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This Mintz health care post covers HHS’s investigation into the practices of Korunda Medical, LLC, after the Florida-based health care provider failed to comply with HIPAA regulations relating to the Right of Access Initiative.
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At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part plan to allow foreign prescription drugs to be imported into the United States in an effort to reduce drug prices. We wrote about the release of the Safe Importation Action Plan here, and the detailed proposals made public by the Administration on December 18, 2019, follow the framework that the agencies sketched out earlier this year. Specifically, HHS and FDA have proposed two different pathways: one that is being implemented via notice-and-comment rulemaking, and one that is being implemented via an FDA guidance document. HHS Secretary Alex Azar touted the two pathways together in a same-day FDA press release as “historic actions…[that] represent the bold nature of President Trump’s agenda for lowering drug costs.”
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A New Decade of HIPAA: What Can We Expect?

December 23, 2019 | Blog | By Sarah Beth Kuyers, Dianne Bourque, Ellen Janos

As the decade winds down, it’s hard to believe that the HIPAA Privacy and Security Rules are almost twenty years old.  It has been ten years since the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published the first breach notification rule – the one based on the harm standard.   And the Omnibus Rule’s “low probability of compromise” standard is almost seven years old!   Regulators and regulated entities are heading into the new year and decade with a lot of momentum on some important issues.  As we prepare to welcome 2020, we’d like to indulge in a bit of hindsight – as well as speculation – about what the new decade might hold for HIPAA-regulated entities. 
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This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.
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As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This final post in our blog series focuses on a proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes. The OIG is also proposing modifications to the existing safe harbor for local transportation and a new safe harbor for remuneration provided in connection with certain payment and care delivery models developed by the Centers for Medicare & Medicaid Innovation Center or by the Medicare Shared Savings Program. Lastly, the OIG is codifying an existing statutory safe harbor for Accountable Care Organization (ACO) beneficiary incentives and an existing statutory exception to the Civil Monetary Penalty (CMP) rules on beneficiary inducement for telehealth technology related to in-home dialysis services.
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2020 Medicine Wrap Up Viewpoint Mintz
In many ways, the past year could be called a “business as usual” year for the FDA’s drugs and biologics centers in that they continued to make progress all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively.
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FCC Simplifies Evaluations of Certain Wireless Medical Devices

December 11, 2019 | Blog | By Laura Stefani

The Federal Communications Commission (FCC) regulates wireless medical devices in conjunction with the Food and Drug Administration (FDA), with the FCC’s role related to certain technical concerns such as the successful sharing of wireless frequency bands. Another area that FCC regulates is radio frequency (RF) safety – the possible harmful effects to human health from RF energy created by wireless devices. The FCC looks to health and safety agencies such as the FDA, EPA, and OSHA, to provide guidance and recommendations on what level of RF emissions are deemed “safe,” and then sets rules for how responsible parties must evaluate compliance with these limits. These rules on safe emission levels apply generally to devices that produce RF signals. The FCC proposed modifications to its RF safety rules in 2013, and finally on December 4, 2019, issued a decision that adopts many of its proposals.
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Evolution & Revolution: Device Policy Priorities at FDA in 2019

