Weekly Health Care Policy Update - May 14, 2021

In this update:

Biden Administration Announces Updates on Combating COVID-19
- FDA Authorizes Pfizer Vaccine for Kids 12-15
- CDC Updates Mask Guidance for Vaccinated Americans
- Provider Relief Fund Updates
- CMS Increases Payment for COVID-19 Antibody Therapies
- CMS Announces New Vaccine Requirements for LTC Facilities and ICFs
Senate Confirms Andrea Palm for HHS No. 2 Leadership Role, Moves Brooks-LaSure Nomination
House Ways and Means Committee Releases Maternal Mortality and Morbidity Report
CMS Issues Guidance on American Rescue Plan Funding for Medicaid HCBS
Treasury Announces Launch of ARP State and Local Funds
Treasury Provides Statement of Purpose for Capital Funds Projects
OMB Seeks Stakeholder Input on Methods for Advancing Equity and Support for Underserved Communities
CMS Sends Warning Letters for Non-Compliance with Price Transparency Rule
CMS Issues Advance Guidance on ADT Notification Requirements
HHS Announces Prohibition on Discrimination on the Basis of Sexual Orientation and Gender Identity
Rules Being Reviewed by OMB
CDC Releases Data on Variance in COVID-19 Vaccination Among Older Adults
Congressional Hearings
DOH Increases Medicaid Reimbursement for COVID-19 Vaccine Administration
DOH Updates Guidance for Resumption of Non-Essential Elective Surgeries and Non-Urgent Procedures
Governor Cuomo Issues Executive Orders to End Cluster-Based Strategy and Further Extend Disaster Provisions
New York State Medicaid Expands Covered Practitioners for Self-Management Training and Smoking Cessation Counseling Services
CMS Approves Temporary Adjustments to New York Medicaid State Plan During Disaster Emergency
DOH Releases 2021 MLTC VBP Quality Measure Sets
DOH Releases Updated Wage Parity Compliance and Certification Guidance
Regional Economic Development Council Initiative Round 11 Awards
Fund for Public Health in New York City Vaccine Equity Partnership Engagement RFP
Updated Guidance Documents

Administration Updates

Biden Administration Announces Updates on Combating COVID-19
This week, the Biden Administration announced new updates on the COVID-19 response:

FDA Authorizes Pfizer Vaccine for Kids 12-15: On May 10^th, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech Covid-19 vaccine for adolescents aged between 12 and 15 years. On May 12^th, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Policy (ACIP) voted 14-0, with one abstention, to recommend the vaccine’s use in the new age group. ACIP also waived the recommendation that adolescents and adults getting the vaccine wait at least two weeks before getting other vaccinations, so they can catch up on other immunizations.
CDC Updates Mask Guidance for Vaccinated Americans: On May 13^th, the CDC issued new guidance that fully vaccinated Americans may stop wearing masks or social distancing in most indoor and outdoor settings, regardless of size. Masks should still be worn in certain circumstances, including health care settings, prisons, jails, and homeless shelters. About one-third of Americans are currently fully vaccinated, while 46% have received one shot.
Provider Relief Fund Updates: The deadline for providers to use the funding they have received so far from the $178 billion Provider Relief Fund (PRF) is currently June 30^th. A bipartisan group of members of Congress and the American Hospital Association have both written to the Department of Health and Human Services (HHS) requesting an extension of this deadline and for other flexibilities in the use of these funds. As required by the American Rescue Plan (ARP), HHS is expected make available another tranche of PRF funding shortly, although no date has been announced. The ARP directs HHS to use at least 85 percent of the roughly $32 billion (as of April 14^th, according to Kaiser Family Foundation calculations) that remains in the PRF for relief to providers for expenses and losses incurred during the second half of 2020 and the first quarter of 2021. The ARP also contained a new $8.5 billion in rural provider relief funds that remains to be distributed.
CMS Increases Payment for COVID-19 Antibody Therapies: On May 6^th, the Centers for Medicare & Medicaid Services (CMS) announced an increase in the Medicare payment rate for administering monoclonal antibodies (mAb) to treat beneficiaries with COVID-19. The national payment rate increased from $310 to $450 in most health care settings. Additionally, COVID-19 mAb treatment requires no out-of-pocket payment from beneficiaries. CMS has also established a higher rate of $750 for home administration of COVID-19 mAb treatment. CMS noted that the changed rates reflect the higher costs associated with “the one-on-one nature of this care model” and the costs of providing these services “in a safe and timely manner, such as clinical staff and personal protective equipment.” More information is available here.
CMS Announces New Vaccine Requirements for LTC Facilities and ICFs: On May 11^th, CMS released an interim final rule with comment period (IFC) to encourage COVID-19 vaccinations among residents and staff of long-term care (LTC) facilities. The rule, which takes effect 10 days after publication in the Federal Register (expected on May 13^th), requires LTC facilities to offer COVID-19 vaccines to residents and staff, provide appropriate education about the vaccine to residents and staff, and to report on a weekly basis the vaccination status of all residents and staff, including reasons for residents’ vaccine refusal. CMS will publicly post facility-specific vaccination data. The facilities must also report use of any COVID-19 therapeutics. The IFC also establishes similar, though less strict, requirements for intermediate care facilities for individuals with intellectual disabilities (ICFs). More information is available here and here.

