Welcome to the May 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, May’s CHA Regulatory Briefing Call is scheduled from 10-11 a.m. on Wednesday, May 3. 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 Marie Cone LeBeaumont, CHA program coordinator, at [email protected]. This month’s deep dive will be presentations from behavioral health experts on ongoing work related to behavioral health in the state. First, Megan Shelton, interim division director at the BHA, will provide an update on what is currently going on at the BHA and the resources they have available for hospitals. Next, Mark Quierlo, Accountable Care Collaborative planning and implementation supervisor at HCPF, and Kevin Wilson, interim director of Medicaid strategy at Children’s Hospital Colorado, will provide an update on the state’s Accountable Care Collaborative 3.0 work and how behavioral health fits into that effort.
Biden: COVID-19 National Emergency Ended
On April 10, President Biden signed HJ Res 7, a law that terminates the President’s National Emergencies Act for COVID-19. The numerous waivers and flexibilities put in place in response to the COVID-19 public health emergency declaration and/or the Stafford Act declaration will not be impacted by this emergency declaration ending. The Stafford Act declaration was made by former President Trump in 2020 and does not have a pre-set end date. The COVID-19 public health emergency; however, is set to end on Thursday, May 11. Additional information on waivers and flexibilities set to end can be found on CHA’s regulatory website here, and CHA will be providing additional details on upcoming changes in a CHA Executive Brief soon. CDPHE: New Guidance on Candida auris In an April 6 Health Alert Network Broadcast, CDPHE announced updated guidelines and procedures for antimicrobial resistance containment in response to the increased spread of antimicrobial resistance in the United States and Colorado. Health care providers should conduct admission screening tests for Candida auris and carbapenemase-producing organism colonization in patients with the following exposures: Patients who have had an overnight stay or invasive medical or surgical procedure in a health care facility outside the United States in the previous year. Patients who have had an overnight stay in a long-term acute care hospital (LTACH) or ventilator-capable skilled nursing facility (vSNF) anywhere in the United States in the previous year. Contact CDPHE for detailed instructions on how to collect and submit specimens for colonization screening tests to the Regional Antimicrobial Resistance Laboratory in Utah.
CDPHE: Develops Toolkit for Special Pathogens
CDPHE has developed a toolkit to help frontline hospitals with planning for management of an Ebola Virus Disease (EVD) or other special pathogen (including Marburg Virus Disease) suspect case for 12-24 hours while awaiting transport to an assessment facility. According to CDPHE, this will require planning and training of frontline hospital staff. Hospitals should leverage triage, isolation, and personal protective equipment plans established for COVID-19 response and adapt them for response to a suspect case of EVD. This toolkit addresses:
Identifying suspected EVD cases Isolating suspected EVD cases Informing public health of a suspected EVD case
Treating a suspected EVD case before transfer to a special pathogen assessment hospital Preparing and training staff for suspected EVD cases
FDA: Authorizes Single Bivalent Dose for COVID-19 Vaccine
On April 18, the FDA authorized using a single dose of the Moderna or Pfizer bivalent COVID-19 vaccine for primary vaccination as well as for future doses. Under the amended emergency use authorizations (EUAs), the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
HHS: Plan for Access to COVID-19 Vaccines for Uninsured
On April 18, HHS announced a $1.1 billion public-private partnership to help maintain access to COVID-19 vaccines and treatment for uninsured individuals through pharmacies, health centers, and state and local public health departments after the federal government no longer pays for or distributes them, a transition expected this fall.
Under the HHS Bridge Access Program, the CDC will purchase and distribute COVID-19 vaccines to local health departments and participating health centers, and contract with pharmacies to continue offering COVID-19 vaccines and designated treatments with no out-of-pocket costs to uninsured individuals. The contracts also will allow uninsured individuals to receive access to certain COVID-19 treatments with no out-of-pocket costs.
State (Non-Public Health Threat) Updates:
AG: Colorado Privacy Act
On March 15, the Colorado Attorney General’s (AG) Office filed the final Colorado Privacy Act (CPA) Rules. The rules will go into effect on Saturday, July 1. They detail the technical specifications for one or more universal opt-out mechanisms that clearly communicate a consumer’s affirmative, freely given, and unambiguous choice to opt out of the processing of personal data for purposes of targeted advertising or the sale of personal data. The CPA does not apply to certain types of personal data maintained in compliance with specific federal privacy laws, such the Health Insurance Portability and Accountability Act (HIPAA).
