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Everything you need to know about BMD and the industry.

The Latest CMS Guidance: HIPAA Edition

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.

Healthcare Industry Business Development: Insights from a Legal and Marketing Perspective

Kate Hickner sits down with Jennifer Malcolm, who is a multi-award-winning entrepreneur who is passionate about showcasing organization’s stories through multi-creative measures. Jennifer works locally, nationally, and internationally. Some main topics in the Healthcare Marketing: Legal Considerations covered in this webinar are as follows: Federal Anti-Kickback Statute (AKS), Eliminating Kickbacks in Recovery Act of 2018 (EKRA), Free-Splitting, Licensure, and Other State Requirements, Civil Monetary Penalties (CMP) Law, and HIPAA. Be sure to subscribe to our YouTube channel to learn more!

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!

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.

BMD Client Spotlight: AxessPointe Community Health Centers

BMD is happy to share background on our client AxessPointe. Client Contacts: Mark Frisone, Interim CEO Jay Williamson, MD, Board President Industry: AxessPointe Community Health Centers is a federally qualified health center (FQHC) serving patients throughout Summit and Portage counties, including five current sites in Northeast Ohio: three in Akron, one in Kent and one in Barberton. As an FQHC, AxessPointe is a non-profit corporation that delivers primary medical, dental and preventive health services in medically underserved areas. AxessPointe also provides pharmacy, women’s health and behavioral health services. Across all five sites, AxessPointe currently employs 130 total medical and administrative staff. In 2019, they served more than 21,000 individual patients, with more than 66,000 encounters.

“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.

American Heart Association's 2021 Go Red For Women

The BMD Season of Giving in 2020 was a great way to help out organizations that help others. Continuing community involvement in 2021, we will be looking to the American Heart Association's Go Red for Women campaign. Healthcare and Hospital Law Member and Vice President Amanda Waesch is the Chair of Go Red for Women for the American Heart Association, which is kicking off the 28 days of Heart Health. Show your support on February 5th with “Wear Red and Give” Day. Consider hosting a Jeans Day every Friday in the month of February at your place of business in support of Go Red For Women, even encouraging remote employees to participate. Snap a pic of your team members in their red gear and post on social media (socially distanced in person or a virtual group photo will work, too!) – see the toolkit here for sharing on your favorite social platforms. Click here to learn more and donate to the GRFW Campaign.

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.

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.

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.

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.

Ramping Up – A Quick Guide to Pressing COVID-19 Employment Law Issues

As the country continues to grapple with a global pandemic that now seems to be never-ending, businesses everywhere are waking up to realize that the calming of the COVID-19 employment issues over the summer has come to an end. As cases rise exponentially in all 50 states as we head into the winter months, the number of employment issues related to COVID-19 will also increase dramatically. For these reasons, it is important that we return to the employment law basics that were covered this prior spring, while highlighting the many lessons we have learned along the way. As COVID-19 matters and concerns continue to hinder the working environment of every business, it is important that you reference this review to guide you through these tough issues and questions.

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.

Should I Apply for Phase 3 Funds? Important Considerations Every Provider Should Know

On October 1, 2020, the Department of Health and Human Services (“HHS”) announced an additional $20 billion in new funding for providers through a Phase 3 distribution. Importantly, providers that previously received HHS Provider Relief Funds or already received payments of approximately 2% of annual revenue from patient care are eligible to apply. Eligible providers have until November 6, 2020 to apply for these Phase 3 Funds. However, the question from providers continues to be: Should I Apply for Phase 3 Funds?

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.

Time to Update Your HIPAA Compliance Plan for Telehealth Policies and Procedures

The delivery of healthcare in this country may be forever changed following the COVID-19 pandemic. Providing services through telehealth technologies initially allowed providers to connect with patients in a safe and socially distant manner and helped keep vital hospital beds free for COVID-19 care. Now, while still a safe, socially distant option, telehealth allows patients to access healthcare services in an efficient manner, decreases the likelihood of cancellations, and expands access to services that do not require an in-person encounter (i.e., surgery, procedure, or test). Telehealth is now widely reimbursed by both federal and commercial payors and more provider types are able to provide telehealth services within their licensed scope of practice.

Ohio House Passes Bill 388 Including Out-of-Network Reimbursement Requirements

On May 20, 2020, the Ohio House of Representatives unanimously passed House Bill 388, which would enact five new Ohio Revised Code sections regarding out-of-network care and reimbursement.

BMD President Matt Heinle Shares Insights on the Critical State of Hospitals

The critical state of Hospitals in America due to the coronavirus pandemic.

Healthcare Providers: Comparison of New OIG Waivers and Flexibilities under Anti-Kickback Statute in Response to COVID-19

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued several temporary regulatory waivers to further enable the American healthcare system to respond to the COVID-19 pandemic with more efficiency and flexibility (the “Blanket Waivers”).

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.

The CARES Act Provider Relief Fund: What We Know So Far…

The CARES Act that was signed into law of March 27, 2020 provides for the Provider Relief Fund, which set aside $100 billion in relief funds for healthcare providers with expenses or lost revenue attributable to COVID-19. On April 9, 2020, the Department of Health and Human Services (“HHS”) released the first round of $30 billion of funding. All healthcare providers that received Medicare fee-for-service reimbursements in 2019 should have received a distribution. Payments will be made via electronic payment. Providers that do not receive electronic payment will receive paper checks over the next few weeks.

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.

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.

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.

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.

Blockchain in Healthcare

Martin Pangrace and Jeana Singleton presented at the Inaugural Midwest Telehealth Resource Center Annual Conference held July 23-24, 2019 in South Bend, Indiana.

BMD welcomes Chelsea Niggel to Akron office

BMD is proud to announce that attorney Chelsea M. Niggel has joined the firm as associate in the firm's Akron office focusing her practice on healthcare, business and corporate matters and intellectual property.

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.

Amanda Waesch Weighs in on Leasing v. Buying Medical Office Space

Amanda Waesch weighs in on leasing v. buying medical office space

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.

Highlights from the BMD Healthcare Leadership Summit Held in Orlando, FL, January 11, 2018 - January 13, 2018

BMD's 2nd Annual Healthcare Leadership Innovation Summit theme focused on entrepreneurism in healthcare as we sought to reach various specialties and stakeholders within the healthcare industry. There were 3 days of insightful programming and exclusive networking

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.