2019 Novel Coronavirus (COVID-19) Resources
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HortySpringer Office Update
Allegheny County is in the “Green Phase” of the Pennsylvania reopening process, so our Pittsburgh office is open. However, in line with the suggestion from the Governor that telework is strongly encouraged, many of our attorneys and staff are still working remotely. Regardless of where we are on any given day, we are still here for you.
If you have any questions or need any legal assistance — whether coronavirus-related or otherwise — please feel free to call us at 412-687-7677 or e-mail us at firstname.lastname@example.org and we will be happy to assist you.
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Get the Facts!
One of the most frequent comments we are hearing from our clients about the coronavirus situation is their constant struggle to combat misinformation about the virus stirred up by the TV news and social media. This is distracting them from dealing with real challenges such as supply chain disruption, staff shortages, and patient care issues.
To help, here are some links to online resources with objective information and helpful tips about the practical problems you all are facing. As always, it is our privilege to represent hospitals, health systems, and their clinical and administrative leaders. You are the true heroes who, like every time in the past, get us all through this current public health situation.
July 24 – 30, 2020:
HHS Issues New Report Highlighting Trends in COVID-19 Telehealth Utilization
HHS published a new report regarding trends in Medicare beneficiary telehealth utilization amid COVID-19. The report includes an analysis of claims data from January through the beginning of June. HHS discovered that by April, nearly half of Medicare primary care visits were provided through telehealth (compared with less than one percent in February). A press release is available here.
CMS Updates Data on COVID-19 Impacts on Medicare Beneficiaries
CMS released a monthly update of data showing the impact of COVID-19 on the Medicare population. The data set spans the period from January 1 through June 20, 2020. A press release is available here.
FDA Posts Template for COVID-19 Emergency Use Authorization Requests
The Food and Drug Administration posted a new template for commercial developers to use in submitting emergency use authorization requests for COVID-19 diagnostic tests that can be performed at home, or in other settings besides a lab, such as offices or schools. A news release is available here.
CMS Updates COVID-19 FAQ on Medicare Fee-for-Service Billing
CMS updated FAQs that address Medicare Fee-for-Service billing. Among other things, the FAQs include new information on CPT code 99211 and on the use of the Cost-Sharing (“CS”) modifier on claims for pre-surgery examination services that include COVID-19 testing. The FAQs can be found here.
July 17 – 23, 2020:
HHS Distributes Second Round of COVID-19 High-Impact Relief Payments
The Department of Health and Human Services (“HHS”) announced that it will be providing $10 billion in additional relief payments to hospitals located in high-impact COVID-19 areas. More than 1,000 hospitals nationwide will be receiving this assistance. Hospitals will be paid $50,000 per eligible admission. This second-round distribution of high-impact relief payments, set to begin on July 27, 2020, builds upon HHS’s initial first-round distribution back in May.
OIG Updates Its Work Plan
The Department of Health and Human Services Office of Inspector General (“OIG”) updated its public-facing Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. The latest updates include reviews of the Centers for Disease Control and Prevention’s collection and use of data regarding disparities in COVID-19 cases and outcomes, the geographic distribution of Provider Relief Funds to communities disproportionately affected by adverse COVID-19 outcomes, and the Centers for Medicare & Medicaid Services’ distribution and recovery of payments via its Accelerated and Advance Payment Program.
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July 10 – 16, 2020:
HHS Provides Additional COVID-19 Provider Relief Fund Payments
The Department of Health and Human Services (“HHS”) is providing approximately $4 billion in provider relief payments to certain health care providers facing financial hardships because of the COVID-19 pandemic. Approximately $3 billion of these funds is allocated for safety-net hospitals that serve a large percentage of vulnerable populations. The remaining $1 billion is allocated to eligible rural providers, as well as other providers from certain small non-rural and metropolitan areas. More information can be found here.
IRS Extends CHNA Requirements Deadline
In response to the ongoing COVID-19 pandemic, the Internal Revenue Service (“IRS”) is providing relief to tax-exempt hospital organizations that are required to meet the Community Health Needs Assessments (“CHNA”) requirements. Notice 2020-56 extends the deadline by which hospital organizations must conduct a CHNA and adopt an implementation strategy to meet the community health needs identified through the most recently conducted CHNA. Under previous guidance, hospital organizations originally had until July 15, 2020. Now, the time for hospital organizations to comply with any CHNA requirements due to be completed on or after April 1, 2020, and before December 31, 2020, is extended to December 31, 2020. More information can be found here.
