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Newsletter

April 13, 2020

Health Headlines – April 13, 2020


HHS Begins Delivery of Initial $30 Billion of Provider Relief Funding from CARES Act – On April 10, 2020, HHS announced it is beginning the delivery of an initial $30 billion in relief funding to providers as part of the $100 billion provider relief fund in the Coronavirus Aid, Relief, and Economic Security (CARES) Act in connection with the response to COVID-19. HHS states that the $100 billion of funding from the CARES Act will be used to support providers for healthcare-related expenses or lost revenue from COVID-19, as well as ensure that uninsured Americans are able to access testing and treatment.

The initial $30 billion in payments will be delivered to facilities and providers that received Medicare fee-for-service (FFS) reimbursements in 2019. Providers and facilities will be allotted a portion of the funds based on their share of 2019 FFS reimbursements. HHS has partnered with UnitedHealth Group (UHG) to deliver the payments. Providers will be paid via automated clearing house (ACH) account information on file with UHG, UnitedHealthcare, or Optum Bank, or used for reimbursements from CMS. Those providers who typically receive a paper check for reimbursement from CMS will receive a check in the mail for this payment in the coming weeks.

These payments do not need to be repaid, although recipients must agree to terms and conditions specified by CMS, including that the funds will only be used to prevent, prepare for, and respond to the novel coronavirus, and shall reimburse the recipient only for healthcare related expenses or lost revenues that are attributable to the novel coronavirus. Within 30 days of receiving payments, providers must sign an attestation confirming receipt of the funds and agreeing to the terms and conditions of payment. The terms and conditions can be found here.

With respect to the remaining $70 billion in funds, HHS states it is working on additional distributions focused on providers in areas disproportionally impacted by COVID-19, rural providers, providers of services with lower shares of Medicare FFS reimbursement, providers who predominantly serve Medicaid patients, and to reimburse providers for COVID-19 related care for uninsured patients.

Additional information is available on the HHS website here and here.

Reporter, Lauren S. Gennett, Atlanta, + 1 404 572 3592, lgennett@kslaw.com.

CMS Approves $34 Billion in Medicare Payment Advances – On April 7, 2020, CMS announced it has approved nearly $34 billion in requests from over 17,000 healthcare providers and medical equipment suppliers through the expansion of the Accelerated and Advance Payment Program (the Program). (By April 9, the estimated figure climbed to $51 billion.) The Coronavirus Aid, Relief, and Economic Security (CARES) Act expanded eligibility for the Program, which provides expedited Medicare payments when there is a disruption in claims processing or submission during national emergencies or natural disasters. Just one day after CMS’s announcement, a bipartisan group of more than 30 senators urged CMS to further support the providers’ and suppliers’ efforts battling the COVID-19 pandemic by eliminating or modifying interest rates for repaying the advanced payments.

Healthcare providers and suppliers do not need to meet specific COVID-19-related criteria to qualify for the advanced payments. They need only meet four eligibility requirements: (1) have billed Medicare for claims within the past 180 days, (2) not be in bankruptcy, (3) not be under active medical review or program integrity investigation, and (4) not have outstanding delinquent Medicare overpayments.

Providers must repay the payment advances funded by the Hospital Insurance (Part A) and Supplementary Medical Insurance (Part B) trust funds. Most hospitals will have up to one year to repay the advance payment. However, if CMS does not recoup the advance payments in the time provided, providers and suppliers are charged 10.25% interest on the remaining balance. In a letter to CMS dated April 8, 2020, 32 senators explained “hospitals, physicians and other health-care providers have significant concerns about the 10.25 percent interest rate and the implications of such interest rates on their ability to participate in the [Program].” The senators requested CMS extend the deadline for CMS to recoup the advance payments without interest or modify or eliminate the interest requirement altogether.

The amount of the payment depends on the type of provider with most providers and suppliers able to request up to 100% of the Medicare payment amount for a three-month period. However, inpatient acute care hospitals, children’s hospitals, and certain cancer hospitals are able to request up to 100% of the Medicare payment amount for a six-month period. Critical access hospitals can request up to 125% of their payment amount for a six-month period.

