CHA Regulatory Update – Oct. 4, 2023

Welcome to the October 2023 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, due to CHA’s Annual Meeting this month, CHA will not be hosting an October CHA Regulatory Briefing Call. To receive calendar invites for future regulatory update calls, please contact Marie Cone LeBeaumont, CHA program coordinator, at [email protected].

Remember to register for the CHA and Polsinelli Regulatory Compliance Summit on Tuesday, Oct. 24. The full agenda can be foundhere. The Summit will be held from 7:30 a.m. – noon on Tuesday, Oct. 24 at Polsinelli (1401 Lawrence St., Denver). There will also be a virtual option for those who cannot attend in-person.

• Register for in-person here
• Register for virtual here

CHA is rolling out a new quarterly report on our advocacy work in the regulatory, legislative, federal, and thought leadership spaces. The quarterly reports review achievements from the previous quarter and forecast important dates in the upcoming quarter.

October’s Regulatory Update includes information on the following issues:

State Updates

• Register Now for the 2023 Regulatory Compliance Summit with Polsinelli
• CHA: Releases Q2 2023 Hospital Financial and Industry Update
• CHA: Sends Carrier Issues Survey to Hospital CFOs
• CHA and CWDC: Register Now for the 2023 Colorado Health Care Workforce Summit
• Colorado Community College System: Offers Free Training for Health Care Jobs
• DOI: Issues Consumer Alert About Access to Behavioral Health Providers
• DOI: Releases Draft on Changes for Public Option Regulations
• HCPF: Guidance on SB 23-252 (Hospital Price Transparency)
• HCPF: RAC Program Inpatient/Outpatient Rebilling Updates
• PDAB: Requesting Feedback on Drugs Selected for Affordability Reviews

Federal Updates

• AHA: Releases Strategies for Health Care Worker Suicide Prevention
• CDC: Reports Infant Mortality Rate Unchanged in 2021
• CMS: To Launch New State-based, Total-cost-of-care Reimbursement Model
• CMS: Proposes Changes to No Suprises Act IDR Fees
• CMS: Releases Proposed Rule on Minimum Staffing in Nursing Homes
• FDA: Advisors Declare Ineffectiveness of Over-the-Counter Decongestant Ingredient
• FDA: New COVID Vaccine Approved
• HHS: Alerts Health Sector to Critical Cyber Vulnerability

State Updates

AQCC: Regulation on 28 Building Performance Standards Finalized

On Sept. 12, the Air Quality Control Commission (AQCC) released the final version of Regulation 28 establishing building benchmarking and performance standards following a review by the Attorney General.

CHA engaged in the rulemaking as part of the Colorado Real Estate Alliance (CREA), which secured the following improvements to the rule:

• Less ambitious building performance standard targets.
  • The types of buildings that can apply for a timeline adjustment are much broader due to addition of the phrase “including, but not limited to.” The building types will ultimately be decided by Colorado Energy Office guidance.
  • If a building owner has exhausted the available cost-effective electrification and efficiency measures, the building owner can avail themself of renewable energy, including utility subscription services.

Note that the finalized regulation has penalties of $500 – $2,000 for failing to submit a benchmarking report and $2,000 – $5,000 for failure to meet building performance standards.

Next steps: Review the finalized regulation and start working with your facility team on implementation. Additional information can be found on CHA’s regulator webpage here.

BHA: Hospital Reporting on Boarding and Extended Stay Patients

As part of House Bill 23-1269, hospitals are required to report data to the BHA on the number of boarding and extended stay patients under the age of 21 over the next year. A memo from the BHA on the reporting requirements can be found here and the Google form to report can be found here. The first reporting quarter will be Sept. 1 – Dec. 31 and will be due in January 2024.

BHA: CHA Submits Comments to Colorado State Board of Human Services

On Sept. 8, CHA submitted comments to the State Board of Human Services rulemaking hearing on the BBHA proposed rule packet for providers. At the hearing, the BHA expressed outstanding issues that they wanted the BHA to look into further, and so they voted to extend consideration of the rule to their next meeting on Friday, Oct. 6.

Next steps: The rules are scheduled to be finalized on Friday, Nov. 3. Additional information can be found on CHA’s regulatory webpage here.

