CHA Regulatory Update

Welcome to the November 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 Department of Human Services (CDHS), CDPHE, DORA, HCPF, and the Colorado Department of Labor and Employment (CDLE).

As a reminder, November’s CHA Regulatory Briefing Call is scheduled from 10-11 a.m. on Wednesday, Nov. 9. 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 CDLE, who will provide a status update on its progress in building the family and medical leave insurance (FAMLI) program and important dates and timelines employers should be aware of. Additional information concerning FAMLI can be found here.

CHA has updated the 2022 Implementation Overview document to summarize how CHA plans to prioritize different regulatory priorities in response to hospital prioritization during last month’s regulatory survey. The document does not highlight every statutory change and state action, rather it highlights notable implementation timelines, links to existing resources, and outlines how CHA plans to engage in implementation activities. This document outlines if CHA will proactively engage in rulemaking and implementation work, or if CHA plans to monitor regulatory implementation activities based on the impact on hospital operations. Members are encouraged to review all legislation and determine if there are laws that their hospital or health system would like to engage in more proactively. Additionally, members are encouraged to reach out to Adeline Ewing, CHA policy analyst, at [email protected] with any bills that they think may warrant additional engagement from CHA.

Public Health Threat Updates

CDC: COVID-19 Boosters Recommended for Children 5 and Older

On Oct. 12, the CDC recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the FDA authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults.

CDC: Monkeypox More Severe for Immunocompromised

Recently, the CDC informed health care providers that people who are immunocompromised due to HIV or other conditions are at higher risk for severe manifestations of monkeypox than others. CDPHE issued a HAN, noting that Colorado providers caring for patients suspected to have severe manifestations of monkeypox should contact [email protected] or 303.370.9395 (after hours and weekends) for help coordinating clinical consultation with CDC or to request medical countermeasures such as tecovirimat (TPOXX), which is available both orally and IV in Colorado.

CDC: First U.S. Monkeypox Case in Health Care Worker

The CDC reported the first U.S. monkeypox case in a health care worker – an emergency department nurse in Florida who was exposed to the virus through a needlestick. In a Morbidity and Mortality Weekly Report released on Oct. 21, the CDC describes the first occupationally acquired case of Monkeypox in the health care worker and recommends approaches to preventing infections in health care workers.

CDPHE: RSV Reporting Requirements

According to CDPHE, RSV-associated hospitalizations within the five-county metro area (Adams, Arapahoe, Denver, Douglas, and Jefferson) must be reported to the state within four days of diagnosis. RSV outbreaks in residential care facilities must be reported to the state immediately. From Oct. 1 through Oct. 29, Colorado had 367 RSV hospitalizations in the metro area, with 95 percent of them among pediatric patients. For more information, visit CDPHE’s Reporting a Disease webpage. Additional information from CDPHE on RSV can be found here.

CDPHE: Updates on Omicron Booster Rollout

CDPHE recently updated its COVID-19 vaccine data dashboard to include more data about the omicron dose administration. The updated dashboard displays the percentage of eligible Coloradans who have received at least one primary series dose, completed their primary vaccination series, or completed their primary vaccination series and received an omicron dose. The recording from the most recent CDPHE Immunization Branch COVID-19 Vaccine Provider call is available here and has additional details about the continued rollout of the omicron booster.

FDA: EUA for COVID-19 Tests Updated

The FDA has revised its emergency use authorizations (EUA) for all COVID-19 antigen tests to require updates to product labeling regarding serial testing. The revised EUAs and labeling call for users with COVID-19 symptoms to repeat testing at least twice over three days and users without symptoms to repeat testing at least three times over five days. Additionally, the FDA designated the recall of 60,500 Teleflex Iso-Gard S filters, a Class I recall, meaning the devices may cause serious injury or death.

HHS: COVID-19 PHE Renewed for 90 Days

On Oct. 13, HHS renewed the COVID-19 public health emergency (PHE) declaration for another 90 days. The PHE continues critical flexibilities hospitals depend on to deliver needed care and minimize additional disruptions to a challenged health care delivery system.

