get your operational/compliance house in order! Though your list might be a mile (or an inch) long, here are five places to start.Client Alert

2022 Healthcare Recap and 2023 Healthcare Check-Up

December 20, 2022As the country begins to return to a new “normal” following the COVID-19 pandemic, there are many healthcare rules changing on both the federal and state levels as a result. Thus, it is important for healthcare providers and their employers to be aware of these changing rules, and any implications they may have on their practice. Look back on healthcare in 2022 and find a checklist for 2023.Client Alert

Patient Abandonment and Termination

November 17, 2022Healthcare professionals have a responsibility to patients with whom they have established a treatment relationship. However, there may be some instances when they will need to terminate their relationship with a patient. FAQs for patient abandonment and termination are provided to help guide physicians.Client Alert, News Article

Recent Litigation Challenges the Affordable Care Act Preventive Services Requirement

November 15, 2022The Affordable Care Act (ACA) has been met with numerous legal challenges. The most recent legal challenge, Braidwood Management Inc. v. Becerra, could affect millions of people covered by private health insurance.Client Alert

340C – Prospective Legislation to Protect Federally Qualified Health Centers

November 14, 2022Advocates for Community Health (ACH), an organization created to implement policy and advocacy initiatives for health care systems across the United States, has begun drafting legislation that is geared towards protecting Federally Qualified Health Centers (“FQHCs”) enrolled in the 340B Program, which is being dubbed “340C.”Multimedia

Hot Topics in Physician Employment Agreements

June 13, 2022Our very own, Kate Hickner, sits down with Ronnen Isakov, who is the Managing Director of the Healthcare Advisory Group at Medic Management Group with more than 25 years of experience in the healthcare industry. During this webinar, they discuss various topics like The Big 3, Fair Market Value, Challenges in Industry-wide Healthcare Dynamics, and many more topics. Be sure to subscribe to our YouTube channel to learn more!Client Alert

New York, Kansas, Massachusetts, and Delaware Become the latest States to Adopt Full Practice Authority for Nurse Practitioners

May 19, 2022While the COVID-19 pandemic certainly created many obstacles and hardships, it also created many opportunities to try doing things differently. This can be seen in the instant rise of remote work opportunities, telehealth visits, and virtual meetings. Many States took the challenges of the pandemic and turned them into an opportunity to adjust the regulations governing licensed professionals, including for advanced practice registered nurses (APRNs).Client Alert

No Surprises Act Compliance (Published by NAMAS, 2/25/22)

March 7, 2022The Department of Health and Human Services published three parts to the No Surprises Act towards the end of 2021, which took effect January 1, 2022. The Act is intended to protect consumers from “balance billing,” which occurs when a patient receives a bill with a higher price than they may have anticipated because they did not have knowledge that the provider or facility was out-of-network. The purpose of this article is to note certain requirements that compliance employees will need to be aware of at their facilities, including notice and consent, good faith estimates, and public disclosures.Client Alert

No Surprises Act Update: Federal Judge Strikes Portions of the No Surprises Act

February 25, 2022In a win for providers, a Texas federal court granted the Texas Medical Association’s (TMA) motion for summary judgment and struck down portions of a federal rule that establishes a reimbursement rate arbitration process between payors and providers under the No Surprises Act (NSA).Client Alert

Federal and Ohio Laws on Surprise Billing

January 18, 2022Beginning in January 2022, Ohio providers and healthcare facilities will need to comply with both the federal No Surprises Act (“NSA”) and the state surprise billing law (HB 388), which are both designed to protect patients from unexpected medical bills.Client Alert

New OSHA Guidance for Workplaces Not Covered by the Healthcare Emergency Temporary Standard

June 11, 2021On June 10, 2021, OSHA issued an Emergency Temporary Standard (ETS) for occupational exposure to COVID-19, but it applies only to healthcare and healthcare support service workers. For a detailed summary of the ETS applicable to the healthcare industry, please visit https://youtu.be/vPyXmKwOzsk. All employers not subject to the ETS should review OSHA’s contemporaneously released, updated Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace. The new Guidance essentially leaves intact OSHA’s earlier guidance, but only for unvaccinated and otherwise at-risk workers (“at-risk” meaning vaccinated or unvaccinated workers with immunocompromising conditions). For fully vaccinated workers, OSHA defers to CDC Guidance for Fully Vaccinated People, which advises that most fully vaccinated people can resume activities without wearing masks or physically distancing, except where required by federal, state, or local laws or individual business policies.Client Alert

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

March 18, 2021Last 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.Client Alert

The Future of the Families First Coronavirus Response Act

February 3, 2021Over 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.Client Alert

