Hundreds of health and technology groups urge Congress to extend telehealth flexibility for Medicare beneficiaries past the end of the Covid-19 pandemic.
Last yearâs CARES Act let the Centers for Medicare & Medicaid Services temporarily waive certain restrictions on how providers can deliver remote care.
A Biden administration proposed rule (RIN 0938âAU42) would extend temporary Medicare coverage of some telehealth services through Dec. 31, 2023, but the 430 groups said in a letter to congressional leaders that they donât think the proposal goes far enough. They want telehealth to become a permanent fixture of the health-care system.
The groups that signed the letter included the American Medical Association, the American Board of Telehealth, the Alliance for Connected Care, the Federation of American Hospitals, Amazon, Google, and Zoom Videoconferencing.
âWithout action from Congress, Medicare beneficiaries will abruptly lose access to nearly all recently expanded coverage of telehealth,â according to the groupsâ letter.
âThis would have a chilling effect on access to care across the entire U.S. health system, including on patients that have established relationships with providers virtually, with potentially dire consequences for their health,â the letter stated.
Telehealth use has increased dramatically during the pandemic because many patients have been unwilling or unable to see doctors in person. Telehealth represented 0.22% of private health plan medical claims in December 2019, booming to 6.51% in December 2020, according to data from FAIR Health.
Virtual visits have been especially helpful to mental health providers who are having a hard time meeting the demand of an ever-growing population of patients seeking care.
Beneficiaries like telehealth too, with 75% of Americans showing âa strong interest in using telehealth moving forward,â according to a telehealth study from the COVID-19 Healthcare Coalition.
The CMS canât permanently expand telehealth without changes to the Social Security Act, which limits the telehealth services Medicare can and canât pay for. Before Covid-19, Medicare would only cover visits for beneficiaries in certain rural locations that originated in qualifying sites.
Given these restrictions, âCongress must act to ensure that the Secretary has the tools to transition following the end of the public health emergency and ensure telehealth is regulated the same as in-person services,â the letter said, referring to Department of Health and Human Services Secretary Xavier Becerra.
The groups asked Congress to remove the geographic restrictions on patients and providers. The pandemic has demonstrated the importance of telehealth services âin rural and urban areas alike,â they said.
The groups want Congress to ensure flexibility in which services are eligible for telehealth and how they are delivered. Audio-only services should be permitted for reimbursement by the CMS âwhen clinically appropriate,â they said.
They want to remove a new restriction that would require mental health patients to have an in-person visit every six months. âNot only is there no clinical evidence to support these requirements, but they also exacerbate clinician shortages and worsen health inequities,â they said.
Several telehealth bills are moving through Congress, which range from directing the HHS to extend Covid-19 flexibility (S. 368) to a widely supported bill that would amend the Social Security Act to expand telehealth access (S. 1512). Lawmakers are also pushing for legislation that addresses the in-person requirement for mental health services (S. 2061).
While these bills would improve access, the Alliance for Connected Care signed the letter because âwe wanted to keep the pressure on,â Executive Director Krista Drobac said. âWe need Congress to take action.â
âCongress not only has the opportunity to bring the U.S. health care system into the 21st century, but the responsibility to ensure that the billions in taxpayer funded COVID investments made during the pandemic are not simply wasted but used to accelerate the transformation of care delivery, ensuring access to high quality virtual care for all Americans,â the groups said in their letter.
House lawmakers advanced a bill aimed at ending shortages in domestic personal protective equipment supply chains to prepare for future pandemics.
The House Committee on Oversight and Reform approved H.R. 4470 by a unanimous vote Tuesday. Its next stop is the House floor.
The Covid-19 pandemic sent a shock through global supply chains of personal protective equipment, exposing shortages of N95 masks, gowns, gloves, and face shields in the U.S. Strategic National Stockpile.
âWe all know weâre going to have another pandemic at some point,â said Committee Chair Carolyn Maloney (D-N.Y.).
âAs we enter a post-pandemic world, it is essential that we learn from the trauma of the coronavirus crisis and what it taught us about our national vulnerabilities,â Maloney said. One of those vulnerabilities was the failure of supply chains, which led to shortages of medical supplies and personal protective equipment âwhen we needed it the most,â she said.
The bill would create stockpile requirements and incentives for domestic manufacturers of personal protective equipment to ensure the U.S. is prepared for future public health emergencies.
It would require that all personal protective equipment in the stockpile be produced in the U.S., unless an item cannot be produced to meet the U.S.’s demand for quality and quantity. The intent is to lessen U.S. reliance on other countriesâ ability, and willingness, to trade their supplies.
The bill would also provide a 20% tax credit to producers of personal protective equipment that qualifies for inclusion in the stockpile. The credit would support manufacturers and âput Americans to work building the skills and materials we need to sustain us when our nation is hit with the unthinkable,â Maloney said.
The bill is one of a series of congressional efforts to ensure the U.S. is better prepared for the next pandemic. Sens. Patty Murray (D-Wash) and Richard Burr (R-N.C.) plan to work together to introduce a bill about lessons learned from Covid-19. Murray and Burr earlier crafted legislation to update the Pandemic and All-Hazards Preparedness Act, which was enacted in 2006 to prepare for public health emergencies. They are also working on workforce training solutions in the wake of Covid-19.
Murray introduced S. 674 March 10, which would support public health infrastructure. She has advocated for boosting public health funding by $4.5 billion a year and called for revitalizing local and state health departments.
At the House markup, Rep. Jody Hice (R-Ga.) asked Maloney about the current inventory of the Strategic National Stockpile. Maloney said she was unsure and emphasized that domestic production is important even when supplies are high.
