CHA Regulatory Update

Oct. 4, 2022

Welcome to the October 2022 edition of the Colorado Hospital Association (CHA) Regulatory Update. Monthly updates cover important information on regulatory issues in the health care field, specifically those associated with the federal government, as well as Colorado state agencies involved in health care issues – including the Colorado Department of Human Services (CDHS), CDPHE, DORA, HCPF, and the Colorado Department of Labor and Employment (CDLE).

As a reminder, October’s CHA Regulatory Briefing Call is scheduled from 10-11 a.m. on Wednesday, Oct. 5. To join, please click on this link. This call allows for informal discussion regarding priority regulatory issues. To receive calendar invites for future calls, please contact Michelle Comerford, CHA administrative assistant, at [email protected] or 720.330.6031. This month’s deep dive will be on behavioral health grant projects and reforms at HCPF presented by Meredith Davis, population health behavioral health special projects manager in the Health Programs Office at HCPF. Please feel free to share the invitation with any members of your team who could benefit from this presentation.

CDC: Updated Guidance on COVID-19 Infection Control
New COVID-19 infection control guidance for health care settings has been released by the CDC. Included among the updates are changes to recommendations for source control and universal PPE, considerations given to vaccination status, guidance for health care personnel, and the use of community transmission data versus community levels. State public health orders for health care settings (Public Health Order [PHO] 20-20 and PHO 20-38) have not yet been updated, but changes are expected after the CDC finishes issuing its updated guidance related to long term care facilities. CHA will communicate updates to the public health orders via CHA HealthBEAT.

CDPHE: Materials for COVID-19 Vaccine Provider Meeting Available
The recording and slides from the COVID-19 Vaccine Provider Meeting held on Friday, Sept. 23 are now available. A summary of provider guidance and additional resources are available in a Health Alert Network Update from CDPHE on Monday, Sept. 26.

CDPHE: Letter on New Omicron Boosters
On Wednesday, Sept. 7, CDPHE sent a letter to providers with guidance on administration of the new Omicron boosters, details on vaccine shipments and future ordering, and other resources. As a reminder, the new booster formulation de-authorizes the original monovalent booster for people ages 12 and older. Providers should reschedule any booster dose appointments until the updated vaccine is in stock.

CDPHE: Moderna Doses Available
CDPHE now has Omicron booster doses from Moderna available for order in the Colorado Immunization Information System (CIIS). Providers should only order what they can administer in a 14-day period; the minimum order quantity is 100 doses. As a reminder, all COVID-19 vaccine providers are required to complete an inventory reconciliation in CIIS within seven days of placing a COVID-19 vaccine order. Instructions are available for both manual and aggregate inventory users. For help ordering or completing a reconciliation, view the COVID-19 Vaccine Ordering Job Aid or email [email protected].

CMS: Omicron Boosters Available at No Cost
On Monday, Sept. 12, CMS announced that bivalent Omicron boosters will be available at no cost as long as the federal government continues to purchase and distribute the doses. Details on provider requirements and payment are available on the CDC COVID-19 Vaccination Program website and in a CMS toolkit.

State (Non-COVID-19) Updates:

Reminder: Sept. 1 Deadlines
CHA would like to remind hospitals of the following requirements they should be complying with as of Thursday, Sept. 1.

House Bill (HB) 22-1401, Hospital Nurse Staffing Standards:
Report staffed-bed capacity data in EMResource or submit a request for an alternate baseline prior to Sept. 1
Notify CDPHE if a hospital’s ability to meet staffed-bed capacity falls below 80% of the required baseline and submit a plan to return to 80% or hardship waiver 
Establish a nurse staffing committee (at least 60% or greater participation by clinical staff nurses in addition to auxiliary personnel and nurse managers) 
Develop a master nurse staffing plan (specified annual review and reporting obligations) 
Update emergency management plan (Note: A hospital with fewer than 25 beds does not have to include in its emergency plan a demonstrated ability to surge to 125% after a statewide emergency.) 

