Comments on Policy
On Your Behalf
We foster relationships to promote the common good and hold ourselves accountable for the human, financial and natural resources entrusted to our care. We invite you to read our comments on emerging federal regulations that may impact our community.
By standing united, we will be better able to advocate for improved health care and lower cost for everyone – including and especially, underserved and vulnerable.
Read Our Comments
2024
In a policy letter sent to MedPAC in advance of the commission setting its policy priorities for the upcoming congressional cycle, Trinity Health offered recommendations on the 340B drug pricing program; Medicare payment for inpatient, outpatient, physician and continuing care; alternative payment models; and telehealth.
In our comments on the CY25 OPPS proposed rule, Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to:
- Use its special exceptions and adjustment authority to make a one-time retrospective adjustment of 10 to 15% to the market basket to account for what hospitals should have received in 2022 when accounting for inflation.
- Establish a threshold whereby if the payment differential between what was provided and actual costs is greater than 1.5 percentage points, CMS would retroactively adjust payments for that year.
- Work with Congress to permanently extend telehealth flexibilities by year end and reinstate the facility be reimbursed for the originating site facility fee or an equivalent code.
- Include one additional year of voluntary reporting for the new health equity and Information Transfer Patient-Reported Outcome Performance Outcome Measure (PRO-PM) measures with mandatory reporting in CY 2027.
- Make the period of July 2024 to June 2025 mandatory without penalties for data validation for the Hybrid Hospital-wide All-cause Readmission and Mortality Measures.
In Trinity Health’s comment letter on the CY25 PFS rule, Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to:
- Work with Congress to develop a permanent solution to physician payment.
- Work with Congress to permanently extend telehealth flexibilities by year end and finalize the policy that would permit distant site providers to use the currently enrolled practice instead of home address when providing telehealth services from their home through CY 2025.
- Provide additional guidance and clarification on documentation requirements for the new proposed codes for evaluation and management (E/M) complexity, add on for infectious disease, and caregiving services.
- Not finalize the proposed enhanced case management, and work with stakeholders to identify way to continue to promote and incentivize participation in total cost of care arrangements.
- Finalize the Atherosclerotic Cardiovascular Disease Risk Assessment and create distinct codes that address the management of uncontrolled high blood pressure.
- Finalize the proposed policies on behavioral health and colorectal cancer screening.
- Make certain clarifications for the Medicare Diabetes Prevention Program.
- Implement the proposed policy to permit a signed and dated therapy order to serve as the physician’s or nonphysical practitioner’s initial certification of the plan of care.
- Finalize the Quality Performance Standard calculation methodology without the requirement of the two additional measures in the proposed Alternative Payment Model Performance Pathway Plus (APP) Quality Measure Set. Finalize the addition of the Complex Organization Adjustment and the extension of the electronic Clinical Quality Measures (eCQM) reporting incentive.
- Delay the adoption of the APP Plus Quality Measure Set until 2026 and extend the Web Interface as a reporting option in 2025.
- Repeal the certified electronic health record technology (CEHRT) and mandatory Merit-based Incentive Payment System (MIPs) Promoting Interoperability requirement for Advanced Alternative Payment Models that is set to begin in 2025.
Trinity Health responded to the Centers for Medicare and Medicaid Services (CMS) regarding its CY 2025 Home Health Prospective Payment System. In its comments, Trinity Health at Home:
- Urges CMS to adjust the percentage update to account for the real expenses experienced by home health providers. If not, these proposed changes, coupled with underpayment from Commercial Insurance, Medicare Advantage Plans and Medicaid, will lead to significant access challenges for those requiring care in the home.
- Details the negative impact of proposed cuts is dire, including a reduction in Medicare reimbursement of $4.9 million in CY 2025 across its services area that includes 12 states.
- Outlines that the proposed cut would continue to severely inhibit the ability to retain staff and provide services to patients. Denials for home health care admission, due to lack of staff, have more than tripled since 2019.
- Continues to oppose the inclusion of the Outcome and Assessment Information Set (OASIS) tool and disagrees with the inclusion of data collection on non-Medicare/Medicaid home health patients. Trinity Health views this is an unnecessary sharing of protected health information (PHI).
- Agrees with reporting to the National Healthcare Safety Network (NHSN) in the event of a public health emergency. However, the current requirement to continue the reporting requirements to NHSN are duplicative, burdensome and unnecessary.
Trinity Health responded to a proposed rule from the Center for Medicare and Medicaid Services (CMS) that would begin to address the impact of anomalous and suspect billing on accountable care organizations (ACOs) focusing on two codes used for catheters. Trinity Health’s comments applaud CMS for addressing this issue and urge the agency to address other areas of significant, anomalous and highly suspect billing, and provide additional details to support longer term strategies.
Trinity Health submitted comments on the proposed Increasing Organ Transplant Access (IOTA) model. In this regulation, the Centers for Medicare and Medicaid Services (CMS) proposes a new mandatory payment model to increase the number of kidney transplants for end-stage renal disease (ESRD) patients. In its comments, Trinity Health comments urge CMS to:
- Provide participants with at least a one-year notice before the model launch.
- Begin the model as a voluntary program and shift to a mandatory model after an initial trial period of three years.
- Provide all participants with infrastructure payments to address upfront costs.
- Remove the organ offer acceptance rate measure in the efficiency domain.
- Adopt the payment model from the Kidney Care Choices (KCC) model.
- Remove the requirement to notify patients on the waitlist monthly of the number of times an organ was declined on each patient’s behalf.
Trinity Health submitted comments on the proposed FY2025 Inpatient Prospective Payment System annual payment regulation. In this regulation, the Centers for Medicare and Medicaid Services (CMS) proposes a new mandatory episode-based payment model—Transforming Episode Accountability Model (TEAM)—that would require selected hospitals assume responsibility for the cost and quality of care from surgery through the first 30 days after the Medicare beneficiary leaves the hospital for certain care episodes. Trinity Health comments include:
- Revise the inadequate payment update and provide a fair market basket update. Specifically, CMS should:
- Use its special exceptions and adjustment authority to make a one-time retrospective adjustment of 10 to 15% to the market basket to account for what hospitals should have received in 2022 when accounting for inflation.
- Establish a threshold whereby if the payment differential between what was provided and actual costs is greater than 1.5 percentage points, CMS would retroactively adjust payments for that year.
- Rebase the market baskets more frequently, at least every three years to ensure the market basket reflects the appropriate mix of services provided to Medicare beneficiaries.
- Work with Congress to maintain the COVID-19 diagnosis-related group (DRG) add-on payment for inpatient admissions and analyze data to determine what the appropriate payment should be for a permanent DRG.
- Work with Congress to distribute additional general medical education (GME) residency positions.
- Not finalize proposed modifications to the criteria for new residency programs.
- Continue to link payment for social influencers of health to payment in traditional Medicare, explore additional factors influencing health status and contact with health services, also known as, Z codes to add in the future, and incentivize the use of Z codes.
- Wait to require reporting on the patient safety structural measure until it is backed by a consensus-based entity and work with the Centers for Disease Control and Prevention (CDC) to ensure National Healthcare Safety Network (NHSN) can accommodate new measures and data submission.
- Not finalize an increase to the mandatory electronic clinical quality measure (eCQM) reporting requirements under the Hospital Inpatient Quality Reporting (IQR) and Medicare Promoting Interoperability Program and instead continue to work with stakeholders to address persistent challenges with eCQM reporting.
- Make modifications to the Transforming Episode Accountability Model (TEAM) to make it more sustainable and decrease risk and burden for hospitals.
Trinity Health responded to a Centers for Medicare and Medicaid Services (CMS) request for information (RFI) on Medicare Advantage (MA) data. The goal of the RFI is to identify data requirements CMS may want to provide in future rulemaking. Trinity Health comments include data points outlining how Trinity Health’s own Medicare Advantage Plan, MediGold, operates differently than commercial MA plans and the imperative for CMS to ensure MA plan guidelines allow patients to access necessary care. In addition, Trinity Health recommends:
- CMS align equity measures between accountable care organizations and MA and require that MA plans share data on value-based care arrangements in a manner consistent with recommendations made by the Health Care Payment Learning and Action Network.
- MA plans release certain data in a matter similar to what is required for Medicare fee-for-service.
- CMS collect specific information on prior authorization and other utilization management techniques as well as beneficiary access to care.
- CMS review and evaluate what data is already collected prior to implementing new requirements to reduce administrative burden.
Trinity Health provided limited comments on the proposed fiscal year 2025 Inpatient Rehabilitation Facility (IRF) annual payment regulation. Trinity Health offered a recommendation urging the Center for Medicare and Medicaid Services complete a comprehensive review of the patient assessment instrument (PAI) to evaluate whether any of the items can be removed to reduce burden to providers, as the PAI has nearly doubled in length over the last five years.
