This week in Medicare updates—3/18/2020
Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) by Hospice Agencies
On March 9, CMS published a Memorandum to state survey agency directors regarding guidance for hospice agencies on infection control for COVID-19. The memo contains an FAQ on addressing COVID-19 in hospices and discusses how to handle visitors, staff, inpatient prevention and control practices, considerations for patient placement, when to discontinue transmission-based precautions or in-home isolation, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on this guidance on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019
On March 9, CMS published a Memorandum to state survey agency directors regarding the implications of COVID-19 on EMTALA requirements. Every emergency department is required to screen all individuals who come into the ED and is expected to have the capability to apply appropriate COVID-19 screening criteria to immediately identify and isolate individuals who meet the screening criteria to be a potential COVID-19 case. EDs must contact state or local public health officials when encountering a potential COVID-19 case to determine next steps. If a patient is suspected or confirmed to have COVID-19, hospitals and CAHS should consider CDC and public health official guidance to determine whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. The memorandum also includes guidance on alternate screening sites and other enforcement considerations.
CMS published a Press Release on this guidance on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Interoperability and Patient Access Final Rule
On March 9, CMS published a draft version of a Final Rule on advancing interoperability and patient access to health information. The policies include a change to the Conditions of Participation that will require hospitals--including psychiatric hospitals and CAHs--to send admission, discharge, and transfer notifications to help support care coordination. This change will apply six months after publication of the final rule. Policies also include requirements regarding application programming interfaces (API) to allow patients to access claims and encounter information beginning January 1, 2021.
These regulations will be effective 60 days after publication of the rule in the Federal Register. CMS published a Press Release and a Fact Sheet on the same date to accompany the rule.
Coverage and Payment Related to COVID-19
On March 9, CMS published a Fact Sheet on Medicare coverage for coronavirus-related care and testing. The fact sheet provides information for a variety of provider types and services, including diagnostic lab services, vaccines, inpatient hospital care services, inpatient quarantines, ambulatory services in a hospital or other location, telehealth services, and more. The fact sheet also discusses what is covered under Medicare Advantage, including a provision that may allow Medicare Advantage organizations to waive or reduce enrollee cost-sharing for COVID-19 lab tests, effective immediately, as long as this is done for all plan enrollees on a uniform basis. Medicare Advantage organizations may also waive prior authorization requirements for tests or services related to COVID-19.
CMS published a Press Release on the fact sheet on the same date.
Ensure Required Patient Assessment Information for Home Health Claims
On March 9, CMS published Special Edition MLN Matters 20010 regarding steps to take to ensure claims match the corresponding OASIS assessment.
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter of 2019
On March 9, the OIG published a Memorandum regarding the quarterly comparison of average sales prices (ASP) and average manufacturer prices (AMP) to identify drugs whose ASP exceeds the AMP by 5% or more. The OIG found that 11 drug codes met CMS’ price substitution criteria in the third quarter of 2019, and seven had ASPs that exceeded the AMP by at least 5% but the drug codes did not meet other CMS price substitution criteria.
Florida Should Improve its Oversight of Selected Nursing Homes’ Compliance with Federal Requirements for Life Safety and Emergency Preparedness
On March 10, the OIG published a Review of whether Florida ensured that selected nursing homes participating in Medicare or Medicaid complied with requirements for life safety and emergency preparedness. The OIG found deficiencies at all 20 of the nursing homes reviewed related to a variety of life safety deficiencies (e.g., building exits, smoke barriers, fire detection and suppression systems, etc.) and emergency preparedness deficiencies (e.g., emergency supplies and power, emergency communication plans, etc.). The OIG concluded that these deficiencies occurred due to a variety of factors, including inadequate management oversight as well as frequent staff turnover. Florida also did not have a standard life safety training program for all nursing home staff and generally performed surveys no more than once every 12-15 months.
The OIG recommends Florida work with CMS to develop a life safety training program, conduct more frequent surveys, and follow up with the 20 deficient nursing homes to verify corrective actions have been taken regarding the identified life safety and emergency preparedness deficiencies. Florida did not agree with all findings, and the OIG modified its findings related to resident call systems but maintained that the rest of its findings and recommendations were accurate and correct.
Key Medicare Tools to Safeguard Against Pharmacy Fraud and Inappropriate Billing Do Not Apply to Part D
On March 10, the OIG published a Report regarding key tools to safeguard against pharmacy-related fraud and inappropriate billing in Part D. It notes that Part D does not have three key tools available in other parts of Medicare: pharmacy enrollment, revocation, and preclusion. The OIG noted that Part D paid $168 billion for drugs in 2018, and it recommends CMS institute changes detailed in the report to help fight fraud and inappropriate billing.
Updated List of Excluded Individuals and Entities (LEIE)
On March 10, the OIG updated its LEIE with an updated LEIE database for download and lists of February 2020 exclusions, reinstatements, and profile corrections.
Information Related to COVID-19
On March 10, CMS published a Memorandum to all Medicare Advantage organizations, Part D sponsors, and Medicare/Medicaid Plans to inform them of obligations and permissible flexibilities related to disasters and emergencies resulting from COVID-19. These flexibilities include:
- Waiving cost-sharing for COVID-19 tests
- Waiving cost-sharing for COVID-19 treatments in doctor’s offices or emergency rooms and services delivered via telehealth
- Removing prior authorizations requirements
- Waiving prescription refill limits
- Relaxing restrictions on home or mail delivery of prescription drugs
- Expanding access to certain telehealth services
CMS published a Press Release on the memorandum on the same date.