CDLE: FAMLI Division Holding Virtual Public Hearing on Proposed Rule Amendments

On Sept. 15, the FAMLI Division submitted a set of proposed rule amendments. You can find redlined copies of the proposed rules here.

Next steps: There will be a virtual public hearing for these proposed amendments at 4:30 p.m. on Tuesday, Oct. 17,  via Zoom. The hearing will conclude after hearing from all interested participants. RSVP by completing this form.

Alternatively, you can submit written comments using FAMLI’s public comment form. The comment period for the proposed rule amendments will close at 9 a.m. on Wednesday, Oct. 18.

CDPHE: CO-CARES Continues Offerings to Support Health Care Workforce

As a result of Senate Bill (SB) 22-226: Programs to Support Health Care Workforce, CHA-led legislation that secured an investment of $61 million in American Rescue Plan Act funds, CDPHE launched the Colorado Alliance for Resilient and Equitable Systems (CO-CARES) program this spring.

CO-CARES aims to provide support for health care workers with resources for workforce wellness, pandemic recovery, individual and organizational resilience, and more.

Upcoming opportunities:

• Resilience Roundtables: Virtual conversations about burnout, stress management, self-care, and more | Every second Tuesday and third Thursday of the month
• CO-CARES Work and Well-Being Webinars | Held every other month | Next is “Healthy Sleep” | Noon – 1 p.m. | Wednesday, Oct. 25 | Register here
• First Priority Peer Support Program: Trains peer supports in organizations to help others in need | Register here

For more information, please visit co-cares.org. Additional information can be found on CHA’s regulatory webpage here.

CDPHE: New Submission Portal for Nurse Staffing Plans

Hospitals are required to submit an annual report of their nurse staffing plans to CDPHE now as part of Chapter 4 standards. This submission is a requirement due at the time of the license renewal process. To facilitate this process, CDPHE has created a new submission portal, available here.

If you have any questions, please email ??. Additional information can be found on CHA’s regulatory webpage here.

CHA: Announces Creation of Center for Clinical Leadership and Excellence

CHA has announced the creation of its Center for Clinical Leadership and Excellence (CCLE). The CCLE will serve as CHA’s department dedicated to supporting member hospitals and health systems in delivering excellent care to their patients and communities. The CCLE is predominantly funded by a combination of grants and philanthropic donations. Its work will be guided by the 13-member Clinical Leadership and Excellence Council (CLEC), which is made up of clinical leaders from a diverse group of members that represent rural, urban, and independent hospitals and health systems.

The Center will also serve as a critical resource in CHA’s advocacy work, ensuring that the clinical needs of patients are part of important health policy discussions that CHA has at the state capitol.

The CCLE will be led by Richard Bottner, DHA, PA-C, CPHQ, CHA vice president of clinical excellence and a practicing PA. If you’d like to learn more about the CCLE, reach out to him directly at [email protected]

CHA: Releases Q2 2023 Hospital Financial and Industry Update

CHA recently released a review of the Q2 2023 financial and operational data from its member hospitals and health systems to show that the challenges of the last several years have continued. Of note in this quarterly update:

• Colorado has eclipsed the 60 percent mark for government payers with Medicare accounting for 40.3 percent and Medicaid for 20.8 percent of patient charges.
• Expenses are up significantly across the board and still trending up.
• Statewide operating margins are still way down from 2019 (pre-pandemic).
• Utilization trends continue to shift post-pandemic, with increasing ED and ambulatory surgery visits but cumulative utilization down compared to 2019.
• More than half of Colorado’s hospitals have unsustainable finances.

If you have any questions, please contact Tom Rennell, CHA senior vice president, at [email protected].

CHA: Sends Carrier Issues Survey to Hospital CFOs

As a part of CHA’s 2024 advocacy strategy, CHA continues to evaluate the landscape regarding payer-provider interactions and is asking for a response to this survey.

On Sept. 28, CHA shared this survey with hospital CFOs to assist CHA’s efforts to develop a more robust quantitative data collection effort with hospitals to support the Association’s advocacy efforts. CHA recognizes the significant burden many of these commercial health plan policies have placed on Colorado’s hospitals and health systems and is committed to addressing these concerns through advocacy, messaging, partnerships, and more.

A report from the AHA, Commercial Health Plans’ Policies Compromise Patient Safety and Raise Costs, highlights how commercial payer requirements are adding unnecessary cost to the health care system, hurting both patients and providers.