Trinity Health Senior Communities provided comments to the Centers for Medicare and Medicaid Services (CMS) on its proposed rules for Skilled Nursing Facilities (SNFs) with a sense of impending crisis. The Medicare and Medicaid Programs; Minimum Staffing Standards for Long[1]Term Care Facilities and Medicaid Institutional Payment Transparency Reporting, rule published May 2024 would significantly impact Trinity Health’s ability to remain financially sustainable and continue to serve the most vulnerable patient populations; any payment update should be reflective of this final rule. The population is aging, and more people have chronic conditions that will ultimately require care. The cost to deliver this care will grow. Nursing Homes must remain a viable option for those in need of long-term care. Trinity Health asks CMS to:
- Increase Medicare SNF Rates by 10% to adequately sustain the industry in consideration of the current regulatory, workforce, and inflationary environment.
- Provide a one-year transition period for the wage index changes based on the 2020 census data.
- Eliminate further adjustments that would reduce the Non-Therapy Ancillary (NTA) component.
- Allow not-for-profit nursing home providers to be a part of the solution to the problems that CMS has identified across the industry. Trinity Health welcomes further conversation and efforts that will work to advance the common good and sustainability of an industry on the brink of collapse.
Trinity Health at Home provided comments to the Centers for Medicare and Medicaid Services (CMS) on its proposed payment rule for hospice. As the nation’s population ages, the hospice Medicare benefit becomes increasingly important to the care of patients. The ability to remain financially sustainable and serve the most vulnerable patient populations is threatened by high labor costs, workforce shortages, and inflationary demands. Any payment update should be reflective of sustainability in an increasingly difficult environment. Trinity Health is concerned that the proposed payment increase of 2.6% fails to cover cost of care related to staffing issues as well as inflation on medical supplies and pharmaceuticals. In its comments, Trinity Health asks CMS to:
- Increase the hospice payment rate to be reflective of the current workforce and inflationary environment.
Trinity Health submitted comments to the Centers for Disease Control and Prevention on proposed data collection for the Diabetes Prevention Recognition Program (DPRP). Trinity Health recommendations include modification to proposals that reduce administrative burden and clarify requirements. In addition, Trinity Health urges the CDC to offer additional supports to delivery organizations when proposing supplementary collection metrics and advocates for increased reimbursement rates for both public and private payers to help offset any increased administrative burden.
2023
The departments of Health and Human Services, Labor and the Treasury issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions. This is in response to feedback and challenges shared by stakeholders as well as several federal court decisions. The proposed provisions impact the ability to batch items/services. The provisions also outline information that payers must provide and revise the timeline for determining if a claim dispute is eligible. In the provisions, HHS also proposes to collect administrative fees directly from disputing parties. Trinity Health comments recommend that the departments:
- Not place a numerical cap on the total number of items or services that can be batched and determined jointly for purposes of a payment consideration during the Independent Dispute Resolution (IDR) process. Should the departments finalize the policy, Trinity Health recommends the cap be increased to 100.
- Include penalties or other actions that would incentivize payers to comply with providing the proposed claim information, which is critical to improving both the open negotiation and IDR process.
- Strongly encourage the use of electronic remittances and not allow payers to use paper if they otherwise use electronic. If a payer does submit paper remittances, providers should be given additional time after the initial payment or denial is received to initiate the open negotiation period.
- Require that plans share with providers the data used to calculate the qualified payment amount (QPA) at the time the QPA is conveyed and conduct frequent oversight of the calculation of QPA by plans.
- Award the party that initiated open negotiations the proposed out-of-network rate (as submitted during the IDR process) by default if the receiving party fails to respond in a timely manner as outlined in the proposed rule. As an alternative, the Independent Dispute Resolution Entities (IDREs) should defer to the position of the party that initiated open negotiations, by treating the initiating party’s proposed out-of-network rate (as submitted during the IDR process) as the presumptively appropriate out-of-network rate.
- Maintain the existing grace period that allows parties initiating IDR to resubmit their dispute if the IDRE determines it to be ineligible.
- Include a penalty or other structure to incentivize payers to comply with the proposed IDR registry.
The U.S. Department of Health and Human Services (HHS), the Office of the National Coordinator for Health Information Technology (ONC), and Centers for Medicare and Medicaid Services released a long-awaited proposed rule to implement a 21st Century Cures Act provision establishing penalties for health care providers determined by the HHS Office of Inspector General (OIG) to have committed information blocking. Health care providers have been subject to the information blocking regulations since April 5, 2021, but there has been no enforcement mechanism. The proposed rule would apply penalties to hospitals participating in the Promoting Interoperability Program, the Merit-Based Incentive Payment Systems, and providers in the Medicare Shared Savings Program.
Trinity Health comments recommend:
- ONC provide clarity and education including more frequently asked questions and examples of actions that will be deemed information blocking.
- The applicability of claims for which “health care provider” information blocking determinations can be made be limited to the period of time that begins when the rule is implemented.
- Only those providers that exhibit a pattern of information blocking should be penalized. For other instances, HHS should work with the provider to offer education and remediate the issue. HHS and ONC should consider tiered penalties.
- Any penalties related to interference with patient access should mirror the penalties that exist for compliance with the Health Insurance Portability and Accountability Act (HIPAA). Both sets of regulations deal with access to patient information, so there is an opportunity for natural alignment.
- HHS should clarify that only one participant may be found at fault for an instance of information blocking and should detail, in the final rule, the process for determining the responsible party.
- An approved hardship application should protect a hospital or provider from incurring a downward payment adjustment, regardless of information blocking determination.
- HHS should not penalize participation in value-based care models and should instead partner with accountable care organizations (ACOs) in identifying instances of information blocking and help flag such instances for ACOs to remediate.
- OIG can investigate instances of information blocking but turn the action over to the ONC or CMS to make the determination. Further, Trinity Health recommends OIG priorities—as they relate to investigations into complaints of providers that have committed information blocking—focus on ‘intent’ versus ‘outcome’.
- HHS should clearly detail an equitable appeals process for providers and get feedback from stakeholders prior to finalizing the rule.
In comments to the Centers for Medicare and Medicaid Services (CMS), Trinity Health Senior Communities (THSC) urgently responds to the proposed staffing ratio rule. Despite provider’s best efforts, the long-term-care industry continues to recover from the Covid-19 pandemic and the health care workforce crisis remains a challenge. CMS’ proposed staffing standards will further jeopardize the sustainability of the industry, reduce patient access to nursing home care, and have a ripple-effect across the care continuum, particularly in rural and other underserved communities. THSC strongly urges CMS to allow hours worked by licensed practical nurses (LPNs), registered nurse (RN) leadership, and other members of the care team to be countable towards any hours per resident per day (HPRD) standard.
THSC also anticipates the proposed Medicaid IPTR will lead to longer waits for emergency and inpatient hospital care, worsen staffing shortages across the care continuum and hinder innovative and new approaches to delivering quality care.
In its comments, THSC urges CMS to abandon the rule in its entirety because the proposed:
- RN staffing standards are not achievable in the midst of a health care workforce shortage crisis. There are simply not enough RNs to meet the demand proposed in the ratio.
- Standards fail to account for nursing leadership and the critical role of LPNs.
- Rule fails to account for patient acuity and other support staff.
- Nursing assistant staffing standards are not achievable in the curent health care workforce shortage crisis.
- Rule will result in fewer patients having access to nursing home care.
Trinity Health submitted a response to a request for information (RFI) from the Congressional House Budget Committee’s Health Care Task Force seeking ways to decrease health costs and improve outcomes. Our comments include recommendations to:
- Reform wasteful insurer practices, including standardizing prior authorization requirements.
- Rein in pharmaceutical and medical device costs through price negotiation.
- Support a continued emhasis on movement to value and innovative care coordination by passing the bipartisan Value in Health Care Act (H.R. 5013) and additional policies that advance alternative payment models.
- Advance legislation that would reform the Stark and anti-kickback statute policies.
- Permanently extend telehealth flexibilities with appropriate guardrails to allow providers to continue to furnish services effectively and efficiently to patients remotely.
- Create standardized reimbursement structures and elevate the unique professional roles of community health workers.
- Expand access to affordable housing by passing the bipartisan Affordable Housing Credit Improvement Act (H.R. 3238) and support programs for the homeless; for example street medicine.
- Increase access to healthy, affordable food through Food is Medicine programs.
The Department of Health and Human Services (HHS) released a proposed rule that aims to improve the Mental Health Parity and Addiction Equity Act of 2008 by clarifying what insurers may or may not do regarding prior authorization, in-network coverage and payments. Trinity Health submitted comments in support of the rule and offered recommendations for how to further expand access to behavioral health and substance use disorder services, including:
- Ensure adequate reimbursement across all payers to all providers (e.g. community health workers, social workers) and eliminate Medicare and Medicaid billing restrictions related to behavioral health services.
