Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier.
HHS Delays Compliance for Sweeping Interoperability and Information Blocking Rules
Following more than a month of silence from the U.S. Department of Health and Human Services (HHS) on the publication of its widely anticipated companion interoperability and information blocking final rules to the Federal Register, HHS’s Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the Office of the Inspector General (OIG), issued a joint statement announcing a policy of enforcement discretion to allow compliance flexibilities regarding the implementation of the final rules in response to the COVID-19 public health emergency. The agencies indicated that they would continue to monitor the developing public health emergency to determine if further action is necessary.
OIG Proposed Rule
OIG issued an unpublished proposed rule amending the civil monetary penalty (CMP) regulations to include new CMP authorities for violations of ONC’s information blocking final rule. OIG is seeking comment on when information blocking enforcement should begin, but has proposed to delay enforcement until 60 days after publication of the OIG’s final rule. At a minimum, enforcement would not begin sooner than the compliance date for the ONC final rule established in 45 CFR § 171.101(b), which is November 2, 2020.
CMS Final Rule
CMS announced that the agency is extending the implementation timeline by an additional six months for certain components of its interoperability rule, including, for example, the admission, discharge, and transfer notification Conditions of Participation (CoPs). In the unpublished version of CMS’ final rule, the agency initially stated these CoPs would be effective six months after the publication of the final rule. Now, they will be effective one year after the final rule is published in the Federal Register – a date that is still to be determined. CMS will implement and enforce other policies contained in the final rule on schedule.
ONC Final Rule
Earlier this week, ONC reissued the unpublished version of its final rule, which is now set for publication on May 1, 2020, with an effective date of June 30, 2020. While the publication date triggers multiple compliance dates for various components of the interoperability and information blocking provisions (set at 60 days, 6 months, and 24 months following publication), the agency is changing that timeline for certain requirements in light of the COVID-19 crisis. ONC has published new enforcement discretion dates and timeframes on its website. We have summarized some key changes to the ONC final rule compliance timeline below.Continue Reading HHS Delays Compliance for Sweeping Interoperability and Information Blocking Rules
HHS Finalizes Healthcare Interoperability and Information Blocking Rules
The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information. The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the 21st Century Cures Act (Cures Act) and support the MyHealthEData initiative, designed to allow patients to access their health claims information electronically through the application of their choosing.
Major provisions of each final rule are highlighted below. Note that the final rules have not yet been formally submitted to the Federal Register, so some of the precise effective dates are still to be determined.
ONC Final Rule
For Providers, Health Information Networks or Exchanges, and Health IT Developers
- Prohibition on Information Blocking. Effective six months following the publication of the final rule, health care providers, health IT developers of certified health IT, and health information exchanges and networks, are banned from “information blocking.” Information blocking is defined in the rule as engaging in a practice that is likely to interfere with, prevent, or materially discourage access, exchange or use of electronic health information (EHI) and, if (a) conducted by a health IT developer or health information network or exchange, such developer, network or exchange knows, or should know – or (b) if conducted by a health care provider, such provider knows – the practice is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI.
- EHI means electronic protected health information (EPHI) as the term is defined for HIPAA, to the extent that it would be included in a designated record set, with certain exceptions, regardless of whether the group of records are used or maintained by or for a HIPAA covered entity. This EHI definition will be effective 24 months after the publication of the final rule. In the interim, for purposes of information blocking, EHI is limited to the EHI identified by the data elements represented in the U.S. Core Data for Interoperability (USCDI) standard.
- Health care providers include health care facilities, entities, practitioners, and clinicians listed in the Public Health Service Act. ONC did not expand the definition of health care provider in the Final Rule to cover all individuals and entities covered by HIPAA. However, the final rule leaves this door open by giving the Secretary of HHS discretion to expand the definition of health care provider to any other category the Secretary deems appropriate by future rulemaking.
- Examples of Information Blocking. According to ONC, information blocking practices could involve, among other things: formal restrictions in contract or licensing terms; limiting or restricting the interoperability of health IT through organizational policies or procedures or other EHI or health IT documentation; information restrictions, such as if an entity simply refuses to exchange or facilitate access to EHI as a general practice or in isolated cases; or use of certain technological measures that limit EHI exchange.
- Information Blocking Exceptions. The final rule identifies eight activities as exceptions to information blocking. According to ONC, the exceptions apply to certain activities that are likely to interfere with, prevent, or materially discourage the access, exchange, or use of EHI, but that would be reasonable and necessary if certain conditions are met. Each exception falls into one of two categories: (i) exceptions that involve not fulfilling requests to access, exchange, or use EHI; and (ii) exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI.
- Penalties for Information Blocking. Consistent with the Cures Act, ONC’s information blocking prohibition seeks to deter information blocking through penalties that differ based on the actor. Health IT developers and health information networks and exchanges are subject to civil money penalties capped at $1 million per violation, while health care providers who violate the information blocking provisions may face unspecified disincentives for violations, to be determined by the appropriate HHS department or agency in subsequent rulemaking.
Continue Reading HHS Finalizes Healthcare Interoperability and Information Blocking Rules
HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020
The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS’ ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.
The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability.
Continue Reading HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020
States Banding Together on HIPAA Enforcement
In the first settlement of its kind, a medical software provider has agreed to pay $900,000 to 16 state attorneys general for alleged violations of state and federal privacy laws. The settlement, stemming from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, demonstrates the resolution of the first-ever multistate
Major Mental Illness, Substance Use Disorder Reforms, Opioid Abuse Treatment Funding Included in 21st Century Cures Act
Advocates have been pushing hard over the past couple of years for the reform and expansion of mental illness and substance use disorder (i.e., behavioral health) treatment in the U.S. The 21st Century Cures Act — which has cleared Congress and is awaiting the President’s signature — includes a number of important provisions that reflect those efforts, including sections intended to strengthen, promote, and expand access to information, care, and coverage with respect to behavioral health care across communities and for individuals, families, and the nation’s health care workforce. The Act also includes $1 billion in block grant funding to target the “epidemic of death” associated with the opioid abuse crisis.