State (Non-COVID-19) Updates:

BHA: 2022 Behavioral Health Plan

Colorado’s new Behavioral Health Administration (BHA) released its General Assembly Report, 2022 Behavioral Health Plan, which includes the early conceptualization of an inclusive, “people-first” behavioral health system. The report offers a forecast of the BHA’s strategic and responsive approach to achieving better outcomes for those with mental health and substance use concerns in Colorado. While the BHA is at 20 percent capacity as planned, the BHA has an expansive strategy and approach for behavioral health reform over the coming year as it reaches its goal of 50 percent capacity by June 2023. The BHA is currently working on county assessments of behavioral health needs, formal agreements with other state agencies, an access to care methodology, and development of the Behavioral Health Administrative Service Organization (BHASO) structure. Note: rulemaking for the behavioral health structural reforms (e.g., development of the safety net requirements, universal contracting, HB 22-1256 involuntary mental health hold procedure update, etc.) is in planning stages now and will occur in spring 2023.

CDLE: Family and Medical Leave Insurance Update

On Nov. 1, the FAMLI Division hosted another virtual hearing regarding multiple FAMLI rules including: Premiums 7 CCR 1107-1, Local Governments 7 CCR 1107-2, and Coordination of Benefits 7 CCR 1107-4. This hearing covered proposed amendments to the previously adopted rules. A cost-benefit analysis has also been produced for the proposed amendments to the Premiums rule 7 CCR 1107-1.

The FAMLI Division is looking to interview health care providers as they are in the early stages of building the FAMLI benefits system that Colorado workers will eventually use to file a claim for FAMLI leave once benefits become available in 2024. They are currently looking for providers who provide direct patient care and/or support patients in approving insurance claims or filling out the traditional federal FMLA forms to interview. They’ve created a new screener survey for health care providers. Interested participants should fill out this survey, and the FAMLI Division will reach out to them to schedule an interview.

CDPHE: Mask Mandate for Health Facilities Removed

CDPHE issued the 22nd version of Public Health Order (PHO) 20-38, which has been extended for another month and amended to:

Repeal all requirements in Section I, including face covering requirements in health care and nonmedical congregate settings, with the exception of schools continuing to be required to report cases and outbreaks to public health and cooperate with public health investigations and requirements.
Repeal definitions in Section IV.

These changes bring the state in line with updated guidance from the CDC for health care settings that was issued at the end of September.

CDPHE: Flu Vaccine Tracking Started Oct. 1

Current Colorado health facility rules require annual reporting of influenza vaccination to meet a threshold of 90 percent of employees and direct contractors having received the influenza vaccine during a given influenza season. The timeframe to count employees to be included in reporting is Oct. 1, 2022 – March 31, 2023, and this flu season’s data must be submitted to CDPHE by May 15, 2023. Read more here. CDPHE also issued a Health Alert Network (HAN) Broadcast with surveillance details for providers for this year’s flu season. Read the details here.

CDPHE: Guidance for Suspected Ebola Cases

CDPHE issued a Health Alert Network (HAN) Broadcast with guidance for Colorado providers who may treat patients with suspected Ebola virus. The guidance, based on previously issued CDC guidance, includes isolation and PPE protocols, as well as the notification process to the state. The HAN notes that the current risk of Ebola cases in the United States associated with the outbreak in Uganda is low.

CDPHE: Hospital Nurse Staffing Standards Update

The next stakeholder meeting on implementing HB 22-1401, Hospital Nurse Staffing Standards, is scheduled for 12:30-2:30 p.m. on Tuesday, Nov. 15, via Zoom. At this meeting, CDPHE will review the emergency rule language in Part 14 – Nursing Services (i.e., nurse staffing committee and nurse staffing plan). CHA will be submitting comments in advance of the meeting based on feedback from the nursing services workgroup. If your organization has any specific examples or input related to Part 14, please send to [email protected] by COB on Friday, Nov. 11.