Ohio Supreme Court Clarifies Medical Statute of Limitations

February 1, 2021The Ohio Supreme Court issued a decision in late December that clarifies and finalizes the Ohio law regarding the period of time in which patients can assert claims for medical malpractice. The Court was examining the interplay between three different statutes being the statute of limitations, the statute of repose, and the savings statute.Client Alert

Ohio Hospitals and Healthcare Clinics: It’s Time to Revisit Your Billing and Collection Practices

February 1, 2021According to a recent Cuyahoga County case, certain healthcare entities may not be protected from liability when engaging in unfair or deceptive billing acts. This decision is consistent with the growing trend across the country to encourage price transparency and eliminate unfair surprise billing practices by health care organizations. Now is the time for hospitals and other health care organizations to revisit their billing and collection policies and procedures to confirm that they are legally defensible and consistent with best practices.Client Alert

HIPAA Business Associate Agreements: Why These Contracts Matter

January 27, 2021No one loves drafting, reading or negotiating HIPAA Business Associate Agreements (BAAs). Yet many of us need to do so, and some of us do so daily. They are often boring, dense and technical, but BAAs are important from both a legal and a business perspective, and they deserve our attention. Failure to enter a BAA when one is required can constitute a HIPAA violation that results in substantial liability, as demonstrated by certain recent Department of Health & Human Services (HHS) settlements.1 A business associate who makes a disclosure that is not authorized by the applicable BAA or required by law can be subject to civil and, in some cases, criminal penalties. Further, parties are often presented with BAAs that contain onerous one-sided indemnification and other provisions that can be devasting to an organization in the event of a HIPAA breach. The significance of a BAA is often not fully understood by the parties until something goes wrong (e.g., a HIPAA security incident or breach, an Office of Civil Rights (OCR) audit or a fracture in the relationship between the parties) and, at that point, there is limited opportunity to mitigate legal and business risk. Ideally, attention should be given at the commencement of the business associate relationship, when the parties are able, to thoughtfully addressing regulatory requirements, planning and preparing for potential adverse events and appropriately allocating risk among the parties. As with most healthcare regulatory compliance initiatives, a proactive approach with respect to BAAs is preferable. This article provides a broad overview of certain BAA requirements and some practical negotiating tips for the parties involved.Client Alert

“I’m Out Of Here!” Now What?

January 27, 2021We all know that the healthcare industry is experiencing a wave of integration. This trend has been evident for many years. Fewer physicians are willing to assume the legal, financial and other business risks associated with owning their own practices. More and more physicians, including anesthesiologists, are becoming employed by large physician groups, health systems and national providers. This shift necessarily involves not only entry into new employment arrangements but also the termination of existing relationships. And those terminations are often governed by written employment agreements, state and federal healthcare laws and employer benefit plans and other policies and procedures. Before pursuing their next opportunity, physicians should pause for a moment and first attend to the arrangement that they are leaving. Departing physicians need to understand their legal rights and obligations when leaving their current employment relationships in order to avoid unintended consequences and detrimental missteps along the way. Here are a few words of practical advice for physicians contemplating an exit from their current employment arrangements.Client Alert

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

January 14, 2021S.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.Client Alert

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

January 14, 2021The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.Client Alert

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

January 14, 2021Just 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.Blog Post

COVID-19 Legal Issues Update and Ask Us Anything Webinar Recording

January 5, 2021Join Brennan Manna Diamond Employment & Labor law Member Jeffrey Miller and Healthcare & Employment law Partner Bryan Meek on December 10 ET for 'COVID-19 Legal Issues Update and Ask Us Anything' webinar.Client Alert

UPDATE - Vaccine Policy Considerations for Employers

January 4, 2021If 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.Client Alert

Healthcare Speaker Programs: New OIG Alert

December 11, 2020In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.Client Alert

Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

December 11, 2020The 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.Client Alert

Lessons Learned: Five Tips for Buying or Selling a Practice

November 19, 2020If 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.Client Alert

HHS Provider Relief Funds Reporting Requirements: Important Updates Every Provider Should Know

November 4, 2020HHS continues to revise its reporting requirements for the use of the Provider Relief Funds. Providers with more than $10,000 in Provider Relief Fund payments must report on the use of the funds through December 31, 2020. The reporting window will begin on January 15, 2021 and providers must complete reporting obligations for FY 2020 by February 15, 2021 through a portal designed by HHS. However, providers that have unexpended funds as of December 31, 2020, will have an additional 6 months to use the remaining funds through June 30, 2021. These providers must submit a second and final report no later than July 31, 2021.Blog Post

Ohio COVID Immunity Bill

October 24, 2020Scott P. Sandrock, a Member of BMD shares the logistics of Amended House Bill 606, which grants immunity to essential workers who transmit COVID-19.Client Alert

