CHA Regulatory Update – Dec. 5, 2022

Welcome to the December 2022 edition of the 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 Behavioral Health Administration (BHA), Colorado Department of Human Services (CDHS), Colorado Department of Public Health and Environment (CDPHE), Colorado Department of Regulatory Affairs (DORA), Colorado Department of Health Care Policy and Financing (HCPF), and the Colorado Department of Labor and Employment (CDLE).

As a reminder, December’s CHA Regulatory Briefing Call is scheduled from 10-11 a.m. on Wednesday, Dec. 7. 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 a presentation from Molly Collins Offner and Terry Cunningham with the American Hospital Association (AHA) regarding compliance with the good faith estimate and informed consent provisions of the No Surprises Act. As a reminder, the good-faith estimate requirement has been in effect for uninsured/self-pay patients since Jan. 1, 2022; however, CMS recently delayed compliance of this provision (previously Jan 1, 2023) pending future rulemaking.

Save the Date: In January, instead of hosting a regulatory update call, CHA is partnering with Polsinelli to put on a regulatory review series. The series will be held from 8:30 a.m. to noon on Jan. 10, 2023 with boxed lunches to follow. Attendees can join either virtually or in person (1401 Lawrence St, Unit 2300, Denver, CO 80202). Additional details on the virtual option will be included in next month’s regulatory update email.

Public Health Threat Updates

Polis: Emergency Order for Respiratory Season

On Friday, Nov. 11, Gov. Polis issued an Emergency Order to provide additional regulatory flexibilities for hospitals as admissions from COVID-19, flu, and RSV continue to climb, straining pediatric capacity. Specifically, the DOI has issued emergency rules to improve insurance coverage of patient transfers, and DORA’s Division of Professions and Occupations has waived various scope of practice provisions applicable to a number of heath care professions, including physicians, nurses, techs, and others. HCPF also released a list of regulatory actions to improve capacity. CHA prepared a crosswalk of regulatory flexibilities. CHA also requested that the state seek a “blanket” 1135 waiver from the Centers for Medicare and Medicaid Services (CMS) to provide additional regulatory flexibility to all hospitals. CMS indicated this is not possible at this time but encouraged hospitals to apply for individual 1135 waivers if needed to expand capacity or improve operations and throughput. Due to concerns regarding post-acute facilities not accepting patients due to concerns with certain carriers honoring the EO for commercial patients, CHA requested a blanket attestation that KP sent to post-acute facilities confirming that they will suspend prior auth. requirements for commercial plans in compliance with the executive order. Please let Megan Axelrod, CHA manager of regulatory policy, know if there are ongoing capacity concerns for this reason [email protected].

ASHP: Drug Shortages Could Impact Treatment of Respiratory Conditions

The American Society of Health-Systems Pharmacists’ (ASHP) current drug shortages list includes the following drugs that could negatively impact providers’ ability to treat RSV and other respiratory illnesses:

As of Nov. 15, sodium chloride solution of various formulations for injection from Fresenius Kabi and Pfizer is on shortage due to manufacturing delays. Resupply dates are anticipated at the end of November for Pfizer and early December for Fresenius Kabi.
As of Nov. 14, Rocuronium injection, used during tracheal intubation, is on shortage from several manufacturers due to increased demand and manufacturing delays. Estimated resupply dates vary from manufacturers.
As of Nov. 9, certain formulations of Oseltamivir, commonly known as Tamiflu, has been reported in short supply by several manufacturers. The FDA has not yet reported a national shortage of this drug as they believe other manufacturers can meet demand. As this antiviral is used to treat influenza, physicians may need to prescribe other medications if their patients are unable to find Tamiflu in pharmacies.