NPDB Continues Waiver of Query Fees
In order to continue supporting informed licensing, credentialing, privileging, and hiring decisions during the COVID-19 pandemic, the Health Resources and Services Administration announced that it will continue to temporarily waive user fees for eligible entities making National Practitioner Data Bank (“NPDB”) queries. This fee waiver includes one-time and continuous queries, but not self-queries. This update continues these waivers through September 30, 2020. More information can be found here.
OMB Releases Regulatory Agenda
The Office of Management and Budget (“OMB”) released its latest Unified Agenda of Federal Regulatory and Deregulatory Actions. Included in this Agenda is a listing of planned HHS regulatory activities, which include, among other things, policy/regulatory revisions made in response to the COVID-19 public health emergency, changes to various payment systems and models, modernization of the physician self-referral regulations, updates to the Health Insurance Portability and Accountability Act’s enforcement and privacy rules, amendments to the civil monetary penalty rules, strengthening oversight of accrediting organizations, and the revision of safe harbors under the anti-kickback statute.
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July 3 – 9, 2020:
OIG Updates Its Work Plan
The OIG has updated its public-facing Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. The latest updates include an examination of the use of telehealth services in Medicare during the COVID-19 pandemic and a review of federal and state policy modifications to ensure that Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic.
June 26 – July 2, 2020:
CMS Releases Proposed Rule for Home Health Payment System
The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would make payment rate and policy changes to the calendar year 2021 Home Health Prospective Payment System. Two of the changes being proposed in this rule including the following. First, this rule would increase projected aggregate payments to home health agencies by 2.6%, or $540 million. Second, this rule would make permanent the interim changes to the plan-of-care requirements that had been recently implemented in response to the COVID-19 public health emergency. More specifically, the rule would require that plans of care include any provision of remote patient monitoring or other services to be furnished via a telecommunications system, as well as a description of how the use of these technologies would achieve patient care goals. Furthermore, these technological services must be tied to patient-specific needs, cannot substitute for an in-person home visit, and cannot be considered a home visit for the purposes of patient eligibility or payment. CMS is accepting comments through August 31, 2020. More information can be found here.
June 19 – 25, 2020:
OIG Updates Work Plan
The Department of Health and Human Services Office of the Inspector General (“OIG”) has updated its public-facing Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. The latest updates include reviewing Medicare data to understand hospital utilization during the COVID-19 public health emergency and analyzing Medicare claims data for laboratory testing to identify patterns of billing by laboratories that may indicate fraud or abuse.
June 5 – 11, 2020:
New Flexibilities in Paycheck Protection Program Requirements
The Paycheck Protection Program Flexibilities Act of 2020 relaxes requirements for small business loans under the Paycheck Protection Program. Among other things, this law extends the time period during which a loan recipient may use funds, reduces the percentage of funds that must be used for payroll costs in order to qualify for forgiveness, and establishes a minimum maturity period of five years for loans with a remaining balance. For more information, click here.
CMS Publishes Recommendations to Safely Resume Non-Emergent, In-person Care
The Centers for Medicare and Medicaid Services (“CMS”) published a guide for health care facilities and providers who are resuming non-emergent, in-person health care. Among other things, these recommendations address testing and sanitation protocols, workforce availability, facility considerations, and personal protective equipment and supplies. In addition, CMS issued separate recommendations for patients to help guide them as they consider seeking in-person treatment. To review these recommendations, click here or here.
OIG Updates Work Plan
The Department of Health and Human Services Office of Inspector General (“OIG”) has updated its public-facing Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. This latest update includes identifying opioid treatment program challenges during the COVID-19 pandemic, an audit of the CARES Act Provider Relief Fund payments made to hospitals and other providers, and an audit of nursing homes’ reporting of CMS-required information related to COVID-19.
May 29 – June 4, 2020:
OIG Submits Semi-Annual Report to Congress
The Department of Health and Human Services Office of Inspector General (“OIG”) provided its Semiannual Report to Congress. This document summarizes its activities for the 6-month period ending on March 31, 2020. Among other things, this report highlights the OIG’s work on combating opioid-related fraud, as well as a summary of its strategic plan on preparing for and responding to the current public health emergency. To view the report, click here. For more information on OIG’s strategic plan for overseeing COVID-19 response and recovery, click here.
