Knowledge Base Article

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 25th through the 31st.

Resource Spotlight: How to Select, Wear, and Clean Your Mask

Alabama Governor Kay Ivey has extended the state’s safer-at-home order through October 2, 2020. This order includes the following mask mandate:

• “Each person shall wear a mask or other facial covering that covers his or her nostrils and mouth at all times when within six feet of a person from another household in any of the following places: an indoor space open to the general public, a vehicle operated by a transportation service, or an outdoor public space where ten or more people are gathered.” Note, there are exceptions to the mandate, for example, the requirement does not apply when seated at a restaurant to eat or drink.
• You can read the entire Safer at Home order on the Alabama.Gov website at https://governor.alabama.gov/newsroom/covid-19/.

This week’s Resource Spotlight is on the CDC’s new COVID-19 webpage How to Select, Wear, and Clean Your Mask. Included on this page are seven ways to NOT wear a mask. If you are like me, you have been witness to each of the following ways NOT to wear a mask:

• Around your neck,
• On your forehead,
• Under your nose,
• Only on your nose,
• On your chin,
• Dangling from one ear,
• On your arm.

August 25, 2020: FDA’s Guide to Search Hand-Sanitizer Do-Not-Use List

The FDA has been urging consumers to not use certain hand sanitizer products since mid-June. Initially, the concern was methanol contamination in certain hand sanitizers. On August 12th they expanded their warning to include e 1-propanol contamination. In their guidance, the FDA indicates “1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.”

Most recently, on August 25th, the FDA published the consumer update Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? This update includes a “Step-by-step Search Guide” to assist consumers in accessing their Hand Sanitizer Do-Not-Use List which as of August 26th include 165 hand sanitizer products.

August 24, 2020: OCR Issues Amends June 2020 Plasma Donation Guidance

HHS announced the Office of Civil Rights (OCR) at HHS has issued amended guidance on how the HIPAA Privacy Rule permits covered health care providers and health plans to contact patients who have recovered from COVID-19 to inform them about donating their plasma containing antibodies (known as “convalescent plasma”) to help treat patients being actively treated for COVID-19.

“OCR added health plans to the June 2020 guidance that explains how HIPAA permits covered health care providers and health plans to identify and contact patients and beneficiaries who have recovered from COVID-19 for individual and population-based case management or care coordination. The guidance also emphasizes that, without individuals' authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals.”

August 25, 2020: New Interim Final Rule: Impact on Nursing Homes Testing and Hospitals Reporting COVID-19 Data

CMS issued an Interim Final Rule on August 25th. In a related CMS Press Release, CMS Administrator Seema Verma noted that “These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19…Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it.” Following are specific requirements specific to Nursing Homes and Hospitals.

Nursing Homes

• Revisions to infection-control regulations for long-term care facilities to no longer recommend but make it a requirement for participation in Medicare and Medicaid programs that nursing homes test their staff for COVID-19.
• Frequency of Nursing Home Staff testing will be based on community spread and CMS indicated guidance will be announced shortly.
• Nursing Homes will now be required to offer tests to residents when there is an outbreak or residents show symptoms.
• Surveyors will inspect nursing home for adherence to new testing requirements.
• Nursing Homes that do not comply will be cited for non-compliance, may face enforcement actions based on the severity of noncompliance, such as civil monetary penalties in excess of $400 per day.

Hospitals and Critical Access Hospitals

Will be required to report daily data, including, but not limited to:

• The number of confirmed or suspected COVID-19 positive patients,
• ICU beds occupied, and
• Availability of essential supplies and equipment such as ventilators and PPE.

Currently many hospitals are reporting this information voluntarily. The Interim Final Rule makes reporting data a condition of participation in Medicare and Medicaid programs. “Hospitals will face possible termination of Medicare and Medicaid payment if unable to correct reporting deficiencies.”

Note, the Interim Final Rule is applicable for the duration of the PHE for COVID-19 and addresses several other issues. For example, “this IFC also announces that with respect to the Hospital VBP Program, HRRP, HAC Reduction Program, SNF VBP Program and the ESRD QIP, if, as a result of a decision to grant a new nationwide ECE without request or a decision to grant a substantial number of individual ECEs, we do not have enough data to reliably compare national performance on measures, we may propose to not score facilities based on such limited data or make the associated payment adjustments for the affected program year.” I strongly encourage key stakeholders take the time to read this document.