CDPHE: Vaccine Data Entry Support Ending Dec. 31

After Dec. 31, CDPHE will no longer manually enter doses into the Colorado Immunization Information System (CIIS) on behalf of vaccine providers. COVID-19 vaccine providers will be able to utilize the following other reporting options:

Direct data entry by clinic staff – get training (course ID 1094854)
IZ Quick Add module in CIIS – get training
Electronic data exchange – to set up electronic reporting, contact [email protected]
PrepMod – contact the help desk at [email protected] or complete the PrepMod interest form

CDC: Ebola Health Alert Network Health Advisory Issued The CDC issued a Health Alert Network (HAN) Health Advisory about a recently confirmed outbreak of Ebola virus disease (EVD) in Uganda caused by Sudan virus to summarize CDC’s recommendations for U.S. public health departments and clinicians, case identification and testing, and clinical laboratory biosafety considerations. No suspected, probable, or confirmed EVD cases related to this outbreak have yet been reported in the United States. The HAN includes best practices and clinical resources for health care workers that care for suspected or confirmed Ebola patients.

CDPHE: Join Public Health Improvement Planning Committee The CDPHE Office of Public Health Practice, Planning, and Local Partnerships is inviting Colorado hospitals to share input during the next statewide assessment and planning cycle through participation in the Public Health Improvement Planning (PHIP) Committee. Hospital representatives serving as active members of the committee will join a multi-sectoral group of individuals to help guide the process of assessment and plan development for up to two years. The first 14 months will focus on development of a statewide health assessment and prioritization of health issues, with the following 10 months focused on guiding the development of the final plan (committee members have the option to leave the committee after the initial 14 months).

CHA: Tier 1 of Combined Hospital Transfer Center Activated On Monday, Nov. 7, CHA activated Tier 1 of the Combined Hospital Transfer Center (CHTC) in response to increased pressure on pediatric bed capacity in the state. Tier 1, the lowest level of activation, partners rural and independent hospitals with larger health systems to facilitate surge measures and patient transfers. The CHTC plan, including a breakdown of the tiers, is available here. CHA is continuing to work with hospital leaders and the state to identify flexibilities that the state can provide to increase hospital staffing, throughput, and capacity.

HHS: Mpox Public Health Emergency Renewed for Final Time

On Wednesday, Nov. 2, HHS renewed its mpox public health emergency (PHE) declaration for another 90 days. When the PHE was announced in August, CDC Director Rochelle Walensky, MD, said the declaration would provide access to resources and flexibilities, expedite state data sharing, and provide more detailed data on testing and hospitalizations. At the beginning of November, CDPHE reported a total of 344 cases of monkeypox in the state since May of this year, with the peak in August. On Monday, Nov. 28, HHS announced that it is supporting the World Health Organization’s move to rename monkeypox to mpox. Last week, HHS also announced that, due to low case volume, it does not expect to renew the mpox PHE beyond Jan. 31, 2023.

HHS: COVID-19 Public Health Emergency Will Be Extended HHS will extend the COVID-19 PHE beyond Wednesday, Jan. 11, 2023. HHS committed to provide states 60 days’ notice prior to allowing the PHE to expire, providing states time to prepare for a return to normal operations. HHS did not provide notice on Friday, which means the declaration will remain in place. The PHE was first declared in January 2020 and has been renewed every 90 days since then and supports flexibility waivers and policies to support Medicaid enrollment. In preparation for the PHE to expire and the potential for many Coloradans to lose Medicaid coverage, HCPF has launched the “Update Your Address” campaign with outreach materials for providers to use. CHA members are encouraged to use these resources and to share other messaging activities with CHA for use in its advocacy efforts.

HHS: COVID-19 Data Transition from TeleTracking to NHSN

HHS is transitioning federal COVID-19 hospital data reporting from TeleTracking to the CDC’s National Healthcare Safety Network (NHSN). Starting Thursday, Dec. 15, the TeleTracking portal will no longer be active for submitting data, and all data will be collected through NHSN. HHS has made a number of resources available on its transition webpage, including webinars, quick reference guides, and frequently asked questions. For assistance, support is available through the NHSN Help Desk by emailing [email protected] with the subject line “COVID-19 hospital.”