Mental Health and Substance Abuse Disorder Provisions
In one of the most noteworthy behavioral health provisions, the Act strengthens leadership within the Substance Abuse and Mental Health Services Administration (SAMHSA) by creating a new Assistant Secretary position. The new role will oversee mental health and substance abuse research, funding, and evidence-based health care practices, and will drive and coordinate federal policy in this area. To do so, the Assistant Secretary will consult with stakeholders to improve community-based and other mental health services, including care for adults and children with serious mental illness, as well as collaborate with other federal departments, including the Departments of Defense, Veterans Affairs, Housing and Urban Development, and Labor, to improve care for veterans and service members and support programs to address chronic homelessness. The Assistant Secretary is also tasked with working with stakeholders to improve the recruitment and retention of mental health and substance use disorder professionals.
Continue Reading Major Mental Illness, Substance Use Disorder Reforms, Opioid Abuse Treatment Funding Included in 21st Century Cures Act
Upcoming FDA Public Meeting on Speech and Medical Products
As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of
FDA Issues Draft Guidance on Labeling For Biosimilar Products
The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.
What is a biosimilar product?
Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. Notwithstanding minor differences in clinically inactive components, there can be no clinically meaningful differences between the biological product and the reference product in terms of the safety and efficacy. In 2010, the Biologics Price Competition and Innovation Act (“BPCIA”) was enacted as part of the Affordable Care Act in order to provide an abbreviated licensure pathway for a biosimilar that partly relies on the data originally submitted to the FDA by the reference product sponsor for approval.
Continue Reading FDA Issues Draft Guidance on Labeling For Biosimilar Products
FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices
On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable logic once they have entered the market. The draft guidance represents a part of the agency’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats at all stages in their lifecycles. Specifically, the draft guidance follows multiple public workshops on the issue and previous FDA guidance titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which contains premarket recommendations for managing cybersecurity risks during the design stage of device development. We previously blogged about this here.
Continue Reading FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices
Agencies Release Proposed Overhaul of the Common Rule
On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
Continue Reading Agencies Release Proposed Overhaul of the Common Rule
FDA Issues New Draft Guidance and Related Proposed Rule on Naming Biological Products
On August 28, 2015 the federal Food and Drug Administration (“FDA”) issued two important policies regarding naming biological products, including biosimilars. First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public
FDA Announces Medical Device User Fee Rates for Fiscal Year 2016
Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. For FY 2016, the standard premarket application (PMA) fee will be $261,388; by comparison, the PMA fee in FY 2015 is $250,895.
Continue Reading FDA Announces Medical Device User Fee Rates for Fiscal Year 2016
FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages
On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). FDA believes that this final rule will improve its ability to identify potential drug shortages and to prevent or mitigate the impact of these shortages.
Continue Reading FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages
FDA Requests RSVP for Public Meetings on PDUFA Reauthorization
The federal Food and Drug Administration (FDA) has issued a notice requesting that public stakeholders –including patient and consumer advocacy groups, health care professionals, and scientific and academic experts– notify FDA of their intent to participate in monthly consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). When the statutory
FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy
The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will not be enforced until November 1, 2015. This means dispensers have an additional four months to establish a commercially-viable and operational system that can exchange, capture, and maintain product tracing information for certain prescription drugs. Specifically, on July 6, 2015, the FDA issued a notice announcing the availability of guidance for industry entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy” (DSCSA Compliance Policy). The guidance arises from the 2013 DSCSA, which added sections 581 and 582 to the federal Food, Drug, and Cosmetic Act (FD&C Act) and set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. The DSCSA requires trading partners (i.e., manufacturers, wholesale distributors, dispensers, and repackagers) to exchange product tracing information when engaging in transactions involving certain prescription drugs. For dispensers, DSCSA requirements for the tracing of products through the pharmaceutical distribution supply chain went into effect on July 1, 2015.
Continue Reading FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy
FDA Issues Three Biosimilar Final Guidances
On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.
FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight
On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new regulatory oversight framework for LDTs, which are defined by the FDA as “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory” and which are intended for clinical use. Release of the documents follows on the heels of FDA’s notification to Congress in late July of its intent to issue draft guidance in this area. The first draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (Framework Guidance), describes a risk-based framework for addressing the regulatory oversight of LDTs. The Framework Guidance also describes FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. The second draft guidance, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (Notification and Reporting Guidance), describes the process for clinical laboratories to notify FDA of the LDTs they manufacture as well as the Medical Device Reporting (MDR) requirements for clinical laboratories that manufacture LDTs. Both draft guidances reflect the FDA’s effort to take steps to encourage the advancement of personalized medicine by helping to ensure the reliability of certain diagnostic tests. The guidances are neither final nor in effect at this time.
The following is an overview of the specific issues addressed in the draft guidances:Continue Reading FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight
FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials
Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, “A Guide to Informed Consent,” which was last updated over 15 years ago, in 1998. The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.
Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.
The following provides an overview of some of the draft guidance’s notable new and revised provisions.Continue Reading FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials
FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)
On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying the legislation. The central purpose of GDUFA is to help speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. GDUFA requires manufacturers to pay a user fee to supplement FDA’s costs of reviewing generic drug applications and inspecting facilities. Per the GDUFA Commitment Letter, the user fees enable the Agency to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.
Continue Reading FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)