HB 21-1198, Hospital Discounted Care:
Post the patient rights and uniform application on the facility website (linked on the landing page)
Make patient rights available in patient waiting areas
Make the information available to the patient before they leave the facility
Inform the patient of their rights on the billing statement
Screen uninsured, self-pay, and insured patients upon request using the universal application
Follow screening best efforts for those they are unable to screen in the setting
For qualifying patients, follow all rate/billing requirements, and notify physicians who are in the hospital setting
HCPF: Hospital Discounted Care Resources
Below are all the Hospital Discounted Care resources that CHA has gathered. Please let CHA staff know if you have questions as your organization implements the new law.
CHA Executive Brief: here
CHA Resources Webpage: here
CHA Implementation Resource: CHA has updated a document that outlines the frequently asked questions/answers from Colorado hospitals for which HCPF has provided a response. As a reminder, CHA does not provide legal advice and always recommends that its members consult with their general counsel regarding legal questions.
CHA HB 22-1198 Hospital Collaboration Call: CHA has held two hospital collaboration calls on July 18 and Aug. 25 for hospitals to gather and share best practices for implementing the new law.
July 18 meeting: Recording here; passcode: sL0EyC#+
Aug. 25 meeting: Recording here; passcode: #qb#$&1C
Flowcharts: Per CHA’s request, HCPF has prepared created flowcharts for providers to reference that will help guide through the screening, application, and screening best efforts processes – linked here
Recordings of HCPF Trainings: HCPF has held multiple trainings on policies and procedures, uniform application, and the screening and application process. Below are two recordings of the trainings that HCPF has provided:
Hospital Discounted Care Policies and Procedures Recording
Uniform Application Training Recording
HCPF’s Hospital Discounted Care website: here
HCPF Hospital Discounted Care and Colorado Indigent Care Program Operations Manual: here

HB 19-1001, Hospital Transparency Measures to Analyze Efficacy:
HB 19-1001 requires hospitals to submit financial, utilization, and acquisition information to HCPF by Sept. 1 of each year. HCPF is required to produce an annual written Hospital Expenditure Report, detailing uncompensated hospital cost and the different categories of expenditures, by major payer group made by hospitals, to be released on Jan. 15 of each year. Further information about the report requirements can be found on the Hospital Transparency website and CHA’s issue brief on the legislation.

For 2022, HCPF has expanded hospital reporting requirements to include extensive salary/wage and compensation information including by class (e.g., executive, management, nursing, physician, etc.), incentive compensation, average earnings, and minimum/maximum wage for each employee class, as found in the tab titled “Employee Compensation & Hours” in the reporting template. The reporting instructions included in the template (Notes and Instructions Tab) do not indicate these are required data fields (as indicated by * for required information).

Regardless, CHA believes this information is outside the scope of the requirements of the legislation and is contesting its inclusion in the reporting template. CHA has contacted HCPF regarding these concerns and, at HCPF’s request and in consultation with CHA’s attorneys, the Association submitted a formal letter on Aug. 26 requesting that the “Employee Compensation & Hours” tab be removed from the reporting template. Unfortunately, CHA heard from HCPF on Aug. 30 that it does not anticipate providing an additional response or guidance prior to the Sept. 1 hospital reporting deadline.

While hospitals have a responsibility to demonstrate a good faith effort to comply with the reporting requirements of the law, CHA considers HCPF’s authority to collect information in the “Employee Compensation & Hours” section to be under dispute. As such, CHA is recommending that hospitals not submit information in that tab in the reporting template for the Sept. 1 reporting deadline until and if any further guidance is provided from HCPF to hospitals. CHA recommends members complete the other required information in the reporting template provided by HCPF.

BHA: Meeting on Implementation of Behavioral Health Service Organizations
The Colorado Behavioral Health Administration (BHA) invites hospital and primary care stakeholders to participate in a conversation related to planning for the implementation of Behavioral Health Service Organizations (BHASOs) from 1-2:30 p.m. on Friday, Oct. 7. Register for the meeting here. There will be an alternative date for providers from 1:30-3:00 p.m. on Thursday, Oct. 13 – register here. The newly proposed safety net system under HB 22-1278 creates regional BHASOs that consolidate the current Administrative Service Organizations (crisis services) and Managed Services Organizations (substance use disorder treatment), and includes services currently offered by the Community Mental Health Centers through contracts with the BHA. The BHASOs must be established no later than July 1, 2024, to provide a continuum of behavioral health safety net services and care coordination. BHA is seeking input from various stakeholders and perspectives across the state to inform how the BHASOs are implemented. To ensure you are up to date on the latest news about the BHASOs, you can subscribe to the BHA newsletter here.

BHA, HCPF: Mobile Crisis Intervention Meetings
BHA and HCPF are hosting several meetings to discuss plans to use an option included in the American Rescue Plan Act (ARPA) to establish a community-based mobile crisis intervention service under Medicaid for individuals experiencing a mental health or substance use disorder crisis.

During the meetings, BHA and HCPF provide an overview of the federal option included in ARPA, outline the proposed design for the mobile crisis response benefit in Colorado, and solicit feedback from a variety of stakeholders on regional needs in implementation of the benefit. Register here to attend one of the upcoming in-person sessions scheduled through October. Locations and times for additional sessions in November are forthcoming.