- Reduce licensing barriers that support efforts to facilitate health care worker movement across states, including expedited licensure review and expansion of licensure compacts.
- Allow psychiatrists, psychologists, social workers, nurses, care coordinators, community health workers and peer support specialists to practice in collaborative, team-based environments according to their highest level of education, training and licensure.
- Support community care teams, crisis intervention teams, and high-utilizer programs that include services for social needs such as housing, food and social isolation.
- Test new models to support community health transformation by creating linkages between health systems, providers and community-based services, and encourage care coordination to optimize access and delivery of wrap-around support services.
The proposed calendar year (CY) 2024 rule would increase payment by a net 2.8% compared to CY 2023. The rule also includes proposals related to hospital price transparency requirements, behavioral health services and Rural Emergency Hospitals. In its comments, Trinity Health:
- Urges the Centers for Medicare and Medicaid Services (CMS) to use its special exceptions and adjustment authority to make a one-time retrospective adjustment to the market basket to account for what hospitals should have received in 2022 when accounting for inflation.
- Reiterates how hospitals differ from ASCs and independent physician offices and urges CMS to refrain from expanding site neutral policies in the future and to educate Congress on the impact of expanding site neutral policies to patients.
- Details its support for policies that would expand access to behavioral health.
- Urges CMS to develop strong price estimator tool solutions for patients and focus on the advanced explanation of benefits instead of finalizing proposed price transparency changes to the standardized machine-readable file.
- Urges CMS to work with Congress to implement policy changes that support the permanent continuation of telehealth flexibilities to enable an efficient and equitable health care system.
The proposed Calendar Year (CY) 2024 rule would cut physician payments by 3.4% and includes proposals related to the Medicare Shared Savings Program (MSSP), the Quality Payment Program (QPP), and would reimburse for services to address social needs. In its comments to the Centers for Medicare and Medicaid Services (CMS), Trinity Health:
- Urges CMS to work with Congress to tie physician payment increases to an inflation-based payment update based on the Medicare Economic Index (MEI).
- Urges CMS to maintain time and medical decision-making as key determinates of which physician or practitioner bills for an evaluation and management (E/M) visit.
- Supports delaying the rebasing of the MEI in order to review additional data.
- Supports paying for behavioral management and training for guardians and caregivers of patients.
- Supports reimbursing for services that would address social needs, including community health integration, social determinants of health, and principal illness navigation.
- Outlines policies that would ensure current MSSP participants remain in the program and attract new participants, including: removing burden, addressing benchmarking issues, strengthen financial incentives and encourage other providers, including primary care providers, to join.
In comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed rule on the remedy for 340B-acquired drug payment policy for calendar years (CYs) 2018-22, Trinity Health calls on CMS not to pursue any “budget neutrality adjustment” to offset the legally required remedy. Trinity Health also outlines its support for parts of the proposed rule, including:
- The one-time, lump sum repayment to hospitals for underpayments for outpatient drugs purchased under the 340B program between CYs 2018 and 2022.
- The decision of CMS to include in its repayment the additional amount that hospitals would have received in beneficiary cost-sharing.
- The proposed methodology for calculating what 340B hospitals are owed, which minimizes administrative burden.
In recent comments to the Centers for Medicare and Medicaid Services (CMS) fiscal year (FY) 2024 Home Health Prospective Payment System (HHPPS), Trinity Health at Home (THAH) expressed an overall sense of impending crisis as the CMS proposed cuts would significantly impact Trinity Health’s ability to remain financially sustainable, address staffing shortages, and continue to serve the most vulnerable patient populations. Likewise, the proposed cuts would negatively impact all providers of home health. In its comments, THAH:
- Urges CMS to adjust the percentage update to account for real-time expenses experienced by home health providers.
- Advocates for evidence-based reimbursement rates from Medicare, Medicaid and Medicare Advantage that are sufficient to cover the full range of costs to provide high-quality care and services including supply needs, training, and fair wages for staff.
- Encourages CMS to include exceptions to the Covid-19 vaccination measure, such as refusal or contraindications.
- Does not support cognitive function and behavioral/mental health as a performance measure domain in home health care.
- Supports the proposed additional checkbox of hospice ownership to include private equity and real estate investment trust. THAH believes it is important for patients to have a clear understanding of hospice ownership to fully vet a provider.
The Center for Medicare and Medicaid Innovation (CMMI) released a request for information to obtain feedback on mandatory episode-based payment models that would inform future policy and potential rulemaking. In its comments, Trinity Health:
- Urges CMMI to do no harm to accountable care organizations (ACOs).
- Recommends how to nest ACOs into future bundles.
- Proposes ways to address health equity and reporting.
- Suggests ways to promote and incentivize value.
A bipartisan group of U.S. Senators released a request for information (RFI) on the 340B drug pricing program. In comments, Trinity Health expressed strong support for the program that allows safety net hospitals to provide programs and services to vulnerable patients. In its comments, Trinity Health outlines:
- The 340B program works as intended to manage the rising cost of prescription drugs by providing cheaper drugs to eligible hospitals that serve low-income and rural patients.
- Savings from the 340B program are used to offer programs and services that benefit specific local community needs.
- Congress should grant the Health Resources and Services Association explicit statutory authority to prohibit drug company actions that limit access to 340B pricing through contract pharmacy arrangements.
- Congress should pass legislation prohibiting discriminatory actions against 340B providers by pharmacy benefit managers and insurers.
- Current legislative proposals that would require reporting of detailed data by service line would be onerous without clear benefit to program integrity.
A proposed rule by the Centers for Medicare and Medicaid Services (CMS) focuses on ensuring access to services for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries in managed care delivery systems. The goal of the rule is to increase transparency, improve accountability and ensure standardized data and monitoring, particularly for provider network adequacy requirements and state directed payment programs. Trinity Health’s comments:
- Recommend CMS and its state partners work to ensure that surveys developed and implemented by states solicit meaningful data that can appropriately support assessments of access and network adequacy.
- Does not recommend CMS finalize the wait time penalties as proposed and instead encourages wait times within guidance and work to address the root causes of wait times. In addition, Trinity Health notes Medicare and Medicaid payment for physicians must improve to encourage access and health equity.
- Recommend CMS work to ensure that the cost of developing and administering secret shopper surveys at the state-level does not take needed funds away from care nor create negative, unintended consequences that ultimately impact access to care and services.
- Urge CMS to decrease the amount of time states have to remedy access issue. Trinity Health recommends states submit a remedy plan to CMS within 30 days and take steps within 3 months or 6 months to resolve the identified issue (rather than the 12 months proposed).
- Support a mandatory measure set for the Medicaid and CHIP quality rating system and urge CMS to align measures across programs where possible.
- On state directed payments:
- Note our concern that some components of the proposal would weaken incentives for plans to negotiate with providers to serve in-network.
- To ensure fair payment, recommend CMS take the higher of the average commercial rate or 200% of the Medicare fee-for-service rate as the ceiling for total payment rates for the selected services.
The proposed rule by the Centers for Medicare and Medicaid Services seeks to increase transparency in payment rates, standardize data and monitoring and create new opportunities for states to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care. The rule also has a particular focus on home and community-based services (HCBS), including direct care worker compensation requirements, grievance process development, critical incident reporting definitions and HCBS quality reporting. Trinity Health comments:
- Strongly recommend that CMS include hospital and safety net provider representatives in the list of interested parties that should/must be included in the Medicaid Advisory Committee.
- Urge CMS to consider sub-contractual circumstances while finalizing policies on incident management system/reporting.
- Suggest CMS wait for the results of the National Association of Home Care (NAHC) national survey of members to solicit feedback on payment for the direct care workforce (now taking place) before moving forward with finalizing requirements related to the minimum percentage of a state’s Medicaid payments that should be spent on compensation for certain direct care workers.
- Support the CMS aim to establish additional standards that will increase access to Medicaid services for those in states with fully fee-for-service based delivery systems.
Trinity Health submitted comments on a rule proposed by the Office of the National Coordinator (ONC) at the Department of Health and Human Services that would implement the Electronic Health Record Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology developers under the ONC Health IT Certification Program. Trinity Health comments are generally supportive of the proposed rule, though ONC was urged to ensure any policy finalized regarding patient information restriction criterion aligns with requirements for the Health Insurance Portability and Accountability Act (HIPAA).
- Urge CMS to use its special exceptions and adjustment authority to make a one-time retrospective adjustment of to the market basket to account for what hospitals should have received in 2022 when accounting for inflation.