Congressional Updates

Senate Confirms Andrea Palm for HHS No. 2 Leadership Role, Moves Brooks-LaSure Nomination
On May 11^th, the Senate voted to confirm Andrea Palm as HHS Deputy Secretary by a vote of 61-37. Palm previously served as the head of Wisconsin’s Department of Health Services and as HHS Chief of Staff during the Obama Administration. She will oversee the daily operations of the Department.

On May 12^th, the Senate voted 51-48 to advance the nomination of Chiquita Brooks-LaSure as CMS Administrator, despite a hold on the nomination by Senator John Cornyn (R-TX) in protest of the Biden Administration’s decision to revoke the extension of Texas’s Medicaid waiver. Senator Chuck Schumer (D-NY) moved a procedural vote to discharge her nomination from the Finance Committee, and Senators Susan Collins (R-ME) and Jerry Moran (R-KS) joined Democrats in favor. Brooks-LaSure’s final confirmation vote is expected shortly.

House Ways and Means Committee Releases Maternal Mortality and Morbidity Report
On May 10^th, the House Ways and Means Committee released a General Accountability Office (GAO) report entitled “Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas.” The report, requested by the Committee two years ago, highlighted that deaths during pregnancy or up to one year postpartum due to pregnancy-related causes are higher in rural and underserved areas, compared to metropolitan areas. However, the report also found that severe maternal morbidity (unexpected outcomes of labor and delivery resulting in significant health consequences) was higher in metropolitan areas (72.6 per 10,000 delivery hospitalizations) than rural areas (62.9 per 10,000).

Regulatory Updates

CMS Issues Guidance on American Rescue Plan Funding for Medicaid HCBS
On May 13^th, CMS issued guidance to State Medicaid Directors on the 10 percentage point enhancement in the Federal Medical Assistance Percentage (FMAP) for home and community-based services (HCBS) for Medicaid recipients, as established in the ARP. States are eligible for this enhanced FMAP, on top of other FMAP increases (including the 6.2 percent increase during the COVID-19 emergency), for all expenditures on Medicaid HCBS, as defined in Appendix B of the guidance, made during the year from April 1, 2021 to March 31, 2022. Such services include HCBS provided through 1115 or 1915 waivers as well as private duty nursing, home health services, personal care services, case management, and school-based services.

States may use the state funds freed up by the enhanced FMAP as additional state match at the applicable FMAP, but only once and only up to the amount of the enhancement. For example, a state with $10 billion in HCBS spend and a temporary one-year 66.2% FMAP could use the additional $1 billion as state share for a total of up to $2.96 billion in additional HCBS spending, if expended before March 31, 2022.

Funds may be spent through March 31, 2024. To fulfill the ARP requirement that states “supplement, not supplant” existing HCBS funding, states must maintain the following at the same standards that were in effect on April 1^st:

Existing HCBS and their amount, duration, and scope;
HCBS eligibility standards, methodologies, and processes; and
Provider payment rates for HCBS.