Importantly, the payments through the Program are separate from the $100 billion provided in the CARES Act, which distributes funds that do not need to be repaid.

The CMS announcement is available here. The CMS Fact Sheet is available here and provides more details on the application process. The senators’ letter to CMS is available here.

Reporter, Nicholas Kump, Sacramento, +1 916 321 4817, nkump@kslaw.com.

CMS Issues New Section 1135 Waivers to Assist Healthcare Providers Combatting the COVID-19 Pandemic – Using its authority granted under Section 1812(f) of the Social Security Act, CMS has issued several new Section 1135 blanket waivers to waive or modify certain Medicaid, Medicare, CHIP, or HIPAA requirements when a federal emergency has been declared. The new waivers focus on expanding staff and giving healthcare facilities more flexibility to organize staff in a way that will allow key personnel to effectively respond to the potential surge in patients. These new waivers are now in effect with a retroactive effective date of March 1, 2020 and will last until the emergency declaration ends. To receive a blanket waiver, no request is required, and providers do not need to notify the CMS regional offices. These new waivers come after CMS issued several blanket waivers last month. A summary of the waivers issued on March 30 is available here.

CMS has updated its website to include these additional waivers with a comprehensive list of all blanket waivers available here.

Rural Health Clinics and Federally Qualified Health Centers

A new blanket waiver modifies the nurse practitioner supervision requirements at Rural Health Clinics and Federally Qualified Health Centers, permitting nurse practitioners to practice without medical supervision to the extent permitted by state law. However, physicians are still responsible for providing medical direction to the clinics but may do so remotely. Physicians are also permitted to work across state lines to provide care directly for rural hospital patients, using phone, radio, or online communication. Physicians are not required to be physically present with the patient at the rural clinic, allowing remotely-located physicians to coordinate with on-site nurse practitioners. This waiver permits nurse practitioners to practice to the full extent possible while allowing physicians to turn their attention to other demands. To address potential staffing shortages, CMS is also waiving the requirement that nurse practitioners, physician assistants, and nurse-midwives be available to provide care at least half the time that the rural health clinic operates.

Long-Term Care Facilities and Skilled Nursing Facilities (SNFs)

Nurse practitioners, physician assistants, and clinical nurse specialists are now permitted to perform certain physician-delegated tasks on SNF patients that previously required a physician’s presence. However, any physician who delegates a task must continue to provide supervision and physicians may not delegate tasks that are prohibited under state law or the facility’s policy. Further, physicians may delegate physician visits to nurse practitioners, physician assistants, or clinical nurse specialist who work with the physician as long as the task does not require the assistant to perform any service that is outside of the state’s scope of practice law. Given these new flexibilities it is important to note that the number of required physician visits has not changed under these waivers, even if an assistant may perform these visits. The purpose of these waivers is to ensure that SNF patients continue to receive care when physician resources are strained to meet the demands of the COVID-19 pandemic.

Home Health Agencies (HHAs)

HHAs are now allowed to perform Medicare-covered initial assessments to determine an individual’s homebound status either by record review or remote assessment. Occupational therapists at home health agencies are also allowed to perform initial assessments on all patients who are receiving therapy services—not just occupational therapy services—as a part of the patient’s plan of care. In addition, CMS is waiving the bi-weekly, on-site nurse visit requirement so long as in the nurse’s absence an aide is providing care consistent with the patient care plan. These new waivers are intended to relieve home health nurses and give them more time to perform direct patient care.

Hospices

Under the new waiver, hospice nurses are no longer required to perform hospice aide in-service training tasks, giving them more time to spend with patients. Another hospice-focused waiver waives bi-weekly, on-site nurse supervisory visits. Under these newly-issued waivers, hospices are also no longer required to use volunteers for at least 5% of patient-care hours because of the potentially limited availability of volunteers during quarantine. These waivers are intended to alleviate staffing pressures and allow hospices to operate with limited staff and volunteers.

Reporter, Taylor Whitten, Sacramento, +1 916 321 4815, twhitten@kslaw.com.