To receive ongoing updates about this work or to indicate interest in participating in one of several workgroups, use this form. Find additional details, as well as up-to-date information on virtual and in-person stakeholder meetings, on the BHA webpage.

CDLE: FAMLI Proposed Private Plan Rules Open for Comment
The Family and Medical Leave Insurance Program (FAMLI) Division at CDLE has posted proposed rules on Regulations Concerning Private Plans (7 CCR 1107-5). The public comment period is open now through 8 a.m. on Tuesday, Oct. 18. An employer may comply with the FAMLI Act by providing an approved private plan that provides equivalent rights, protections, and benefits provided to employees. To ensure that the FAMLI Division can review and approve an employer’s request for a private plan exemption in time for the Jan. 1, 2024, effective date, employers must apply for a private plan exemption by Oct. 31, 2023. The draft rule outlines the process to apply for an exemption, however the process outlined in the draft rules could change once the final rule is adopted. The application to apply for an exemption will be available on the My FAMLI+ Employer system by Q1 or Q2 of next year.

A virtual public rulemaking hearing will be hosted by the FAMLI Division at 5 p.m. on Monday, Oct. 17 via Zoom — register here. CHA is collecting member comments related to the proposed rules. Contact Bridget Garcia, CHA manager of public policy, at [email protected] to share comments from your hospital or health system. The FAMLI Division is also hosting statewide regional town halls to prepare employers before premium collections begin in January 2023. View a map of regional town hall locations or go straight to the registration page to reserve your spot. You can attend any of the town halls regardless of whether it is your region as each town hall will also have a virtual option for participants.

Implementation Timeline:
Q4 2022: Soft launch of My FAMLI+ Employer
Jan. 1, 2023: Employers begin payroll deductions for FAMLI premiums
Q1 2023: Employers must complete registration in My FAMLI+ Employer
Apr. 30, 2023: First quarterly premium payments and wage reports due (30-day grace period)
Oct. 31, 2023: Deadline to apply for private plan exemption by January 2024 implementation
Jan. 1, 2024: Covered workers can begin submitting requests for FAMLI leave

CDPHE: Monkeypox Update
In a letter sent to hospitals on Sept. 6, CDPHE ordered all acute care hospitals, including critical access hospitals, to submit an emergency plan for scaling testing, treatment, and vaccination for monkeypox by Thursday, Sept. 22. CDPHE provided a template for hospitals to use, stating in an accompanying letter that hospitals may use a different format for submissions so long as the information required in the CDPHE template is included. The deadline for implementation of the emergency plan is Saturday, Oct. 8. In response, CHA recommended hospitals submit existing emergency plans applicable to communicable disease with references to any applicable appendices or annexes prior to the Sept. 22 deadline. Monkeypox continues to have a minimal impact on hospitals, and hospitals’ existing communicable disease emergency plans would align with those developed specifically for monkeypox.

However, on Tuesday, Sept. 20, CHA sent a letter to CDPHE Executive Director Jill Hunsaker Ryan expressing CHA’s concerns regarding CDPHE’s letter to Colorado hospitals regarding their preparedness for monkeypox. In its first letter, CDPHE stated that hospital readiness requirements outlined in HB 22-1401 give the department authority to require hospital facilities and hospital-owned facilities to submit the emergency plans it requested. The law’s requirement for hospitals to provide testing, vaccinations, and treatment is predicated on 1) a threat to inpatient bed capacity; 2) authorities granted to the state only through the declaration of a public health emergency; or 3) rules promulgated by CDPHE consistent with the statute. Because none of these express criteria are met, CHA strongly believes that CDPHE may not invoke the law to create new requirements for hospitals.

CDPHE: Nurse Staffing Standards Update
The next stakeholder meeting on implementing HB 22-1401, Hospital Nurse Staffing Standards, is from 12:30-3:30 p.m. on Oct. 18 via Zoom and will dive into Part 9 – Personnel, Part 2 – Definitions, and Part 7 – Emergency Preparedness. CDPHE has asked stakeholders to come prepared to get into the details of those sections and what changes, additions, clarifications, etc. need to be made and that CDPHE should consider. CHA is collecting member comments related to the proposed rules. Contact Bridget Garcia, CHA manager of public policy, at [email protected] to share comments from your hospital or health system. You can find more information about this and future stakeholder meetings here. CDPHE has established a form for stakeholders to use when submitting questions about HB 22-1401 and the rulemaking process, and will review each submission individually and will respond to the contact information provided.