CMS Adjusts Innovation Center Models
CMS is engaging in an ongoing effort to provide new flexibilities and adjustments to its Innovation Center payment and service delivery models in response to the COVID-19 public health emergency. Among other things, these changes focus on financial methodologies, quality reporting, and model timelines. For more information on current adjustments, click here or here.
May 22 – 28, 2020:
HHS Announces 45-Day Compliance Deadline Extension for Providers
The U.S. Department of Health and Human Services (“HHS”) has announced a 45-day deadline extension for providers who are receiving payments from the Provider Relief Fund. This means that providers now have 90 days from the date they received a payment to accept HHS Terms and Conditions or return the funds. The announcement is available here.
CMS Updates FAQ for Medicare Providers
The Centers for Medicare and Medicaid Services (“CMS”) has updated a Frequently Asked Questions document on its website that is intended to assist Medicare providers. The document focuses on topics relating to Medicare Fee-for-Service billing and certain changes effected by COVID-19 legislation and regulation. To access the document, click here.
Regular Surveys and Reviews Resuming in June
The Joint Commission announced that regular surveys and reviews will resume in June with extra safety considerations. In a blog post listed yesterday, The Joint Commission explained how it will employ certain physical distancing practices to ensure the safety of all parties. These practices include limiting the numbers of individuals in group sessions, minimizing the number of people accompanying the surveyor, and using masks and PPE. To access the full blog post, click here.
May 15 – 21, 2020:
HHS Updates FAQs on CARES Act Funds
The Department of Health and Human Services (“HHS”) has released an updated set of Frequently Asked Questions relating to the Cares Act Provider Relief Fund. This document provides an overview of the program, discusses eligibility, and further explains the terms and conditions of the program. The document was last updated yesterday. It is available here.
PODCAST: Physician Burnout — Addressing a
*PODCAST:Public Health Crisis Worsened by the
POD****CAST: by Rachel Remaley and Charles Chulack
May 8 – 14, 2020:
HHS Updates FAQs on CARES Act Funds
The Department of Health and Human Services (“HHS”) has released an updated set of Frequently Asked Questions relating to the Cares Act Provider Relief Fund. This document provides an overview of the program, discusses eligibility, and further explains the terms and conditions of the program. The full document is available here.
CMS Issues New COVID-19 FAQs on Medicaid and CHIP
The Centers for Medicare and Medicaid Services (“CMS”) released a new set of Frequently Asked Questions relating to State Medicaid and Children’s Health Insurance Program (CHIP) Agencies. These cover topics involving emergency preparedness and response, verification of application information, and benefit flexibilities, among other things. The FAQ document is available here.
OIG Updates FAQ on Application of Enforcement Authorities
The Office of Inspector General (“OIG”) has updated its Frequently Asked Questions relating to the application of its administrative enforcement authorities to arrangements directly connected to the COVID-19 Public Health Emergency. This document provides informal feedback that applies only to arrangements in existence solely during the time period subject to the COVID-19 Public Health Emergency. The document was last updated on May 14, 2020. It is available here.
CMS Releases Video on Medicare Coverage and Payment of Virtual Services
CMS has made available a video that answers common questions about the expanded Medicare telehealth services benefit under its waiver authority. It covers a broad range of topics, such as using telehealth for remote patient monitoring, the ability of home health agencies and hospice providers to use telehealth, and CARES Act changes relating to rural health clinics and federally qualified health centers. The video is available here.
May 1 – 7, 2020:
PODCAST: Paycheck Protection Program —
PODCAST: Proceed with Caution!
PODCAST : by Dan Mulholland and Phil Zarone
CMS Releases Interim Final Rule
The Centers for Medicare and Medicaid Services (“CMS”) released an interim final rule last week. This rule, which is slated to be published in the Federal Register on May 8, 2020, provides additional policy and regulatory revisions in response to the COVID-19 Public Health Emergency. Among other things, these revisions affect specimen collection fees for COVID-19 testing, discuss payment for audio-only telephone evaluation and management services, and contain updates regarding the provision of telehealth services.