Funds may be used for a wide variety of purposes, including immediate COVID-19 response and longer-term HCBS investments. Possible longer-term projects include, among others:

Developing cross-system partnerships (including incentives for managed care plans or providers to partner with community-based organizations, or the formation of social determinants of health network partnerships);
Community transition projects, including one-time funding to support transition away from institutional settings;
Addressing social determinants of health and health disparities;
Employing cross-system data integration efforts;
Expanding the use of technology and telehealth;

The full guidance is available here.

Treasury Announces Launch of ARP State and Local Funds
On May 10^th, the Treasury Department announced the launch of the $350 billion allocated in the ARP for State and Local Fiscal Recovery Funds. States that have experienced an unemployment rate increase of more than two percentage points will receive their full funding allotment in one payment. Local governments will receive 50% of their funds this month and 50% in May 2022. New York State (NYS) will receive more than $12.7 billion, while New York City (NYC) will receive more than $4.2 billion in total. Other New York counties, cities, and other local governments (non-entitlement units) will also receive distributions.

Treasury provided some details regarding how recipients may use the funding, including to support public health infrastructure, address negative economic impacts of the public health emergency, replace lost public sector revenue, providing enhanced pay for essential workers, and making infrastructure investments. Notably, funds may not be used for:

General infrastructure projects other than water, sewer, or broadband that do not respond to a specific pandemic-related public health need;
Interest or principal on outstanding debt;
Expenses for the state share of Medicaid; or
Rainy day or reserve funds.

More information is available here and here.

Treasury Provides Statement of Purpose for Capital Funds Projects
On May 10^th, the Treasury Department issued a Statement of Purpose and Process for the Coronavirus Capital Projects Fund. This fund, established in the ARP, will provide $10 billion for state, territory, and Tribal governments to undertake capital projects in response to the public health emergency. New York is expected to receive approximately $350 million.

According to the Statement, Treasury will focus on funding connectivity through this pool. Funds will be directed towards critical capital projects that enable work, education, and health monitoring, including remote options, and provide full internet access to those who lack it. This may include investments in high quality broadband, or other capital assets that provide access to work, education, and health monitoring. Treasury will issue additional guidance before it begins accepting applications in the summer of 2021.

More information is available here.

OMB Seeks Stakeholder Input on Methods for Advancing Equity and Support for Underserved Communities
Last week, the Office of Management and Budget (OMB) posted a request for information (RFI) seeking input on effective methods for assessing whether agency policies and actions equitably serve all eligible individuals and communities, particularly those that are historically underrepresented. The RFI is part of a broader effort enacted in the President’s initial Executive Order on equity, which required each federal agency to develop an Equity Action Plan due to the Domestic Policy Council by January 19, 2022, outlining steps they will take to address identified gaps in equity. HHS has issued a similar RFI in each of its proposed payment rules to date as well. Responses to the OMB’s RFI are due July 6^th.

More information is available here.

CMS Sends Warning Letters for Non-Compliance with Price Transparency Rule
Last week, CMS confirmed that it has begun sending warning letters to hospitals for failure to comply with federal price transparency rules, which require them to publicly disclose the prices they negotiate with insurers. These requirements, established by the Trump Administration in November 2019 (press release here), took effect on January 1, 2021. They mandate that hospitals make accessible a comprehensive, machine-readable file containing pricing data, including payer-negotiated rates, for all items and services, as well as a consumer-friendly version that covers at least 300 shoppable services. A recent Health Affairs study revealed that most of the country’s largest hospitals are not in compliance with the new regulations.

CMS stated that the first round of warning letters was sent in April. However, CMS does not intend to make public which hospitals were warned at this time. The final rule requires this disclosure once CMS issues a civil monetary penalty. Hospitals will have up to 90 days to correct issues identified in the warning letter, which will be followed by a second review. Hospitals may be fined up to $300 per day for violating the disclosure requirements.

CMS Issues Advance Guidance on ADT Notification Requirements
On May 7^th, CMS issued a memo to State Survey Agency Directors providing guidance on the admission, discharge, and transfer (ADT) notification requirements included in the Interoperability and Patient Access final rule. These requirements, published by the Trump administration in May 2020, are intended to facilitate care coordination and appropriate follow-up care. The memo is an advance copy of interpretive guidance for hospitals, psychiatric hospitals, and Critical Access Hospitals (CAHs).