Guidance for Use of Certain Industrial Respirators by Health Care Personnel
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance on the types of facemasks healthcare workers may use in situations involving COVID-19 and other respiratory infections. The CDC has updated their personal protective equipment (PPE) recommendations, and CMS surveyors will consider this to determine if Medicare and Medicaid providers and suppliers are complying with infection control protocols. The memorandum details when providers can use expanded types of facemasks and when to return to the use of respirators rather than facemasks. It also notes that surveyors will be validating the date of the last FIT test for health care workers in Medicare and Medicaid certified facilities. Any CMS guidance that explicitly, or by reference, indicates N-95 or PPE usage will automatically incorporate any any filtering facepiece respirators (FFR) authorized under this EUA and any guidance issued by the CDC.
CMS published a Press Release on the memorandum on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators within 30 days of this memorandum.
Guidance for Infection Control and Prevention Concerning COVID-19 in Home Health Agencies
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance for home health agencies on infection control for COVID-19. The memo contains an FAQ on addressing COVID-19 in home health agencies and discusses how to handle patient screening, monitoring or restricting home visits for health care staff, determining when to allow patients with confirmed COVID-19 to be treated at home, infection prevention and control practices for family member exposure, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on the same date to accompany the memorandum.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Guidance for Infection Control and Prevention of COVID-19 in Dialysis Facilities
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance for dialysis facilities on infection control for COVID-19. The memo contains an FAQ on COVID-19 management and includes questions addressing early identification of the virus among patients, staff, and visitors; how to monitor or restrict facility staff members, where to place patients with undiagnosed respiratory symptoms or suspected or confirmed COVID-19, what types of personal protective equipment to use, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on the same date to accompany the memorandum.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Part D Savings Model
On March 11, CMS published a Press Release and Fact Sheet to announce the creation of a new Medicare Part D Senior Savings Model aimed toward lowering out-of-pocket costs for insulin to no more than $35 for a 30-day supply. CMS is testing a change to the Manufacturer Coverage Gap Discount Program where Part D sponsors would offer supplemental benefits that apply after manufacturers provide a discounted price for a broad range of insulins included in the model. The model is voluntary.
CMS is releasing two requests for applications--one for Part D sponsors and one for pharmaceutical manufacturers--to apply to participate beginning January 1, 2021.
Updated Corporate Integrity Agreement Documents
On March 11, the OIG published information on closed Corporate Integrity Agreements with:
- American Family Care, Inc., of Hoover, AL
- Dignity Health, of Pasadena, CA
- American Senior Communities, see Extendicare Health Services, Inc., of Indianapolis, IN
- Guardian Elder Care, see Extendicare Health Services, Inc., of Brockway, PA
- Noble Healthcare Management, see Extendicare Health Services, Inc., of Louisville, KY
- Saber Healthcare Group, see Extendicare Health Services, Inc., of Cleveland, OH
- Valley Manor Rehabilitation and Healthcare Center, see Extendicare Health Services, Inc., of Coopersberg PA
- Ocean Dental, P.C., of Stillwater, OK
- Southeast Orthopedic Specialists, of Jacksonville, FL
- Suthar, Manish, M.D., and Integrative Spine Care, LLC, of Chesterfield, MO
FAQs on Essential Health Benefit Coverage and COVID-19
On March 12, CMS published an FAQ on essential health benefit coverage of COVID-related services. It discusses whether isolation and quarantine for COVID-19 is covered, whether a vaccine would be covered should it become available, and more.
On March 13, CMS published a Press Release to accompany the FAQ.
Schedule and Policies for Termination of the Rural Community Hospital Demonstration
On March 13, CMS published One-Time Notification Transmittal 2443 regarding the schedule and policies for termination of the Rural Community Hospital Demonstration. The transmittal also includes information on when MACs will begin to end interim payments and final settlements of cost reports.
Effective date: April 30, 2020
Implementation date: June 12, 2020
The Supplemental Security Income/Medicare Beneficiary Data for Fiscal Year 2018 IPPS Hospitals, IRFs, and LTCHs
On March 13, CMS published One-Time Notification Transmittal 2444 regarding updated data for determining disproportionate share adjustments for IPPS hospitals and the low-income patient adjustment for IRFs. It also includes data for payments applicable for LTCH discharges.
CMS published MLN Matters 11679 on the same date to accompany the transmittal.
Effective date: April 13, 2020
Implementation date: April 13, 2020 - Routine or Recurring Item
April 2020 Update of the Ambulatory Surgical Center (ASC) Payment System
On March 13, CMS published Medicare Claims Processing Transmittal 4545 regarding the April 2020 ASC payment system update. The update introduces several new HCPCS codes, corrections to payment rates for two diagnostic radiopharmaceuticals, and more.
Effective date: April 1, 2020
Implementation date: April 6, 2020
NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR)
On March 13, CMS published National Coverage Determinations Transmittal 217 and Medicare Claims Processing Transmittal 4546 regarding the implementation of expanded coverage for NCD 20.32 Transcatheter Aortic Valve Replacement. The expanded coverage includes changes to qualifications for the hospital programs and changes to the medical personnel on the heart team.
Effective date: June 21, 2019
Implementation date: June 12, 2020