SBA Updates FAQ on Paycheck Program Loans
The U.S. Small Business Administration (“SBA”) has updated a Frequently Asked Questions document relating to the Paycheck Protection Program Loans. Among other things, this document includes a question about borrowers who intend to repay their loan in full by May 7, 2020 (in order to be deemed by SBA to have made the required certification in good faith). SBA is extending the repayment date for this safe harbor to May 14, 2020. Borrowers do not need to apply for this extension. To access the FAQ document, click here. Please also be aware of our recent podcast on this subject: “Paycheck Protection Program — Proceed with Caution!”
OIG Updates FAQ
The Office of Inspector General (“OIG”) has updated a document addressing frequently asked questions relating to the application of its administrative enforcement authorities to arrangements directly connected to the COVID-19 Public Health Emergency. This document provides informal feedback that applies only to arrangements in existence solely during the time period subject to the COVID-19 Public Health Emergency. The document was last updated on May 4, 2020. It is available here.
OSHA Provides Interim Guidance on Respirator Decontamination
The U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) has provided interim guidance on the application of its Respiratory Protection standards to scenarios involving the reuse of filtering facepiece respirators that have been decontaminated. This guidance applies in workplaces in which workers need respirators to protect against exposure to infection agents, including during the care of patients with suspected or confirmed COVID-19. The memorandum further expands flexibilities offered in previous enforcement memoranda. It is available here.
COVID-19 Guidance and Resources
CMS continues to host multiple COVID-19 related calls and podcasts. Audio files of the COVID-19 Stakeholder Calls are available through April 15, 2020. These files and other resources can be found here. To access the CMS waivers and flexibilities for health care providers, click here. To receive updates from the Joint Commission, you can sign up for E-Alerts here.
April 24 – 30, 2020:
Coronavirus (COVID-19) Guidance and Resources
Government agencies continue their efforts to provide COVID-19 guidance and resources to health care providers:
- The Centers for Medicare and Medicaid Services (“CMS”) continued to host multiple COVID-19 related calls and podcasts. Recently posted items and topics of discussion include calls regarding front-line nursing, Medicaid, and the Children’s Health Insurance Program, as well as the recurring “CMS Call from the Front Lines” and CMS “Office Hours.” Transcripts and audio of these events can be found here.
- CMS, the Department of Health and Human Services’ (“HHS”) Office of Inspector General (“OIG”), and the HHS Office of the National Coordinator for Health Information Technology have released statements announcing that they will exercise enforcement discretion regarding new requirements under the March 9, 2020 interoperability final rules. These enforcement discretions are meant to provide compliance flexibility to the nation’s health care providers responding to the COVID-19 public health emergency.
- The OIG updated its Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. This latest update includes an examination of the Food and Drug Administration’s role in facilitating diagnostic and serological testing for COVID-19 and an audit of the Assistant Secretary for Preparedness and Response’s operation of the Strategic National Stockpile in response to COVID-19.
April 17 – 23, 2020:
Coronavirus (COVID-19) Guidance and Resources
Government agencies continue their efforts to provide COVID-19 guidance and resources to health care providers:
- The Centers for Medicare and Medicaid Services (“CMS”) continues to host multiple COVID-19 related calls and podcasts. Recently posted items include calls with nurses, dialysis facilities, nursing homes, home health, and hospice agencies, as well as the recurring “Lessons from the Front Lines” and CMS “Office Hours.” Transcripts and audio of these events can be found here.
- CMS released guidelines regarding the gradual “re-opening” of the nation’s health care system and the provision of non-emergent, non-COVID-19 in-person patient care in areas of the country with low or relatively low and stable incidence of COVID-19 cases. These guidelines recommend that health care providers considering re-starting or increasing their non-COVID-19 in-person patient care services should coordinate with their local and state public health officials, as well as review the availability of their workforce and supplies (including personal protective equipment), facility readiness, and testing capacity. More information can be found here.
- CMS and the Assistant Secretary of Preparedness and Response have launched an online COVID-19 Healthcare Workforce Virtual Toolkit. This toolkit was created to help health care decision makers determine the best ways to manage their workforces based on their communities’ unique needs. The toolkit includes information on funding flexibilities, liability protections, workforce training, and up-to-date best practices. More information can be found here.
- In order to support informed licensing, credentialing, privileging, and hiring decisions during the COVID-19 pandemic, the Health Resources and Services Administration has temporarily waived user fees for National Practitioner Data Bank (“NPDB”) queries. This fee waiver includes one-time and continuous queries, but not self-queries. This waiver is effective immediately and has retroactive effect from March 1, 2020 through May 31, 2020. The NPDB will issue query credits to reimburse those entities that have conducted eligible queries between March 1, 2020 and the fee waiver’s implementation. More information can be found here.