In a previous stakeholder meeting held on Tuesday, Sept. 20, CDPHE provided a high-level overview of HB 22-1401 and the emergency rulemaking and rule revision process. Hospitals can anticipate a notice from CDPHE in the coming weeks with more information on the reporting process for nurse staffing plans which will go to an email address determined by CDPHE. Hospitals will have a 90-day window to submit. After that initial submittal, hospitals will submit annually with their license renewal.

Regulatory Timeline:
Stakeholder meetings: September 2022 through January 2023 (View meeting materials here)
Second emergency rulemaking: November 2022
Request for permanent rulemaking to the state Board of Health: December 2022
Third emergency rulemaking to ensure rules do not lapse and permanent rulemaking before the state Board of Health: February 2023
Effective date of permanent rules: March/April 2023

CHA: Troubling Financial Report Shared with State Legislators
On Thursday, Sept. 15, CHA reached out to Colorado legislators to share a troubling new analysis prepared for AHA by Kaufman, Hall & Associates, LLC, that details how labor shortages and inflation are driving up expenses, putting the nation’s hospitals and health systems in the worst financial crisis since the COVID-19 pandemic began.

In the report, analysts point to the strain hospitals and health systems continue to face due to intense pressure on staff and resources while simultaneously managing rising expenses for supplies, drugs and equipment, and the workforce. In its message to legislators, CHA noted that even the most optimistic projections for the entirety of 2022 indicate margins will be down 37% compared to pre-pandemic levels, with more than half of hospitals operating in the red, according to the report.

CHA shared with state lawmakers that internal data shows that Colorado hospitals saw losses of more than $300 million in the first half of 2022, despite historically strong margins in recent years. In its message to legislators, CHA pointed to these and other figures as a warning for the state and called for regulatory relief as Colorado hospitals work to implement a slew of major health care reform efforts from the last several years. Learn more about the new analysis in the AHA Special Bulletin.

CHA: Joins Business Coalition on Air Quality Regulations
CHA has joined the Coloradans for Practical Policies Coalition — which represents 12 industries with more than 400,000 employees across Colorado — to engage around a proposal from the Environmental Protection Agency (EPA) that would reclassify the Front Range as a “severe” nonattainment zone. The Front Range is currently classified as a “serious” nonattainment zone. Such a change would result in burdensome regulations being imposed on businesses in the region, including hospitals, without evidence that such regulations would significantly improve ozone or air quality.

In June, CHA joined many of the same business organizations on a letter to EPA Administrator Michael S. Regan opposing the reclassification. Last week, the coalition reiterated the concerns shared with the EPA in comments submitted to the Colorado Air Quality Control Commission (AQCC) during a meeting held to consider an ozone rulemaking hearing request. CHA and the other signees are dedicated to reducing air pollution as a means to protect public health and deliver the quality of life Coloradans deserve but urge the state to use incentives — not mandates — to improve air quality.

To approve a State Implementation Plan (SIP) to reduce ozone levels in the region, the AQCC is expected to facilitate a stakeholder process later this fall with an opportunity for public comment. Upon approval by the General Assembly, the SIP will be sent to the EPA.

DOI: CHA Submits Comments on Colorado Option
On Friday, Sept. 16, CHA submitted comments to the DOI regarding rate setting proposed rules for HB 21-1232, the Colorado Option. The comment letter follows previous feedback submitted to the DOI and outlines safeguards to ensure hospital reimbursements developed through the rate setting process are sufficient to support continued access to care. The letter comes with a strong recommendation from CHA that hospitals be able to demonstrate their unique circumstances to ensure that rates accurately reflect the needs of their communities, workforce, and input costs. Comments call for additional definition, the reconsideration of inadequate formulas, and revisions to language regarding negotiated floors, and other changes.

On Tuesday, Oct. 4, CHA submitted comments to the DOI regarding premium rate reduction proposed rules for HB 21-1232. CHA’s comments reiterate previous feedback that hospitals should have the opportunity to react to DOI-calculated rates before the final rate determination; there should be a process for calculating the hospital share of the total health care premium and the final rate determination should not expect hospitals to contribute more than their calculated share; and the evidence presented during the hearing should be clearly linked to the final rate determination.

As the original DOI stakeholder meeting on rate-setting conflicted with CHA’s annual meeting, DOI has agreed to hold a second hospital specific meeting for those who are unable to attend. That meeting was originally scheduled for Oct. 5, 3-4pm, but is being rescheduled for next week due to an unforeseen conflict- CHA will re-share the invitation once we have confirmation from DOI on their schedule.