CDPHE: HB 22-1284 Implementation

HB 22-1284 aligns the federal and state balance billing standards, including surrounding disclosure and informed consent. CDPHE intends to streamline their Chapter 2 regulations to confirm with federal and state law, but due to current bandwidth, it has not been able to update the facility disclosure notices. CDPHE indicated that those changes will occur within the next six months. In the interim, facilities should utilize the federal informed consent/disclosure forms and standards. More information and links to resources can be found in CMS’ FAQs and CHA’s implementation brief.

CEO: Building Performance Standards Deadline on Dec. 1

Per HB 21-1286, Energy Performance For Buildings, owners of large commercial, multifamily, and public buildings 50,000 square feet or larger must report their energy use annually to the Colorado Energy Office (CEO), starting Dec. 1, 2022, and on or before June 1 of each subsequent year. Hospitals that meet these requirements must either submit a benchmarking report or submit a waiver request, both of which can be found here. Additional information about the new requirements can be found here.

CHA: Community Benefit Educational Webinar

Join CHA from 3-4:30 p.m. on Wednesday, Nov. 9, for a discussion about community benefits, with a focus on best practices that hospitals should be employing, especially as scrutiny about hospital finances and community benefit investments continues to increase. The webinar will feature Keith Hearle, founder and president of Verite Healthcare Consulting, as well as a panel of Colorado hospital leaders. Join the webinar here.

CHA: Joins Organizations to Support Proposition 123

CHA has joined more than 200 other organizations and local community leaders to stand in favor of Proposition 123, which is on statewide ballots this fall. CHA believes voting yes on Prop 123 will give local communities the tools needed to address Colorado’s deepening housing crisis. Without raising taxes, Prop 123 will make housing more affordable for working people by providing down payment assistance for first-time homebuyers, lowering rent, and building more affordable housing across the state. Prop 123 will do this by requiring a small portion of the state budget be set aside to help fix Colorado’s housing crisis.

CIVHC: New President and CEO Announced

Following the retirement of long-time CEO Ana English, the Center for Improving Value in Health Care (CIVHC) has selected Kristin Paulson to serve as its next president and CEO. Paulson joined CIVHC in 2013 as Manager of Policy and Initiatives, leading the palliative care and care transitions focus areas as well as other population health initiatives. Paulson officially starts Dec. 1.

DOI: CHA Comments on Colorado Option Public Hearings

On Oct. 4, CHA submitted comments to the DOI on the Colorado Option public hearings 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.

On Oct. 14, the DOI released a notice of virtual rulemaking hearing for 11 a.m. on Tuesday, Nov. 15, (register here) on two Colorado Option draft rules – 4-2-91 on provider rate setting and 4-2-92 on public hearings. Oral comments will be taken from participants who are present via webinar. If you cannot make the meeting virtually or wish to make written comments rather than speaking, you may email your written comments to DOI Rules and Records by 5 p.m. on Friday, Nov. 18, for review and consideration.

DOI: Bright Health Leaves Colorado Insurance Marketplace

On Oct. 11, Bright Health announced that it will not offer individual health plans in 2023 in all of its existing markets, including in Colorado. This follows an earlier decision by Bright to not offer small group plans in Colorado next year. Bright Health had about 55,000 Colorado members this year (54,000 individual and about 900 in small group). People with Bright coverage can continue to use their health insurance through the end of this year, and their claims will continue to be paid according to their policies. Additional information is available in this DOI fact sheet.

DOI: Individual and Small Group Plan Rates Increase for 2023

On Oct. 25, the DOI released rates for 2023, and most plan rates are up with average increases of 10.4 percent for individual plans and 7.4 percent for small group plans. Additionally, of the $326 million “savings” the state touts in its press release, $294 million comes from the state’s reinsurance program. Of note, the lowest cost plans in the individual market are NOT the administration’s Colorado Option, but rather the non-standardized plans build by health insurance providers (in partnership with hospitals and providers). As part of the Colorado Option stakeholder feedback process, CHA, working alongside Colorado Medical Society and Colorado Association of Health Plans, made numerous suggestions/requests on plan design that were not adopted and may have contributed to higher plan costs.