- The Department of Health and Human Services Office for Civil Rights announced that it will exercise its enforcement discretion not to impose penalties against covered health care providers for certain violations of the Health Insurance Portability and Accountability Act in connection with the good faith provision of telehealth services during the COVID-19 public health emergency. This enforcement discretion became effective March 17, 2020 and will continue until the declared public health emergency either expires or no longer exists, whichever occurs first.
- The U.S. Food and Drug Administration (“FDA”) has authorized the first diagnostic COVID-19 test that can be completed by individuals within their homes. Test takers use the provided self-collection kit to self-swab a sample from their nose. The individual then mails that nasal specimen to a designated laboratory for testing. A doctor’s order will be needed to get this home test.
- The Federal Communications Commission announced the launch of the COVID-19 Telehealth Program. This program is providing $200 million to eligible health care providers who want to provide “connected care services” to their patients in response to COVID-19. The program will fully fund the telecommunications and information services, as well as the connected devices, needed by the health care providers. This funding opportunity will continue until the program’s funds are depleted or the COVID-19 pandemic has ended. Applications are now being accepted.
April 10 – 16, 2020:
Coronavirus (COVID-19) Guidance and Resources
Government agencies continued their efforts to provide COVID-19 guidance and resources to health care providers:
- The Centers for Medicare and Medicaid Services (“CMS”) continued to host multiple COVID-19 related calls and podcasts. Recently posted items include calls on telehealth, front line nursing, “Hospitals Without Walls,” and CMS’s “Office Hours” call with hospitals and health systems. Transcripts and audio of these events can be found here.
- CMS temporarily waived a number of supervision, certification, and licensure requirements in an effort to bolster and provide flexibility to frontline health care workforces. Some of these waivers include permitting remotely located physicians to directly care for patients at rural hospitals via telehealth services (including across state lines, if necessary) and an expansion of the scope of practice for nurse practitioners and occupational therapists.
- In an effort to expand COVID-19 testing and diagnosis, CMS announced that Medicare will nearly double the payments it makes for certain COVID-19 laboratory tests that use high-throughput technologies. These increased payments are designed to particularly help those individuals, such as nursing home residents, who are especially vulnerable to COVID-19 outbreaks. More information can be found here.
- The U.S. Food and Drug Administration (“FDA”) issued a second emergency use authorization (“EUA”) to decontaminate N95 respirators for reuse. This EUA permits hospitals to decontaminate compatible N95 or N95-equivalent respirators using vaporized hydrogen peroxide sterilization.
- In further efforts to expand COVID-19 testing and diagnosis, the Department of Health and Human Services (“HHS”) released guidance authorizing licensed pharmacists to order and administer FDA-authorized COVID-19 tests, including serology tests. More information can be found here.
- The HHS Office for Civil Rights announced that it will exercise its enforcement discretion not to impose penalties against covered entities or their business associates for certain violations of the Health Insurance Portability and Accountability Act in connection with the good faith participation in the operation of COVID-19 Community-Based Testing Sites. This enforcement discretion has retroactive effect to March 13, 2020. More information can be found here.
- The HHS Office of Inspector General (“OIG”) updated its Work Plan. The OIG Work Plan summarizes new, ongoing, and revised areas of review that the OIG plans to pursue. These latest updates include audits and evaluations of HHS’s production and distribution of COVID-19 lab test kits, CMS’s internal controls regarding hospital preparedness for infectious disease epidemics like COVID-19, hospital compliance with CMS emergency preparedness requirements, and HHS agencies’ adherence to health, safety, and operational protocols during repatriation and quarantine efforts for the COVID-19 outbreak.
The Joint Commission Updates its Standards FAQ
The Joint Commission has updated its hospital and critical access hospital Standards FAQ databases with additional information regarding COVID-19. Some of the topics discussed include the use of ambulatory surgery centers as alternative inpatient care sites for hospitals, documentation challenges while providing care under an emergency operations plan, considerations for sterile compounding, and the conservation of facemasks and respirators during a shortage.
