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340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation

January 18, 2021 | Blog | By Daryl Berke, Ellyn Sternfield

The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.
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Looking Ahead: FDA in 2021

January 8, 2021 | Blog | By Aaron Josephson

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.
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In a recently decided case, Rutledge v. Pharmaceutical Care Management Association, the U.S. Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that regulates reimbursement levels paid by Pharmacy Benefit Managers (PBMs) to local pharmacies.
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HIPAA 2021 – What Can We Expect?

December 28, 2020 | Blog | By Dianne Bourque, Ellen Janos, Michelle Caton

As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only for health care providers, but for all manner of businesses, employers, property owners, and the national media. HIPAA – or more often than not “HIPPA” – was frequently touted in the news and on social media as the reason why COVID-related information could or could not be shared. As we head into 2021 with the pandemic raging on, the vaccination program underway, and a new administration taking over, here is a look at what we expect for “HIPPA” in 2021.
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FDA in 2020: What a Year! (Part 3 of 3)

December 23, 2020 | Blog | By Joanne Hawana

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well, which we cover in this part 3 of our year-end post.
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FDA in 2020: What a Year! (Part 2 of 3)

December 22, 2020 | Blog | By Joanne Hawana

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration.
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FDA in 2020: What a Year!

December 15, 2020 | Blog | By Aaron Josephson, Benjamin Zegarelli

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.
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HHS Keeps On Sprinting with Proposed Modifications to the HIPAA Privacy Rule

December 14, 2020 | Blog | By Dianne Bourque, Michelle Caton

The Department of Health and Human Services (HHS) is pushing ahead in its Regulatory Sprint to Coordinated Care with a new proposed rule, announced by HHS’ Office for Civil Rights on December 10, to modify the HIPAA Privacy Rule. This proposed rule follows HHS’ 2018 Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, which sought to identify regulatory impediments to value-based care presented by HIPAA. With this proposed rule, HHS aims to “reduce burden on providers and support new ways for them to innovate and coordinate care on behalf of patients, while ensuring that [HHS] uphold[s] HIPAA’s promise of privacy and security,” according to HHS Deputy Secretary Eric Hargan. It would achieve these objectives through a variety of updates to the Privacy Rule, which we highlight in this blog post, along with initial reactions from our HIPAA privacy team.
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As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations, which go into effect January 19, 2021. Today, we are taking a look at changes to existing AKS safe harbors and Stark Law exceptions, and, an extra add-on: a new Stark Exception for Limited Remuneration to a Physician. Mintz is also hosting a webinar during which we will review the key provisions from the final rules and provide practical examples of how the industry can take advantage of these significant changes. We hope you can join us.
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This third post in our multi-part series on the final rules examines the three new AKS safe harbors and four new Stark Law exceptions that offer protection for value-based arrangements. The primary goal of these final rules is to reduce regulatory barriers and advance the health care industry’s transition to value-based care. Value-based care, often referred to as pay-for-performance, is a payment model that offers health care providers and suppliers financial incentives to meet certain performance measures that improve quality of care or appropriately reduce costs, as opposed to traditional fee-for-service or capitated payments healthcare reimbursement.

Plus, we have prepared easy-to-read comparison charts breaking down the current, proposed, and final regulations. These comparison charts offer a quick way to get up to speed on these voluminous final rules and their many historic changes to the AKS and Stark Law.
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HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part II: Beneficiary Inducement

December 1, 2020 | Blog | By Karen Lovitch, Ellyn Sternfield, Rachel Yount, Jane Haviland

While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both the federal Anti-Kickback Statute (AKS) and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP), so minimizing risk when providing such items or services is important.  Fortunately, as announced last week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule making sweeping changes to the regulations implementing the AKS and the Beneficiary Inducements CMP, many of which will result in greater flexibility and reduced administrative burdens for the health care industry. 
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Are Speaker Programs a Thing of the Past? OIG’s Fraud Alert Indicates It Thinks They Should Be