- Urge CMS to establish a threshold whereby if the payment differential between what was provided and actual costs is greater than 1.5 percentage points, CMS would retroactively adjust payments for that year.
- Recommend CMS rebase the market baskets more frequently, and at least every three years, to ensure the market basket reflects the appropriate mix of services provided to Medicare beneficiaries.
- Request CMS re-evaluate DSH assumptions regarding the number of uninsured in light of the expiration of certain COVID-19 public health emergency provisions when updating its estimate of uninsured in the final rule and engage stakeholders and consider ways to capture uncompensated care provided in non-acute settings.
- Urge CMS to work with Congress to maintain the COVID-19 diagnosis related group (DRG) add-on payment for inpatient admissions and analyze data to determine what the appropriate payment should be for a permanent DRG.
- Support the proposal to treat a hospital that reclassifies to a rural area as the same as a hospital that is physically located in a rural area.
- Applaud CMS for policies that would return all of the funds recouped from hospital-based schools of nursing and allied health, per The Consolidated Appropriations Act.
- Support modifications to the severity of the international classification of disease (ICD)-10 diagnosis codes describing homelessness to recognize the increased resources used when treating certain patients.
- Urges CMS to delay the Patient Driven Payment Model parity adjustment recalibration.
- Requests CMS address the immediate needs of skilled nursing facilities to stabilize the industry as it continues to emerge from the pandemic, including evidence-based reimbursement rates that are sufficient to cover the full-range of costs to provide high-quality care and services including needed supplies, training, and fair wages for staff. THSC proposes a 10% to 15% one-time increase to address previous years of underpayment.
- Recommends CMS halt staffing ratio requirements until providers and policymakers have resolved the critical nursing shortage.
- Offers multiple recommendations regarding the proposed changes to the Skilled Nursing Facility Quality Reporting Program (SNF QRP).
- Shares its belief that decreasing nursing turnover rates should be a priority. However, it will be the most challenging value-based purchasing benchmark to meet. Any penalties resulting in lower Medicare reimbursement would only work to compound the problem.
Trinity Health submitted comments on the FY24 proposed rule for the Inpatient Rehabilitation Facility (IRF) Prospective Payment System. In its comments, Trinity Health:
- Urges the Centers for Medicare and Medicaid Services (CMS) to use its special exceptions and adjustment authority to make a one-time retrospective adjustment to the market basket of 10% to 15% to account for what hospitals should have received in 2022 when accounting for inflation.
- Applauds CMS for increasing access to care by eliminating the outdated requirement that IRF units only begin operating at the beginning of hospital cost-report periods.
- Requests that CMS suspend the Review Choice Demonstration as it is overly burdensome and would require IRFs to divert critical resources to the process.
In comments to the Centers for Medicare and Medicaid Services (CMS) regarding the fiscal year 2024 Hospice Payment Rate Update, Trinity Health at Home (THAH) expressed support for a 2.8% rate increase, while outlining that it was woefully inadequate to meet the ever-growing costs of care. Trinity Health’s year-to-date numbers reflect an alarming statistic: expenses have increased 5.3%, while revenue has increased less than 2%.
- Supports the proposed rule requiring hospice physicians be either enrolled in, or validly opted out of Medicare but recommends that CMS exclude hospice patient attending physicians from this requirement.
- Requests CMS continue to seek provider input prior to implementing additional quality measures.
- Recommends CMS consider payment for Remote Patient Monitoring (RPM) as one way to provide timely reassessment of Pain Impact and Non-Pain Symptom Impact as RPM is a best-practice.
- Encourages CMS to implement a web-based version of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice survey.
Trinity Health believes access to affordable, quality health care is a basic human right and supports policies that create such access. Trinity Health submitted a comment letter in support of a proposed rule by the Centers for Medicare and Medicaid Services (CMS) that would extend Medicaid and Children’s Health Insurance Program coverage to qualified individuals in the DACA program in states that cover legally residing immigrant children and pregnant women. In addition, we also support allowing DACA recipients to 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.
Trinity Health submitted comments to the U.S. Department of Housing and Urban Development (HUD) in response to its proposed rule Affirmatively Furthering Fair Housing. The intent of the rule is to require housing authorities, local and state governments to advance housing equity and create more opportunities for disinvested neighborhoods. Trinity Health urged HUD to place the voice of members from these communities and protected classes at the forefront of the Equity Plan development. Our comments shared information about Trinity Health's community investing program including the role community engagement plays.
In response to a request for information (RFI), Trinity Health submitted comments to the Senate Committee on Health, Education, Labor & Pensions (HELP) regarding health care workforce shortages. Comments outline the impact of shortages on patient access to care, Trinity Health's innovative actions to support our workforce, and policy recommendations to address these challenges. Trinity Health's recommendations include:
- Address the immediate workforce crisis by supporting efforts to retain and recruit health care workers:
- Fund loan repayment and clinician well-being programs.
- Address violence against health care workers.
- Support expedited licensure review and expansion of licensure compacts.
- Build and maintain a strong workforce pipeline:
- Increase Medicare general medical education and reauthorize the Health Resources and Services
- Administration workforce programs.
- Create incentives for faculty recruitment and residency programs.
- Fund the development of "earn and learn" programs like apprenticeships.
In response to a Request for Information (RFI), Trinity Health submitted comments to leaders in Congress on the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The goal of PAHPA is to improve the nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental or natural. In this RFI, Trinity Health requests that Congress:
- Build strong preparedness infrastructure including development of a robust national response strategy.
- Improve response capabilities including interoperable data infrastructure, workforce supports and cybersecurity defenses. Fund preparedness efforts including improvements to the Hospital Preparedness Program.
- Ensure supply chain coordination related to public-private partnerships and the Strategic National Stockpile.
Trinity Health applauds a proposed rule by the Center for Medicare and Medicaid Services (CMS) that would help address challenges with delayed patient care, increased provider burden, and the administrative costs that are associated with the existing prior authorization process. In addition, we outlined that effective data sharing and system interoperability is critical to improving the provision and coordination of health care. Trinity Health also detailed our support of the focus CMS has placed on advancing these issues using standard application programming interfaces (APIs).
Trinity Health submitted comments on a proposed regulation by the Centers for Medicare and Medicaid Services (CMS) that focuses on prior authorization marketing strategies of Medicare Advantage Organizations (MAOs) as well as health equity for patients served by MAOs. In addition, the regulation proposes policy changes for the Program of All-Inclusive Care for the Elderly (PACE). Trinity Health comments:
- Support proposed changes to address challenges in the MAO prior authorization process and for tighter restrictions on MAO marketing strategies.
- Urge CMS to take steps to incentivize MAOs to move more aggressively toward value-based care and to align policies across Medicare Advantage and Medicare fee-for-service value-based payment models.
Offer support for policies that would promote health equity. - Reflect concern regarding any policy that would result in an unrealistic timeline for providers to identify, investigate and return Medicare overpayments. Trinity Health recommends that CMS withdraw this portion of the proposed rule.
- Recommend leveling the playing field between PACE and MAOs by offering incentives such as gift cards and monetary incentives to members.
The Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule to align regulations that govern patient records for substance use disorder (SUD), CFR Part 2, with those of the Health Insurance Portability and Accountability Act (HIPAA).
Trinity Health urges the Department of Health and Human to align Part 2 regulations as close as possible to HIPAA as operating on two different standards is not efficient and impedes critical care coordination for patients. In addition, Trinity Health note it is critical that U.S. Department of Health and Human Services afford the same flexibilities to population health entities, such as accountable care organizations (ACOs), as they do for payers, especially when it comes to consent for disclosure. ACOs and coordinated care models are held accountable by the Centers for Medicare and Medicaid Services for coordinating care and outcomes of beneficiaries and they cannot do this without access to full patient data. In addition, Trinity Health supports changes to the breach notification obligations as outlined in the proposed rule.
The U.S. Department of Health and Human Services (HHS) released a request for information (RFI) seeking public comment on issues related to the Essential Health Benefits (EHB) under the Affordable Care Act. Trinity Health comments:
- Given the variability across states and plans – in terms of the level of detail included in EHB plan documents and benefit descriptions – Trinity Health recommends the Center for Medicare and Medicaid Services (CMS) consider establishing a limited set of national standards for certain features of EHB-benchmark plan documents.
- Urge that behavioral health and substance use disorder services be treated similarly to services graded as A and B by the U.S. Preventive Services Task Force, and that coverage be at no cost to the patient.
- Recommend continuation of policies that allow for access to and reimbursement for tele-behavioral health care including diagnosis and treatment.
- Strongly support the use of value-based contracting as a way to improve care, quality, outcomes and, importantly, to control the cost of care.