DOI: Proposed Regulations Implementing HB 22-1284
On Friday, Aug. 26, DOI released proposed regulations implementing HB 22-1284, which aligns current state law on surprise billing with the federal “No Surprises Act” (P.L.116-260). DOI will hold a hearing on the proposed rulemaking on Wednesday, Oct. 5 with a written comment deadline of 5 p.m. on Monday, Oct. 10. You can register for the hearing here. CHA’s comments will focus on alignment with state/federal practice. You can find the draft regulations here:
DRAFT Proposed New Regulation 4-2-88 Concerning Gag Clauses in Individual and Group Health Benefit Plans
DRAFT Proposed New Regulation 4-2-89 Compensation Disclosures for Health Insurance Carriers
DRAFT Proposed Amended Regulation 4-2-67 Concerning Carrier Disclosures for Emergency and Non-Emergency Out-of-Network Services

DOI: PDAB Update
The next Prescription Drug Affordability Board (PDAB) meeting and rulemaking hearing for the proposed rule on upper payment limits (UPLs) and continued discussion on the proposed rule on affordability reviews will take place on from 10 a.m.-1 p.m. on Friday, Oct. 7 (Register here). To provide written testimony, sign up here. CHA will submit written comment in advance of the meeting. The final stakeholder meeting on Friday, Nov. 18 will be continued discussion on the proposed rule on UPLs. You can register for the meeting here and find meeting materials here.

HCPF: Grant Opportunity for Behavioral Health Providers
A new grant opportunity is available through HCPF for behavioral health providers looking to adopt, update, or upgrade their digital technology. The grant, totaling $18 million with a maximum award amount of $500,000, is funded through the American Rescue Plan Act. Providers can submit an “intent to apply” form to confirm eligibility beginning on Monday, Oct. 3, with the full application opening on Tuesday, Nov. 1.

Eligible expenses include:
New or enhanced electronic systems — electronic health record systems, electronic billing systems, software that replaces paper or manual systems and processes
Telehealth systems
Connection to statewide health/social information networks — health information exchanges, state or local social services organizations, community resource referral platforms
Devices and equipment — pending approval from federal authority, and must support digital transformation/interoperability, care coordination, or delivery of virtual care
Technical assistance
Indirect administrative costs — taxes, shipping, anti-virus software
Eligible grant recipients are Medicaid-enrolled behavioral health providers in Colorado actively billing Medicaid for fee-for service or managed care behavioral health services to 30 or more Medicaid members, regardless of whether those services are delivered to people on Home and Community-Based Services waivers.

HCPF: Naloxone Medicaid Payments Now Available
HB 22-1326, Fentanyl Accountability and Prevention, requires HCPF to reimburse hospitals or emergency departments for discharging Medicaid patients at risk of overdose with an opioid antagonist prescription starting July 1. The Medical Services Board adopted emergency rules pursuant to this provision in July. Hospitals can now bill Medicaid for Naloxone prescriptions provided at outpatient visits (inpatient codes should be coming soon) for dates of service on or after July 8 using the following billing codes:
G1028 and NDC 59467067901: billed at 1 unit for a 2 pack of 8mg/0.1ml nasal sprays at a rate of $125
G2215 and one of the NDCs 00781717612, 69547035302, 00093216568, or 45802081184: billed at 1 unit for a 2 pack of 4mg/0.1ml nasal sprays at a rate of $116.50

HCPF: HTP Interim Activity and CHNE Quarterly Reporting Reminder
The Hospital Transformation Program (HTP) quarterly reporting period for Program Year One – Quarter Four (PY1Q4) Interim Activity and Community and Health Neighborhood Engagement (CHNE) opened Monday, Oct. 3. Submissions are due by Monday, Oct. 31; reports must be timely and complete to earn the associated at-risk dollars.

Information regarding the PY1Q4 Interim Activity and CHNE Quarterly Report can be found in the Ongoing CHNE Requirements document, in the HTP Quarterly Reporting Guide, and in the HTP Quarterly Reporting training slides. For additional assistance, email Myers and Stauffer, the contractor working with HCPF, at [email protected]. Visit CHA’s HTP webpage for more helpful resources.

Federal (Non-COVID-19) Updates:

AHA: Report on Rural Hospital Closures
On Thursday, Sept. 8, the AHA released a report highlighting a variety of causes that contributed to 136 rural hospital closures from 2010 to 2021, including a record of 19 closures in 2020 alone. In the report, AHA details how longstanding pressures like low reimbursement, staffing shortages, low patient volume, and regulatory barriers have created enduring challenges for rural hospitals. The report argues that these difficulties, paired with continued financial challenges associated with COVID-19 and dramatic increases in expenses for labor, drugs, supplies, and equipment, threaten access to care for people in rural communities. AHA also outlines several pathways for rural hospitals to achieve financial sustainability in the report. Solutions proposed include additional federal support, flexible models of care, decreased regulatory burden, partnership arrangements, and state Medicaid expansion.