King & Spalding Client Alert: HIPAA Enforcement Discretion During the COVID-19 Public Health Emergency – Over the last two months, HHS has published guidance regarding the enforcement of HIPAA and its privacy and security requirements in response to the COVID-19 public health emergency. The guidance covers issues including telehealth, uses and disclosures of protected health information (PHI) for public health and health oversight activities, hospital disaster protocol implementation, and substance use disorder patient records. Click here for a Client Alert issued by the King & Spalding Life Sciences and Healthcare Crisis Practice analyzing the guidance and discussing measures to minimize risk.

ALSO IN THE NEWS

OCR Notice of HIPAA Enforcement Discretion for Community-Based COVID-19 Testing Sites – On April 9, 2019, the Office for Civil Rights (OCR) of HHS issued a notice that it will not impose penalties for noncompliance with regulatory requirements under the HIPAA privacy, security and breach notification rules against covered healthcare providers and their business associates in connection with “good faith participation” in the operation of community-based COVID-19 specimen collection and testing sites. The notice is limited to mobile, drive-through, or walk-up sites that provide only COVID-19 specimen collection or testing services to the public. The notice does not apply to activities that are unrelated to COVID-19 testing or involve handling PHI outside of the testing site. The notice encourages implementing “reasonable safeguards” such as setting up canopies or barriers for privacy, controlling traffic to minimize chances of screening interactions being observed or overheard, posting signs prohibiting filming and establishing a “buffer zone” for media, using only secure technology to record and transmit PHI, and posting a Notice of Privacy Practices. A copy of the notice is available here, and a press release from OCR relating to the notice is available here.

OIG Will Not Enforce Anti-Kickback Statute for Certain Remuneration Related to COVID-19 Covered by the Stark Law Blanket Waivers – On April 3, 2020, OIG issued a policy statement announcing that it will exercise its enforcement discretion not to impose administrative sanctions under the Federal Anti-Kickback Statute (AKS) “for certain remuneration related to COVID-19” covered by the Stark Law Blanket Waivers, subject to specified conditions (the Policy Statement).  (emphasis added) OIG will exercise its discretion not to impose administrative sanctions if: (i) the remuneration is covered by one of the Blanket Waivers listed in B.1 through B.11 of the Stark Law Blanket Waivers; and (ii) all of the conditions in the Stark Law Blanket Waivers apply.  The Policy Statement applies to conduct occurring on or after April 3, 2020 and ending on or before same date that the Stark Law Blank Waivers terminate.  Providers should be mindful, however, of the scope of OIG’s Policy Statement.  OIG’s exercise of enforcement discretion only applies to the Stark Law Blanket Waivers, so arrangements with pharmaceutical and device manufacturers and arrangements not involving a physician would not be protected.  Moreover, OIG’s Policy Statement does not apply to all remuneration covered by the Stark Law Blanket Waivers.  The Policy Statement is available here. Click here for a summary of the Stark Law Blanket Waivers.

CMS Proposes 2.6% Payment Hike for Nursing Homes, Hospices, and Inpatient Psychiatric Facilities – In proposed rules announced April 10, 2020, CMS proposed a 2.6% increase in payment rates for nursing homes, hospice providers, and inpatient psychiatric facilities. Nursing homes would see the highest additional payment nationwide, as the proposed rate hike would increase payments to skilled nursing facilities by $784 million in fiscal year 2021. The proposed 2.6% pay hike would increase payments by $580 million for hospices and $100 million for inpatient psychiatric facilities.  Comments are due by 5 p.m. on June 9, 2020. The proposed payment rule for hospices is here.  The proposed payment rule for SNFs is here, and the proposed payment rule for inpatient psychiatric facilities is here

CMS Finalized Payment Methodologies for Medicare Advantage Part C and Part D for CY 2021 – On April 6, 2020, CMS finalized the 2021 Rate Announcement for Medicare Advantage Part C and Part D. In the past, the Call Letter was included as part of the Final Rate Announcement. This year, however, CMS stated it will not be issuing a 2021 Call Letter and instead will be issuing information regarding the Part C and Part D bidding process separately. CMS will incorporate information typically found in the Call Letter into proposed rules for CY 2021 and 2022. The final rate announcement can be found here, and the fact sheet for the rate announcement is here.