- Provide recommendations for addressing gaps in coverage for habilitative services, behavioral health, and chronic conditions.
- Recommends CMS not allow substitution of EHBs unless the proposed substitution is based on scientific evidence and an analysis of economic benefits including impact on the quality of life of an additional service.
Trinity Health submitted comments to the Health Resources and Services Administration (HRSA) regarding its plan to revise the 340B administrative dispute resolution (ADR) process. The ADR process uses panels of government officials to adjudicate covered entities’ claims that manufacturers overcharged for covered outpatient drugs or manufacturers’ claims that covered entities they audited had committed 340B diversion or duplicate discount violations. Trinity Health asks HRSA to:
- Clarify that ADR panels can consider overcharge claims involving drug companies that are refusing access to 340B pricing or setting conditions on that access.
- Abandon a provision to suspend ADR claims related to issues pending before federal courts, or at a minimum to describe the criteria the agency will use to determine when such situations apply and provide covered entities an opportunity to weigh in.
- Clarify that a three-year statute of limitation on filing ADR claims would begin on a date other than the date of sale in cases where drug companies restate data that affects the ceiling price or where they should have restated such pricing data.
The U.S. Department of Health and Human Services (HHS) released a request for information (RFI) seeking public comment about the development of a National Healthcare System Patient Safety Action Alliance (Action Alliance) as a vehicle to advance patient and workforce safety. In comments, Trinity Health highlighted that our nation cannot thoroughly address safety without also addressing the unprecedented workforce shortage crisis, escalating violence against health care workers, and mounting financial pressures that stifle innovative solutions that would improve safety and training. Trinity Health urges policymakers to provide funding for workforce development and safety initiatives. In addition, comments provided:
- A summary of Trinity Health’s safety initiative, TogetherSafe.
- A highlight of Trinity Health’s transformational team care model, Virtual Connected Care.
- A call for new hospital national safety metrics and standards, and for the standardization of safety training and safety measures to address safety risks unique to post-acute care settings.
- The urging of the Action Alliance to collaborate with the Occupational Safety and Health Administration on workforce safety.
The United States Senate sought information on care for the dually enrolled Medicare and Medicaid population. Trinity Health responded with comments reflecting our position on the importance of the growth of Programs of All-inclusive Care for the Elderly (PACE) as well as applying the best features of PACE to other models, which Trinity Health believes is the most appropriate way to build upon best practice in the care for the dually enrolled. Trinity Health comments include:
- True integration exists when the provider has accountability for the total cost of care and the outcomes for both Medicare and Medicaid funding: and addressing the total needs of the patient, clinical, social, and behavioral with a comprehensive plan of care. Integration includes the payor and provider, that means communication flows, there is clinical accountability, and contracting is directly with the provider of care. PACE offers the best example of this method.
- Lack of funding for the dually enrolled is a fundamental shortcoming to achieve integrated care.
- The PACE model of care is by far the best way to care for dually enrolled. The Centers for Medicare and Medicaid Services should:
- Expand PACE nationally, making it a mandatory program for all states.
- Pilot PACE for new populations.
- Apply the best features of PACE to accountant care organizations for patients who are also eligible for Medicaid.
- Apply full financial integration of dual eligible special needs plans (D-SNPs) for those enrolled in Medicare Advantage Plans.
2022
The Food and Drug Administration (FDA) proposes to move to a single Institutional Review Board (IRB) review for FDA regulated clinical trials. Trinity Health comments reflect our position that local IRB reviews are critical to the conduct of research and protection of research participants and to move to a single IRB review will be detrimental. Trinity Health comments include:
- Allowing a sponsor (in this case, the drug company) to select an IRB for its drug/device trial, based on its own internal business criteria, is a conflict of interest.
- Local IRB reviews play a critical role in ensuring human subject protections.
- A single IRB review will dilute the meaningful efforts that have been established to bring down barriers in the name of health equity, diversity, and inclusion.
- The rule as proposed would shift administrative burden to local principal investigators, research coordinators and research nurses.
- If one of the underlying goals of the regulation is to reduce travel and inspection burden as it relates to FDA inspectional activity, Trinity Health urges the FDA to consider other inspectional options or activities for IRBs that are less burdensome in lieu of finalizing the proposed rule.
- Trinity Health supports the rigor of examining the length of time it takes for an IRB to review and approve a trial, and notes there may be more activities contributing to delays in the conduct of clinical trials that can be addressed at an operational level (such as FDA guidance documents) other than IRB reviews.
Trinity Health appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) request for information on the Advanced Explanation of Benefits (AEOB) and Good Faith Estimate (GFE) for covered individuals included in the No Surprises Act regulation; comments include:
- Trinity Health believes that plans, issuers, and carriers (collectively “Plans”) are in the best position to coordinate and aggregate GFEs received from providers and facilities and supports the development and availability of Office of the National Coordinator (ONC) Health IT Certification criteria for use by Plans.
- CMS should delay the AEOB-GFE requirement until ONC Health IT Certification is made available.
- Like the convening provider/facility requirement for the self-pay/uninsured GFE, the Plan that receives the provider or facility GFE should be treated as the convening Plan for GFE - AEOB purposes.
- CMS should ensure that attempts at verifying coverage do not delay or otherwise impede care delivery.
Trinity Health supports policies outlined in the Centers for Medicare and Medicaid Service's (CMS) notice of public rulemaking that would improve access and quality of care for Medicaid, the Children's Health Insurance Program (CHIP) and the Basic Health Program. In addition, Trinity Health urges:
- CMS to work with Congress to remove the five-year bar from coverage for legal permanent residents who are currently not eligible for Medicare (if they are over 65 years of age) and do not have means (employed, self-employed or self-pay) to pay for health care coverage.
- CMS and state partners to make permanent telehealth flexibilities permitted during the public health emergency, including reimbursement for telehealth and remote patient monitoring.
- CMS to improve Medicaid provider credentialing across state lines.
- CMS to continue to work with states to implement value-based payment models and arrangements that support population health and accountability for care.
Trinity Health submitted comments on a request for information (RFI) from Congress focused on the Medicare Access and Children’s Health Insurance Program (CHIP) Reauthorization (MACRA) Act and the Medicare payment system. In comments Trinity Health outlines:
- The need for fair and adequate Medicare payment.
- Policy improvements that would encourage more take up of alternative payment models to shift the focus of payment from volume to value.
- Improvements in the Medicare Advantage program that would stop improper utilization management techniques that add cost to our nation's health system and delay care.
Trinity Health submitted comments on the OPPS rule highlighting the woefully inadequate proposed reimbursement for calendar year (CY) 2023. In the letter, Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to use updated data similar to what was finalized in the fiscal year 2023 Inpatient Prospective Payment System regulation. In addition, Trinity Health comments:
- Urge CMS extend the proposed exemption from the site neutral payment policy proposed for Sole Community Hospitals to rural hospitals with 100 beds or less.
- Following the court ruling in American Hospital Association v. Becerra, request CMS restore payments to 340B hospitals in a non-budget neutral manner so as not to penalize other hospitals for CMS actions.
- Recommend CMS modify the proposed policy that would adjust payment to hospitals for domestically produced National Institute of Occupational Safety and Health (NIOSH)-approved surgical N95 masks so as not to add significant reporting burden to hospitals.
- Urge CMS to develop a national standard for emergency department (ED) visit guidelines for all ED levels.
- Provide recommendations on how to improve behavioral health.
Trinity Health submitted comments in response to the proposed calendar year (CY) 2023 Medicare Physician Fee Schedule regulation, urging the Centers for Medicare and Medicaid Services (CMS) to pay a fair rate for physician services. Trinity Health also asks that CMS use all its authority as well as work with Congress to eliminate the proposed 4.4% conversion factor cut. Additionally, Trinity Health recommends that CMS:
- Ensure hospitals have enough time to unwind processes put in place during the public health emergency (PHE) after the PHE ends and CMS begins to unwind flexibilities.
- Maintain time and medical decision making as key determinants when physicians and practitioners bill for visits.
- Preserve existing telehealth flexibilities following the PHE.
- Provide support for payment updates for Opioid Treatment Programs (OTP), which would increase access to these services.
- Offer targeted recommendations for the Medicare Shared Savings Program (MSSP) and the Quality Payment Program (QPP).
The Centers for Medicare and Medicaid Services (CMS) is seeking recommendations to improve Medicare Advantage (MA). Trinity Health comments highlight our success and commitment to value-based care as well as the strength of our MA plan, MediGold, and the vital role it plays in our integrated delivery network. MediGold is a great example of how an MA plan can work with providers to improve care and health outcomes, while using fair practices that don't rely on inappropriate prior authorization or payment denials. In addition, Trinity Health comments highlight:
- The role health plans can play in addressing social determinants of health.