April 3 – 9, 2020:
Many federal agencies have weighed in with various waivers, policy statements and guidance regarding arrangements between and among health care providers and their patients to address the COVID-19 pandemic. These include several blanket waivers by CMS of sanctions under the Stark Law and an OIG Policy Statement declining to impose administrative sanctions under the Federal anti-kickback statute. These actions are helpful, but should not be a blanket license to ignore these laws. In this special podcast, HortySpringer partners Dan Mulholland and Henry Casale review the recent guidance, explain what you can and can’t do and look ahead to the potential for a tsunami of False Claims Act litigation once the pandemic subsides.
PODCAST: Coronavirus Fraud and Abuse Issues —
PODCAST: Protections and Pitfalls
PODCAST: by Dan Mulholland and Henry Casale
Governmental Agencies Issue Further Guidance in Response to COVID-19
Government agencies continued their efforts to provide COVID-19 guidance and resources to health care providers:
- The Centers for Medicare and Medicaid Services (“CMS”) continues to host multiple COVID-19 related calls and podcasts each week. Recently posted items and topics of discussion include CMS’s weekly Stakeholder Call with Seema Verma, “Lessons from the Front Line” (with Seema Verma and Dr. Deborah Birx), waivers and new rules promoting flexibility, and changes to accelerated and advance payment programs. Transcripts and audio of these events can be found here.
- CMS released a series of updated infection control guidance documents for inpatient and outpatient care settings. Based on Centers for Disease Control and Prevention (“CDC”) guidelines, this updated guidance is designed to promote infection control in a variety of contexts, including patient triage, screening (including drive-through screenings), treatment, visitations, and staffing.
- CMS published a Dear Clinician Letter that summarizes the steps that CMS has taken to ensure that the nation’s clinicians have maximum flexibility to reduce unnecessary barriers when caring for patients. The letter discusses such steps as emergency waivers, testing and claims reporting, expanded options for telehealth services, E-visits, virtual check-ins, and workforce flexibilities. The letter also contains links to clinical and technical guidance resources.
- CMS released a guidance document containing recommendations regarding the limitation of medical services that can be deferred, such as preventive medical services and non-emergent, elective treatments.
- The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a report detailing the challenges and needs faced by U.S. hospitals responding to the COVID-19 pandemic. Some of the challenges outlined in the report include shortages of testing supplies and personal protective equipment, difficulty maintaining staffing, difficulty maintaining and expanding capacity to treat patients, and anticipated shortages of respirators. A summary of the report can be found here.
- The OIG also released a policy statement indicating that it will exercise its enforcement discretion not to impose administrative sanctions under the federal anti-kickback statute for certain COVID-19 related remuneration arrangements covered by the HHS Secretary’s recent Blanket Waivers. Regarding the physician self-referral law, the policy statement notes that the “Blanket Waivers effectuate a waiver of certain sanctions that otherwise apply to violations of the physician self-referral law, if certain conditions are met.” Stakeholders that have questions regarding the OIG’s application of its enforcement authorities and how it would view an arrangement that may implicate these authorities can submit inquiries here.
- The HHS Office for Civil Rights (“OCR”) released its own notification announcing that it, too, will exercise its enforcement discretion. The OCR will not impose potential penalties for violations of certain Health Insurance Portability and Accountability Act provisions regarding the uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 public health emergency. More information can be found here.
- The CDC issued a recommendation for the use of cloth face coverings in public settings where other social distancing measures are difficult to maintain. This is especially important in areas of significant community-based transmission. The recommended face coverings are not surgical masks or N-95 respirators. Rather, the CDC indicates that “face coverings fashioned from household items or made at home from common materials at low cost can be used as an additional, voluntary public health measure.”
Joint Commission Updates Standards FAQ Database
The Joint Commission has updated its hospital and critical access hospital Standards FAQ databases with additional information regarding COVID-19. Topics include the decontamination of single-use respirators, FPPE and OPPE requirements while operating under an emergency operations plan, the requirements for granting privileges to volunteer licensed independent practitioners during an emergency or disaster situation, the deferment of medical imaging equipment performance evaluation requirements, and locating CMS 1135 waiver information.
The Joint Commission has also written blog posts on the conservation of face masks and respirators during a shortage, personal protective equipment considerations, and the duration of disaster privileges.