Effective May 1^st, these providers are required to send an electronic notification to all relevant health care providers whenever a patient is admitted, discharged, or transferred to another facility. Requirements are applicable to all patients registered in the emergency department (ED) or receiving inpatient services. Providers are expected to make every attempt to send notifications to the patient’s post-acute care service providers and primary care practitioner (PCP).

More information is available here.

HHS Announces Prohibition on Discrimination on the Basis of Sexual Orientation and Gender Identity
On May 10^th, HHS announced that its Office for Civil Rights (OCR) will expand its interpretation and enforcement of current prohibitions on discrimination based on sex to include discrimination on the basis of sexual orientation and on gender identity. This update was made in light of the Supreme Court’s decision in Bostock v. Clayton County last June, in which the Court held that employment discrimination based on sex also encompasses discrimination based on sexual orientation and gender identity.

HHS’s press release is available here.

Rules Being Reviewed by OMB
The Office of Management and Budget (OMB) has received the following rules for final review before publication in the Federal Register:

A final rule to provide Medicare beneficiaries with faster access to “breakthrough” medical devices, as designated by FDA. The September 2020 proposed rule is available here.
The calendar year (CY) 2022 proposed rule for the Hospital Outpatient Prospective Payment System (PPS) and Ambulatory Surgical Center (ASC) Payment System, including policy changes and payment rates.
The 2022 proposed rule for the funding methodology for Basic Health Program (BHP), also known as the Essential Plan in New York.

Other rules still pending at OMB include CY 2022 revisions to the Physician Fee Schedule (PFS) and the Home Health PPS. Additionally, OMB completed review of a proposed rule on establishing minimum standards in Medicaid State Drug Utilization Review (DUR) and supporting value-based payments (VBP) for Medicaid-covered drugs.

Other Updates

CDC Releases Data on Variance in COVID-19 Vaccination Among Older Adults
On May 11^th, the CDC released data on demographic and social factors associated with COVID-19 vaccination among adults aged 65 and older. Between December 2020 and April 2021, 79.1% of American adults aged 65 and older received at least one dose of a COVID-19 vaccine, with vaccination initiation rates 2.1 percentage point higher for men than for women. Vaccination rates were lowest in Alabama (66.8%) and Mississippi (69.1%) and highest in New Hampshire (99.9%). Counties with low vaccination rates (<50% of older adults having received at least one vaccine dose) also had higher percentages of older adults living without a computer, living in poverty, without internet access, or living alone. These counties also had significantly higher percentages of older adults with social vulnerabilities such as loneliness, absence of regular companionship, and limited transportation options.

Congressional Hearings

Tuesday, May 18^th:

At 10am, the House Oversight and Reform Committee will hold a hearing titled “Unsustainable Drug Prices Part III: Testimony from AbbVie CEO Richard Gonzalez.” More information is available here.

Wednesday, May 19^th:

At 10am, the Senate Finance Committee will hold hearings to examine COVID-19 health care flexibilities. More information is available here.
At 10:15am, the House Education & Labor Subcommittee on Early Childhood, Elementary, and Secondary Education will hold a hearing entitled “Picking up the Pieces: Strengthening Connections with Students Experiencing Homelessness and Children in Foster Care.” More information is available here.
At 10:30am, the House Select Subcommittee on the Coronavirus Crisis will hold a hybrid hearing entitled “Examining Emergent BioSolutions’ Failure to Protect Public Health and Public Funds.” More information is available here.
At 2:30pm, the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights will hold a hearing to examine antitrust concerns about hospital consolidation. More information is available here.
At 2:30pm, the Senate Homeland Security and Government Affairs Committee will hold hearings on COVID-19, focusing on the medical supply chain and pandemic response gaps. More information is available here.

Thursday, May 20^th:

At 9:30am, the Senate Special Committee on Aging will hold hearings on Alzheimer’s disease, focusing on frontline perspectives and caregiver challenges. More information is available here.
At 10am, the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security will hold hearings to examine solving the “dire shortage” in the health care workforce. More information is available here.