- The importance telehealth plays in access.
- Actions CMS can take to ensure utilization management does not negatively affect access to care.
- Recommendations to drive innovation and value-based care.
Trinity Health submitted a letter to the Office of Assistant Secretary for Health (OASH) in response to a request for information (RFI) regarding steps the federal government can take to strengthen primary care. The Trinity Health response:
- highlights the importance of primary care.
- outlines successful models/innovations that can help achieve a goal state for primary care.
- identifies barriers to implementing successful models/innovations.
- recommends actions the Department of Health and Human Services (HHS) can take to advance the health of individuals and communities through primary care.
The proposed fiscal year (FY) 2023 IPPS rule includes updates to IPPS payment rates, Disproportionate Share Hospital (DSH) payment rates, the wage index, graduate medical education and hospital quality and payment programs. Trinity Health comments to the Centers for Medicare and Medicaid Services (CMS):
- Urge CMS to revise the FY23 IPPS payment update to reflect the increased financial demands that have been placed on hospitals, including increased labor costs (and ensuring the calculations specifically account for contract labor costs) and the impact of inflation. In addition, Trinity Health asks that CMS implement a one-time retrospective payment adjustment and use more timely information when deliberating future market basket adjustments.
- Urge CMS to take into account the expiration of coverage provisions that were implemented during the public health emergency and account for their expiration when updating its estimate of uninsured for the purposes of calculating DSH rates. At a minimum, CMS should provide additional detail on how it accounted for the expiration of these policies in its analysis, as the proposed rule includes a decrease of $654 million compared to FY22 that is driven in part by a lower expected uninsured rate.
- Ask CMS to work with Congress to extend authority for the Low-Volume Hospital Payment Program and the Medicare Dependent, Small Rural program.
- Applaud CMS for proposed policies that recognize the impact COVID-19 has had on hospital quality reporting and value programs and targeted recommendations on proposed policies.
- Respond to a request for information on screening for social influencers of health, including encouraging CMS to work with stakeholders to move toward more standardized instruments so comparable data may be collected.
- Respond to a request for information on how to advance maternal health equity, including recommending CMS partner with health systems and incentivize more community collaboration that is done in line with community health needs assessments.
The Internal Revenue Services (IRS) has proposed a rule that would fix the "family glitch" and extend marketplace subsidies to millions of people—primarily children and women—who are currently ineligible for financial help through the health insurance marketplaces. Driven by the belief that everyone should have access to care, Trinity Health views access to health care coverage as key. Trinity Health supports public policies that provides better health, better care and lower costs to ensure affordable, high quality, people-centered care for all. As such, Trinity Health supports the revisions in the proposed IRS rule that would fix the family glitch issue by changing how affordability would be determined for an employed individual's family members. The proposed rule is consistent with the intent of the Affordable Care Act to make affordable coverage more widely available.
Trinity Health applauds the Department of Homeland Security (DHS) for returning to its long-standing interpretation of public charge, and no longer penalizing immigrants for choosing to access health services – Children's Health Insurance Program and Medicaid, Supplemental Nutrition Assistance Program and other services – that are available to them while also determining eligibility for entry or permanent residency status.
The public charge rule finalized in 2019 made a dramatic departure from historic policy that undermined the health and well-being of immigrant communities. Trinity Health strongly opposed these policies as they were in direct conflict with our Catholic values and our Mission of providing people-centered care for all patients—including immigrants—and serving as a transforming and healing presence within our communities.
The Centers for Medicare and Medicaid Services (CMS) solicited input on issues related to health care access, accessing health care services and supports, and ensuring adequate provider payment rates to encourage provider access and quality within the Medicaid and Children's Health Insurance Program (CHIP) programs. In these comments, Trinity Health:
- Applauds the CMS decision to provide states 12 months to initiate and 14 months to complete all Medicaid renewals and other outstanding eligibility actions during the unwinding period following the end of the public health emergency (PHE).
- Urges CMS and state partners to take other actions to support new applications, renewals and enrollment including increasing publicity and marketing targeted towards helping current and potential enrollees understand upcoming changes in coverage and coverage options they may be eligible for (e.g. Medicaid, marketplace, CHIP, Basic Health Program (BHP), and employer sponsored insurance).
- Recommends that CMS and states consider the roles that other partners and stakeholders—such as navigators, social workers, and employers’ human resources departments—could play in outreach, education and enrollment support.
- Outlines recommendations that would support states addressing barriers to Medicaid enrollment and retention and policies CMS can support/implement that would improve the eligibility redetermination process.
- Recommends that CMS consider how to rely on critical members of a patient’s care team to support communication, education, and potentially enrollment among beneficiaries at risk of disenrollment.
- Recommends that CMS establish access standards for medical and behavioral health services, and long-term care and supports given these are critical elements for the delivery of whole-person care. Trinity Health also urges CMS to consider standards for access to services that support health-related social needs.
- Outlines approaches CMS can take to support access to supportive services, including the Supplemental Nutrition Assistance Program (SNAP) and the Temporary Assistance for Needy Families (TANF).
- Urges CMS to consider ways to incentivize providers to accept Medicaid patients, which could include encouraging states to implement minimum payment rates that adequately cover the cost of care for the annual physical, immunizations, screenings and other key services.
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Recommends that CMS continue to work with states to implement value-based payment models and arrangements that support population health and accountability for care.
The Occupational Safety and Health Administration (OSHA) sought comments on specific topics and questions for the development of a final COVID-19 emergency temporary standard (ETS). In comments, Trinity Health urges OSHA to align its policies with the Centers for Disease Control and Prevention recommendation and guidelines to ensure one set of science-based requirements are applied to health care providers. In addition, Trinity Health strongly recommends OSHA use existing reporting and data sources to extrapolate information rather than placing new reporting requirements on providers.
Prior authorization places a heavy burden on clinicians, contributes to workforce burnout and adds increased administrative costs to our nation's health care system. Trinity Health responded to an Office of the National Coordinator (ONC) request for information seeking feedback on electronic prior authorization data standards. Trinity Health noted its general support as it would standardize the process, lead to efficiencies and reduced administrative burden. More specially, Trinity Health recommends that the ONC pilot the proposed electronic process or allow it to be optional initially to ensure provider and payer information technology systems are prepared for this workflow.
Trinity Health responded to a request for information (RFI) focused on prior authorization for post-acute care that was included in the Medicare Advantage 2023 proposed rule. In comments, Trinity Health highlights the barriers prior authorization can create for accessing post-acute care for patients as well as other challenges, and urges the Centers for Medicare and Medicaid Services to require plans to waive these processes during public health emergencies and identify a long-term policy solution to issues raised.
Previous Comments on Policy
Trinity Health strongly supports protecting patients from surprise medical bills that result from gaps in insurance coverage. In comments submitted to the U.S. departments of authority on Surprise Billing Regulations, Part II, Trinity Health urges:
- Modification of the regulation to ensure it is aligned with the No Surprises Act statute and Congressional intent. Specifically, the qualified payment amount should not be the default for arbiters during the independent dispute resolution (IDR) process. Instead, arbiters should be given deference to use their expertise to weigh the additional factors outlined in statute.
- The U.S. departments of authority should allow for broader discretion in the batching of claims than proposed in the rule, as this would disincentivize plans and issuers from adopting inappropriate out-of-network payment methodologies that would trigger the IDR process. It would also create efficiency by reducing the number of requests being submitted through the IDR process.
Trinity Health supports the Centers for Medicare and Medicaid Services (CMS) proposal to rescind the Most Favored Nation (MFN) Model, which would reimburse Medicare Part B drugs at the lowest price paid by any country. While Trinity Health shares the concerns of CMS about the skyrocketing cost of prescription drugs, the MFN model as designed would do nothing to address the root cause of these high drug prices and would harm patient care. Trinity Health urges the Biden Administration to work with Congress to pass comprehensive prescription drug reform.
Trinity Health also provided additional comments on the model for CMS consideration of future drug payment policies, including:
- Any future policy must be transparent and CMS should provide necessary information to stakeholders to validate the methodology and data sources.
- CMS should ensure prescription drug policies do not harm patients.
- CMS should avoid adding significant financial burdens to hospitals
- Policies should protect the 340B program from negative impacts.
In comments on the proposed OPPS rule, Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to reverse the continued cuts to the 340B drug saving program and immediately restore payments, as these cuts are inconsistent with congressional intent of the 340B drug savings program, represent a further assault on safety-net institutions, and continue to strain the ability of providers to better serve our patients and communities. Additional comments on the proposed rule offer:
- Support for the reversal of CY21 policies for the inpatient only list and ambulatory surgical center covered procedures list. In addition, Trinity Health urges CMS to more fully consider stakeholder concerns related to the burden and implementation challenges of future policies and to take it slow rather than moving forward with a regulatory requirement and later having to re-adjust when the process does not work.