March 27 – April 2, 2020:
Governmental Agencies Issue Guidance, Sweeping Waivers in Response to COVID-19
Governmental agencies continue to act swiftly to provide guidance and resources to frontline health care providers. These efforts include the following guidance, waivers and statements:
- The Centers for Medicare and Medicaid Services (“CMS”) issued new rules and waivers of federal requirements to address potential surges of COVID-19 patients. Among several waivers, CMS waived requirements relating to medical records, telemedicine, verbal orders, and the Emergency Treatment and Active Labor Act (“EMTALA”). For more information on the COVID-19 waivers and guidance, click here or here.
- CMS has updated its EMTALA requirements memorandum to include additional guidance on drive-through testing sites, triage processes, medical screening examinations, and the use of telehealth. This guidance also provides additional information on the Section 1135 waiver of sanctions under EMTALA for relocation to an offsite location to prevent the spread of COVID-19. To review this guidance, click here.
- CMS has issued blanket waivers of sanctions under the Physician Self-Referral Law (“Stark Law”). Under certain arrangements related to COVID-19, health care providers that furnish items or services that would otherwise violate Stark Law may be reimbursed for these services and exempted from sanctions for any noncompliance. For more information on these blanket waivers, click here.
- CMS announced the expansion of its accelerated and advance payment program for Medicare participating health care providers. These payments may be requested by hospitals, doctors, durable medical equipment suppliers, and other Medicare Part A and Part B providers and suppliers who meet specific eligibility criteria. For more information on the accelerated and advance payment process, or on how to submit a request, click here.
- CMS has approved Medicaid Section 1135 waivers for 40 states. These waivers are effective as of March 1, 2020 and will remain effective until the termination of the public health emergency. To see whether your state received an 1135 waiver, click here.
- Vice President Mike Pence penned a letter to the nation’s hospitals requesting that they report COVID-19 testing data to the Department of Health and Human Services (“HHS”). Hospitals should also report data regarding bed capacity and supplies to the National Healthcare Safety Network COVID-19 Patient Impact and Hospital Capacity Module. For more information, click here.
- The Office of the Inspector General (“OIG”) at HHS issued a message of its intent to minimize burdens on providers. To the extent possible, OIG will work with health care organizations that need extensions on OIG deadlines and will carefully consider intent when assessing whether to proceed against an organization for conduct that may be subject to an OIG administrative enforcement action. To view this message, click here.
Joint Commission Releases Position Statement on Use of Face Masks Brought from Home
The Joint Commission has released a statement in support of allowing staff members to bring standard face masks and respirators from home when access to protective equipment is not commensurate with the individual’s risk of exposure. To review this statement and the accompanying policy analysis, click here.
DNV GL Issues Advisory Notice in Response to COVID-19
The DNV issued an advisory notice in light of the COVID-19 national emergency, outlining extensions and modifications of regulatory timelines. These extensions and modifications will be accepted in areas including, but not limited to, credentialing and privileging, internal audits, contract services, and medical equipment. To review this notice, click here.
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March 20-26, 2020:
Official Senate Section-by-Section Summary of the Coronavirus Aid, Relief, and Economic Security (CARES) Act
Governmental Agencies Continue their Efforts to Respond to COVID-19 National Emergency:
As this public health emergency develops, governmental agencies continue their efforts to slow the spread of COVID-19. These efforts include the following guidance, waivers, and statements released this week:
- The Office of Inspector General (“OIG”) released a COVID-19 fraud alert to warn the public about several health care fraud scams related to COVID-19. According to the OIG, scammers are targeting Medicare beneficiaries and offering them illegitimate COVID-19 services in exchange for personal information. For more information, click here.
- OIG has updated its public-facing Work Plan. Recently added items include Highlights of OIG’s Emergency Preparedness Work, COVID-19 Hospital Responses, and an assessment of HHS Agencies’ Adherence to Health, Safety, and Operational Protocols During Repatriation and Quarantine Efforts for the COVID-19 Outbreak. To view the Work Plan, click here or here.
- The Office for Civil Rights at HHS released guidance detailing circumstances in which covered entities may disclose protected health information about an individual who has been infected or exposed to COVID-19 to first responders and other public health authorities while maintaining compliance with the Health Insurance Portability and Accountability Act (“HIPAA”). For more information on HIPAA and COVID-19, click here or here.
- HHS awarded $100 million to health centers across the country in response to COVID-19. Facilities may use the award to address screening and testing needs, acquire medical supplies, and boost telehealth capacity. For a list of award recipients, click here.