HCPF: CHA and Hospital Advocacy Secures Add-On to Proposed Inpatient Base Rate Methodology

In early October, HCPF discussed its updated proposed inpatient base rate methodology change with hospitals. Based on feedback from hospitals and advocacy by CHA, HCPF plans to add an adjustment for hospitals that are designated to be a sole community hospital or Medicare dependent hospital. Hospitals that have either Medicare designations would receive a 20 percent add on in the inpatient base rate calculation. Other new add-ons included in the proposal are for Critical Access Hospitals, low discharge, pediatric hospitals, payer mix, and solvency. On Nov. 4, HCPF presented its final inpatient base rate calculation proposal that it will be submitting to the Medical Services Board for final approval. The new methodology calculation will be implemented on July 1, 2023.

HCPF: Hospital Discounted Care Update

Following the Sept. 1 implementation of the Hospital Discounted Care (HDC) program (established by HB 21-1198), CHA will host a third hospital collaboration call to discuss operational strategies from 11 a.m. – noon on Friday, Nov. 11. Join the Zoom meeting here. CHA also continues to advocate for regulatory reforms and clarifications. HCPF has issued clarifications and additional information on some key issues:

Annual Rating: Once a patient qualifies for HDC, HCPF confirmed that the rating applies for one year. There is no need to screen a patient at every visit. During the year, the hospital only needs to re-rate during that time if the patient’s financial situation has changed.
Screening Requirements for Non-Residents: Non-residents do not need to sign the decline screening form. All uninsured patients must be screened, but if the patient is not a Colorado resident, they are ineligible, and no additional information needs to be completed.
Clinic Ratings: Hospitals may accept income determinations for patients made at Colorado Indigent Care Program (CICP) clinics, Federally Qualified Health Centers (FQHCs), and Regional Health Connectors (RHCs). Hospitals can use the patient’s card or other determination documentation from those clinics to fill out the necessary information on the Uniform Application, and with the patient’s permission, may contact the clinic to obtain any missing information necessary for the HDC application. An uninsured CICP client who does not want to have HDC added to their account would need to sign the Decline Screening form. If a hospital does not want to accept a card from a CICP clinic and/or an income determination/rating from a FQHC or RHC for an uninsured patient, a screening and application will need to be completed or a Decline Screening form will need to be collected.

For additional questions, HCPF office hours resumed for 9-10 a.m. every Wednesday. Join via Zoom here. Additional resources are available on the HCPF HDC webpage and the CHA HDC webpage.

Polis: Avian Flu Disaster Emergency Declaration Extended

On Oct. 20, Gov. Polis issued an Executive Order extending the declaration of state of disaster emergency due to the Highly Pathogenic Avian Influenza (HPAI) in Colorado, enabling state agencies to continue to coordinate for mitigation of disease spread, response, consequence management, and recovery efforts.

Polis: 2023-24 Budget Request Submitted

On Nov. 1, Gov. Polis submitted his administration’s 2023-24 budget request to the Joint Budget Committee (JBC) and the General Assembly. The budget proposal requests $42.7 billion in total funds (a 3.5 percent increase) and $16.7 billion in general funds (a 7 percent increase). Most notably, the budget adds $22.8M for behavioral health services and includes 0.5-3 percent provider rate increases.

Next in the process, Gov. Polis will present his budget to the JBC, which will be followed by a variety of hearings and briefings with JBC staff and department leaders over budgeted items. As a reminder, the Governor’s budget is a proposal for spending, but the state budget will be finalized during the 2023 legislative session.

Federal (Non-COVID-19) Updates:

AHA: New Clean Energy Tax Credits Available to Hospitals

The AHA has released a Legislative Advisory that outlines tax incentives available to hospitals, including tax-exempt hospitals, for energy efficient construction and clean energy vehicles. These tax credits are available as a result of the Inflation Reduction Act (P.L. 117-169), which was signed into law on Aug. 16. AHA recommends hospitals consult with their organization’s accountants and tax professionals to determine how the Act’s provisions may benefit their hospital or health system.