The exemptions provided for covered entities only extend to the following categories of personal information: protected health information (PHI); de-identified information; patient identifying information; identifiable private information; health care information that is processed solely for the purpose of access to medical records; information or documents created by CHA for HIPAA compliance purposes; information derived from any health-care related information; or patient safety work product information. Any personal information that does not fall under the definitions of the categories listed here will be subject to the CPA Rules.
AQCC: Building Performance Standards Rulemaking Delayed Until August
The Air Quality Control Commission recently voted to delay the May rulemaking hearing on implementing House Bill (HB) 21-1286, Building Performance Standards, to August. This action was in response to a legislative proposal to extend the statutory deadline for adopting the rule as well as stakeholder feedback on needing more time to prepare for the rulemaking hearing. The delay in the rulemaking hearing will not impact the date for when building owners would need to comply with the rule. The proposed regulations as they currently stand can be found here.
BHA: New Resources on Crisis Resolution Teams
The BHA released new fact sheets for providers and clients utilizing Crisis Resolution Teams (CRT). CHA has been advocating on behalf of its members to urge the BHA to formalize the referral structure for pediatric referral services and increase access to services to keep them in their communities. In December 2022, BHA launched the CRT program to assist youth and young adults experiencing mental health crises in 17 Colorado counties have a new option for in-home support when reaching out to Colorado Crisis Services.
CDLE: Updates to Wage Report Submissions for FAMLI and Health Care Provider Portal Coming Soon
The sample file templates used to upload bulk registration files and wage reports into My FAMLI+ Employer have been updated. Employers submitting wage reports have options to submit their wage data within My FAMLI+ Employer. Here are the tools and updated file templates needed: Use the Quick Reference Guide on Reporting Wages for instructions on how to manually input wage data for each employee individually.
To bulk upload wage data for all employees by submitting a wage report file, please refer to the Wage Reporting File Specifications or Wage Reporting API Specifications and use one of the following wage report sample templates to build your wage report files: .CSV Sample Single Filer Wage Report.XML Sample Single Filer Wage ReportWage Report SchemaMy FAMLI+ Employer User Guide for Employers These sample templates can also be found on the Employers page under the “Submitting Your Wage Reports” section.
Colorado employers and third-party administrators have until Sunday, April 30, to submit Q1 2023 wage reports and premium payments to FAMLI. FAMLI is offering a 30-day grace period, which is currently reflected in My FAMLI+ Employer with May 31 listed as the first deadline. On another note, FAMLI anticipates launching the health care provider portal by the end of the summer. After the portal is launched, a step-by-step user guide and how-to videos will be published on famli.colorado.gov. In the meantime, providers are encouraged to subscribe here to get updates related to our health care provider portal as soon as they are available.
CDPHE: Board of Health Approved Final Rules Implementing HB 22-1401
On April 19, the Board of Health approved four rules implementing HB 22-1401. As a reminder, the items under HB 22-1401 have been in place since the fall under emergency rulemaking until the department could undertake a formal rulemaking process. 6 CCR 009-5: This rule outlines hospital bed reporting. CHA’s feedback was incorporated in the final rule to require that CDPHE consider federal reporting requirements to reduce duplicative reporting. CDPHE will continue to use EMResource for data reporting. Hospitals will continue to report on Tuesdays and Fridays. Staffed-bed capacity is defined in the final rule as to what should be included in the count. Critical access hospitals (CAH) should not include swing beds in their calculations. 6 CCR 1011-1, Chapter 4, General Hospitals: This rule outlines requirements for hospital nurse staffing committees, nurse staffing plans, and emergency management plans.
CDPHE has not yet requested nurse staffing plans be submitted at this time. CHA was successful in ensuring the language was incorporated consistent with HB 22-1401 and the Governor’s letter with regard to fines and enforcement so that factors outside of a hospital’s control would be considered and they would not be penalized. 6 CCR 1001-1, Chapter 2, General Licensure Standards: This rule establishes regulations regarding infection control and prevention practices in licensed health facilities. 6 CCR 1009-1, Epidemic and Communicable Disease Control: This rule names communicable diseases and related events that are reportable to the department and local public health agencies and details how these conditions must be reported. This rule also includes language about access to pertinent medical records and outlines public health’s authority to conduct investigations.
HCPF: FAQ on Accessing Behavioral Health Services in Long Term Care Settings
HCPF released a new FAQ that presents the authority, parameters, and processes related to accessing Regional Accountable Entity covered behavioral services for Medicaid members living in long term care settings.