Pondering Over Patient Billing: CARES Act and Provider Relief Fund Lead to More Questions

April 16, 2020On April 11, 2020, HHS, along with the Department of Labor and Department of the Treasury, issued jointly prepared FAQs regarding the FFCRA, the CARES Act, and other health coverage issues. The FFCRA was enacted on March 18, 2020 and requires group health plans and health insurance issuers to provide benefits for certain items and services related to diagnostic testing for COVID-19. Additionally, plans and issuers must provide coverage without imposing any cost-sharing requirements (deductibles, copayments, and coinsurance), prior authorization, or other medical management requirements.Client Alert

Important Update and FAQs: HHS Tweaks Guidance on The CARES Act Provider Relief Fund Terms and Conditions

April 16, 2020On April 10, 2020, many providers awoke to find electronic payment deposits from Department of Health and Human Services (HHS) in their bank accounts. This was the first round of $30 billion of payments from the HHS Provider Relief Fund as a result of the CARES Act, which was signed into law on March 27, 2020. All healthcare providers that received Medicare fee-for-service payments in 2019 should have received a payment.Client Alert

FCC Funding Opportunity for Telehealth Equipment – Portal Open

April 13, 2020Telehealth is becoming a necessary practice for healthcare providers during the COVID-19 pandemic. However, not all providers have the means to institute a telehealth program. In order to help non-profit and public healthcare providers utilize telehealth, the Coronavirus Aid, Relief and Economic Security (CARES Act) set aside $200 million in funds for telehealth equipment, broadband connectivity, and information services. The FCC has recently released a guidance document that describes how eligible providers can apply for this “COVID-19 Telehealth Program” and the portal for applying will open today, April 13, 2020 at 12:00 PM ET.Blog Post

Will Your Business be Keying More Credit Card Transactions as a Result of COVID-19?

April 9, 2020In this hectic time and uncertainty, owners are making hard decisions regarding their businesses. Some are shutting down, while others are adapting to the daily life changes of COVID-19. Many medical practices are seeing patients on an emergency basis and others are starting to implement a telehealth approach.Client Alert

CLIENT ALERT UPDATE: AHCA License Alert

January 31, 2020IMPORTANT UPDATE: AHCA updated its website to clarify that all Behavior Analysis (“BA”) Groups have either (1) a health care clinic license or (2) an exemption from licensure as a health care clinic under Fla. Stat. 400.9905(4)(g) by December 1, 2020. Florida Medicaid has also updated Section 9.5, Appendix E of the Florida Medicaid Enrollment Policy, which confirms the December 1, 2020 date. This date extends the previously published date from July 1, 2020 to December 1, 2020.Client Alert

AHCA License Alert: What Every Behavior Analysis Provider Should Know!

January 9, 2020By July 1, 2020 the Florida Agency for Health Care Administration (“AHCA”) will require that all Behavior Analysis (“BA”) Groups have either (1) a health care clinic license or (2) an exemption from licensure as a health care clinic under Fla. Stat. 400.9905(4)(g).Client Alert

CLIENT ALERT: CMS Unveils New Price Transparency Rules

November 22, 2019On November 15th, the Trump administration put forth two long-anticipated rules that increase price transparency for both hospitals and insurers. These rules are a step toward price transparency across the health care industry and are in furtherance of the Trump administration’s goal of empowering healthcare consumers. The finalized rule and the proposed rule strive to make pricing information more available to healthcare consumers so they can make informed health care decisions. Through price transparency, consumers should expect to see a reduction in healthcare costs in the future. In order to provide hospitals enough time for compliance with the new requirements, the effective date of the finalized rule is January 1, 2021. The comment period for the proposed rule is open until January 14, 2020.Client Alert

CLIENT ALERT: Will Ohio Recognize a Biddle Claim in a Post-HIPAA World?

October 17, 2019OHIO SUPREME COURT WILL HEAR CASE INVOLVING CLASS ACTION FOR ALLEGED HIPAA VIOLATIONS: Will Ohio Recognize a Biddle Claim in a Post-HIPAA World?Client Alert

CLIENT ALERT: Proposed New Rules to both the Stark Law and the Anti-Kickback Statute

October 14, 2019On October 9, 2019, as part of the “Regulatory Sprint to Coordinate Care,” the Centers for Medicare and Medicaid Services (“CMS”), along with the US Department of Health and Human Services, Office of Inspector General (“OIG”), proposed new rules to both the physician self-referral law (“Stark Law”) and the Anti-Kickback Statute (“AKS”). Rule changes are aimed at fostering innovative arrangements for coordinating care consistent with a shift to a value-based system. Both proposed rules are expected to be published to the Federal Register on October 17, 2019. Public comments are due 75 days after publication.News Article