Rep. James Comer (R-Ky.) supported the bill, but said âitâs simply not enough.â He encouraged lawmakers to âtake affirmative steps to fully investigate the origins of Covid-19.â
Pandemic Preparedness Bill to Boost U.S.-Made Stockpile AdvancesBloomberg | July 20, 2021
Biden admin to stiffen penalty on hospitals for hiding pricesPolitico Pro | July 19, 2021
CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P)Centers for Medicare & Medicaid Services | July 19, 2021
CMS Proposes Rule to Increase Price Transparency, Access to Care, Safety & Health EquityCenters for Medicare & Medicaid Services | July 19, 2021
HHS Enforcer OKs Barred Kickbacks in Insurer-Hospital AgreementBloomberg | July 19, 2021
Medicare Moves to Hike Payments, Penalties for Hospitals in 2022Bloomberg | July 19, 2021
Dems eye infrastructure for Medicare expansionAxios | July 19, 2021
Hospitals Worry About Infrastructure PlanBloomberg | July 19, 2021
Most Physicians Avoid Major Payment Cuts in Medicare ProposalThe Hill | July 19, 2021
Menendez drug pricing concerns highlight budget obstacles for DemocratsRoll Call | July 17, 2021
More Medically-Necessary Coverage Might Cut New Dental Benefit CostsInside Health Policy | July 16, 2021
Providers: Leave Sequester Extension Out Of Infrastructure PackageInside Health Policy | July 16, 2021
Medicare Expansion Would Be Financial Balm for an Aging U.S.Bloomberg | July 15, 2021
Budget Plan Proposes Medicare ExpansionBloomberg | July 15, 2021
Nursing Homes Ask HHS To Distribute Remaining Provider Relief ASAPInside Health Policy | July 15, 2021
Schumer Sets Infrastructure, Budget DeadlineBloomberg | July 15, 2021
Doggett: E&C, W&M Working On Different Ways To Fix Medicaid GapInside Health Policy | July 15, 2021
Home Health Agencies to Fight Proposed Medicare Pay CutBloomberg | July 15, 2021
Pay-Fors a Question Mark in Budget PlanBloomberg | July 15, 2021
Gun Injuries in the U.S. Cost $1 Billion Per Year, Watchdog SaysBloomberg | July 14, 2021
Climate, immigration, Medicare lead progressive highlights in Demsâ $3.5T budget planBloomberg | July 14, 2021
Bidenâs Two-Track Economic Agenda Hits Turbulence in SenateBloomberg | July 13, 2021
Coalition says health workers should be required to get coronavirus vaccineWashington Post | July 13, 2021
Most Physicians Avoid Major Payment Cuts in Medicare ProposalBloomberg | July 13, 2021
CMS Proposes To Cover Some Telehealth Through 2023Inside Health Policy | July 13, 2021
WSC has selected, and provided links, to particular WSC policy briefs and news articles from the past week that our clients may have missed. Â
The Biden administration is proposing harsher fines for hospitals that donât publish the prices they charge, strengthening a new Trump-era transparency measure opposed by the industry.
What happened: The Biden administration, citing early reports that many hospitals are not complying with the new requirements, wants to up the maximum annual penalty from $109,500 to $2 million per hospital.
Hospitals as of Jan. 1 have been required to publicize rates for 300 common services in easy-to-read formats. Many experts thought that the penalty for noncompliance â $300 per day â wasnât strong enough to force some hospitals to disclose negotiated rates that had long been kept private.
CMS wants to require hospitals to ensure that patients can download the list of prices and find them in website searches. CMS notes that some hospitals had embedded the information on their website without ways for consumers to âeasily or directly downloadâ the information in an easy-to-read file. Other hospitals had employed methods that made it difficult or impossible for search engines to discover the data.
Why the change: Patient advocates have complained that only a sliver of hospitals are complying with the transparency rules meant to arm patients with more information about the cost of care. Hospitals, who lost a last-minute court battle to overturn the policy, said the requirements were burdensome.
The Biden administration is proposing harsher fines for hospitals that donât publish the prices they charge, strengthening a new Trump-era transparency measure opposed by the industry.
On July 19, 2021, the Centers for Medicare & Medicaid Services (CMS) proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021. The final rule with comment period will be issued in early November.
In addition to proposing updated payment rates, this yearâs rule includes proposals that align with several key goals of the Administration, including addressing the health equity gap, fighting the COVID-19 Public Health Emergency (PHE), encouraging transparency in the health system, and promoting safe, effective, and patient-centered care.
The proposed rule would further the agencyâs commitment to strengthening Medicare and uses the lessons learned from the COVID-19 PHE to inform the approach to quality measurement, focusing on changes that will help to close the health equity gap.
As with these other rules, CMS is publishing this proposed rule to meet the legal requirements to update Medicare payment policies for OPPS hospitals and ASCs on an annual basis. This fact sheet discusses the major provisions of the proposed rule (CMS- 1753-P), which can be downloaded at: https://www.federalregister.gov/documents/current
Price Transparency of Hospital Standard Charges
On January 1, 2021, the Hospital Price Transparency final rule became effective. This final rule implements section 2718(e) of the Public Health Service Act, which requires each hospital operating within the United States to establish (and update) and make public a yearly list of the hospitalâs standard charges for items and services provided by the hospital, including for diagnosis-related groups established under section 1886(d)(4) of the Social Security Act.
CMS is committed to ensuring consumers have the information they need to make fully informed decisions regarding their health care. Hospital price transparency helps Americans know what a hospital charges for the items and services it provides. CMS expects hospitals to comply with these legal requirements, and is enforcing these rules to ensure Americans know what a hospital charges for items and services.
The Hospital Price Transparency final rule established regulations at 45 CFR 180 and includes the following: (1) definitions of âhospital,â âstandard charges,â and âitems and services;â (2) requirements for making public a machine-readable file online that includes all standard charges (specifically, gross charges, payer-specific negotiated charges, discounted cash prices, and de-identified minimum and maximum negotiated charges) for all hospital items and services; (3) requirements for making public standard charges for a limited set of âshoppableâ services that are displayed and packaged in a consumer-friendly manner, or use of an online price estimator tool; and (4) monitoring for hospital noncompliance and actions to address hospital noncompliance (including issuing a warning notice, requesting a corrective action plan, and imposing civil monetary penalties of $300/day), and a process for hospitals to appeal these penalties.
In this proposed rule, CMS is proposing several modifications designed to increase compliance and reduce hospital burden beginning January 1, 2022, including the following:
Proposed Increase in Civil Monetary Penalties (CMP): CMS proposes to set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500. Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital. CMS is seeking comment on alternative or additional criteria that could be used to scale a CMP such as: hospital revenue; the nature, scope, severity, and duration of noncompliance; and the hospital’s reason for noncompliance. The proposed approach to scaling the CMP amount would retain the current penalty amount for small hospitals, while also proposing to increase the penalty amount for larger hospitals, and signal the Secretaryâs continued support for public access to pricing information and enforcement.