AHA: Final Section of Workforce Strategies Guide Released
On Wednesday, Sept. 7, AHA released the final section in its three-part guide to strengthening the health care workforce. In this final section, titled “Building the Team,” AHA focuses on strategies related to recruitment and retention, diversity and inclusion, and creative staffing models. The first two sections of the guide — “Supporting the Team” and “Data and Technology to Support the Workforce” — centered on addressing well-being, supporting behavioral health, and workplace violence prevention, as well as the role of data analytics and technological supports, respectively. The full three-part guide is available, along with other AHA workforce resources and a digital toolkit, on the AHA website. As a reminder, the CHA Board of Trustees convened a workforce task force in June to evaluate the significant workforce challenges Colorado hospitals are facing, characterize those challenges, and propose solutions designed to strategically address hospitals’ needs.

AHA: Annual United Against the Flu Campaign Launched
AHA is standing up its United Against the Flu campaign for the eighth year in a row to help hospitals and health systems encourage their communities to stay healthy and protect themselves against the flu and COVID-19 through vaccination. AHA’s webpage includes guidance and a variety of resources for use in efforts to raise awareness. Find information on partnership opportunities, website and social media graphics, augmented reality filters, customizable content, and additional helpful resources like the CDC’s vaccine finder tool. Download the messaging toolkit here. Resources specific to COVID-19 are available on this AHA webpage.

CHA will be joining AHA in the effort to share clear, cohesive messaging about the importance of vaccinations on social media this fall. Member hospitals and health systems are encouraged to help spread the word by utilizing resources provided by AHA and/or engaging with AHA and CHA social media posts.

AHA: Webinar on Operationalizing Good Faith Estimates
AHA is hosting a members-only webinar from 9:30-10:30 a.m. on Wednesday, Oct. 12, discussing the requirements to provide good faith estimates to uninsured patients — as required by the No Surprises Act — with a specific focus on the challenges with operationalizing the convening provider/co-provider requirements. Joined by representatives from the Cleveland Clinic and Hospital for Special Surgery, AHA staff will provide a general overview and discuss challenges. Register here to participate.

CDC: Increase in Pediatric Hospitalizations
On Friday, Sept. 9, the CDC alerted health care providers to an increase in pediatric hospitalizations for severe respiratory illness in patients who tested positive for rhinovirus and/or enterovirus, including enterovirus D68 (EV-D68). EV-D68 has been associated with acute flaccid myelitis, a rare but serious neurologic complication involving limb weakness. In 2014, EV-D68 caused a nationwide outbreak of severe respiratory illness. That outbreak has been followed by increased activity every other fall. The CDC alert includes recommendations for testing and treating children with severe respiratory illnesses. It also includes recommendations for laboratories, infection control in health care settings, and recommendations for the public.

CDC: Over 80% of Pregnancy-related Deaths Preventable
According to a new CDC report, an estimated 84% of pregnancy-related deaths in 36 states between 2017 and 2019 were preventable, based on data about deaths during and up to one year after pregnancy. The leading underlying cases of pregnancy-related death were cardiac and coronary conditions among Black people, mental health conditions among Hispanic and white people, and hemorrhage among Asian people.

From noon – 1:15 p.m. on Thursday, Oct. 13, CHA will be exploring social determinants of health and health inequities among Colorado birthing people in its sixth session of the Fundamentals of Social Determinants of Health in Hospitals learning series. The session will provide a virtual screening of the award-winning short film “Toxic: A Black Woman’s Story” and include time for reflection and moderated discussion. Register here for access to the remainder of the sessions in the series and the recordings of previously held live sessions.

CDC: Monkeypox Infection Control Advisory for Clinicians
On Monday, Sept. 19, the CDC recommended clinicians adhere to all recommendations to prevent monkeypox transmission in health care settings, including using the recommended PPE (i.e., gown, gloves, eye protection, and NIOSH-approved respirator with N95 filter or higher), particularly in outpatient settings where initial patient evaluations are more likely. The CDC released a Colorado study showing low risk to health care personnel exposed to monkeypox patients. However, the study suggests health care personnel “could benefit from public health outreach regarding infection prevention education and training,” noting that only 23% of exposed personnel wore all the recommended PPE. Additional resources are available on the CHA Monkeypox Resources webpage.