Polis: COVID-19 Disaster Declaration Extended On Nov. 8, Gov. Polis signed an Executive Order amending and extending the COVID-19 disaster declaration, which allows agencies to continue to access state and federal funding for recovery efforts and rapid response to changes in the public health environment due to COVID-19. It also supports the health care system to remain appropriately staffed and prepared to respond to public health. The amendment provides for a final accounting of federal funds the state has received due to COVID-19.

State (Non-Public Health) Updates

CHA: Patients with Barriers to Discharge Survey Colorado hospitals have robust discharge planning processes, and in most cases, hospitals are able to successfully discharge patients and transfer them to an appropriate care setting in a timely manner. However, with certain patient populations, hospitals commonly experience challenges discharging patients. CHA would like feedback on your hospital’s experiences working with patients facing barriers to safe discharge. CHA will use the survey results to better quantify the costs and resources that are being diverted to these patients to support 2023 advocacy efforts (both pediatric and adult). Please complete this survey by Dec. 13 (one survey per organization).

BHA/HCPF: Recording of Behavioral Health Secure Transportation Meeting On Oct. 28, the BHA and HCPF held a joint stakeholder meeting to address behavioral health secure transportation. The meeting provided an overview of the new benefit and solicited feedback on implementation concerns. A recording of the meeting can be found here. Behavioral Health Secure Transportation is legislatively mandated by House Bill (HB) 21-1085 and CDPHE has written standards in 6 CCR 1011-4. This meeting begins the stakeholder process for Medicaid reimbursement for Behavioral Health Secure Transportation. Behavioral Health Secure Transportation will be paid as a benefit by no later than July 1, 2023.

BHA/HCPF: Webinar on Colorado’s Application for Major Behavioral Health Grant Last month, the Substance Abuse and Mental Health Services Administration (SAHMSA) in coordination with CMS released a funding opportunity for states to apply for a planning grant. The Certified Community Behavioral Health Clinics (CCBHC) program is a federal initiative launched in 2014 designed to increase access and improve the quality of community mental health and substance use disorder treatment services. Colorado intends to apply for this one-year planning grant, due Monday, Dec. 19, for up to $1 million. The BHA and HCPF are hosting a webinar at 4 p.m. on Tuesday, Dec. 7 to discuss the model and why the agencies are pursuing this opportunity. They welcome participants to share thoughts on the payment models, required metrics, data reporting, and more. Learn more about the grant opportunity here and join the webinar here.

BHA: Seeking Feedback from Providers Service Definition Standards The BHA will be administering a needs assessment through Administrative Service Organizations (ASOs) to providers this month to inform the distribution of capacity building funds. The funds are to support provider ability to meet the service definition standards by July 2023. Prior to receiving the assessment, the BHA encourages providers to take time to review the definition and think about support needed per definition area. You can find the service definition here as well as slides and recordings to review. Feedback can be submitted here.

CDPHE: $10 Million Fund to Re-Engage Health Care Workers On Nov. 21, Gov. Polis and CDPHE announced a $10 million fund to help re-engage health care workers that left the workforce during the pandemic, part of the $61 million investment outlined in legislation advocated for by CHA, Senate Bill (SB) 22-226. The grant fund is intended to be offered as incentives, bonuses, or additional services to attract workers and assist in license renewal or maintenance. More information about the Healthcare Workers Recruitment and Re-engagement fund is available on CDPHE’s website. The other program announced as part of SB 22-226 is Care Forward. Other programs for the workforce package are still in development by the state.

CDPHE: Sponsoring EMResource API CDPHE is sponsoring the Post Resource Status Application Programming Interface (API) to offer hospitals, at no cost, a web service to connect and automatically send electronic medical records to update status data electronically in Juvare’s EMResource.

CDPHE: HB 12-1294 Open Forum

Starting last week, CDPHE is holding open stakeholder forums as mandated by HB 12-1294 that requires CDPHE’s Health Facilities and Emergency Medical Services Division to host stakeholder forums to discuss development and implementation of rules. Attendees can submit agenda topics here. The open forum will take place from 2 – 3 p.m. every first Thursday of the month. Join the meeting here.

For more information and to sign up for email updates on the stakeholder process, visit the HB 12-1294 webpage.