Proposing to Deem State Forensic Hospitals as Having Met Requirements: CMS proposes to modify the hospital price transparency regulationâs deeming policy to include state forensic hospitals as having met requirements, so long as such facilities provide treatment exclusively to individuals who are in the custody of penal authorities and do not offer services to the general public.
Proposing to Prohibit Additional Specific Barriers to Access to the Machine-Readable File: CMS proposes to update the list of activities that present barriers to access to the machine-readable file, specifically to require that the machine-readable file is accessible to automated searches and direct downloads.
Clarifications and Seeking Comment: CMS clarifies the expected output of hospital online price estimator tools, if a hospital chooses to use an online price estimator tool in lieu of posting its standard charges for 300 shoppable services in a consumer-friendly format. Specifically, CMS is clarifying that an online price estimator tool must provide a cost estimate to an individual that takes the individualâs insurance information into account, and that the estimate reflects the amount the hospital anticipates will be paid by the individual for the shoppable service, absent unusual or unforeseeable circumstances.
Additionally, CMS is seeking public input on a variety of issues it may consider in future rulemaking including:
Consolidated Appropriations ActâRural Emergency Hospital (REH) Provider Type Request for Information
There has been a growing concern that closures of rural hospitals and CAHs are leading to a lack of services for people living in rural areas. One of these key services is access to emergency care. Section 125 of the Consolidated Appropriations Act of 2021 (CAA) established a new provider type called Rural Emergency Hospitals (REHs), effective January 1, 2023.
REHs are facilities that convert from either a critical access hospital (CAH) or a rural hospital (or one treated as such under section 1886(d)(8)(E) of the Social Security Act) with less than 50 beds, and that do not provide acute care inpatient services with the exception of skilled nursing facility services furnished in a distinct part unit. REHs will be required to furnish emergency department services and observation care, and may provide other outpatient medical and health services as specified by the Secretary.
CMS has included a Request for Information (RFI) to seek public input on a broad range of issues that should be taken into account in establishing this new provider type. For example, CMS is interested in feedback on the health and safety standards, payment policies, and quality measures for REHs. Public comment on these areas will help inform proposed rulemaking for CY 2023. CMS also intends to host other opportunities for public engagement as it considers policies related to establishing the REH provider type, including open door forums and listening sessions.
Updates to OPPS and ASC payment rates
In accordance with Medicare law, CMS is proposing to update OPPS payment rates for hospitals that meet applicable quality reporting requirements by 2.3 percent. This update is based on the projected hospital market basket increase of 2.5 percent reduced by 0.2 percentage point for the productivity adjustment.
In the CY 2019 OPPS/ASC final rule with comment period, we finalized our proposal to apply the hospital market basket update to ASC payment system rates for an interim period of 5 years (CY 2019 through CY 2023). Using the proposed hospital market basket, CMS is updating the ASC rates for CY 2022 by 2.3 percent. The proposed update applies to ASCs meeting relevant quality reporting requirements. This change is based on the projected hospital market basket increase of 2.5 percent with a 0.2 percentage point productivity adjustment.
Use of CY 2019 Claims Data for CY 2022 OPPS and ASC Payment System Ratesetting Due to the PHE
For the OPPS and ASC ratesetting process, the best available data for ratesetting is used so that the payment rates can accurately reflect estimates of the costs associated with furnishing outpatient services, and thus set appropriate payment rates. Ordinarily, the best available claims data is the most recent set of data which would be from two years prior to the calendar year that is the subject of rulemaking. However, due to a number of COVID-19 PHE-related factors, CMS believes that the CY 2020 data are not the best overall approximation of expected outpatient hospital services in CY 2022. Instead, we believe the CY 2019 data, as the most recent complete calendar year of data prior to the COVIDâ19 PHE, are a better approximation of expected costs for CY 2022 hospital outpatient services for ratesetting purposes. As a result, CMS is proposing to use CY 2019 data to set CY 2022 OPPS and ASC payment system rates.
Changes to the Inpatient Only List
Since the beginning of the OPPS, the Inpatient Only (IPO) list has defined the list of services that, due to their medical complexity, Medicare will only pay for when performed in the inpatient setting. In the CY 2021 OPPS/ASC final rule, CMS finalized a policy to eliminate the IPO list over a three-year period, removing 298 services from the IPO list in the first phase of the elimination. However, we received a large number of stakeholder comments throughout the CY 2021 rulemaking cycle and following issuance of the final rule with comment period that opposed the elimination of the IPO list primarily due to patient safety concerns, stating that the IPO list serves as an important programmatic safeguard.
For CY 2022, CMS is proposing to halt the elimination of the IPO list and, after clinical review of the services removed from the IPO list in CY 2021, we propose to add the 298 services removed from the IPO list in CY 2021 back to the IPO list beginning in CY 2022. This change in policy would ensure that any service removed from the IPO list has been reviewed against Medicareâs longstanding IPO list criteria to determine if it is appropriate for Medicare to pay for the provision of the service in the outpatient setting. Furthermore, CMS is proposing to codify the longstanding criteria for removal of procedures from the IPO list to make clear in regulatory text how we will evaluate future procedures for removal.
In addition, we solicit comment on several policy modifications including whether CMS should maintain the longer-term objective of eliminating the IPO list or maintaining the IPO list but continuing to systematically scale the list back so that inpatient only designations are consistent with current standards of practice.
Two-Midnight Rule Medical Review Activities Exemptions
In the CY 2021 OPPS/ASC final rule, CMS established a policy in which procedures removed from the IPO list beginning January 1, 2021 would be indefinitely exempted from certain medical review activities related to the two-midnight policy. For CY 2022, CMS is proposing to revise the exemption for procedures removed on or after January 1, 2021 from the IPO list to the exemption period that was previously in effect (e.g., two years), so that all services paid for under the OPPS are eventually subject to medical review.