Medical Records Update

February 27, 2019In order to help standardize forms to authorize the release of medical records, the Ohio Legislature directed the Ohio Medicaid Department to develop a standardized form to be used by healthcare providers which would authorize the release of medical information in compliance with provisions of HIPAA, state law and the substance abuse and other disorder regulations. Ohio Medicaid has issued a standardized form which use will be effective February 1, 2019.new

Unprecedented Medicare Reversal Victory for BMD's Health Law Department

February 25, 2019BMD's RAC Team, lead by attorney, Amanda L. Waesch, reversed a $3.6 million over-payment at Level 1.Client Alert

CLIENT ALERT: Medicare Trust Fund to Run Out of Funding Beginning in 2026, Likely to See an Increase in Audits, Overpayment Demands and Extrapolations

June 6, 2018Pursuant to a Medicare Trustee Report released on June 5, 2018, the Medicare trust fund will run out of funding beginning in 2026, which is three years earlier than previously expected. Although the Trustee’s report requests that Congress and the President act with urgency to remedy this problem, in the short term, we expect to see an increase in government payer audits, overpayment demands, and extrapolations.Client Alert

CLIENT ALERT: Prohibition on Recoupment Prior to Exhaustion of Administrative Remedies

May 18, 2018In April, the Fifth Circuit Court of Appeals, in Family Rehabilitation, Inc. v. Azar No. 17-11337 (5th Cir. 2018), held that district courts are authorized to enjoin the Centers of Medicare & Medicaid Services (“CMS”) and its contractors from recouping alleged overpayments prior to the completion of the administrative appeal process.Client Alert

CLIENT ALERT: Low Volume Appeals Settlement for RAC Appeals

May 4, 2018In April, the Centers for Medicare & Medicaid Services (“CMS”) issued a new settlement proposal to providers with outstanding appeals at the Office of Medicare Hearings and Appeals (“OMHA”) and the Medicare Appeals Council (“MAC”). Essentially, CMS is offering to pay up to 62% of the claim to the provider for qualifying claims that are currently in the appeal process. Interested providers may submit an Expression of Interest (“EOI”) to CMS by June 8, 2018. Providers should explore this settlement opportunity and submit an EOI to receive an offer of settlement. Providers may decline the offer after the EOI is submitted. Brennan, Manna & Diamond, LLC’s Provider Relations, Audit, and Appeals Unit, a division of its Healthcare Department, is able to assist providers with filing the EOI, analyzing the outstanding claims subject to the settlement, and reviewing the Administrative Agreement that is offered by CMS.Client Alert

Medical Marijuana Rules and You

April 4, 2018The Ohio Medical Board has adopted regulations in conjunction with the Ohio Pharmacy Board that would govern physicians who may elect to participate under the Ohio Medical Marijuana statutes.News Article

BMD's Daphne Kackloudis Drafting Legislation Seeking Additional Funding for Children Born Addicted to Opioids

March 5, 2018BMD's Daphne Kackloudis has been working with her client, Brigid's Path, to help them gain access to additional federal funds for their mission. She has drafted legislation which would do just that. The CRIB Act would amend the Social Security Act to allow Medicaid reimbursement for residential pediatric recovery centers such as Brigid's Path. Congressman Turner is going to ask Sen. Portman to amend his opioid bill (CARA 2.0) to include the CRIB Act.News Article

Daphne Saneholtz Discusses ACA Repeal and Effects on Ohioans

August 1, 2017The latest roadblock in efforts to dismantle the Affordable Care Act has many Ohioans living with HIV and AIDS relieved, but still concerned about what's next.News Article

BMD Recognized for Health Law Practice

November 8, 2016“Ever since its founding in 2000, attorneys at Brennan, Manna & Diamond have focused on offering a full range of services to all the firm’s clients, including developing industry-specific practice areas like healthcare,” said Matt Heinle, co-managing partner at the firm.News Article

Defining Concierge and Boutique Medicine

September 21, 2016Amanda 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.Client Alert

Urine Drug Testing Best Practices

August 18, 2016The purpose of this suggested compliance plan is to provide guidance and best practices for prescribers of opiates and benzodiazepines. Compliance with OARRS is required. In addition, urine drug testing (UDT) among pain management physicians, OBGYNs, psychiatrists, and orthopedics is a useful tool that can not only assist in diagnostic and therapeutic decision making, but can also be used as a personal risk reduction tool for those physicians prescribing pain medications.Blog Post

HIPAA Compliance Update

January 20, 2016HIPAA 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.

Changes to Physician Assistant Requirements Under SB 110

September 24, 2015On July 16, 2015 Governor Kasich signed Senate Bill 110 into law, which will become effective October 15, 2015. This bill seeks to modernize physician assistant practices.