CDPHE: HB 22-1401/Chapter 4 Rule Revisions

On Tuesday, Nov. 15, CDPHE held its third stakeholder meeting for the Chapter 4 rule revision pertaining to HB 22-1401. At the meeting, CDPHE reviewed changes made to the emergency rules (Part 2 – Definitions, Part 7 – Emergency Preparedness, and Part 9 – Personnel) since the last stakeholder meeting on Oct. 18, as well as presented their proposed changes to Part 14 – Nursing Services. View redlined version here. CDPHE will not hold a meeting in December but will resume stakeholder meetings in January 2023. Additionally, the Board of Health adopted the second set of emergency rules presented by CDPHE on Wednesday, Nov. 16. The second proposed emergency rulemaking contains no substantive changes from the original emergency rule language that was adopted in August. The purpose of this second emergency rule hearing is to maintain a consistent set of standards for hospitals while CDPHE continues its stakeholder engagement process. CDPHE anticipates requesting a third emergency rulemaking hearing in February prior to presenting final rule.

CHA: Webinar on Previewing the 2023 Legislative Session On Wednesday, Dec. 7, CHA is hosting a call to give members an insider’s look at what to expect from the 2023 legislative session. The midterm elections saw Democrats gain even more seats in the General Assembly, and CHA anticipates yet another significant legislative session for hospitals. Joshua Ewing, CHA vice president of legislative affairs, will take members through the issues CHA anticipates, including workforce, affordability and access, public health response, and more. The webinar will take place from noon – 1 p.m. on Wednesday, Dec. 7 – Register here.

CHA: Resource on Caring for Pediatric Patients in Adult Hospitals On Monday, Nov. 21, CHA and the Rocky Mountain Chapter of the Society for Hospital Medicine (SHM) hosted a discussion about best practices for caring for pediatric patients in adult hospitals to help

hospitals deal with current capacity challenges due to RSV, flu, and COVID-19 volumes. The session offered a primer on the medical, legal, and social differences in caring for minors. Slides for the webinar are available here. Additionally, HHS’ Administration for Strategic Preparedness and Response launched a website to help address the current pediatric surge in respiratory illnesses that is impacting hospital capacity in Colorado and nationwide. The website includes a resource library, assistance center, and an information exchange discussion board to allow for near-real time engagement among users.

DOI: CHA Comment Letter on Colorado Option Regulations

On Friday, Nov. 18, CHA submitted a comment letter to the DOI on its proposed rules for calculating reimbursement rates and the public hearing process for the Colorado Option. In addition to other concerns, CHA outlines two priority issues with the proposed rule:

Medicare reimbursement rates must be based on the most recent time period; and
evidence provided pursuant to the public hearing must not conflict with antitrust laws.

While DOI has made some revisions to the Colorado Option proposed rule based on previous feedback submitted by the Association, CHA continues to advocate for changes and clarifications that are important for hospitals. The Association expects the final rules to be issued this fall.

DOI: Prescription Drug Affordability Board Update On Friday, Nov. 18, the Prescription Drug Affordability Board (PDAB) voted to continue the hearing on the proposed Upper Payment Limit Methodology rule at the Jan. 13, 2023 meeting (register here) to allow for additional stakeholder feedback. Board staff have incorporated stakeholder feedback received prior to the November meeting and provided redlined versions of proposed changes to Proposed Draft Rule Part 4 – Upper Payment Limit Methodology and Policy 05 Upper Payment Limit Methodology. CHA testified to hospitals’ concerns and at the request of the PDAB Board have additional items to follow up with.

FAMLI: Final Rules Adopted, New Resources for Employers

On Tuesday, Nov. 1, CDLE adopted the final rules for private plans for the state-run Family and Medical Leave Insurance (FAMLI). Some notable changes from the proposed rules include:

Approved private plans must take effect no earlier than 60 days after the application date.
Private plan approvals are good for eight years, with more frequent data reporting and program attestation requirements.
Employers applying for private plan approval will be subject to an initial $500 administration fee. Employers with approved private plans will be responsible for an annual maintenance fee based on the administrative costs of their particular plan.
If an employer moves from a private plan to the state-run FAMLI plan, there will not be a fee to do so.