AHA: Nursing Groups Update Principles for Mitigating Workplace Violence

The AHA’s American Organization for Nursing Leadership affiliate and the Emergency Nurses Association updated their Guiding Principles on Mitigating Violence in the Workplace to incorporate best practices based on the latest research and a toolkit to help hospitals and health systems customize their workplace violence protection program to best protect their employees and patients.

AHA: Urging NLRB to Withdraw Notice of Proposed Rulemaking on Joint-Employer Status

On Nov. 4, the AHA urged the National Labor Relations Board (NLRB) to withdraw a notice of proposed rulemaking regarding the standard for determining joint-employer status or, consistent with the board’s historical approach, exempt hospitals from compliance. Among other topics, the letter says the proposed rule (1) exacerbates the significant financial challenges hospitals are currently facing; (2) fails to account for how it will impact federal health care regulations, such as the market basket; (3) runs contrary to NLRB’s historical treatment of hospitals and congressional intent; and (4) would create chaos for hospitals and is inimical to collective bargaining.

ASPR: $21M Awarded to Regional Treatment Centers for Emerging Pathogens

HHS’s Administration for Strategic Preparedness and Response (ASPR) awarded funding for 13 hospitals and health systems to serve as Regional Emerging Special Pathogen Treatment Centers for highly infectious diseases. Three hospitals received $3 million each to serve as new centers, and 10 existing centers – including Denver Health – received $1.2 million each.

CDC: U.S. Screening Uganda Travelers for Ebola

The U.S. Embassy in Uganda announced that the CDC and Department of Homeland Security Customs and Border Protection will route airline passengers destined for the United States who have been in Uganda within the previous 21 days to one of five airports for enhanced screening. The CDC also issued an advisory reminding U.S. clinicians of best practices for evaluating patients for suspected Ebola, which include obtaining a detailed travel history.

CMS: Resources on Changes from Inflation Reduction Act

On Oct. 5, CMS released materials with information about the Medicare, Medicaid and Children’s Health Insurance Program, and Health Insurance Marketplace provisions of the Inflation Reduction Act, including a fact sheet, a timeline, and external frequently asked questions. Key highlights of the legislation include:

Extends for three years the expanded eligibility and value of ACA marketplace subsidies, originally passed in the American Rescue Plan;
Allows Medicare to negotiate drug prices on a limited set of drugs, including insulin;
Addresses climate change through a combination of tax changes and spending subsidies; and
Reduces the deficit.

CMS: Bundled Payment Model Extended Through 2025

On Oct. 13, CMS announced that the Bundled Payments for Care Improvement Advanced (BPCI Advanced) model will be extended through 2025. The model tests whether bundling Medicare payments for certain inpatient and outpatient care reduces spending and improves quality. The agency expects early next year to request applications from Medicare providers, suppliers, and accountable care organizations to participate in the two-year extension, which will include changes to the pricing methodology. The BPCI Advanced Model, which launched on Oct. 1, 2018, was set to end on Dec. 31, 2023, and will now conclude on Dec. 31, 2025. CMS plans to announce a Request for Applications (RFA) in early 2023 for Medicare-enrolled providers and suppliers and Medicare Accountable Care Organizations (ACOs) to participate in the Model’s two-year extension (2024-2025). To be eligible for participation in the extension, Convener Applicants must be Medicare-enrolled entities or ACOs. Those interested in applying as Non-Convener Applicants will need to either be an acute care hospital or a physician group practice [CW6] .

CMS: Data Released Highlighting Progress by Colorado Hospitals Saving People Money on Health Care

On Oct. 18, CHA issued a media statement and stakeholder report about recent reports from the CMS National Healthcare Expenditure Data that show that Colorado hospital costs are better than national averages:

In 2020, Coloradans spent $4 billion less than the national average on hospital care.
Colorado households spend the second lowest amount on hospital costs in the country.
Hospital costs in Colorado are now 18% lower than the U.S. average and are rising at a slower pace than national trends.
In the last 10 years, Coloradans have saved $22.5 billion dollars through lower hospital costs, compared to the U.S. average.