Changes to the ASC Covered Procedures List
In the CY 2021 OPPS/ASC final rule, CMS revised the long-standing safety criteria that were historically used to add covered surgical procedures to the ASC Covered Procedures List (ASC CPL), and adopted a notification process for surgical procedures the public believes can be added to the ASC CPL under the criteria we retained. Using these revised criteria, CMS added 267 surgical procedures to the ASC CPL beginning in CY 2021.
For CY 2022, CMS is proposing to reinstate the criteria (which related to patient safety) for adding a procedure to the ASC CPL that were in place in CY 2020 and prior. CMS is also proposing to remove from the ASC CPL 258 of the 267 procedures that were added in CY 2021.
CMS is requesting comment on whether any of the 258 procedures proposed for removal from the ASC CPL meet the proposed reinstated criteria.
CMS is also proposing to adopt a nomination process, under which, on or after January 1, 2023, an external party could nominate a surgical to be added to the ASC CPL. If CMS determines that a surgical procedure meets the requirements to be added to the ASC CPL, including a surgical procedure nominated by an external party, it would propose to add the surgical procedure to the ASC CPL in the next applicable rulemaking.
OPPS Payment for Drugs Acquired Through the 340B Program
Section 340B of the Public Health Service Act (340B) allows participating hospitals and other providers to purchase certain covered outpatient drugs from manufacturers at discounted prices. In the CY 2018 OPPS/ASC final rule, CMS reexamined the appropriateness of paying the Average Sale Price (ASP) plus 6 percent for drugs acquired through the 340B Program, given that 340B hospitals acquire these drugs at steep discounts. Beginning January 1, 2018, Medicare adopted a policy to pay an adjusted amount of ASP minus 22.5 percent for certain separately payable drugs or biologicals acquired through the 340B Program.
In this rule, we are proposing to maintain the payment rate of ASP minus 22.5 percent for certain separately payable drugs or biologicals acquired through the 340B Program. Under this proposal, rural sole community hospitals, childrenâs hospitals, and PPS-exempt cancer hospitals would continue to be excepted from this policy.
Payment for Non-Opioid Products Under Section 6082 of the SUPPORT Act
The law requires that the Secretary must review payments under the OPPS and ASC for opioids and evidence-based non-opioid alternatives for pain management to ensure there are not financial incentives to use opioids instead of non-opioid alternatives. For CY 2022, CMS is proposing to modify its current policy, adopted under section 1833(t)(22)(A) and section 1833(i)(8), as added by section 6082(a) and (b), respectively, of the SUPPORT Act, to provide for separate or modified payment for non-opioid pain management drugs and biologicals that function as supplies in the ASC setting when those products meet certain criteria, as determined by CMS.
CMS proposes that beginning on or after January 1, 2022, a non-opioid pain management drug or biological that functions as a surgical supply in the ASC setting would be eligible for separate payment when it is FDA approved and indicated for pain management or as an analgesic, and with a per day cost above the OPPS/ASC drug packaging threshold. Accordingly, CMS is proposing to continue separate payment in the ASC setting in CY 2022 for the two products currently receiving separate payment under this policy since they meet the proposed criteria.
CMS is soliciting comment on establishing an application process, through which an external party could submit an application for separate payment for a non-opioid pain management drug or biological that functions as a surgical supply.
In addition, CMS is soliciting comment on several additional criteria that could be implemented through future rulemaking, such as the presence of peer-reviewed literature that demonstrates a clinically significant decrease in opioid use for the surgical procedure and post-operative period.
Comment Solicitation on Temporary Policies for the PHE for COVID-19
In response to the COVID-19 PHE, CMS undertook emergency rulemaking to implement a number of flexibilities to address the PHE, such as preventing spread of the infection and supporting diagnosis of COVID-19. While many of these flexibilities will expire at the conclusion of the PHE, CMS is seeking comment on the extent to which stakeholders utilized these flexibilities as well as whether stakeholders believe there are certain policies that should be made permanent to the extent possible. Specifically, CMS is seeking comment on:
OPPS Transitional Payment for Drug and Biological Pass-Through and Transitional Payment for Device Pass-Through
For CY 2022, CMS received eight applications for device pass-through payments. One of these applications (the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) catheter) received preliminary approval for pass-through payment status through our quarterly review process. CMS is soliciting public comment on all eight of these applications and final determinations on these applications will be made in the CY 2022 OPPS/ASC final rule.
In addition, as a result of the proposal to use CY 2019 claims data, rather than CY 2020 claims data, for CY 2022 ratesetting, CMS is also proposing to use its equitable adjustment authority under 1833(t)(2)(E) to provide up to four quarters of separate payment for 27 drugs and biologicals and one device category whose pass-through payment status will expire between December 31, 2021 and September 30, 2022.
Partial Hospitalization Program
Partial Hospitalization Program (PHP) Rate Setting
The CY 2022 OPPS/ASC proposed rule would update Medicare payment rates for Partial Hospitalization Program (PHP) services furnished in hospital outpatient departments and Community Mental Health Centers (CMHCs). The PHP is a structured intensive outpatient program consisting of a group of mental health services paid on a per diem basis under the OPPS, based on PHP per diem costs.
Update to PHP Per Diem Rates
CMS is proposing to maintain the existing unified rate structure, with a single PHP Ambulatory Payment Classification (APC) for each provider type for days with three or more services per day. In order to maintain consistency with OPPS, for this CY 2022 ratesetting, CMS is proposing to use CY 2019 claims and the cost information from prior to the COVID-19 PHE, that is, the cost information that was available for the CY 2021 OPPS/ASC rulemaking. CMS believes this is appropriate and necessary for PHP services, because of the substantial decrease in the number of PHP days in the CY 2020 claims dataset, which we would normally use for ratesetting
Radiation Oncology Model
In September 2020, the Center for Medicare and Medicaid Innovation (the Innovation Center) published a final rule that established the Radiation Oncology (RO) Model with a start date of January 1, 2021. The RO Model will test whether making site-neutral, modality agnostic, prospective episode-based payments to Hospital Outpatient Departments (HOPDs) and physician group practices (including freestanding radiation therapy (RT) centers) for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing or maintaining Medicare spending.
