HHS Extends Provider Relief Fund Deadline to September 13th
On August 25th, the Department of Health and Human Services (HHS) announced that the deadline to apply for Phase 2 General Distribution Funding from the CARES Act’s Provider Relief Fund has been further extended to September 13th. Through the Phase 2 General Distribution, providers who bill Medicare, Medicaid, CHIP, or are dental providers may apply to receive up to 2% of their annual patient revenue if they have not already received 2% of funding in Phase 1, which was only for Medicare fee-for-service-billing providers.
More information on the Provider Relief Fund is available here.
CMS Issues New Interim Final Rule Modifying COVID-19 Response
On August 25th, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) that implements new policy modifications in response to the COVID-19 public health emergency (PHE), including new testing requirements and enforcement of data reporting for long-term care (LTC) facilities. Major provisions in the IFC include:
- Requirement for LTC Facility Testing of Residents and Staff: CMS is requiring LTC facilities to perform COVID-19 testing on their residents and staff, including individuals providing services under arrangement and volunteers. The HHS Secretary will issue guidance as to the required frequency and other parameters for such testing. LTC facilities would be “responsible for the costs of testing in order to comply with the infection control requirements of this rule.” CMS included a sensitivity analysis of costs required for testing up to 20 times per year, but has “no reason to believe that testing will be required anywhere near the extent demonstrated at the high end of this range.”
- LTC Facility Data Reporting: Effective immediately, CMS will impose a civil monetary penalty (CMP) each time an LTC facility fails to report COVID-19 related information to the Centers for Disease Control (CDC). The CMP imposed will start at $1,000 and increase by $500 per infraction, to a maximum of $10,000.
- Hospital Data Reporting: CMS is issuing a formal requirement for hospitals and critical access hospitals to report all data elements specified by the HHS Secretary during the PHE. The specific data items required may change as HHS requires new information. The current list, along with other reporting requirements, is described in a July 29th HHS guidance memo (available here)
- Laboratory Result Reporting: CMS will require laboratories that perform SARS-CoV-2 tests to report their results to HHS. The format and requirements for such reporting will be specified by the HHS Secretary in guidance. The current guidance is described in a June 4th HHS memo (available here). Laboratories that fail to submit results will be in violation of CLIA standards, resulting in condition level deficiencies for which CMPs or other penalties may apply.
- End of Extraordinary Circumstances Exceptions: CMS is ending the Extraordinary Circumstances Exceptions status that was granted to the following value-based purchasing programs for reporting purposes:
- The End-Stage Renal Disease Quality Incentive Program;
- The Hospital-Acquired Condition Reduction Program;
- The Hospital Readmissions Reduction Program; and
- The Hospital Value-Based Purchasing Program.
- COVID-19 Testing Without Physician Orders: CMS is revising the May 8th COVID-19 IFC, which authorized testing of Medicare beneficiaries for COVID-19 or related tests without an order from a physician or other practitioner. As of the publication of this rule, only one such COVID-19 diagnostic test and one of each other related test may be performed under these conditions. Subsequent tests may be performed only with a physician or other practitioner order. Other practitioners may include pharmacists and other healthcare professionals who are authorized to order diagnostic laboratory tests, in accordance with state scope of practice and other pertinent laws.
- Adjustments for Temporary Premium Credits: Some issuers of individual and small group health insurance coverage may have offered temporary premium credits to enrollees. The IFC clarifies that issuers who offered such credits must include these reductions in their reported premiums, for the purposes of 2020 risk adjustment. These credits will therefore reduce the reported premium.
- Modifications to Part C and Part D Star Ratings: CMS will remove application of the 60 percent rule and avoid the exclusion of Medicare Advantage and Part D contracts with 60 percent or more of their enrollees living in FEMA-designated Individual Assistance areas from calculation of the non-CAHPS measure-level cut points and calculation of the Reward Factor for the 2022 Star Ratings.
- MIPS Modifications: CMS is expanding telehealth codes used in beneficiary assignment for the CMS Web Interface and CAHPS for MIPS Survey and adding/modifying improvement activities in the Quality Payment Program.
The IFC is available here.
CMS Issues Updated Covid-19 Waivers and Flexibilities
On August 25th, CMS updated policy and regulatory revisions in response to the COVID-19 PHE and the aforementioned IFC. The updated flexibilities include:
- CMS is allowing pharmacists, and other auxiliary personnel that are able to order lab tests under state scope of practice and other relevant laws, to order COVID-19 tests for Medicare beneficiaries during the PHE.
- For the Merit-based Incentive Payment System (MIPS) improvement activity titled “COVID Clinical Trials,” CMS is 1) expanding the improvement activity to also allow credit for clinicians who participate in the care of patients diagnosed with COVID-19 and simultaneously submit relevant clinical data to a clinical data registry for ongoing or future COVID-19 research; 2) updating the title to “COVID-19 Clinical Data Reporting with or without Clinical Trial;” and 3) extending the activity for the CY 2020 and CY 2021 performance periods.
- CMS is delaying the implementation of the Qualified Clinical Data Registry measure testing and data collection policies by 1 year.
- CMS is postponing the September 1st deadline for submitting applications to the Medicare Geographic Classification Review Board (MGCRB) for FY 2022 reclassifications until 15 days after the public display date of the Fiscal Year 2021 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital final rule.
More information is available here.
OCR Releases Updated HIPAA Guidance on Contacting Patients About Plasma Donation
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has released updated guidance on HIPAA and contacting former COVID-19 patients about plasma donation. The guidance has been updated to include health plans, in addition to covered health care providers such as hospitals or pharmacies, as an entity permitted under HIPAA to identify and contact patients who have recovered from COVID-19 to provide them with information about plasma donation. The use of protected health information (PHI) to identify and contact such individuals without their authorization is permitted as a health care operations activity to the extent that it will improve case management for patients or beneficiaries that have or may become infected with COVID-19. Communications that inform or encourage individuals to use a particular blood or plasma donation center is generally considered marketing and is not permitted under HIPAA.
The guidance is available here.
CMS Announces National Training Program for Nursing Home Infection Control
On August 25th, CMS announced a national nursing home training program for frontline nursing home staff and nursing home management for controlling the spread of COVID-19 within nursing homes. The training for frontline staff, called “CMS Targeted COVID-19 Training for Frontline Nursing Home Staff” covers five topics separated into five modules, and focus on basic infection control and prevention. The training for management, called “CMS Targeted COVID-19 Training for Nursing Home Management” covers ten topics separated into ten modules, and focus on infection control and cleanliness, implementation of telehealth, emergency preparedness, and vaccine delivery.
The training can be found on the CMS Quality, Safety & Education Portal, available here.