CHA: Advocates for Low-Volume Hospital Adjustment
CHA called on all members of the state’s congressional delegation to support an extension for the Medicare low-volume hospital adjustment set to expire on Friday, Sept. 30. Outreach included an educational brief on the impact of the low-volume adjustment in Colorado and letters from CHA President and CEO Jeff Tieman to each delegate. Of note, Sen. Michael Bennet has already signed on to support the extension.

While a low-volume adjustment existed in practice prior to fiscal year 2011, the eligibility criteria was defined so narrowly by CMS that few hospitals could qualify. In its advocacy, CHA argues that the current and improved low-volume adjustment — which is set to expire — better accounts for the relationship between cost and volume and should be extended. The low-volume hospital adjustment serves as a critical lifeline for rural hospitals and the preservation of access to care in rural communities. CHA is requesting support for an extension of the low-volume hospital adjustment in any upcoming funding agreement from the federal government. President Biden signed a continuing resolution into law on Friday, Sept. 30, extending the low-volume adjustment through Dec. 16. CHA will continue to advocate for a longer-term extension.

CMS: RFI on Promoting Efficiency and Equity
CMS released a Request for Information (RFI) to gather public input on challenges and opportunities related to health equity, access to care, reducing burden, and encouraging innovation. According to the press release, CMS also seeks to understand the greatest challenges health care workers face in meeting the needs of individuals, and the impact of CMS policies, documentation and reporting requirements, operations, and communications on provider experiences.

The “Make Your Voice Heard: Promoting Efficiency and Equity Within CMS Programs” RFI will remain open for a 60-day public comment period. Comments must be received by Friday, Nov. 4, for consideration. A web-based public comment form and additional details on the RFI are available on the CMS webpage.

FBI: Recommendations to Prevent Medical Device Cyberattacks
The Federal Bureau of Investigation (FBI) released recommendations to help protect medical devices from cyberattacks that can threaten health care operations, patient safety, and data privacy and integrity. In its recommendations, the FBI cited a growing number of unpatched medical device vulnerabilities.

In its coverage of the FBI recommendations, the AHA noted a letter of support it issued to Congress in June regarding pending legislation meant to require medical device manufacturers to implement increased cybersecurity requirements for medical devices. “In the interim, it is good practice to increase cybersecurity requirements in medical device and medical technology business associate agreements,” said John Riggi, AHA national advisor for cybersecurity and risk, in a statement. An excellent resource for medical technology model contract language can be found here.

FBI: Health Care Payment Processor Attacks Warning
The FBI reported that cyber criminals are increasingly targeting health care payment processors to redirect payments meant for health care providers to accounts controlled by the criminals, costing victims millions of dollars. The report describes at least 68 attacks since June 2018 in which unknown cyber criminals used publicly available personally identifiable information and social engineering techniques to impersonate victims and access accounts. It also recommends actions to help network defenders reduce the risk of compromise. Visit the AHA Cybersecurity and Risk Advisory Services webpage for additional resources.

FDA: Potential Cybersecurity Risk with Insulin Pump System
On Tuesday, Sept. 20, the U.S. Food and Drug Administration (FDA) alerted users of the Medtronic MiniMed 600 Series Insulin Pump System that the communications protocol could allow an unauthorized person to access the pump to deliver too much or too little insulin. Medtronic is recommending users take actions and precautions to protect their device from unauthorized access. The FDA said it is not aware of any reports related to the cyber security vulnerability. Learn more about cybersecurity threats related to medical device vulnerabilities and last week’s alert from the FBI, summarized on the AHA website here.

HHS: Information Blocking Requirements
On Thursday, Oct. 6, information blocking compliance requirements are scheduled to go into effect. This set of requirements arose from the 21st Century Cures Act and Office of the National Coordinator for Health Information Technology (ONC) interoperability rule. The rule expands the definition of electronic health information (EHI) and defines the circumstances under which health care facilities are able to reasonably and necessarily withhold information (i.e., preventing harm, privacy, etc.). Additional information regarding compliance can be found on slide 9 of AHA’s PowerPoint.

Note: AHA sent a letter to HHS asking them to delay the compliance date by one year and there is no regulatory disincentive for hospital noncompliance at this time. There are penalties established against Health Information Exchanges and Health IT developers if they do not comply with the expanded information sharing standards.

