Health Care

Ellen Janos discusses the role telemedicine is expected to play in the management of the coronavirus outbreak as well as the Emergency Appropriations Bill passed Congress which contains provisions intended to loosen the restrictions on Medicare reimbursement for telehealth services.

Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.

Last week, the Third Circuit joined several other appellate courts in finding that medical opinions related to medical necessity of hospice services can be subject to scrutiny and found to be “false” for purposes of proving a violation of the False Claims Act (FCA) in U.S. ex rel. Druding v. Care Alternatives. Our Health Care Enforcement Defense Group has been closely tracking recent qui tam cases brought under the FCA based on allegations that health care services or procedures lacked the requisite medical necessity, including the conclusion of the landmark AseraCare case last week.  As we’ve previously discussed on the blog, several district courts across the country have determined that differences of opinions between physicians and medical experts alone cannot be used to prove the FCA’s falsity requirement. However, some appellate courts have reached different conclusions. The Third Circuit’s decision last week in Care Alternatives joins those appellate courts in rejecting this argument and finding that “a difference of medical opinion is enough evidence to create a triable dispute of fact regarding FCA falsity.”

Some clinical trial sponsors and principal investigators will be digging through their archives soon as a result of a recent ruling in the case of Seife v. U.S. Department of Health and Human Services, case number 1:18-cv-11462 (S.D.N.Y. 2018). In Seife, the plaintiffs – an investigative journalist and a former Associate Commissioner at the Food and Drug Administration (FDA) – challenged a Department of Health and Human Services (HHS) final rule that implemented clinical trial reporting requirements mandated by the Food and Drug Administration Amendments Act (FDAAA).

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.

As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services lacking “medical necessity” violate the False Claims Act (FCA) as well as to efforts by providers to defend such cases. On Wednesday, we learned that the AseraCare case has reached its dramatic conclusion with an agreement to resolve $200 million in alleged damages for the agreed amount, as reported by AseraCare, of $1 million.

ML Strategies’ Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.

As a continuation of our series on the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program (the “Proposed Rule”) released by the Centers for Medicare & Medicaid Services (“CMS”) earlier this month, this blog focuses on CMS’s codification of its recent guidance on supplemental benefits, including guidance on Special Supplemental Benefits for the Chronically Ill (“SSBCI”). It also discusses CMS’s proposed changes to the medical loss ratio (“MLR”) to account for changes in supplemental benefits.

As regular readers of our blog know, the Centers for Medicare & Medicaid Services (CMS) intensified its push for drug pricing transparency in 2019. In 2020, we see a continuation of those efforts, and their impacts on the 340B program are now starting to reveal themselves. On January 1, 2019, the Health Resources & Services Administration (HRSA) finally implemented the ceiling price and manufacturer civil monetary penalties (CMPs) regulations that the agency proposed in 2017. The regulations implement certain provisions of the Affordable Care Act and were initially scheduled to go into effect on February 28, 2017, but were repeatedly delayed.

Rachel Yount discusses the proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes.

Theresa Carnegie reviews both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.

It feels like we’ve been seeing a lot more health care breaches caused by hackers and other IT security incidents recently, and there’s a good reason why: a recent report by cloud security company Bitglass confirms that both the number of breaches and individuals affected by breaches caused by hackers and IT incidents grew significantly last year.  Bitglass analyzed data from the breach portal, affectionately known as the “Wall of Shame,” published by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR).  Pursuant to the HITECH Act, HHS is required to post a list of all reported breaches that affect 500 or more individuals. OCR classifies the types of breaches reported on the Wall of Shame, and the "Hacking/IT Incident" category includes a variety of breaches, including malicious intrusion, malware, ransomware, phishing, and general IT security failures.

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.

In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.

In CMS’s recently released proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly) (the “Proposed Rule”) and supplemental HPMS memos, CMS is proposing several significant changes to its star rating system and to its methodology for reviewing plan past performance. This blog post highlights the key details of the proposed changes to the star rating system and past performance methodology and their potential impact on Medicare Advantage and Part D plans.

As the coronavirus remains to be an active outbreak with cases increasing within the United States, this is a good time to review how HIPAA applies in a public health emergency, including its restrictions and flexibility in these types of situations. Accordingly, last week, the Office for Civil Rights (OCR) released a helpful bulletin on how the HIPAA Privacy Rule comes into play with the coronavirus outbreak and other public health emergencies.

Like many states, Massachusetts is considering drug pricing transparency legislation. The legislation would require pharmaceutical manufacturers to disclose certain pricing information.  Governor Charlie Baker has proposed legislation which would expand upon current reporting requirements for drug manufacturers in Massachusetts, and the Massachusetts Senate passed legislation which includes drug price transparency requirements and increased regulatory oversight of the pharmaceutical industry in Massachusetts. 

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.

Karen Lovitch, Chair of Mintz’s Health Law Practice, discusses the proposed new safe harbor and Stark Law exception for donations of cybersecurity technology and related services as well as the significant proposed modifications to the existing safe harbor and exception for electronic health records (EHR) technology and services.

Joanne Hawana explains how FDA regulatory due diligence fits into the broader diligence that is done when a transaction involves an FDA-regulated entity as well as what the team is looking for when conducting an FDA regulatory diligence project.