- Recommendations on improvements to the Outpatient Quality Reporting (OQR) Program, including proposing CMS coordinate the OQR and Inpatient Quality Reporting (IQR) to ensure that hospitals that are selected for validation are only required to do validation for either the OQR or IQR program, and not both simultaneously.
- Response to CMS questions on the price transparency requirements, including urging the U.S. Department of Health and Human Services (HHS) to align all price transparency requirements in a way that is helpful for consumers and that reduce administrative burden, duplication and patient confusion.
- Recommendations on improvements to the radiation oncology model to make it fair, equitable and truly value-based.
- Response to a request for information on health equity.
Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to improve the efficiency and outcomes driven by the Medicare Physician Fee Schedule Rule and offered specific comments that include:
- Recommending that CMS fully align evaluation and management (E/M) with the American Medical Association (AMA) prefatory language.
- Applauding CMS for extending Category 3 Medicare telehealth services through CY2023 and urging CMS to work with Congress to similarly extend telehealth authorities received during the COVID-19 pandemic that require Congressional action.
- Urging CMS to improve the Medicare Shared Savings Program (MSSP) and the Medicare Diabetes Prevention Program.
Trinity Health strongly supports protecting patients from surprise medical bills that result from gaps in insurance coverage. Trinity Health recently submitted comments on surprise billing regulations, part 1 and broadly urges the several departments of jurisdiction (DofJ) to modify specific provisions of the rule that would 1) result in significant financial incentives for insurers; and 2) impact access to care for patients without any guarantee that the resulting savings will be passed on to consumers. In addition, Trinity Health requests that sufficient time be provided to allow stakeholders to implement the various components and to ensure adequate and comprehensive guidance for the new rule; additional comments:
- Highlight the unfair payment practices from insurance plans and make recommendations on oversight.
- Urge the DofJ to not allow insurance plans to delay funding, authorizing an in-network placement or place conditions on transfers.
- Recommend that providers be allowed to notify insurance plans on claims that the notice and consent process to be balance billed was used to minimize burden. In addition, insurance plans should include language on patients' explanation of benefits (EOB) that patients owe what they have agreed to per their consent to pay for services by the out-of-network provider.
- Recommend that the Centers for Medicare and Medicaid Services (CMS) adopt a standard process for how information should be transmitted to insurance plans to ensure consistency and minimize the burden prior to implementation.
- Outline that the qualified payment amount (QPA) is not an appropriate starting point for reimbursement for out-of-network care, Trinity Health urges the DofJ to not weigh the QPA in the Independent Dispute Resolution Process, and that insurance plans should be required to be transparent and give health providers the data used to calculate the QPA.
- Recognize that the interaction with state surprise billing laws will be complicated. Therefore, Trinity Health recommends the DofJ work with a series of state groups, urge enforcement discretion until the interactions are clear, and require insurance plans to inform providers which patients are in an Employee Retirement Income Security Act of 1974 (ERISA) plan as these plans can opt out of state surprise billing requirements.
- Detail that the surprise billing oversight process is not sufficient. As a result, Trinity Health urges the DofJ to develop an oversight mechanism that will allow providers to file complaints regarding insurance plan abuses of these provisions. In addition, the DofJ will need to identify a way to filter objections as there may be complaints that are unrelated to surprise billing protections.
Occupational Exposure to COVID-19 Emergency Temporary Standard (ETS), August 2021 The safety of colleagues has been top priority and from the start of the COVID-19 pandemic, Trinity Health has closely followed the guidelines and recommendations from the Centers for Disease Control and Prevention (CDC) and the requirements and recommendations of the federal Occupational Health and Safety Administration (OSHA), along with applicable state plans on how to protect health care workers and patients. Key Trinity Health recommendations submitted on the OSHA ETS include:
- Permit flexibility where the physical barriers described would have unintended consequences, including interference with heating, ventilation and air conditioning systems.
- Narrow the scope for notification of those with possible COVID-19 exposure to emphasize this for instances when eye and respiratory protection was not worn and permit flexibility by employers in determining risk when other elements like gown and gloves are missing. In addition, a risk assessment approach for possible exposure incidents is recommended.
- Allow employers the option to require colleagues use employer-provided respirators for the mini respiratory protection program.
- Request OSHA maintain main recordkeeping requirements and align reporting of COVID-19 fatalities and hospitalizations with the OSHA recordkeeping standard to reduce complexity of reporting requirements within different timeframes.
- Lessen the requirement that personal protective equipment supply be at crisis before using conservation strategies like extended use or limited reuse.
Trinity Health shared recommendations with the COVID-19 Health Equity Task Force to address future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations.
The proposed fiscal year (FY) 2022 IPPS rule includes several key policies, including adjustments made due to COVID-19 for rate setting and hospital quality reporting and value programs, continuation of the new COVID-19 treatment add-on payments (NCTAPS), continuation of the wage index policy finalized in the FY2020 IPPS rule, additional Medicare graduate medical education slots, changes to Medicare organ acquisition payment, and a request for information on health equity. Comments from Trinity Health to the Centers for Medicare and Medicaid Services (CMS) include:
- Applauding CMS for the repeal of revisions to the market-based Medicare Severity Diagnosis Related Groups (MS-DRG) data collection weight calculation finalized in the FY2021 IPPS rule. If finalized, this policy may have led to a distortion of the rate-setting process due to a less informed and less precise cost setting methodology.
- Supporting the extension of the NCTAPs through the end of the public health emergency (PHE), and urging CMS to continue payments beyond the proposed timeframe in the event hospitals continue to treat patients with COVID-19 after the PHE.
- Recommending CMS apply the proposed wage index hold harmless for certain facilities to all hospitals and establish a permanent 5 percent floor on wage index decreases to reduce volatility in the wage index.
- Supporting the additional 1,000 Medicare-funded medical residency positions and urging the Department of Health and Human Services to allow providers to practice at the top of their license and support efforts to facilitate care delivery across states.
- Urging CMS not to finalize proposed changes to organ acquisition as they would significantly increase burden on hospitals and may impact beneficiary access.
- Supporting suppression of specific quality measures for certain hospital quality and reporting and value programs if determined COVID-19 has had a significant impact on measures and calculations.
- Sharing our commitment to health equity and feedback on CMS questions around stratifying quality measures by race and ethnicity, improving demographic data collection, and the creation of a hospital health equity score.
Trinity Health supports the policies codified in the MGCRB IFR that will allow hospitals with a rural re-designation to reclassify through the MGCRB using the rural reclassified area as the geographic area in which the hospital is located. In addition, Trinity Health urges the Center for Medicare and Medicaid Services to also allow hospitals that classify as rural per the MGCRB to be treated as rural hospitals consistently for all wage index policies, including for the rural floor calculation.
Trinity Health submitted comments to Congressional leaders on improving the 340B drug savings program. Trinity Health does not believe legislation to change the 340B program is needed. However, the program could be strengthened if Congress were to use its oversight powers to ensure that the Department of Health and Human Services (HHS) enforce the 340B statute and use its existing authority to penalize manufacturers that are not meeting their 340B statutory obligations. Specifically, Trinity Health recommends:
- The 340B program is not scaled back. Savings from the 340B program allow hospitals to offer vital services despite challenges created by poor reimbursement and a weak payer-mix. If the 340B program were scaled back, reduced or saddled with costly administrative burdens, 340B hospitals would lose their ability to provide the same services and benefits that the communities currently rely to meet the needs of the vulnerable.
- Congress should ensure HHS is requiring drug manufacturers comply with the law and prevent them from denying 340B pricing to hospitals for drugs dispensed through community pharmacy arrangements. Drug manufactures should also be curtailed from moving forward with any rebate model without prior approval or, at the very least, until guidance has been issued, subject to public notice and comment.
U.S. Immigration and Customs Enforcement is proposing to change the way that holders of certain nonimmigrant Verified International Stay Approval (VISA) classifications, including J-1 visas, extend their period of authorized stay in the United States.
Specifically, the change would eliminate “duration of status” as an authorized period of stay, replacing it with a specific end date. If finalized, this rule would negatively impact the provision of health care, particularly at a time in which the country is already facing a nation-wide physician shortage while responding to the ongoing COVID-19 pandemic. Trinity Health urges the Department of Homeland Security (DHS) not to finalize this policy.
Trinity Health appreciates the ongoing efforts from the Centers for Medicare and Medicaid Services (CMS) to improve payment processes across the delivery system. However, Trinity Health has significant concerns with many of the policies proposed. Trinity Health comments include:
- 340B Drug Pricing Program cuts: CMS proposes to pay for drugs acquired under the 340B Drug Saving Program at average sales price (ASP) minus 28.7 percent. This represents deeper cuts than those proposed in prior years. Trinity Health strongly opposes any cuts to the 340B program as they are inconsistent with Congressional intent, represent a further assault on safety-net institutions, and continue to strain the ability of providers to better serve patients and communities.