HCPF: Preadmission Screening and Resident Review Process Re-Starting on May 12
During the COVID-19 pandemic, Preadmission Screening and Resident Review (PASRR) was waived and hospitals were able to discharge patients to nursing facilities without going through the PASRR process. Starting on Friday, May 12, any patient discharging from a hospital to a nursing facility will need to have the PASRR process completed, up to and including a Level II evaluation and notice of determination if required. To support hospitals in the transition back to PASRR, HCPF will be hosting a series of trainings on PASRR for social workers, case managers, and anyone else who handles the discharge process.
8 – 9:30 a.m. | Thursday, May 4 – Register Here
4 – 5:30 p.m. | Tuesday, May 9 – Register Here
2 – 3:30 p.m. | Wednesday, May 10 – Register Here
HCPF: HTP Symposium Registration Open
Registration is now open for this year’s Hospital Transformation Program (HTP) Learning Symposium, which will be held on Thursday, June 8 and Friday, June 9. Day one sessions will focus on data and workflows and day two will focus on community engagement and health equity. The Learning Symposium will have virtual as well as in-person attendance options. For more information about the Learning Symposium sessions, and to register, click here. For HTP-participating hospitals, attendance at the Learning Symposium is a requirement for annual Community and Health Neighborhood Engagement (CHNE). HCPF: Hospital Discounted Care Updates HCPF has released updated versions of the Uniform Application (Version 1.4) and Federal Poverty Guideline (FPG) Calculator (Version 2) on the Hospital Discounted Care (HDC) website.Providers should have started using these versions on April 1.
The updated Federal Poverty Guidelines April 2023 – March 2024 has also been posted. HCPF has been holding training for HDC providers. Past training session recordings can be found on the Hospital Discounted Care website and registration links for upcoming trainings can be found below:
1-3 p.m., Tuesday, May 2 | Payment Plans and Collections, Session 2
1-3 p.m., Thursday, May 4 | Data Reporting Template, Session 2
1-4 p.m., Thursday, May 11 | HDC Q&A Session
Additional information on Hospital Discounted Care can be found on CHA’s Website.
HCPF: County Delays in Processing Health First Colorado/CHP+ Applications
Providers have made HCPF aware that there have been issues with counties taking longer than usual to complete patient applications for Health First Colorado. This is an issue, especially for the Colorado Indigent Care Program hospitals, as patients are waiting months with their accounts in limbo or starting payment plans that the provider will have to reimburse if the patient is found eligible for Health First Colorado.
If there are patients who are waiting longer than usual for their application to be completed within the county, please fill out a County and Eligibility Site Member Complaint and Escalation Form to ensure their application is escalated. One application can be filled out for multiple patients if needed. This creates a trackable ticket that HCPF will be able to monitor and work with the county to resolve if needed.
HCPF: Health Equity Plan Meeting
HCPF is developing a health equity plan and is soliciting feedback from providers, members, and community stakeholders on the plan. HCPF’s goal is to establish the current state of health equity and strategically look at innovative ways to improve health outcomes and decrease health disparities for members in Colorado. Registration for the following upcoming public meetings is below:
Noon – 1 p.m. | Tuesday, May 9 | LGBTQIA community focus | Register
3 – 4 p.m. | Tuesday, May 23 | American Indian/Alaska Native (AI/AN) community focus | Register
1 – 2 p.m. | Wednesday, June 21 | African American community focus | Register
Noon – 1 p.m. | Tuesday, Aug. 22 | Disability community focus | Register
3 – 4 p.m. | Tuesday, Sept. 26 | Latino community focus | Register
HCPF: New Maternal Health Equity Report
HCPF released its latest Maternal Health Equity Report, which looks at maternal health during the pandemic, provides a window into the lived experience of members, and lays out HCPF’s roadmap to improve maternal health care and equity. Among the report’s key findings: Prenatal care rates remained stable between 2019 and 2020. Most birthing parents (76 percent) received prenatal care in the first trimester. The rate of neonatal abstinence syndrome and substance-exposed newborns increased from 2019, reflecting a nationwide trend. Postpartum care was expanded for all parents who gave birth in 2020 due to the maintenance of effort for Medicaid eligibility during the COVID-19 public health emergency. The proportion of Medicaid enrollees receiving a postpartum behavioral health service remained stable between 2019 and 2020.
Federal (Non-Public Health) Updates:
AHA: Issue Brief on Strategies to Prevent Workplace Violence
A new issue brief from AHA’s Hospitals Against Violence (HAV) initiative offers evidence-based tools and strategies to help hospitals and health systems assess violence risks and make the care environment safer. The first in a series that will expand on HAV’s 2021 framework for building a safe workplace and community, this issue brief builds on a series of discussions between hospital and risk management leaders.
CHA developed a toolkit with resources for member hospitals and health systems to use to promote a safe workplace. The toolkit includes customizable social media graphics and messages; a public service announcement video; template posters; a workplace safety resolution; and more.