If you have any questions, please contact Tom Rennell, CHA senior vice president, at [email protected].

CHA and CWDC: Register Now for the 2023 Colorado Health Care Workforce Summit

CHA is partnering with the Colorado Workforce Development Council (CWDC) to host the 2023 Health Care Workforce Summit. Throughout this no-cost, one-day hybrid summit participants will be engaged through speaker panels featuring industry leaders involved in behavioral health, health care, public health, and direct care. Interactive exercises will allow participants to reflect on barriers to talent supply and development, ask questions, and connect with regional and statewide partners committed to testing new strategies.

The hybrid summit will be held from 9 a.m. – 3:30 p.m. on Thursday, Oct. 26 at the Pueblo Convention Center (320 Central Main St., Pueblo) with a fully virtual option as well. Attendance is limited; please register by Oct. 12.

DOI: Issues Consumer Alert About Access to Behavioral Health Providers

DOI issued an alert noting that it has received an increasing number of complaints from behavioral health providers about barriers to entry and participation in insurance companies’ networks, as well as complaints from consumers about receiving in-network behavioral health services.

DOI had issued Bulletin B-4.131 in June, directing Colorado insurance companies to adopt credentialing standards that expedite the process and reduce unnecessary administrative burdens for behavioral health providers. DOI also requested information from payers about their credentialing and billing policies for these types of health care providers and has added that to a website.

DOI asks that concerns and complaints be submitted to the Division at [email protected].

DOI: CHA Submits Comments on Draft Changes to Public Option Regulations

On Oct. 3, CHA submitted a comment letter to the DOI on draft changes to public option regulations. On Sept. 22, DOI released draft amended public option regulations based on lessons learned during the first year of public hearings. The DOI is proposing to amend regulations 4-2-91, which establishes reimbursement rate methodology, and 4-2-92, which dictates the public hearing process. At a high level, the DOI has proposed a new aggregate Medicare reimbursement rate, clarifies the DOI’s ability to file complaints, and allows hospitals and carriers to submit a joint attestation on rate floors. Additional information on the Colorado Option can be found on CHA’s regulatory webpage here.

HCPF: Guidance on SB 23-252 (Hospital Price Transparency)

As of Oct. 1, hospitals must post their Medicare rates, as required by SB 23-252.

Medicare rates are considered a standard charge and are to be included in the comprehensive machine-readable file and updated yearly. By Oct.1, hospitals are required to post Medicare rates, however, these may be a separate downloadable file. For CAHs reimbursed at cost, HCPF suggests that you include your most recent cost-to-charge ratio as a rate.

HCPF will begin checking for Medicare rates on Feb. 1, 2024 – hospitals’ Medicare rates must be included in the comprehensive machine-readable file – and publish their review in the Spring 2024 Price Transparency Posting Evaluation Report. To include Medicare Rates in the file, HCPF recommends that it should be included as a “Payer” as this format will not interfere with potential future legislation from CMS that would require a standard posting format if passed.

Additional information on SB 23-252 can be found on CHA’s regulatory website here.

HCPF: RAC Program Inpatient/Outpatient Rebilling Updates

Following CHA advocacy about challenges with the HCPF Recover Audit Contractor (RAC) Program, HCPF is starting a rebilling pilot program to allow participating providers to rebill claims that have been determined to be an overpayment based on a level of care inpatient utilization review audit. HCPF anticipates opening this rebilling program to all providers at the end of the year.

More information can be found in this program update here. Additional information on the program as a whole can be found on CHA’s regulatory website here.

PDAB: Requesting Feedback on Drugs Selected for Affordability Reviews

The Prescription Drug Accountability Board (PDAB) is requesting feedback from individuals with scientific or medical training and safety net providers on the five drugs selected for affordability reviews.

In August, PDAB chose five drugs for an affordability review – Enbrel, Genvoya, Cosentyx, Stelara, and Trikafta.

PDAB is requesting feedback through three channels:

• Online survey that can be filled out here.
  • Small group meeting that can be scheduled at your convenience before Thursday, Oct. 12. These are a focus-group style conversation to gather information as outlined in the input session guide here.
  • Public input session for each drug. The schedule can be found in the stakeholder engagement guide here.