Employers are required to notify their employees about the FAMLI program by Jan. 1, 2023. For more information, visit the CDLE webpage. The state has released a new marketing toolkit for businesses to use in educating their employees about the new FAMLI program. The state has released a webpage with resources for employers, including pre-drafted communications, program timeline, and a “Get Ready” flyer.

HCPF: Identify Hospital Inpatient Review Contact

HCPF is asking hospitals to identify a single point of contact to learn about the next generation of the Inpatient Hospital Review Program (IHRP 2.0). This program was created by SB 18-266 and enables HCPF to pursue cost-controlling strategies but was suspended at the beginning the COVID-19 pandemic. These points of contact will be invited to:

Complete a survey to provide feedback on the first iteration of IHRP;
Attend a meeting on the goals and proposed processes for IHRP 2.0; and
Join a workgroup to address processes and workflows and prepare for system training.

Hospitals can identify a point of contact for IHRP 2.0 by submitting this form. The partner engagement process will begin in early December. Questions can be sent to [email protected].

HCPF: Hospital Discounted Care

CHA held a Hospital Discounted Care collaboration call on Friday, Nov. 11 where members discussed best practices and provided feedback on specific pain points with implementing the new rules. A recording of the call can be found here (passcode: g?G0dMdR).

Federal (Non-Public Health) Updates

AHA: Report Released Urging Greater Oversight of Insurers

At the beginning of November, the AHA released a report calling for greater government oversight of commercial health insurance companies. According to AHA, “Actions are needed to ensure patients get the care they are entitled to, providers do not face unnecessary burdens, and the health care system is appropriately resourced.” The report makes two key recommendations:

Standardize prior authorization requirements and processes.

Ensure necessary oversight to stop inappropriate prior authorization and payment delays and denials.

AHA: Webinar on How Hospitals Can Utilize New Federal Energy Tax Credits Mark Howell, AHA senior associate director for policy, will speak with experts from the Mintz Law Firm on how new tax credits centered on energy and efficiency can be applied to hospitals and health systems. Submit your questions in advance by emailing [email protected] or [email protected]. The webinar will take place at noon MT on Thursday, Dec. 8 – register here.

CHA: Webinar on New Health Equity Standards with The Joint Commission On Jan. 1, 2023, The Joint Commission will launch new health equity standards that require hospitals to facilitate reductions in health care disparities as part of accreditation. Learn more about these new standards from 3-4 p.m. on Thursday, Dec. 15, as CHA welcomes Dr. Christina Cordero, project director for health care standards development in the Division of Healthcare Quality Evaluation at The Joint Commission, who has been leading this work nationally. This informational webinar is free for CHA members and will include time for questions – register here.

CMS: CoPs for Rural Emergency Hospital Designation Finalized At the beginning of November, CMS released the finalized Conditions of Participation (CoPs) for the new rural emergency hospital (REH) designation as part of the 2023 Outpatient Prospective Payment System – Ambulatory Surgical Center (OPPS-ASC) final rule. Additional information on the REH designation is available on the CMS website here.

CMS: Clinical Lab Payer Reporting Begins Jan. 1 CMS is reminding independent, physician office, and hospital outreach laboratories that meet the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule to report certain private payer data between Jan. 1 – March 31, 2023. The AHA and 25 other organizations have urged congressional leaders to enact the Saving Access to Laboratory Services Act to delay Medicare’s payment reductions and reduce burdensome reporting requirements for these laboratories.

CMS: Rural Health Equity Framework Released In its newly released report, “Advancing Rural Health Equity,” CMS outlines the work it has done to address the health care needs of rural communities in 10 key areas. Among the areas included are Medicare, the rural health workforce, models and demonstrations, maternal health, and COVID-19. CMS has also released a number of rural health resources on its website.