AHA: Supports Bill to Protect Healthcare Workers
On April 19, AHA applauded the reintroduction of the Safety from Violence for Healthcare Employees Act (H.R. 2584), bipartisan legislation that would give health care workers the same legal protections against assault and intimidation that flight crews and airport workers have under federal law. The bill would establish a federal grant program at the Department of Justice to augment hospitals’ efforts to reduce violence, by funding violence prevention training programs, coordination with state and local law enforcement, and physical plant improvements, such as metal detectors and panic buttons. CHA supports the bill and urged members of the Colorado delegation to cosponsor the bill during Hill visits at AHA’s annual conference in Washington, D.C.
CMS: 2024 Notice of Benefit and Payment Parameters Rule Finalized
On April 19, CMS issued a final rule for Patient Protection and the Affordable Care Act. This final rule includes user fee rates for 2024 for issuers offering qualified health plans (QHPs) through federally facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs), as well as payment parameters and provisions relating to the risk adjustment and risk adjustment data validation programs operated by HHS. The automatic re-enrollment hierarchy, plan and plan variation marketing name requirements for QHPs, essential community providers (ECPs) and network adequacy, failure to file and reconcile, special enrollment periods (SEPs), the annual household income verification, the deadline for QHP issuers to report enrollment and payment inaccuracies, and other requirements are also included in this final rule. These regulations will be effective on Sunday, June 18.
CMS: 2024 Medicare Advantage and Prescription Drug Plan Final Rule
On April 5, CMS released a final rule that will increase oversight of Medicare Advantage (MA) plans and better align them with traditional Medicare, address access gaps in behavioral health services and further streamline prior authorization processes. The rule also establishes additional health plan utilization management oversight processes to include required annual reviews of MA plans’ policies and coverage denial reviews by health care professionals with relevant expertise.
The rule will tighten MA marketing rules to protect beneficiaries from misleading advertisements and pressure tactics; expand requirements for MA plans to provide culturally and linguistically appropriate services; make changes to MA star ratings to address social determinants of health; and implement Inflation Reduction Act provisions to make prescription drugs more affordable for eligible low-income individuals. Notably, it appears the proposal to change the legal standard for identifying an overpayment, which was of concern to hospitals and health systems, was not codified in the final regulation. See the CMS fact sheet on the final rule.
CMS: Changes to Price Transparency Enforcement
On April 26, CMS announced changes to its enforcement process for the hospital price transparency rule. CMS will now automatically impose a civil monetary penalty if hospitals fail to submit a corrective action plan on time or fail to complete the plan within 45 days. In addition, the agency will no longer issue a warning notice to hospitals that have not posted any machine-readable file or shoppable services list/price estimator tool but will immediately ask the hospital to submit a corrective action plan. Notably, CMS will also now require hospitals to be in full compliance with the rule within 90 days from when they receive a corrective action plan request, rather than allowing hospitals to propose a completion date for CMS approval.
CMS: Proposed Rule for Inpatient and Long-Term Care Hospitals
On April 10, CMS issued a proposed rule for inpatient and long-term care hospitals that aims to advance health equity and support underserved communities. The rule would adopt hospital quality measures to foster safety, equity, and reduce preventable harm in the hospital setting. As required by statute, the fiscal year (FY) 2024 inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) rule updates Medicare payments and policies for hospitals. CMS is also proposing to recognize homelessness as an indicator of increased resource utilization in the acute inpatient hospital setting, which may result in higher payment for certain hospital stays.
For acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting program and are meaningful electronic health record users, the proposed increase in operating payment rates for FY 2024 is projected to be 2.8 percent. This reflects an FY 2024 projected hospital market basket update of 3.0 percent, reduced by a projected 0.2 percentage point productivity adjustment. Read CMS’ fact sheet on the proposed rule here.
CMS: Proposed Rule for Medicaid and Marketplace Coverage for DACA Recipients
On April 26, CMS released a proposed rule that would extend Medicaid and Children’s Health Insurance Program coverage to qualified individuals in the Deferred Action for Childhood Arrivals (DACA) program in states that cover legally residing immigrant children and pregnant women, including Colorado. DACA recipients also could purchase coverage through the Health Insurance Marketplace; qualify for marketplace subsidies based on income; and apply for the Basic Health Program in states that participate (currently Minnesota and New York). If finalized, the agency expects the rule to extend coverage to an estimated 129,000 DACA recipients authorized to work in the United States.