As a result of the ongoing COVID-19 PHE, CMS included an interim final rule with comment period (IFC) in the CY 2021 OPPS/ASC Final Rule to delay the start of the RO Model until July 1, 2021. Subsequently, the Consolidated Appropriations Act, 2021, included a provision that prohibits implementation of the RO Model prior to January 1, 2022, effectively delaying the start date by at least 6 months. CMS is making proposals to address necessary changes as a result of the legislatively mandated delay and additional proposed modifications to the model design.
Proposals to Address the RO Model Timing and Design
The CY 2022 OPPS and ASC Payment System proposed rule includes the following proposals to modify the RO Modelâs timing and design:
Finally, CMS includes clarifications to help address questions from stakeholders and future RO participants related to the interaction between the RO Model and the Quality Payment Program.
For more information on the RO Model, visit: https://innovation.cms.gov/initiatives/radiation-oncology-model/
Hospital Outpatient/ASC Quality Reporting Programs
CMS is proposing changes to the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs to further meaningful measurement and reporting for quality of care in the outpatient setting.
Closing the Health Equity Gap in CMS Quality Programs
Consistent with Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, CMS is committed to addressing significant and persistent inequities in health outcomes in the U.S. through improving data collection to better measure and analyze disparities across programs and policies.
In the proposed rule, CMS is seeking input on ideas to revise the Hospital OQR and ASCQR Programs to make reporting of health disparities based on social risk factors and race and ethnicity more comprehensive and actionable for facilities, providers, and patients.
Under the Hospital OQR Program, CMS is seeking comment on future potential additional stratification of quality measure results by race, Medicare/Medicaid dual eligible status, disability status, LGBTQ+, and socioeconomic status. The agency is also seeking input on potential future application of an algorithm to indirectly estimate race and ethnicity to permit stratification of measures (in addition to dual-eligibility) for facility-level disparity reporting until more accurate forms of self-identified demographic information are available.
CMS is also seeking comment on the possible collection of a minimum set of demographic data elements by facilities at the time of admission, and using electronic data definitions to permit nationwide, interoperable health information exchange, for the purposes of incorporating into measure specifications and other data collection efforts relating to quality.
Under the ASCQR Program, CMS is seeking comment on: (1) ways to address the unique challenges of measuring disparities in the ASC setting, such as small sample sizes, ASC specialization, and the relatively smaller proportion of patients with social risk factors; (2) the utility of neighborhood-level socioeconomic factors toward measuring disparities in quality-of-care outcomes for ASCs; and (3) ways social risk factors influence the access to care, quality of care and outcomes for ASC patients in general or for specific ASC services.
Future of Digital Quality Measurement
CMS is seeking comment on future plans to modernize its quality measurement enterprise:
Hospital Outpatient Quality Reporting (OQR) Program
The Hospital OQR Program is a pay-for-reporting quality program for the hospital outpatient department setting. The Hospital OQR Program requires hospitals to meet quality reporting requirements, or receive a reduction of 2.0 percentage points in their annual payment update if these requirements are not met. In the CY 2022 OPPS/ASC proposed rule, CMS is proposing to (1) adopt three new measures, including the COVID-19 Vaccination of Health Care Personnel (NQF #0431), (2) make the reporting of two voluntary or suspended measures mandatory, (3) remove two measures, and (4) update the validation policies of the Hospital OQR Program to reduce provider burden and improve processes. In addition, CMS is soliciting comments on potential future measure adoptions.
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
The ASCQR Program is a pay-for-reporting quality program for the ASC setting. The ASCQR Program requires ASCs to meet quality reporting requirements or receive a reduction of 2.0 percentage points in their annual fee schedule update if these requirements are not met. CMS is proposing to (1) adopt one new measure, the COVID-19 Vaccination of Health Care Personnel (NQF #0431) and (2) to make the reporting of six voluntary or suspended measures mandatory. CMS is requesting comment on quality measures for pain management procedures performed in this setting.
Hospital Inpatient Quality Reporting (IQR) Program and Medicare Promoting Interoperability Program
The Hospital IQR Program is a pay-for-reporting quality program. By law, hospitals that do not submit quality data or fail to meet all Hospital IQR Program requirements are subject to a one-fourth reduction in their Annual Payment Update under the Inpatient Prospective Payment System (IPPS). The Medicare Promoting Interoperability Program for eligible hospitals (EHs) and critical access hospitals (CAHs) began in 2011 as authorized by the American Recovery and Reinvestment Act of 2009 (ARRA), and provided incentive payments for the demonstration of meaningful use of certified electronic health record technology (CEHRT) through 2016.
Currently hospitals are required to report (a) Three self-selected electronic clinical quality measures (eCQMs), and (b) the Safe Use of Opioids eCQM for the CY 2022 reporting period and subsequent years for the Hospital IQR Program and the Medicare Promoting Interoperability Program.
As we consider future reporting on the Safe Use of Opioids eCQM, we seek comments on the appropriateness of maintaining this previously finalized policy or instead proposing in future rulemaking to allow hospitals to self-select the Safe Use of Opioids eCQM from our finalized set of eCQMs. We also seek any other information or considerations commenters may have to inform future measure updates to the Safe Use of Opioids eCQM.
On July 19, 2021, the Centers for Medicare & Medicaid Services (CMS) proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021. The final rule with comment period will be issued in early November. Â
The Centers for Medicare & Medicaid Services (CMS) is proposing actions to address the health equity gap, ensure consumers have the information they need to make fully informed decisions regarding their health care, improve emergency care access in rural communities, and use lessons learned from the COVID-19 pandemic to inform patient care and quality measurements.
In accordance with President Bidenâs Competition Executive Order, CMS is further strengthening its efforts to increase price transparency, holding hospitals accountable and ensuring consumers have the information they need to make fully informed decisions regarding their health care.