December 5, 2019 | Blog | By Joanne Hawana, Aaron Josephson, Benjamin Zegarelli

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and practical challenges. Today our topic is “medical devices” writ large, which is a product class that is becoming more complex by the day as it grows to encompass software, diagnostics, laboratory tests, and new medical technologies that resemble nothing that Congress had in mind when it first gave FDA authority to regulate medical devices in 1976. In the coming days, we’ll also take a broad look at FDA’s year from the standpoint of therapeutic medical products, including drugs and biologics, as well as the more commonly used category of consumer products.
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The Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration’s nominee to head the Food and Drug Administration (FDA), on December 3, 2019. Hahn faced a flurry of questions at the confirmation hearing before the Senate Health Committee on Wednesday, November 20, 2019, most of which spoke to the youth vaping crisis with little emphasis on other hot topics such as prescription drug shortages or drug pricing. Despite the barrage of questions, many of his responses were non-specific in nature and avoided committing to any set platform. Instead, Hahn focused on his pledge as a doctor to put patient care first and rely on science and data as a basis for decision-making.
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We have previously blogged about the Food and Drug Administration’s year of listening and information-gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp” from the federal Controlled Substances Act. Among other things, the Agency issued a call for scientific information on a variety of topics identified in this April 3, 2019 notice; opened a public docket to receive written comments in response to those questions (docket no. FDA-2019-N-1482); and convened a public hearing in May 2019 to hear from stakeholders directly. Our summary of that May 31st hearing, which also provides an overview of the legal and regulatory landscape post-2018 Farm Bill, is available here. This intensive period of evaluation was led by an internal working group charged with making recommendations for the open scientific, technical, and policy questions created by the new legal status of hemp.
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As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Although the rules’ main focus is on value-based arrangements, the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) also includes a number of provider-friendly changes and clarifications to the Stark Law. As discussed below, CMS is proposing several changes to key Stark Law requirements as well as modifications to existing Stark Law exceptions.
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CMS Finalizes Changes Expanding the Scope of the Open Payments Program

November 18, 2019 | Blog | By Brian Dunphy, Rachel Yount

On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. Perhaps most importantly, CMS broadened the list of Covered Recipients. Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions. CMS also consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs. Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
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The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, which finalizes a proposed reduction in Medicare Part B reimbursement for certain drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B drug discount program. Through the final rule, CMS purports to continue Medicare reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. That ruling, and a Court-imposed stay of the cuts, are the subject of a just-argued appeal.  For a detailed walk-through of the litigation up to this point, please see our prior blog post.
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This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the Department of Health & Human Services (HHS).  The proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) offers new and revised definitions on key Stark Law terms, some of which CMS has previously neglected to define or provide significant guidance.  In addition, CMS proposes a new Stark Law exception for limited remuneration to a physician, which offers health care entities more flexibility for unwritten, short-term compensation arrangements with physicians.
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Health Care Forecast - Massachusetts Legislature

November 12, 2019 | Blog | By Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd

As the Legislature approaches the Holiday recess, health care costs and access continue to be at the forefront of the agenda. The Baker Administration released the VALUE Act on October 18th and the Senate filed the PACT Act on November 7th. 
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FDA Issues Drug Shortage Report Identifying Root Causes and Potential Solutions

November 7, 2019 | Blog | By Michelle Caton, Elizabeth Conti

Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In response to that crisis (and at Congress’s urging), the FDA formed the interagency Drug Shortages Task Force (Task Force) to study the issue. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the consequence of economic factors driven by private and public business practices. Those practices, according to the report, disrupt the supply chain availability of marketed pharmaceuticals. The report offers recommendations to provide a framework for stakeholders to address the underlying economic factors leading to drug shortages.
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Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an extensive application and review by the resident state. Failure to secure appropriate licensing before shipping these kinds of products in interstate commerce can lead to a variety of unwanted scrutiny and negative effects. For instance, the Washington Department of Health has recently been investigating a complaint alleging that Sun Pharmaceuticals distributed medicine samples without the proper license.
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To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA) announcement on October 24, 2019 likely came as no surprise. But to stakeholders in this industry, it was certainly unwelcome news and may portend a coming wave of unapproved drug enforcement actions by the FDA.
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This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Below is an in-depth summary of the Office of Inspector General’s (OIG) proposed modifications to the safe harbors for personal services and management contracts, which includes a proposed new provision protecting outcomes-based payments. We also cover the OIG’s proposed modifications to the warranties safe harbor.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

October 21, 2019 | Blog | By Karen Lovitch, Dianne Bourque, Theresa Carnegie, Rachel Yount

On October 17, 2019, the Department of Health & Human Services published two proposed rules that, if finalized, would implement significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This post is the latest installment in our blog series covering these proposed rules.
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