HHS: Roadmap for Behavioral Health Integration Released
On Friday, Sept. 16, the HHS released a roadmap for better integrating mental health and substance use care into health care, social service, and early childhood systems. The roadmap was developed by the agency’s Behavioral Health Coordinating Council based on feedback from patients and providers shared with HHS Secretary Xavier Becerra during his tour of the country to discuss the issue. Learn more about the roadmap and its development in the HHS press release.

HHS: Guidance for Preventing Forced Labor in Supply Chain
On Wednesday, Sept. 14, the HHS Office on Trafficking in Persons released information intended to help health care administrators, procurement professionals, and suppliers prevent and address forced labor concerns in supply chains through product procurement and labor contracting practices. The communication explains how forced labor occurs in health care supply chains and describes relevant laws, regulations, policy guidance, and resources. The memo is the first in a series of information briefs HHS is planning to distribute as directed by the National Action Plan to Combat Human Trafficking.

HRSA: Grant Funding for Rural Health Network Development
The HHS Health Resources and Services Administration (HRSA) is accepting grant applications for the 2023 Rural Health Network Development program. The funding will assist with the expansion of rural health network capacity by supporting integrated health care networks that address gaps in service, enhancing systems of care, and increasing capacity of the local health care system.
Funding: Forty-four grants of $1.2 million will be awarded. Funds can be used for software, care points, automated care, contractual providers, personnel, travel, and training.
Eligibility: Non-profit and for-profit organizations with experience in serving rural, underserved populations are eligible to apply. Typical applicants include health systems.
Projects must be carried out by a network of at least three or more health care provider organizations, with 66% of the organizations in the network based in rural areas. Learn more about this opportunity in the full program announcement and FAQs.

HRSA: Grant Funding for Small Rural Hospital Improvement Program
In August, the HHS HRSA posted a grant funding opportunity totaling over $20 million under the Small Rural Hospital Improvement Program (SHIP). SHIP supports eligible small rural hospitals in meeting value-based payment and care goals for their organizations. Through the program, hospitals are assisted with purchases of health information technology and training to promote compliance with quality improvement activities. Hospitals can also receive assistance with participation in delivery system reform programs like Medicare Shared Savings Programs, Accountable Care Organizations, and other shared savings programs.

For the purpose of this program in particular, “eligible small rural hospital” is defined as a non-federal, short-term general acute care hospital that is located in a rural area and has 49 available beds or fewer. Additional details are available on the grant opportunity webpage. The deadline for grant applications is Tuesday, Nov. 8.

Joint Commission: Will Review Certain Requirements
On Tuesday, Sept. 13, the Joint Commission released an official statement announcing its plans to review all “above-and-beyond” requirements — those requirements that go beyond the CMS Conditions of Participation (CoPs) and are not crosswalks to the CoPs.

In the announcement, The Joint Commission describes its intention to review each requirement by answering the following three questions:
Does the requirement still address an important quality and safety issue?
Is the requirement redundant?
Are the time and resources needed to comply with the requirement commensurate with the estimated benefit to patient care and health outcomes?
The organization also states that it “will conduct quantitative analyses of scoring patterns and tests for redundancy” and “conduct literature and field reviews and engage experts within the field [where necessary].” The decision aligns with similar plans at CMS, the announcement says, where requirements put on hold during the COVID-19 public health emergency are being evaluated to determine whether some should be permanently retired.

Calendar of Key Upcoming Dates
Oct. 5: DOI Rulemaking Hearing on Surprise Billing Regulations – Register Here
Oct. 7: PDAB Meeting & Rulemaking Hearing – Register Here
Oct. 7: BHA Stakeholder Meeting on BHASOs – Register Here
Oct. 7: HCPF Annual SUD Stakeholder Forum Meeting #1 – Register Here
Oct. 12: AHA Webinar on Operationalizing Good Faith Estimates – Register Here
Oct. 13: HCPF Stakeholder Meeting on Alternative Payment Model for Primary Care (APM 1) – Register Here
Oct. 13: BHA Stakeholder Meeting on BHASOs – Register Here
Oct. 13: HCPF Annual SUD Stakeholder Forum Meeting #2 – Register Here
Oct. 17: FAMLI Rulemaking Hearing on Private Plans – Register Here
Oct. 18: Chapter 4 / HB 22-1401 Stakeholder Meeting
Oct. 18: HCPF Annual SUD Stakeholder Forum Meeting #3 – Register Here
Oct. 27: HCPF Annual SUD Stakeholder Forum Meeting #4 – Register Here
Nov. 15: Chapter 4 / HB 22-1401 Stakeholder Meeting
Nov. 18: PDAB Meeting and Rulemaking Hearing
Dec. 20: Chapter 4 / HB 22-1401 Stakeholder Meeting