Additional information on PDAB can be found on CHA’s regulatory website here.

PDAB will also host an upcoming meeting at 10 a.m. on Friday, Oct. 27. Register here.

Federal Updates

AHA: Releases Strategies for Health care Worker Suicide Prevention

AHA has released 18 new case studies from member hospitals and health systems that focus on the real-world implementation of tactics and strategies for preventing suicide among health care workers. The strategies upon which this work is based can be found in the 2022 report Suicide Prevention: Evidence-Informed Interventions for the Health Care Workforce.

Each hospital participant sought to address one of three key drivers of suicide in the health care workforce: job stressors, stigma, or access to care. The tactics they deployed in their workplaces were done so over the course of six months. These hospitals and health systems met throughout with other participants to share strategies, challenges, and successes in real time.

CDC: Reports Infant Mortality Rate Unchanged in 2021

In September 2023, the CDC reported that the U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2 percent to 19,928. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight.

CHA: Advocates Against Site Neutral Proposals

On Sept. 18, CHA contacted all Colorado Representatives and Senator Hickenlooper to urge them to vote against two proposals in Congress this month.

In the House, H.R. 5378 contains a provision to require site neutral payments for drug administration services provided in off-campus hospital outpatient departments. The vote on the bill was ultimately indefinitely postponed.

In the Senate, the Health, Education, Labor, and Pensions Committee passed the Primary Care and Health Workforce Act, which included a provision to prohibit facility fees for telehealth and for evaluation and managements health care services.

CHA reminded the delegation that these cuts would have significant implications for access to care across the state and urged their opposition to these measures as drafted. In August, CHA sent a formal letter to the delegation urging them to oppose any site neutral payment proposals.

CMS: To Launch New State-based, Total-cost-of-care Reimbursement Model

CMS will select up to eight states to participate in a new voluntary all-payer model that aims to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS plans to detail requirements for the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model in a funding opportunity notice this fall. Participating states will receive up to $12 million each to implement the model during one of three start dates, with the model concluding in December 2034. CMS expects to begin the pre-implementation period for the first cohort next summer. The model will build on best practices from the Maryland Total Cost of Care model, the Pennsylvania Rural Health Model, and the Vermont All-Payer ACO Model.

CMS: Proposes Changes to No Suprises Act IDR Fees

The departments of Health and Human Services, Labor, and the Treasury released a proposed rule that would increase the administrative fee for disputes initiated under the No Surprises Act independent dispute resolution (IDR) process from $50 to $150 per party per dispute, which would remain in effect until changed by subsequent notice-and-comment rulemaking. The departments also propose increasing the fee range for certified IDR entities by 20 percent for single determinations and 25 percent for batched determinations, which also would remain in effect until changed by subsequent notice-and-comment rulemaking. The changes would take effect for disputes initiated on or after Jan. 1 or the effective date of the final rule, whichever is later.

CMS: Releases Proposed Rule on Minimum Staffing in Nursing Homes

CMS released a proposed rule that would impose minimum staffing requirements for long-term care facilities, including skilled nursing facilities, that participate in Medicare and Medicaid. CMS estimates that about 75 percent of nursing homes would have to increase staffing in their facilities under the proposed standards, which exceed those existing in nearly all states. Comments on the rule are due 60 days after it is published in the Federal Register.

For more information, read the AHA Special Bulletin.

FDA: Advisors Declare Ineffectiveness of Over-the-Counter Decongestant Ingredient

The FDA’s independent Nonprescription Drugs Advisory Committee declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.

FDA: New COVID Vaccine Approved

On Sept. 11, the U.S. FDA approved updated mRNA formulations of COVID-19 vaccines more closely targeting currently circulating variants. As such, CDPHE notified all COVID-19 vaccine providers that all previous presentations of Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use. Providers should discontinue the use of these products immediately and follow guidance on disposal and wastage.

HHS: Alerts Health Sector to Critical Cyber Vulnerability

HHS alerted the health care sector to a critical vulnerability in ManageEngine products that allows an attacker to perform remote code execution and which a North Korean state-sponsored actor is reportedly using to target health care entities in Europe and the United States. HHS’ Health Sector Cybersecurity Coordination Center (HC3) strongly encourages organizations to apply the recommended update as soon as possible to avoid potential compromise.