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Everything you need to know about BMD and the industry.

Hot Topics in Physician Employment Agreements

Our 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!

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

While 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).

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

The 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.

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

In 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).

Federal and Ohio Laws on Surprise Billing

Beginning 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.

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

On 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.

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.

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.

Ohio Supreme Court Clarifies Medical Statute of Limitations

The 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.

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

According 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.

HIPAA Business Associate Agreements: Why These Contracts Matter

No 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.

“I’m Out Of Here!” Now What?

We 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.

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

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.

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

The 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.

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.

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

Join 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.

UPDATE - Vaccine Policy Considerations for Employers

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.

Healthcare Speaker Programs: New OIG Alert

In 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.

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

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.

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.

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

HHS 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.

Ohio COVID Immunity Bill

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

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

On 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.

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

On 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.

FCC Funding Opportunity for Telehealth Equipment – Portal Open

Telehealth 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.

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

In 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 UPDATE: AHCA License Alert

IMPORTANT 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.

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

By 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: CMS Unveils New Price Transparency Rules

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

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

On 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.

Medical Records Update

In 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.

Unprecedented Medicare Reversal Victory for BMD's Health Law Department

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

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

Pursuant 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: Prohibition on Recoupment Prior to Exhaustion of Administrative Remedies

In 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: Low Volume Appeals Settlement for RAC Appeals

In 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.

Medical Marijuana Rules and You

The 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.

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

BMD'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.

Daphne Saneholtz Discusses ACA Repeal and Effects on Ohioans

The 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.

BMD Recognized for Health Law Practice

“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.

Defining Concierge and Boutique Medicine

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.

Urine Drug Testing Best Practices

The 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.

HIPAA Compliance Update

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.

Changes to Physician Assistant Requirements Under SB 110

On 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.