CMS: Reporting Hospital Employee COVID Vaccine Rates

In October, CMS started posting hospital performance on its health care personnel COVID-19 vaccination measure. The measure was added to the agency’s inpatient quality reporting and outpatient quality reporting programs in 2021 and reflects the proportion of most hospital personnel that have completed the primary series of any FDA-authorized COVID-19 vaccine. The data will be refreshed on Care Compare quarterly. Measure performance will exclude HCP with medical contraindications to the COVID-19 vaccine but includes HCP that decline the vaccine for religious or other reasons. See this AHA advisory for additional details.

CMS: Increased Oversight of Poor-Performing Nursing Facilities

On Oct. 21, CMS announced revisions to the Special Focus Facility (SFF) Program to improve oversight over the poorest-performing nursing facilities. CMS will (1) make the requirements to graduate from the SFF more stringent, (2) terminate participation in federal funding programs for facilities that do not improve, (3) increase the severity of enforcement remedies, (4) extend the monitoring period of enforcement actions to encourage sustainability of facility improvements, and (5) encourage state survey agencies to assess staffing when conducting quality inspections.

CMS: Webinar on Medicaid/CHIP Continuous Enrollment Unwinding

On Oct. 26, CMS hosted a webinar entitled, Medicaid and CHIP Continuous Enrollment Unwinding: What to Know and How to Prepare, A Partner Education Monthly Series. The webinar is the sixth in a series of monthly educational meetings on the Medicaid and Children’s Health Insurance Program (CHIP) continuous enrollment unwinding process following the end of the COVID-19 public health emergency (PHE). Officials from CMS, Arizona’s state Medicaid Agency, and an Arizona nonprofit discussed the transition from Medicaid to Medicare and specifically highlighted the importance of outreach to communities most at-risk of losing Medicaid coverage following the end of the PHE. Alston & Bird, CHA’s federal lobbying partner, has prepared a summary of the webinar.

CMS: 340B Claims for Calendar Year 2022

On June 15, a Supreme Court ruling struck down Part B cuts to 340B reimbursement and, on Sept. 28, a court ordered CMS to restore reimbursement for such drugs to Average Sales Price (ASP) plus 6 percent immediately, rather than wait until calendar year (CY) 2023 as proposed in the CY 2023 proposed rule. The court order was specifically targeted to claims on a go-forward basis; the court noted that remedies for past underpayments would be addressed at a later time. Pursuant to the Supreme Court ruling, CMS will have to find a way to remedy its unlawful ASP – 22.5 percent payments for 340B-acquired drugs that were in place from Jan. 1, 2018, through Sept. 28, 2022. CMS has stated that they will undertake separate rulemaking on this matter that will be published in advance of the CY 2024 OPPS/ASC proposed rule.

On Oct. 13, CMS announced that it would reprocess claims for 340B acquired drugs paid under Part B for dates of service on or after Sept. 28, 2022. Novitas, the Medicare Administrative Contractor for Colorado, announced that they will adjust Part B claims for 340B-acquired drugs for all CY 2022 dates of service. Due to the volume of impacted claims, Novitas Solutions will be mass adjusting all impacted claims with a 2022 date of service. The issues log will be updated once the mass adjustments have been initiated. No provider action is required.

Providers who prefer to submit adjustments prior to the initiation of the mass adjustments may submit them on any claim submitted with the modifier JG with date of service in 2022 that was paid prior to Sept. 28, 2022. Providers may submit the Type of Bill (TOB) xx7 with condition code D9 and remarks indicating “340B adjustment.” Timely filing rules will apply when submitting adjustments, so Novitas recommend adjusting as soon as possible. If adjustments are submitted beyond timely filing, then the TOB will need to be xxQ with the appropriate coding and the remarks indicating “340B adjustment.” The modifier JG can remain on the claim, but the reduction will no longer be applied. Claims paid on or after Sept. 28, 2022, will be automatically adjusted. Additional information can be found in a memo prepared by CHA’s federal lobbying partner, Alston & Bird.