CMS: Sample Formats for Price Transparency Files

CMS released three voluntary sample formats (i.e., wide, tall, and plain) that hospitals may use to meet the federal requirement to make certain standard charges publicly available through a machine-readable file. The agency also posted a sample data dictionary for the wide and tall formats.

CMS: CHA Comment Letter on Streamlined Medicaid/CHIP Applications

On Monday, Nov. 7, CHA joined a group of health care organizations in submitting a comment letter to CMS on its proposed rule to streamline Medicaid and CHIP applications, among other things. The proposed rule would make important improvements that would specifically benefit people who have been historically and/or systemically disadvantaged by the current system, including,

People aged 65 and over and people with disabilities;
Children, who often experience delays in coverage when enrolling in CHIP or gaps when moving between Medicaid and CHIP; and

People with high medical expenses in the 32 states with a medically needy program.

CMS: Memo on Violence in Hospitals A new memo from CMS is reinforcing the agency’s role in enforcing regulatory expectations that patients and hospital staff have an environment that prioritizes their safety to ensure effective delivery of health care. Per Medicare’s CoPs, hospitals must provide adequate training, sufficient staffing levels, and ongoing assessment of patients for aggressive behavior and indicators. CMS has cited hospitals for failure to meet these obligations. Visit the AHA Workforce and Workplace Violence Prevention webpage for more resources.

HHS: Advisory Group Submits No Surprises Act Data Exchange Recommendations On Monday, Nov. 7, the Workgroup for Electronic Data Interchange advisory group urged HHS Secretary Xavier Becerra to work closely with standards development organizations and other health care partners to identify and pilot test appropriate No Surprises Act standards, harmonize them with existing and forthcoming standards and workflows, and implement them in stages. Terrence Cunningham, AHA director of administrative simplification policy, co-chairs WEDI’s No Surprises Act workgroup and will be providing this month’s deep dive on good faith estimate and informed consent provisions.

HRSA: Alston & Bird Webinar on Provider Relief Fund Audits CHA’s federal lobbying partner, Alston & Bird, will host a webinar to prepare hospitals and health systems with what they need to know to face upcoming Provider Relief Fund (PRF) audits. Alston & Bird expects the HHS Office of the Inspector General to spend significant resources auditing health systems that received more than $100 million in funds. The webinar will take place at noon MT on Thursday, Dec. 9 – register here.

SAMHSA: New Guidance on Behavioral Health Care for Kids SAMHSA released “National Guidelines for Child and Youth Behavioral Health Crisis Care,” which offers guidance to help communities address gaps in behavioral health crisis services for kids. The guidelines recommend that youth in crisis receive care in the least restrictive setting possible, and if safe, at home. They also recommend crisis response systems partner with schools, community organizations, and others across the continuum of care.

Calendar of Key Upcoming Dates

Dec. 6: JBC Meeting: Briefing for DORA (2-3 p.m.)
Dec. 7: HCPF/BHA Webinar on Application for CCHBC Grant – Join Here
Dec. 7: CMS Webinar on Medicaid and CHIP Continuous Enrollment Unwinding – Register Here
Dec. 8: Alston & Bird Webinar on Provider Relief Fund Audits (12-1 pm) – Register Here
Dec. 8: AHA Webinar on How Hospitals Can Utilize New Federal Energy Tax Credits – Register Here
Dec. 9: Medical Services Board Meeting on SB 22-200 Grant Program – Join Here
Dec. 20: JBC Meeting: Dec. Economic and Revenue Forecast (9-10:30 a.m.)
Dec. 20: Chapter 4 / HB 22-1401 Stakeholder Meeting
Dec. 20: JBC Meeting: Hearing for DORA (3-4 p.m.)
Dec. 21: JBC Meeting: Hearing for HCPF (9 a.m.-5 p.m.)
Jan. 9: General Assembly Convenes for 2023 Legislative Session
Jan. 13: PDAB Meeting – Register Here
Jan. 13: Deadline for all remaining bill draft requests to the Office of Legislative Legal Services
Jan. 17: Chapter 4 / HB 22-1401 Stakeholder Meeting