- Site neutrality: CMS proposes to continue its site-neutrality policy. Trinity Health continues to strongly oppose this policy and outlines why continuing this payment cut jeopardizes the ability of hospitals to support hospital-level care in an outpatient setting.
- Hospital Inpatient Only List (IPO): CMS proposes to eliminate the IPO list over a three-year period, beginning in calendar year 2021 with the removal of 266 musculoskeletal-related services. Trinity Health is concerned this proposal may create inconsistencies and barriers to care, if not implemented correctly, this policy may lead to delayed care and unintended consequences. Trinity Health recommend CMS:
- Provide more clarity around appropriate settings.
- Create ambulatory surgery center (ASC) exclusion criteria for services removed from the IPO list and national guidelines for screening patients to determine appropriate setting.
- Develop national guidelines outlining patients who are appropriate candidates for inpatient vs outpatient authorization as well as for patients who are reasonable candidates for same-day discharge. - Supervision of Outpatient Therapeutic Services—Trinity Health supports CMS' proposal to change the minimum default level of supervision for non-surgical extended duration therapeutic services to general supervision for the entire service and urges CMS to also allow for general supervision for pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services.
Trinity Health appreciates the ongoing efforts of the Centers for Medicare and Medicaid Services (CMS) to improve the Medicare program through the delivery of high-value care and burden reduction during COVID-19. Trinity Health offers several recommendations for improving policies to further reduce barriers to necessary care, simplify the program, and reduce administrative burden:
- Telehealth expansions: Trinity Health supports the codification of many of the telehealth flexibilities provided during the COVID-19 public health emergency and encourages CMS to maintain flexibilities for nursing homes, audio-only telehealth, and expand flexibility for critical care services.
- Medicare Shared Savings Program: Trinity Health urges CMS to delay the significant restructuring of the quality program through the alternative payment model (APM) Performance Pathway (APP), a new—and undefined—reporting process, and changes to the quality threshold for the Medicare Shared Saving Program (MSSP). It is not appropriate to make such far sweeping changes during the COVID-19 pandemic. Trinity Health encourages CMS to engage stakeholders to determine appropriate measures and implementation timeline.
- Quality Payment Program: similar to MSSP comments, Trinity Health opposes implementation of the APP for the Merit-Based Incentive Payment System (MIPS). Trinity Health urges CMS to maintain the current existing APM scoring standard and scoring rules. In addition, Trinity Health requests that CMS commit to pay the Advanced Alternative Payment Model incentive payment no later than June 30 in future.
- Professional scope of practice: CMS proposes several policies that would reduce supervision requirements and make permanent flexibility provided during the COVID-19 Public Health Emergency (PHE), including allowing nurse practitioners, clinical nurse specialists and physician assistants to supervise diagnostic tests consistent with state law and scope of practice requirements. Trinity Health is supportive of the increased flexibility and applauds CMS for reducing burden.
- One-year delay of electronic prescribing requirements required under the SUPPORT Act: Trinity Health is committed to the use of Electronic Prescribing for both non-controlled and controlled medications. The COVID pandemic required Trinity Health to reprioritize work and resources – both human and financial – to properly support both employees caring for, and the patients and families impacted by the pandemic. Trinity Health strongly supports the one-year delay in implementation for the electronic prescribing requirements and appreciates that CMS has acted to reduce burdens for this requirement at this time.
This proposed rule would alter the treatment of Medicare Advantage patient days in the calculation of a hospital's disproportionate patient percentage (DPP); and, thereby, modify the disproportionate share hospital (DSH) payments. This rule was issued in response to the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) loss in the U.S. Supreme Court in the Allina case. It is an attempt by CMS to use retroactive rulemaking to implement the same policy that was vacated by the court. This is the second attempt by CMS to apply this policy retroactively prior to fiscal year 2014. Trinity Health vigorously opposes the proposal by CMS to apply the rule retroactively and its attempt to avoid the impact of the Supreme Court’s decision that determined prior attempts at the policy were invalid. Through this proposed rule, CMS is exceeding its authority in attempting to codify a policy already decided by the Supreme Court that would take away funds owed to hospitals.
Trinity Health is committed to the use of Electronic Prescribing for both non-controlled and controlled medications. The COVID-19 pandemic has delayed the implementation of this requirement established by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act. Trinity Health has had to reprioritize work and resources – both human and financial – to properly support both employees caring for, and the patients and families impacted by COVID-19. Through comments on this request for information, Trinity Health recommendations to the Centers for Medicare and Medicaid Services (CMS) on targeted programmatic components for implementing the EPCS requirement, including penalties and appeals. Further, Trinity Health recommend CMS review processes, lessons learned and best practices in those states that have already mandated a similar requirement.
Trinity Health opposes the proposed rule by the Department of Labor (DOL) entitled "Financial Factors in Selecting Plan Investments". The proposed rule would impose significant analytical and documentation burdens on fiduciaries of benefit plans governed by the Employee Retirement Income Security Act (ERISA) wishing to select--or allow individual account holders to select--investments that use environmental, social and governance (ESG) factors in investment analysis or that provide ESG benefits. Consideration of ESG factors in investing has achieved widespread acceptance globally. Academic studies have demonstrated that an ESG perspective can improve performance and reduce earnings-per-share volatility. The proposed rule is lacking in its quantification of any benefits from its implementation. Trinity Health ardently opposes this rule.
The Office of the Assistance Secretary (OASH) within the Department of Health and Human Services released an RFI seeking to gain a better understanding of how organizations, networks, non-federal government agencies, and other relevant stakeholders have operationally defined "resilience" in their respective components of the health system; including their use of data, analytic approaches and proven indicators. OASH also sought comments identifying opportunities to strengthen the U.S. health care system, including through public-private partnerships in data sharing and comprehensive analytics.
On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) released the proposed fiscal year (FY) 2021 IPPS rule. Significant policies proposed include: requiring hospitals to report the median charge negotiated with Medicare Advantage (MA) organizations and third-party payers in efforts to reduce reliance on hospital chargemasters for pricing; a continuation of the wage index changes finalized in the FY2020 IPPS rule, which increases the wage index for hospitals below the 25th percentile while reducing the wage index for other hospitals; and the codification in regulation of what CMS considers to be existing bad dept policies.
Trinity Health is very concerned with the Food and Nutrition Service (FNS) proposed rule, Simplifying Meal Service and Monitoring Requirements in the National School Lunch and School Breakfast Programs. Trinity Health comments and recommendations reflect a strong interest in advancing the health of all communities of which food and nutrition is an integral component. Trinity Health is concerned that this rule will weaken school nutrition standards that serve millions of American children and jeopardize the progress schools have made to provide healthier food to children.
Trinity Health is very concerned about rulemaking that will undermine the existing shareholder resolution process proposed by the U.S. Securities and Exchange Commission’s (SEC) in its Procedural Requirements and Resubmission Thresholds Under Exchange Act Rule and Amendments to Exemptions from the Proxy Rules for Proxy Voting Advice.
Trinity Health advances our mission and core values through a robust shareholder advocacy program that harnesses influence as shareowners in Fortune 500 companies to improve corporate decision-making on tobacco, food/nutrition, health/medications, climate change and violence.
The work of Trinity Health is more successful when done in collaboration with partners including Interfaith Center for Corporate Responsibility (ICCR) and Ceres Investor Network on Climate Risk and Sustainability (INCRS). Trinity Health was a co-signer on the INCRS letter to the SEC and also submitted separate comments and recommendations. These comments reflect a strong interest in advancing the stated mission of the SEC: "to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation."
The Medicaid Fiscal Accountability Rule (MFAR), proposed by the Centers for Medicare and Medicaid Services (CMS), would make significant changes to hospital supplemental payments and state Medicaid program financing. If finalized, the rule would limit provider taxes, intergovernmental transfers, and bona fide provider donations, thereby decreasing state flexibility in financing the state share of their Medicaid programs—likely leading to a reduction in services, coverage, and provider payments. Notably, the proposed rule does not include a robust impact analysis on beneficiaries, states or providers.
Trinity Health is deeply concerned that the implications of the MFAR rule extend well beyond its stated goal of increased transparency and will negatively impact access to care for low-income Medicaid beneficiaries, and place significant new burdens on states.
Trinity Health strongly opposes this rule as it is bad public policy for those with whom we hold near and dear—the poor and underserved—those who are at the heart of our mission. Therefore, Trinity Health recommends that CMS maintain current policy.