CMS: COVID-19 Vaccine Requirements Updated

On Oct. 26, CMS updated its COVID-19 guidance pertaining to vaccination requirements for health care providers, including changes to CMS’ surveyor guidance, and associated enforcement action, for hospitals, ambulatory surgery centers, long-term care facilities, skilled nursing facilities and other health care providers.

CMS: Medicare Enrollment and Eligibility Rule Finalized

CMS finalized a rule updating Medicare enrollment and eligibility rules as required by the Consolidated Appropriations Act of 2021. Effective Jan. 1, coverage for individuals enrolling in traditional Medicare during the last three months of their initial enrollment period or during the general enrollment period will begin one month after enrollment. Effective immediately, individuals with end stage renal disease can enroll in Medicare Part B coverage for immunosuppressive drugs beyond the 36-month post-transplant period. The rule also creates special enrollment periods for people impacted by an emergency or disaster; who were formerly incarcerated or had their Medicaid eligibility terminated; or whose employer or health plan materially misrepresented information related to timely enrolling, among other exceptional conditions.

CMS: CY 2023 Physician Fee Schedule and Hospital Outpatient Prospective Payment System Rules Finalized

On Nov. 1, CMS finalized the CY 2023 Medicare Hospital Outpatient Prospective Payment System rule and Physician Fee Schedule (PFS) rule.

OPPS Final Rule: The rule increases OPPS rates by a net 3.8 percent in CY 2023 compared to 2022. It also includes final policies related to the 340B Drug Pricing Program, Rural Emergency Hospital model, site-neutral clinic visit payment policy, payment for remote behavioral health services, prior authorization, the inpatient only list and the ASC Covered Procedures List.

PFS Final Rule: The rule reduces CY 2023 payments from their CY 2022 levels by almost 4.5 percent. Additionally, it updates telehealth services and modifies other aspects of physician payment. The rule also includes changes related to the Medicare Shared Savings Program and the Quality Payment Program, both of which were created by the Medicare Access and CHIP Reauthorization Act of 2015.

AHA’s summary of the PFS can be found here and a summary of the OPPS rule can be found here. Alston & Bird, CHA’s federal lobbying partner, has also compiled summaries of the two final rules – the PFS summary can be found here, and the OPPS summary can be found here.

FBI, CISA, HHS: Agencies Urge Action to Protect Against Ransomware Gang

The Federal Bureau of Investigation (FBI), Cybersecurity and Infrastructure Security Agency (CISA) and HHS alerted U.S. organizations to a cybercrime group targeting the health care sector with ransomware and data extortion operations. The group has attacked multiple organizations since June, deploying ransomware to encrypt servers responsible for health care services, exfiltrating personal identifiable information and patient health information, and threatening to release the information if a ransom is not paid. The advisory includes indicators of compromise and recommended actions to protect against these attacks.

FCC: Compliance with Kari’s Law and Ray Baum Act

Hospitals should be aware that if they have a multi-line telephone (MLTS) system purchased, installed or significantly upgraded after Feb. 16, 2020, then they must comply with Federal Communications Commission (FCC) Rules pertaining to Kari’s Law. Under Kari’s Law, MLTS manufacturers and vendors are legally accountable to pre-configure these systems to support direct dialing of 9-1-1 – that is, to enable the user to dial 9-1-1 without having to dial any prefix or access code, such as the number “9.” In addition, MLTS installers, managers, and operators are also accountable to ensure that these systems support 9-1-1 direct dialing. You can learn more about Kari’s Law here.

In addition to Kari’s Law, hospitals must also comply with Ray Baum’s Act, which requires organizations to provide a “dispatchable location” to emergency dispatchers for any caller who dials 9-1-1 from their network. Simply put, a “dispatchable location” is detailed enough location information for emergency responders to find the person who dialed 9-1-1. Learn more about Ray Baum’s Act here.