CMS: Resources for Hospital Quality Care Standards
During Surveys CMS Region VIII shared information with CDPHE about how to survey hospitals for compliance with patient safety standards and what hospitals should do to maintain quality access to care. This document also highlights guidelines for protecting protected health information held within Patient Safety Organizations during a survey.
FDA: New Labeling Requirements for Opioids
The FDA implemented new labeling requirements for opioid pain medicines in an effort to reduce unnecessary prescribing and prevent complications such as opioid-induced hyperalgesia, when an opioid causes an increase in pain or increased sensitivity to pain.
“These changes are designed to provide essential information that prescribers need to prescribe opioid pain medicines appropriately, but the prescribing information itself cannot substitute for individual clinical judgment and talking to patients about their pain control,” the agency noted.
HHS: Health Care Workers Free Cybersecurity Training
HHS has begun offering free cybersecurity training online for health care workers, aiming to boost the industry’s defenses against cyber threats. The training will cover issues including ransomware, social engineering, and attacks against medical devices. A recent survey from the Healthcare Information and Management Systems Society found that health care workers don’t receive cybersecurity training often. Some of the most significant barriers the survey found were cost and a lack of time. About one in seven Americans had their sensitive health data breached in 2021 alone, a threefold increase in three years, according to a POLITICO analysis. Cyberthreats put at risk patient safety and health care organizations’ bottom lines.
On April 17, HHS released Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients, which outlines the top five threats facing the health care sector and 10 practices to combat them.
EPA: Proposed New Health Protections to Reduce Exposure to Ethylene Oxide
On April 11, the EPA proposed new Ethylene Oxide (EtO), use including includes tighter air emissions regulations and improved safeguards for employees who are exposed to the gas used to sterilize medical devices and some spices. Hospitals and other health care institutions often use EtO to sterilize essential objects that cannot be sterilized by steam. In terms of impact to health care facilities, the EPA is proposing to require new engineering controls in facilities that use EtO. These requirements are: Separating EtO sterilization spaces from other work areas to reduce the broader circulation of EtO; Implementing negative air pressure in rooms containing EtO sterilization devices to ensure that air will not flow to other areas in the health care facility; Using abatement devices to remove EtO from exhaust air and reduce discharge to the environment; and Discharging exhaust air from EtO sterilization devices through exterior ventilation stacks after passing through abatement devices to reduce the amount of EtO re-entrained into the building.
According to the latest risk data from the EPA, personnel who apply EtO to medical equipment in commercial sterilizer facilities, health care facilities, as well as spices in commercial sterilizer facilities may have significant cancer risks. These projections presuppose that workers will be exposed to EtO for at least 35 years, eight hours per day, 240 days per year. Based on a facility’s control methods and the number of hours individuals work, actual risks will change.
HHS: HIPAA Proposed Rule Would Prohibit Certain Reproductive Health Care Disclosures
On April 12, HHS’ Office for Civil Rights (OCR) released a proposed rule that would prohibit entities regulated by the HIPAA Privacy Rule from using or disclosing protected health information to investigate or prosecute patients, providers, or others involved in providing legal reproductive health services. Reproductive health care would be defined to include, but not be limited to, prenatal care, abortion, miscarriage management, infertility treatment, contraception use, and treatment for reproductive-related conditions such as ovarian cancer, OCR said.
The existing Privacy Rule permits, but does not require, certain disclosures to law enforcement and others, subject to specific conditions, OCR notes. Comments on the proposed rule will be accepted until Friday, June 16. Read an advisory from Alston & Bird, CHA’s federal partners, here.
The Joint Commission: Proposal to Tackle Hospital Climate Impact
The Joint Commission is developing new requirements to address environmental sustainability for the Hospital (HAP) and CAH accreditation programs. The proposal would require both acute care hospitals and CAHs to appoint an individual to oversee the reduction of greenhouse gas emissions in coordination with clinical and facility representatives. Hospitals would be asked to measure three or more of the following: Energy use Purchased energy (electricity and steam) Anesthetic gas use Pressurized metered dose inhaler use Fleet vehicle gasoline consumption Solid waste disposal to landfills or through incineration Hospitals would then have to use the measures to reduce greenhouse emissions in a written plan. The Joint Commission is requesting comments on the proposed requirements through Wednesday, May 3. Read The Joint Commission’s statement here.
Wednesday, May 3: CHA Regulatory Update, Join Here (10- 11 a.m.)
Friday, May 12: Medical Services Board Meeting
Wednesday, May 17: Board of Health Meeting
Thursday, May 18: CO Medical Board Meeting
Wednesday, June 7: CHA Regulatory Update
Friday, June 9: Prescription Drug Affordability Advisory Council Meeting