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Janine Tougas

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On May 3, New York Governor Kathy Hochul signed into law provisions that will require health care entities to submit a notification to the state Department of Health (DOH) providing information about any material transaction involving that health care entity.

The law, passed as part of the state’s budget, was originally crafted to give the DOH authority to review and approve those transactions. Ultimately, following several iterations during the legislative process, that approval power was stripped out by the state general assembly and replaced with the current notice requirement.

The law will take effect on August 1, 2023 and states on its face that it will apply to all “material transactions” involving health care entities that close on or after that date. That said, the requirements for transactions that close between August 1 and August 31 are a somewhat open question, given the 30-day notice requirement in the law. The DOH is tasked by the law with creating regulations that may address this situation.…

Continue Reading New York Passes Health Care Transaction Notice Requirements

On April 24, 2023, the OIG formally announced that it will be modernizing its existing Compliance Program Guidance (“CPG”).

The OIG has provided a CPG for various industry subsections since 1998.  Each CPG was developed in an effort to set forth voluntary compliance standards to be utilized in identifying and preventing fraud and abuse in federal health care programs.  In September 2021, the OIG published a request for information (“RFI”), wherein OIG requested insight on how providers use CPG and what improvements could be made to provide more relevant and accessible guidance.  

Providers and other industry representatives made recommendations including, but not limited to, creating industry-specific guidance, consolidating existing CPG, enabling user-friendly access to CPG, and ensuring ongoing updates to identify the OIG’s current positions on new and emerging risks in health care.…

Continue Reading OIG announces Modernization of Compliance Program Guidance

As the September 1, 2023 deadline for Centers for Medicare & Medicaid Services (CMS) to publish the first 10 “selected drugs” subject to negotiation of “maximum fair prices” under Medicare Parts B and D fast approaches, CMS has recently specified information that manufacturers must submit in order for their drugs to qualify for the “Small Biotech Exception” to being included on the list. The information is to be submitted during the summer of 2023; the specific deadline has not yet been announced.

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). Among other provisions, the IRA provides for the CMS to negotiate “maximum fair prices” with manufacturers of “selected drugs” covered under Medicare Parts B and D. The price negotiation process begins on September 1, 2023, when CMS is required to publish the list of the first 10 selected drugs subject to negotiation, for maximum fair prices which will take effect beginning January 1, 2026.

The IRA provides that the selected drugs will be the 10 “negotiation-eligible drugs” having the highest total expenditures under Medicare Part D during the period June 1, 2022 through May 31, 2023. Negotiation-eligible drugs generally consist of “qualifying single-source drugs”, which are generally defined as branded drugs and biologicals approved by the Food and Drug Administration (FDA) at least 7 years (with respect to drugs) or 11 years (with respect to biologicals) before the date the list is published, and which do not have a marketed generic equivalent or biosimilar. However, for 2026 through 2028, the IRA provides that negotiation-eligible drugs exclude certain drugs under what CMS refers to as the “Small Biotech Exception”.…

Continue Reading CMS Specifies Info Needed for Small Biotech Exception to Medicare Drug Price Negotiation

Under provisions of the 21st Century Cures Act (Cures Act), providers of Medicaid-funded personal care services (PCS) and home health care services (HHCS) will need to be fully compliant with their state’s electronic visit verification (EVV) systems by January 1, 2023

Congress passed the Cures Act on December 13, 2016. Among other things, in an effort to increase transparency and reduce fraud in connection with the delivery of health care services, this law mandated that states implement EVV systems for all Medicaid-funded (including under waiver programs) PCS by January 1, 2019, and HHCS by January 1, 2023, in each case where services include an in-home visit by a provider. Subsequent legislation extended the deadline for PCS to implement EVV requirements to January 1, 2020. However, the deadline for HHCS remains January 1, 2023, and is quickly approaching.

Providers of PCS and HHCS services should make sure that they are working towards implementing EVV systems in their own business operations in compliance with applicable state requirements, the majority of which also are requiring provider compliance by January 1, 2023…

Continue Reading Home Health Care Services Electronic Visit Verification System Implementation Required by January 1, 2023

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak.

CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical…

Today the U.S. Department of Health and Human Services (HHS) announced that it would extend until June 3, 2019 the comment periods for the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) proposed interoperability and information blocking rules.  CMS also announced that as a result of public comments, it “will adjust the effective dates of our policies to allow for adequate implementation timelines as appropriate.”

In related developments, the ONC also released the second draft of the Trusted Exchange Framework and Common Agreement, along with a related Notice of Funding Opportunity.  In addition, HHS released a set of frequently asked questions (FAQs) from the Office for Civil Rights (OCR), addressing HIPAA’s right of access as related to apps designated by individual patients and application programming interfaces (APIs) used by a healthcare provider’s electronic health record (EHR) system.  The FAQs clarify, among other things, that once protected health information (PHI) has been shared by a HIPAA covered entity with a third-party app, as directed by the individual, the covered entity will not be liable under HIPAA for subsequent use or disclosure of electronic PHI, provided the app developer is not itself a business associate of a covered entity or other business associate. …
Continue Reading HHS Announces Extended Comment Period for Healthcare Interoperability Proposed Rules, Releases New HIPAA FAQs