GAO: Report Finds Limited Obstetric Care in Rural America

The U.S. Government Accountability Office (GAO) recently published a report – Maternal Health: Availability of Hospital-Based Obstetric Care in Rural Areas – to address concerns of recent hospital closures’ effect on access to obstetric care. GAO found that more than half of rural counties studied did not have obstetric services in 2018, and stakeholders GAO interviewed identified low Medicaid reimbursement rates and staffing challenges as the two biggest barriers. The stakeholders noted that addressing these two challenges as well as implementing other solutions such as remote telehealth consultations, establishing regional partnerships, financially incentivizing and training providers to practice in rural areas, and reducing the costs of medical liability insurance costs for rural obstetric physicians would also help expand access to rural obstetric care.

GAO: Report on Behavioral Health Workforce

On Oct. 27, the GAO published a report entitled, Behavioral Health: Available Workforce Information and Federal Actions to Help Recruit and Retain Providers. This report describes: (1) available information on the behavioral health workforce; (2) key barriers to and incentives for recruiting and retaining behavioral health providers; and (3) HHS agencies’ actions to support recruiting and retaining behavioral health providers. GAO identified low reimbursement rates, lack of workforce diversity, and lack of qualified supervisors as barriers to recruiting and retaining behavioral health providers. GAO found that incentives such as loan repayment and scholarships for students seeking behavioral health professions help to address these barriers. GAO also found that HHS agencies have taken actions to support recruiting and retaining behavioral health providers. These actions include administering various workforce development programs to help recruit and retain qualified providers to work in underserved and mental health shortage areas.

HHS: Apply OpenSSL Patch Starting Nov. 1

HHS highly recommends all health sector organizations immediately test and deploy a critical OpenSSL patch when it becomes available Nov. 1 because many of the most common operating systems and applications use the OpenSSL software library for secure communications.

HRSA: Post-Payment Notice of Reporting Requirements Updated

The Health Resources and Services Administration (HRSA) has released updated Post-Payment Notice of Reporting Requirements to expand the reporting requirements to cover the American Rescue Plan (ARP) rural payments in addition to the Provider Relief Fund (PRF) general and targeted distribution payments. Notable updates include:

HRSA is creating additional reporting periods.
PRF and ARP Rural recipients may only use payments incurred through the end of the quarter in which the public health emergency ends.
Providers receiving both PRF and ARP funds should use the ARP funds first before applying PRF funds.
Reporting entities will submit required reports for both PRF and ARP Rural payments in the PRF Reporting Portal.
Entities who report a merger or acquisition or transfer Targeted Distribution payments are more likely to be audited.
General Distribution Phase 4 and ARP Rural payments must be held in an interest-bearing account, with total reportable payments including interest earned.
ARP Rural parent entities that received payments on behalf of subsidiaries must report and attest to certain requirements.

Click here for Alston & Bird’s (CHA’s federal lobbying partner) summary of the changes and here for a redline version of the requirements.

IRS: Finalizes Proposal to Fix Marketplace “Family Glitch”

On Oct. 13, the Internal Revenue Service (IRS) finalized a rule revising its methodology for assessing whether employer-sponsored coverage is affordable for family members. The new methodology uses premiums for family coverage rather than individual coverage to assess whether an employee’s family members have access to affordable coverage, which affects whether they qualify for a premium tax credit for coverage purchased through a health insurance marketplace. The Biden administration estimates the change will make coverage more affordable for about one million Americans.

OIG: Report Found That COVID-19 Payments to Hospitals in Compliance with Federal Requirements

On Oct. 25, the HHS Office of Inspector General (OIG) published a report entitled, Payments Made to Providers Under the Covid-19 Accelerated and Advance Payments Program Were Generally in Compliance with the CARES Act and Other Federal Requirements. CMS can provide temporary relief loans through the accelerated payment program for certain Part A providers and through the advance payment program for certain Part B providers and suppliers when those providers and suppliers face cashflow challenges due to circumstances beyond their control. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which Congress passed on March 27, 2020, expanded these programs to more providers to relieve pandemic-caused financial strain through the COVID-19 Accelerated and Advanced Payments (CAAP) Program. OIG’s objective was to determine whether CAAP Program payments were made to providers in compliance with the CARES Act and other federal requirements. OIG found that CMS generally made CAAP Program payments to providers in compliance with the CARES Act and other federal requirements, which led them to offer no recommendations for improvement.