âAs President Biden made clear in his executive order promoting competition, a key to price fairness is price transparency,â said HHS Secretary Xavier Becerra. âNo medical entity should be able to throttle competition at the expense of patients. I have fought anti-competitive practices before, and strongly believe health care must be in reach for everyone. With todayâs proposed rule, we are simply showing hospitals through stiffer penalties: concealing the costs of services and procedures will not be tolerated by this Administration.â
âCMS is committed to addressing significant and persistent inequities in health outcomes in the United States and todayâs proposed rule helps us achieve that by improving data collection to better measure and analyze disparities across programs and policies,â said CMS Administrator Chiquita Brooks-LaSure. âWe are committed to finding opportunities to meet the health needs of patients and consumers where they are, whether itâs by expanding access to onsite care in their communities, ensuring they have access to clear information about health care costs, or enhancing patient safety.â
The proposed rule includes the following actions:
Price Transparency
Hospital price transparency helps Americans know what a hospital charges for the items and services they provide. CMS takes seriously concerns it has heard from consumers that hospitals are not making clear, accessible pricing information available online, as they have been required to do since January 1, 2021.
CMS proposes to increase the penalty for some hospitals that do not comply with Hospital Price Transparency final rule. Specifically, CMS is proposing to set a minimum civil monetary penalty of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500. Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.
Based on information that hospitals have made public this year, there is wide variation in prices â even within the same hospital or the same system, depending on what each insurance plan has negotiated with that hospital. CMS is committed to ensuring consumers have the information they need to make fully informed decisions regarding their health care, since health care prices can cause significant financial burdens for consumers.
Health Equity
CMS is seeking input on ways to make reporting of health disparities based on social risk factors and race and ethnicity more comprehensive and actionable. This includes soliciting comments on potential collection of data, and analysis and reporting of quality measure results by a variety of demographic data points including, but not limited to, race, Medicare/Medicaid dual eligible status, disability status, LGBTQ+, and socioeconomic status.
Access to Emergency Care in Rural Areas
Since 2010, 138 rural hospitals have closed â disproportionately within communities with a higher proportion of people of color and communities with higher poverty rates. Rural communities experience shorter life expectancy, higher mortality, and have fewer local providers, leading to worse health outcomes than in other communities.
Rural hospital closures deprive people living in rural areas of crucial services, including access to emergency care. To address these concerns, Congress enacted Section 125 of the Consolidated Appropriations Act of 2021 (CAA), which establishes a new provider type for Rural Emergency Hospitals (REHs). REHs will be required to furnish emergency department services and observation care and may provide other outpatient medical and health services as specified by the Secretary through rulemaking. In this proposed rule, CMS is requesting information to inform the development of requirements that would apply to Rural Emergency Hospitals (REHs). This new provider designation will apply to items and services furnished on or after January 1, 2023.
CMS is seeking feedback on a wide-range of issues to help inform policy proposals for the CY 2023 rulemaking cycle, including feedback on the potential services to be provided by REHs; health and safety standards and quality measures to be established for REHs; and payment provisions for this provider type.
COVID-19 Lessons
To incorporate lessons learned from the COVID-19 pandemic, CMS is seeking comment on the extent to which hospitals are using flexibilities offered during the COVID-19 public health emergency (PHE) to provide mental health services remotely and whether CMS should consider changes to account for shifting practice patterns. In addition, CMS is proposing changes to measure how many of our nation’s front-line healthcare workers in hospital outpatient departments and ASCs are vaccinated against COVID-19, and to make this information available to the public so consumers know how many workers are vaccinated in different health care settings.
Improving Patient Experience and Outcomes
The Radiation Oncology (RO) Model aims to improve the quality of care for cancer patients receiving radiotherapy and move toward a simplified and predictable payment system. The RO Model tests whether prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for radiotherapy episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.
CMS is proposing changes to the RO Model, which aim to improve the experience of patients receiving radiation treatment, while incorporating evidence-based best practices to help providers improve patient outcomes.
Patient Safety
CMS is increasing Medicare beneficiary safety by reversing changes made for 2021 regarding the care setting for which Medicare will pay for surgical procedures that may pose risk to patients.
Specifically, the agency is proposing to halt the phased elimination of the Inpatient-Only (IPO) listâprocedures that Medicare will only make payment for when provided in the inpatient setting. There are some services designated as inpatient only that, given their clinical intensity, would not be expected to be performed in the outpatient setting. CMS adopted a policy for 2021 to eliminate this list over a phased period and removed musculoskeletal procedures from the list in 2021.
This change happened without individually evaluating whether the procedures met the long-standing criteria previously used to determine if a procedure could be safely removed. Some of the musculoskeletal services removed includes services like limb amputations and invasive spinal procedures.
CMS reviewed each procedure code of services that were removed and found none met criteria for removal, with insufficient supporting evidence that the service can be safely performed on the Medicare population in the outpatient setting.
CMS is proposing to add them back on to the list in 2022, and is seeking comment on whether to maintain the longer-term objective of eliminating the IPO list, maintaining the IPO list, or maintaining the list but continue to streamline the list of services. The latter would continue systematic scaling of the list back to ensure inpatient-only designations are consistent with current standards of practice.
CMS is also proposing to reinstate the patient safety criteria it uses to evaluate whether a procedure should be payable in the Ambulatory Surgery Center setting that were removed in 2021. CMS is proposing to adopt a nomination process whereby the publicly can formally nominate procedures it believes are safe to perform for the Medicare population in the ASC setting.
For a fact sheet on the Calendar Year (CY) 2022 OPPS/ASC Payment System proposed rule (CMS-1753-P), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2022-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
The OPPS/ASC Payment System proposed rule is displayed at the Federal Register, with a 60-day comment period. The proposed rule can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection/current
The Centers for Medicare & Medicaid Services (CMS) is proposing actions to address the health equity gap, ensure consumers have the information they need to make fully informed decisions regarding their health care, improve emergency care access in rural communities, and use lessons learned from the COVID-19 pandemic to inform patient care and quality measurements.
Federal health inspectors green-lit a financial arrangement that will allow a company selling insurance plans that supplement Medicare to offer policyholders incentives for being treated at certain hospitals.
In an advisory opinion released Monday, the Office of Inspector General (OIG) for the Department of Health and Human Services said a licensed offeror of Medicare Supplemental Health Insurance, otherwise known as Medigap, and a preferred hospital organization could encourage policyholders to seek inpatient care from a hospital within the organizationâs network.