New York State Updates

DOH Increases Medicaid Reimbursement for COVID-19 Vaccine Administration
On May 13^th, the New York State Department of Health (DOH) updated the Medicaid coverage policy and billing guidance for the administration of COVID-19 vaccines authorized for emergency use (available here). For service dates starting April 1, 2021, providers will be reimbursed at a higher rate of $40 per dose for the administration of any approved COVID-19 vaccine, an increase from the previous rate of $13.23. Claims submitted prior to June 1^st for dates of service on or after April 1^st that were paid at $13.23 will be automatically reprocessed at the new $40 rate. However, DOH did not indicate that claims for prior dates of service will be increased. This increase is consistent with the Medicare national average payment rate for the administration of the COVID-19 vaccine, which was increased to $40 per dose on March 15^th.

DOH Updates Guidance for Resumption of Non-Essential Elective Surgeries and Non-Urgent Procedures
On May 12^th, DOH released updated guidance (available here) for the resumption of non-essential elective surgeries and non-urgent procedures in hospitals, ASCs, office-based surgery practices, and diagnostic and treatment centers (DTCs). The guidance updates pre-elective procedure testing requirements to include vaccination status and recent recovery from COVID-19 infection. The following types of patients must undergo COVID-19 testing at least five days prior to elective surgeries and procedures:

Patients who are not fully vaccinated;
Unvaccinated patients; and
Patients for whom COVID-19 screening has identified potential risk/need for testing before procedures.

Pre-elective procedure testing is not required for patients who are fully vaccinated or have recovered from laboratory-confirmed COVID-19 during the previous three months. However, DOH continues to encourage such testing for all patients on a voluntary basis, particularly in regions with a positivity rate of 2 percent or greater. Hospitals, ASCs, office-based surgery practices, and DTCs must implement a policy that addresses risk assessment, including exposure, travel, and COVID-19 symptoms, and outlines when pre-elective procedure testing is to occur.

Governor Cuomo Issues Executive Orders to End Cluster-Based Strategy and Further Extend Disaster Provisions
On May 6^th, Governor Cuomo signed Executive Order 202.106 (here), which modifies a directive contained in Executive Order 202.60 that required a coroner or medical examiner to administer a COVID-19 and influenza test within 48 hours after death. An influenza test is no longer required in such circumstances. The Order also formally removes the provision contained in Executive Order 202.68 that directed DOH to determine areas of the state that require enhanced public health restrictions based on “clusters” of COVID-19 infection.

On May 10^th, Governor Cuomo signed Executive Order 202.107 (here), which extends all disaster emergency provisions outlined in Executive Order 202 and its successors that have not been otherwise superseded, modified, or expired through June 9^th.

New York State Medicaid Expands Covered Practitioners for Self-Management Training and Smoking Cessation Counseling Services
Effective April 1, 2021, the NYS Medicaid program has expanded the list of practitioners who can be reimbursed for providing the following services by both Medicaid fee-for-service and Medicaid managed care, as follows:

Asthma self-management training
- Licensed clinical social workers (LCSWs)
- Licensed master social workers (LMSWs)
- Physical therapists
- Occupational therapists
Diabetes self-management training
- Clinical psychologists
- Optometrists
- Occupational therapists
- Podiatrists
Smoking cessation counseling
- Registered nurses
- Clinical psychologists
- LCSWs
- LMSWs
- Licensed practical nurses

Such services are covered when provided through an Article 28 clinic that has been accredited by a CMS-recognized organization. Additional information on expanded coverage for these services is available in the April 2021 New York State Medicaid Update (here).

CMS Approves Temporary Adjustments to New York Medicaid State Plan During Disaster Emergency
On May 12^th, the Centers for Medicare and Medicaid Services (CMS) approved a time-limited State Plan Amendment (SPA) to the New York Medicaid program, which codifies the following adjustments during the disaster emergency, among others:

Waives treatment plan and individualized recovery plan timeframes and periodic reviews;
Allows providers to use a wide variety of communication methods to deliver services remotely;
Expands prior authorization for automatic renewal of medications;
Adjusts or waives face-to-face and virtual contact requirements for certain services;
Provides flexibility for rehabilitative services, including allowing for services to be provided and reimbursed during a period of non-residence if the resident’s absence is due to COVID-19;
Expands qualified providers of COVID-19 vaccinations, specimen collection, and testing;
Suspends continuing education and in-person training requirements for providers of Crisis Intervention, Community Psychiatric Supports and Treatment, Psychosocial Rehabilitation, Family Peer Support Services, and Youth Peer Support Services, provided such trainings be conducted remotely when possible;
Adjusts reimbursement rates for telehealth and COVID-19 vaccine administration; and
Provides supplemental payments for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IDD) to fund active treatment during weekday/daytime hours not captured in the current rate setting methodology.