August 25, 2020: American Hospitals Association Statement on the Interim Final Rule

Rick Pollack, President and CEO of the American Hospital Association (AHA), released a statement in response to the release of the CMS Interim Final Rule on behalf of the AHA. Mr. Pollack indicated the “new heavy-handed regulatory approach put forward by the Administration threatens to expel hospitals from the Medicare program.”

The statement goes on to note that the government has made at least six changes to how they want hospitals to report data since February and in spite of this “94 percent – are reporting information, according to the federal government.”

August 25, 2020: CMS Launches National Training Program to Strengthen Nursing Home Infection Control Practices

CMS announced efforts to train frontline nursing home staff and nursing home management in a Press Release. These efforts will focus on the following topics that are critical to stopping the spread of COVID-19:

• Infection control and prevention,
• Appropriate screening of visitors,
• Effective cohorting of residents,
• Safe admission and transfer of residents, and
• The proper use of personal protective equipment.

In addition to the scenario-based training called the “CMS Targeted COVID-19 Training for Frontline Nursing Home Staff and Management,” CMS and the CDC will also have subject matter experts available on biweekly webinars through January 7 from 4 to 5 pm ET, to answer questions.

August 26, 2020: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on COVID-19 MLN Matters Article SE20011 Revised

MLN SE20011 was most revised again for the fourteenth time since its initial release in March of this year. This revision was made to add information about the HCPCS codes for OPPS, Rural Health Clinics (RHCs), FQHC, and Critical Access Hospital (CAH) billers in the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section.

August 26, 2020: Abbott’s 15-Minute, Easy to Use COVID-19 Test Received FDA Emergency Use Authorization (EUA)

Abbott announced the EUA authorization in a Press Release. The test approved is the BinaxNOW™ COVID-19 Ag Card rapid test which will sell for $5, “is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.”

Along with the test, Abbott plans to launch a complimentary mobile app for iPhone and Android devices named NAVICA™. This app will:  

• Be available at no charge,
• Allow people testing negative to display the results, and
• Organizations will be able to verify the negative test result to facilitate entry into their facility.

In a related FDA News Release, the FDA likens the design of the testing card to the design of some pregnancy tests and goes on to note the “simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.”

August 27, 2020: 150 Million Rapid COVID-19 Tests to be Deployed in 2020

One day after the FDA granted EUA for Abbott’s BinaxNow™ COVID-19 Ag Card, HHS posted a Press Release indicating that “the Administration awarded a contract for $760 million to Abbott for delivery of 150 million rapid, Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests to expand strategic, evidence-based testing in the United States.  Testing will be potentially deployed to schools and to assist with serving other special needs populations.”

August 27, 2020: FDA Warns Consumers about Hand Sanitizer Packaged in Food and Drink Containers

The FDA notes in a News Release , “in one recent example of consumer confusion, the FDA received a report that a consumer purchased a bottle they thought to be drinking water but was in fact hand sanitizer. The agency also received a report from a retailer about a hand sanitizer product marketed with cartoons for children that was in a pouch that resembles a snack. Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer.”

August 27, 2020: CMS Offers Comprehensive Support for Louisiana and Texas with Hurricane Laura

The CMS announced efforts to support Louisiana and Texas in response to Hurricane Laura. CMS notes that they have “provided numerous waivers to health care providers during the current coronavirus disease 2019 (COVID-19) pandemic to meet the needs of beneficiaries and providers. The waivers already in place will be available to health care providers to use during the duration of the COVID-19 PHE determination timeframe and for the Hurricane Laura PHE.  CMS may waive certain additional Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements, create special enrollment opportunities for individuals to access healthcare quickly, and take steps to ensure dialysis patients obtain critical life-saving services.”

August 28, 2020: Remdesivir Emergency Use Authorization Broadened to include All Hospitalized COVID-19 Patients

The FDA announced they have “broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.” This announcement includes links to Fact Sheets for health care providers and patients regarding this use of remdesivir in treating COVID-19 patients.