The unnamed companies sought an advisory opinion because the financial arrangement could violate the federal Anti-Kickback statute. Under the law, itâs a felony for anyone to knowingly and willfully offer, pay, solicit, or receive kickbacks to encourage or reward referrals for health services paid for by federal health programs like Medicare.
The OIG said this particular arrangement poses a sufficiently low risk of fraud and abuse, so the office wonât sanction the companies involved. The OIG was careful to note that its advisory opinion is limited to the parties involved.
By making the opinion public, other compliance officers can get a sense of the enforcement agencyâs approach and perhaps seek guidance for their own arrangements.
âThis advisory opinion is limited in scope to the arrangement and has no applicability to any other arrangements that may have been disclosed or referenced in your request for an advisory opinion or supplemental submissions,â the OIG said.
Under the arrangement, the Medigap plan would offer a $100 premium credit to each policyholder who selects a network hospital for a Medicare-covered inpatient stay. The premium credit would be applied to the next premium payment due to the Medigap plan after the policyholderâs inpatient stay, reducing the amount that person would owe.
The OIG said itâs unlikely this arrangement would result in overutilization of health-care items or services or pose a risk of increased costs to federal health-care programs.
âThe Medigap Plan is an offeror of Medigap policies, with financial responsibility for all Policyholder costs that its policies may cover,â the OIG said. âBecause it is generally in the Medigap Planâs financial interest to ensure appropriate utilization and costs, we believe it is unlikely that it would use either the offer of a premium credit to its Policyholders or savings realized from the Network Hospitalsâ discounts on the Medicare Part A inpatient deductibles to promote inappropriate utilization by its Policyholders.â
Medicare wants to pay acute care hospitals 2.3%âor nearly $10.8 billionâmore for outpatient services next year, the Biden administration announced Monday.
The proposed rule (RIN 0938-AU43) from the Centers for Medicare & Medicaid Services would also increase the penalty for hospitals that donât comply with the hospital price transparency final rule.
The agency is proposing a minimum penalty of $300 a day for smaller hospitals with an inpatient count of 30 or fewer. And a âpenalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500,â the proposal said. Penalties could reach a maximum of $109,500 per hospital for a full year of noncompliance, the rule said.
âAs President Biden made clear in his executive order promoting competition, a key to price fairness is price transparency,â Health and Human Services Secretary Xavier Becerra said in a statement.
âWith todayâs proposed rule, we are simply showing hospitals through stiffer penalties: concealing the costs of services and procedures will not be tolerated by this Administration,â Becerra said.
Hospital reporting data shows wide variation in prices âeven within the same hospital or the same system, depending on what each insurance plan has negotiated with that hospital,â the rule explained.
âCMS takes seriously concerns it has heard from consumers that hospitals are not making clear, accessible pricing information available online, as they have been required to do since January 1, 2021,â the agency said in a statement.
Medicare hospital payments would reach roughly $82.7 billion in 2022 under the proposed rule.
In its March report to Congress, the Medicare Payment Advisory Commission had recommended a 2% payment update for hospitals in 2022, noting it âwould be enough to maintain beneficiariesâ access to care and keep payment rates close to the cost of delivering high-quality care efficiently.â
In 2019, fee-for-service Medicare paid acute care hospitals $186 billion for 8.7 million inpatient stays on behalf of 5.5 million beneficiaries and 97.1 million outpatient visits for 20.6 million beneficiaries.
The proposed rule would also increase Medicare payments for ambulatory surgical centers by 2.3% next year.
The commission has urged the HHS secretary to stop all payment updates for surgical centers until the facilities start providing more details to the CMS about their actual costs.
The proposed rule calls for public comment on âmethods that would mitigate the burden of reporting costs on ambulatory surgical centers while also collecting enough data to reliably use such data in the determination of ASC costs.â
Senate Democrats are debating lowering the Medicare eligibility age as part of the $3.5-trillion “soft” infrastructure package, at the risk of jeopardizing centrist support for a measure being pushed by Sen. Bernie Sanders (I-Vt.).
Why it matters: Giving Americans over age 60 access to Medicare would force Democrats to either add an estimated $200 billion to their overall infrastructure price tag or cut other progressive priorities currently in the package.
The intrigue: The true cost of Sanders’ ambitious plan to expand the social safety net is difficult to determine, in part, because Senate Democrats havenât been precise about how long they plan to fund new programs.
Between the lines: While Biden didnât initially run on expanding access to Medicare, he agreed to support lowering the age from 65 to 60 in April 2020, when his campaign worked on a unity platform with Sanders’ team.
Be smart: Democrats are bracing for an official âscoreâ from the Congressional Budget Office that’s significantly higher than their advertised price tag â $3.5 trillion.
Hospital groups are raising alarms on Capitol Hill over the possibility that a bipartisan infrastructure package will be paid for partly by Covid-19 relief funds earmarked for health-care providers and an extension of Medicare cuts.
Health care trade groups launched a lobbying blitz earlier this month, with the American Hospital Association, Americaâs Essential Hospitals and seven other hospital groups sending letters to House and Senate leaders, warning lawmakers not to tap into health care funds to pay for a $579 billion infrastructure agreement struck with President Joe Biden, which could come up for a vote in the Senate this week.
Hospitals are worried that lawmakers want to claw back the $24 billion in unspent Covid-19 relief funds and extend beyond 2030 mandatory sequestration, which would tack on more years of expected automatic Medicare cuts. The AHA and other groups are arguing they need the relief funds and sequestration extensions should only be considered for health care-related policies.
âThe precedent has been for using Medicare dollars for Medicare,â AHA Executive Vice President Stacey Hughes told Bloomberg Government in an interview.
Early frameworks for the infrastructure deal listed an extension of sequestration and collecting unspent pandemic aid. Lawmakers involved, however, said last week the details remain fluid. Senate Majority Leader Chuck Schumer (D-N.Y.) set a Wednesday deadline to wrap up talks on the package, giving hospitals until then to get their message across, Alex Ruoff reports.
Last month, Republicans and Democrats in Congress came together to announce a historic bipartisan deal on a $1.2 trillion infrastructure bill.