In general, these adjustments were already put into place on an emergency basis during the COVID-19 emergency. The SPA authority is retroactive to March 1, 2020. The SPA and approval letter are available here.

DOH Releases 2021 MLTC VBP Quality Measure Sets
On May 10^th, DOH announced that the 2021 Managed Long Term Care (MLTC) Value Based Payment (VBP) Quality Measure Sets are now available on the VBP Resource Library page (available here). The measurement year 2021 VBP quality measure set for Medicaid Advantage Plus (MAP) was created in collaboration with the MLTC Clinical Advisory Group (CAG), a sub-team empaneled by the CAG to discuss VBP approaches and quality measures for MAP, and Programs of All-Inclusive Care for the Elderly (PACE).

The 2021 VBP MAP Quality Measure set is available here and the 2021 VBP PACE Quality Measure Set is available here. Questions may be submitted to VBP@health.ny.gov.

DOH Releases Updated Wage Parity Compliance and Certification Guidance
On May 11^th, DOH published updated Wage Parity Compliance and Certification Guidance (available here). Updated certification forms must be submitted annually to DOH by Medicaid Managed Care Organizations and MLTC plans, certified home health agencies (CHHAs), long term home health care programs (LTHHCPs), licensed home care services agencies (LHCSAs), and consumer directed personal assistance program fiscal intermediaries (CDPAP FIs).

Such entities must submit forms electronically through the eMedNY Provider Portal by June 1^st and annually thereafter. Instructions for completing the form are available in the guidance linked above. Questions may be submitted to hcworkerparity@health.ny.gov.

Regional Economic Development Council Initiative Round 11 Awards
On May 11^th, Governor Cuomo announced the launch of the 11^th funding round of the Regional Economic Development Council (REDC) initiative. This funding round includes over $750 million in state economic development resources, allocated as follows:

$525 million in resources from state agencies available to support community revitalization and business growth through the Consolidated Funding Application (CFA) process.
$150 million in capital funding for REDC priority projects.
$75 million in Excelsior Tax Credits for projects within each region.

The CFA (available here) opened on May 10^th and applications for most programs must be submitted before July 30^th. Several programs will accept applications on an ongoing basis, including the Empire State Development Grant Funds and Excelsior Jobs Program.

The 2021 REDC Guidebook and list of available resources is accessible here. The Governor’s press release is available here. Next week, SPG will publish a larger summary of the funding opportunities through the REDC initiative.

Fund for Public Health in New York City Vaccine Equity Partnership Engagement RFP
On May 12^th, the Fund for Public Health in New York City (FPHNYC) released a Request for Proposals (RFP) to identify community and faith-based organizations to partner with FPHNYC and the New York City Department of Health and Mental Hygiene in addressing barriers to, building confidence in, and improving access to vaccines in communities hardest hit by COVID-19. Specifically, awarded applicants will choose to provide a minimum of three of the following deliverables:

Tailored messaging;
Community outreach and engagement;
Navigation; and
Evaluation.

FPHNYC anticipates approximately $9 million in private and federal funding to support 40 awards through this RFP. Award amounts will vary, with the average award size expected to be approximately $200,000. Funding will focus on priority neighborhoods with the lowest vaccination rates as identified by the City’s Taskforce on Racial Inclusion and Equity (a list of neighborhoods available here). Funding will also be set aside to serve residents of supportive housing. Projects will last for six months starting on a rolling basis between June 25^th and July 15^th.

The full RFP is available here. Applications are due on June 1^st. There will be a virtual conference on May 19^th from 1pm-2pm. Questions should be submitted by May 21^st to msmith@fphnyc.org with the subject line “Community Partner Vaccine Engagement.”

Updated Guidance Documents
Recently updated or released New York State COVID-19 guidance documents are listed below.