November 25, 2020 | Blog | By Laurence Freedman, Elizabeth Conti

In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as “speaker programs.” The OIG’s Special Fraud Alert (Alert) highlights what it deems the “inherent fraud and abuse risks” associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs by pharmaceutical and medical device companies. The OIG expressed that is skeptical of the educational value of such programs, and thus the Alert sends a clear signal that such programs will undergo intense scrutiny under the federal Anti-Kickback Statute (AKS). OIG is using the pandemic as an opportunity to caution the pharmaceutical and medical device industry to limit or eliminate in-person speaker programs once such programs are able to resume.
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HHS Issues Controversial Drug Rebate Reform Final Rule

November 25, 2020 | Blog | By Theresa Carnegie, Michelle Caton

On Friday, November 20, the Administration took bold action by releasing a contentious rule designed to disrupt the drug supply chain status quo. The Pharmaceutical Rebates final rule will alter how drug discounts offered by pharmaceutical manufacturers to plan sponsors or their PBMs, and service fees paid by such manufacturers to PBMs, are treated for purposes of the federal Anti-Kickback Statute (AKS). As we discuss in this alert, the policies set out in this final rule are not surprising, in light of other actions taken by the Trump Administration to date. However, the transformational effects the rule will have on the drug supply chain, coupled with a lack of consensus among lawmakers and industry stakeholders about the best approach to drug pricing reform, ensures that litigation of this new rule will inevitably ensue.
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On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark Law), and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP). The final rules are part of HHS’s Regulatory Sprint to Coordinated Care and are designed to offer the health care industry more flexibility and to reduce the regulatory burden associated with the AKS and the Stark Law, particularly with respect to value-based arrangements and care coordination. Offering a number of industry-friendly changes, the final rules will have a far-reaching impact on the health care industry.
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Post-Election 2020 - Health Care Preview

November 23, 2020 | Blog | By Alexander Hecht, Anthony DeMaio, Aaron Josephson, Brett Else, Tara E. Dwyer, Ellyn Sternfield

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.
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As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. Existing telehealth waivers continue in effect under the Public Health Emergency, and new legislation seeks to expand telehealth access through home health services. Plus, join us for a webinar on the future of telehealth.
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DEA Releases Long-Awaited Suspicious Orders Proposed Rule

November 6, 2020 | Blog | By Elizabeth Conti, Joanne Hawana

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The proposed rule will implement the Preventing Drug Diversion Act of 2018 (PDDA) and clarify the procedures a registrant must follow for orders received under suspicious circumstances, referred to as “ORUSCs.” There are four key regulatory changes being proposed by DEA: (1) new definitions, (2) expansion of the types of registrants required to report, (3) procedures for identifying and reporting suspicious orders, and (4) reporting and recordkeeping requirements.
Key to the proposed rule is the establishment of a “two-option framework” for registrants to deal with ORUSCs: namely, they could (1) decline to ship the ORUSC and immediately file a suspicious order report to DEA’s centralized database, or (2) conduct due diligence into the ORUSC and make a determination about the order’s validity within seven calendar days, among other requirements. DEA is accepting electronic and written comments on the proposed rule through January 4, 2021.
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An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

November 5, 2020 | Blog | By Joanne Hawana

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the quality of different subsets of tests. Since then, there have been some important policy developments affecting diagnostic and antibody testing. There also has been significant growth in the number of tests authorized by the Food and Drug Administration for point-of-care uses in various patient settings such as clinics, emergency departments, and physician offices. Read on for an update about these developments.
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On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million settlement resolved allegations that Minnesota-based medical device manufacturer Medtronic USA Inc. violated (i) the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by paying kickbacks to a South Dakota neurosurgeon, Wilson Asfora, M.D., and (ii) the Open Payments reporting requirements by failing to accurately report payments it made to Asfora to the Centers for Medicare & Medicaid (CMS). While this settlement is the first public enforcement action involving Open Payments violations, more enforcement actions may be expected in the near future.
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US Health System Warned of Coordinated Ransomware Attacks

October 30, 2020 | Blog | By Dianne Bourque

US hospitals and healthcare facilities struggling to maintain normal operations during the COVID-19 emergency, were warned this week by the federal Cybersecurity and Infrastructure Agency (CISA), the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS) of a “targeted and imminent cybercrime threat.” Specifically, CISA, FBI and HHS have credible information that malicious cyber actors are targeting hospitals and other health care providers with Trickbot malware, leading to ransomware attacks, data theft and significantly, the disruption of healthcare services during the pandemic.
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