- The Centers for Medicare and Medicaid Services (“CMS”) announced a targeted survey process for health care facility inspections in response to COVID-19. This focused survey process will prioritize three types of federal inspections: complaint inspections, targeted infection control inspections, and self-assessments. During this time, standard inspections will not be conducted. For more information, click here.
- CMS announced that it is granting exceptions and extensions from reporting requirements for providers and facilities participating in Medicare quality reporting programs. CMS will not use data reflecting services provided from January 1, 2020 through June 30, 2020 in calculations for Medicare quality reporting and value-based purchasing programs. For more information on specific exceptions and extensions, click here.
- CMS has approved Medicaid Section 1135 waivers for 23 states. These waivers are effective as of March 1, 2020 and will remain effective until the termination of the public health emergency. To see whether your state received an 1135 waiver, click here.
- CMS released Telehealth and Telemedicine Tool Kits for general providers and end stage renal disease providers. Both Tool Kits contain links to sources of information that provide guidance on initiating telemedicine programs, monitoring patients remotely, developing documentation tools, and utilizing virtual services such as FaceTime and Skype during this national emergency.
March 13 – 19, 2020:
Governmental Agencies Issue Waivers and Guidance in Response to COVID-19 Declaration
Earlier this week, the White House declared a national emergency regarding COVID-19. In response to this declaration, governmental agencies issued the following waivers, guidance, and statements:
- The Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) issued nationwide blanket waivers under Section 1135 of the Social Security Act, waiving and modifying health care laws, rules and regulations affected by COVID-19. Among other waivers, HHS waived certain conditions of participation, certification requirements, program participation requirements for health care providers, licensure requirements, and sanctions under the Emergency Medical Treatment and Active Labor Act. In connection with HHS’s 1135 waiver, CMS issued blanket waivers of certain laws, rules and regulations for Skilled Nursing Facilities, Critical Access Hospitals, Acute Care Hospitals, and Home Health Agencies. These waivers became effective on March 15, 2020 for services provided on or after March 1, 2020. For more information, click here or here.
- CMS expanded telehealth coverage for Medicare beneficiaries and will make payments for telehealth visits that are furnished to beneficiaries in their homes. Providers may now offer services via telehealth to beneficiaries regardless of where the patient is located by connecting with their patients through applications that allow for real-time audio and video communication, such as Apple FaceTime, Facebook Messenger video chat, and Skype. In conjunction with CMS’s action, HHS waived sanctions and penalties for Health Insurance Portability and Accountability Act (“HIPAA”) violations against health care providers who use everyday communication applications to connect with patients. For more information on telehealth coverage, click here or here.
- HHS issued a limited waiver of sanctions and penalties for certain provisions under HIPAA. The waiver became effective on March 15, 2020. The official bulletin detailing this action may be found here.
The Office of Inspector General issued a policy statement notifying physicians and other practitioners that they will not be sanctioned or penalized for reducing or waiving cost-sharing obligations that Federal health care program beneficiaries may owe for telehealth services. For the full report, click here.
- The Drug Enforcement Administration (“DEA”) will now permit DEA-registered practitioners to issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical examination, as required under the Controlled Substance Act, so long as the practitioners meet certain conditions. This exception will continue for as long as the HHS Secretary’s designation of a public health emergency remains in effect. To access DEA guidance regarding this exception, click here.
- CMS released guidance to providers to limit all non-essential adult elective surgery and medical and surgical procedures, including dental procedures. The recommendation may be implemented immediately in an effort to manage vital health care resources. More information regarding this guidance may be found here.
Transcript of COVID-19 Calls
CMS Fact Sheets on Corona Virus Coverage
CMS recently published fact sheets on new HCPCS codes for coronavirus tests and clarified coverage for coronavirus hospitalizations.
March 6 – 12, 2020:
REAL TIME information about the virus and its spread throughout the world. Contains facts that you may want to share with your employees and community.
Centers for Disease Control:
The official website which is chock-full of good information and regular alerts and updates you need to know.
American Hospital Association:
Plenty of resources that you will find useful.
Johns Hopkins Coronavirus Resource Center:
This website is aimed at informing the public and briefing policymakers on how to guide a response, improve care, and save lives.
HortySpringer will keep you apprised of any breaking legal developments about the virus. In the meantime, keep up the good work and thanks for all you do!