Tag Archives: healthcare

FDA to Resume Domestic Inspections with New Safety Measures after Temporary Pause Due to COVID-19 Health and Safety Concerns

On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections during the week of July 20th with the assistance of a newly developed COVID-19 Advisory Rating System for assessing the risk of carrying out an inspection in a particular location.

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Every HIPAA Waiver Has Its Thorn

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.

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Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.

The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing.[1]  As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products.  The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date.  The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.

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FDA PDMA Guidance in Response to COVID-19 Pandemic

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.

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Online sales of medicines are allowed

16 May 2020 the Russian Government enacted the rules on online sales and delivery of medicines (the Rules). According to the Rules, online sales of medicines are allowed. The exceptions are: RX medicines, narcotic and psychotropic medicines, and medicines containing more than 25% ethyl alcohol.

To receive authorization for online sales a pharmacy shall have a license for at least 1 year, minimum of 10 retail stores, an Internet website or a mobile app, a delivery service, or a contract with such service provider.

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Video: Telemental Health Benefits During COVID-19 – Employment Law This Week

As featured in #WorkforceWednesday: One way employers can support employee mental health in today’s environment is ensuring that their benefits offerings include telemental health services. Attorneys Cassandra Labbees and Amy Lerman tell us more about telemental health and evaluating your benefits plans.

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Guidance Issued on Resuming Elective Surgeries in New Jersey

On March 23, 2020, Governor Phil Murphy signed Executive Order 109, which “limit[ed] non-essential adult elective surgery and invasive procedures, whether medical or dental, [in order to] assist in the management of vital healthcare resources during this public health emergency.” The purpose of EO 109 was to “limit[] exposure of healthcare providers, patients, and staff to COVID-19 and conserve[] critical resources such as ventilators, respirators, anesthesia machines, and Personal Protective Equipment (‘PPE’) [that] are essential to combatting the spread of the virus.” At the time EO 109 was executed, coronavirus cases were rapidly increasing within the State. On March 23rd, New Jersey had 2,844 coronavirus cases in all 21 counties, an increase of 935 over the previous day, and at least 27 people had died.

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New COBRA Notices & Extended Deadlines May Create Traps for the Unwary: Benefits Guidance in the Time of COVID-19

The economic downturn caused by COVID-19 pandemic has resulted in an unprecedented number of layoffs, furloughs, and reduced hoursUnder the Consolidated Omnibus Budget Reconciliation Act (“COBRA”), when employment is terminated or hours are reduced and there is a loss of coverage, employers (generally those with 20 or more employees) must provide notices to covered employees and their covered spouses and dependent children explaining that they have the right to elect to continue receive health care coverage. In addition, when a covered employee dies, COBRA requires employers to notify the employee’s spouse and dependent children that they have the right to elect to continue health coverage.  On May 1, 2020, the Department of Labor (“DOL”) issued a new model general notice and election notice (“Notices”) for the purpose of providing more information about how Medicare and COBRA interact.  In Frequently Asked Questions, issued with the Notices, the DOL states that employers may use the Notices to satisfy their COBRA notice obligations.

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Appropriate Use of CARES Act Provider Relief Funds

To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[1], Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.[2]

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CARES Act Temporarily Suspends Sequestration: How Will It Affect Provider Reimbursement?

One of the many relief efforts contained in the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), signed into law on March 27th, 2020, is a hiatus of sequestration as it applies to Medicare payments. Section 4408 of the CARES Act exempts Medicare from the effects of sequestration from May 1, 2020, through December 31, 2020.[1] It also postpones the sunset of sequestration as it applies to Medicare from the end of 2029 to the end of 2030.

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