For months, members on both sides of the aisle worked together to negotiate a compromise that will improve the lives of Americans all across the country. As the drama unfolded, we all saw what can happen when congressional leaders are determined. We now need Speaker of the U.S. House of Representatives Nancy Pelosi (D-Calif.) and Senate Majority Leader Chuck Schumer (D-N.Y.) to make lowering prescription drug prices a top priority.
Over the last 15 months, families have struggled to make ends meet in an unprecedented way. Millions of Americans were laid-off, couldnât pay their bills or put food on the table, and the federal and local government, nonprofits and charity organizations came together to provide whatever support they could to keep these families afloat. Evictions were frozen, food bank distribution was at an all-time high, and extra unemployment insurancewas distributed to those in need.Â
One cost that was not supplemented and that families could not cut was their medical prescriptions. Instead of support during a global pandemic, pharmaceutical companies chose to raise the price of nearly 1,000 drugs by an average of 4.5 percent. If weâve learned nothing else during this crisis it is that time and time again pharmaceutical companies will take advantage of and hold hostage sick and older Americans in order to line their pockets.
Americans have had enough. According to KFF, 88 percent of Americans want the government to negotiate with pharmaceutical companies to lower prescription drug costs under Medicare and private insurance. Unusually, elected Republicans and Democrats are on the same page too. After good faith negotiations, countless bipartisan bills, like the Ensuring Timely Access to Generics Act and the Prescription Drug Pricing Reduction Act, among others, have been introduced to give Americans relief. Unfortunately, these measures continue to be left on the cutting room floor as Congress moves forward with other reforms.
With the midterm elections coming up next year, and the Democratic majority very much in jeopardy, Democrats need to consider the people who typically come out to vote in the midterms â seniors. Eighty-nine percent of American seniors take prescription medications, with one in four struggling to afford drug costs. In 2018, these companies raised the price of 1,646 drugs covered by Medicare Part D by 3.5 times the rate of inflation. These price hikes hit seniors particularly hard considering that 50 percent of Medicare beneficiaries live on $29,650 a year or lower.Â
To make matters worse, dozens of states have ended unemployment benefitsand the eviction moratorium is set to expire nationwide at the end of the month, likely putting a further strain on millions of Americans who already canât afford their medication.
We know Congress can do it. Multiple times this year, weâve seen Congress pass legislation to improve Americansâ lives. On the heels of a global pandemic and heading into a midterm election with very slight Democratic majorities, Democrats need to listen to the millions of Americans who expect prescription drug pricing reform to be a top priority this year. The Democratic majority may depend on it.
Sean Shaw served in the Florida House of Representatives and was the 2018 Democratic nominee for attorney general. He is the founder of People Over Profits and an attorney at Vanguard Attorneys.
Last month, Republicans and Democrats in Congress came together to announce a historic bipartisan deal on a $1.2 trillion infrastructure bill. Â
New Jersey Democratic Sen. Bob Menendez isn’t ready to commit to voting for a budget blueprint that will count on hundreds of billions of dollars extracted from the prescription drug industry to help offset $3.5 trillion in new spending over a decade.
âIâm not ready to make any decisions on the budget resolution,â Menendez said Thursday in a brief interview. He reiterated his concerns that Democratsâ plans to have Medicare negotiate drug prices will be a tax on pharmaceutical companies and that savings wonât be passed onto consumers.
“The only industry that gets directly, I’ll call taxed, mostly is the pharmaceutical industry. You have to show me that you’re reducing the cost of prescription drugs to the consumers,â he said. âBecause you keep taking money out of the industry and we never use it in a way that helps the consumer.â
Top Democrats say drug price savings will be used to expand Medicare to cover dental, vision and hearing benefits, among other new spending proposals.
Senate Budget Chairman Bernie Sanders, I-Vt., has said more than $600 billion could be wrung out of various proposals to cut drug costs, mainly through government negotiation to cap prices at a level commensurate with those of other wealthy countries.
Menendez questioned whether consumers would ultimately benefit if those savings go to other programs. “Are we going to now take the $600 billion in savings and reduce [prices] to the consumer, or not?” he asked. “Because otherwise we’ll still have the problem that prescription drug costs are too high and what are we going to do then?”
Menendez is one of several Democratic senators who have concerns or questions about components of a leadership-negotiated outline for a $3.5 trillion reconciliation bill.
The outline is vague on policy details, to be worked out later in implementing legislation after the chamber adopts its budget resolution with reconciliation instructions to the appropriate committees. But some senators are seeking more details in advance of that vote to ensure they’re not blessing a blueprint that will lead to legislation they can’t support.
Senate Democrats have until Wednesday to reach consensus among all 50 of their members on the budget resolution, a deadline Senate Majority Leader Charles E. Schumer set Thursday.
To force the deadline, Schumer scheduled a procedural vote on the legislative vehicle for a separate but connected bipartisan infrastructure bill on Wednesday. He wants to have the votes locked in for both measures — 51 for the budget resolution and 60 for the bipartisan infrastructure bill — by the time of that vote.
“We have to have total agreement on both before we move either,” Schumer told reporters Tuesday.
Several senators said Thursday they still need to study the $3.5 trillion budget reconciliation proposal before committing to vote for the budget resolution.
âI like the general structure, but weâll see,â Sen. Angus King, I-Maine.
Sen. Jon Tester said he will vote to begin debate on the budget but couldnât commit to vote for its final adoption without seeing all the details.
âLet’s do the debate. Let’s figure out how we can make this thing work,â the Montana Democrat said.
Menendez earlier this week reintroduced a bill with Sen. Bill Cassidy, R-La., to cap cost-sharing in Medicareâs Part D prescription drug benefit and restructure government financing as an example of what he is looking for in a final package.
Under House Democratsâ approach, the U.S. would base maximum prices on what other wealthy countries pay. Wyden previously said the measure is causing some pushback among Senate Democrats, and at least one House Democrat, California Rep. Scott Peters, who also represents a number of biotech firms, is opposed.
[Onetime backer of drug pricing bill turns foe]
Another Democrat, Rep. Kurt Schrader of Oregon, supports the idea of negotiation but has said he will vote against a partisan reconciliation package because spending is too high.
Meanwhile more than two dozen vulnerable House Democrats, led by Pennsylvania’s Susan Wild and Michigan’s Haley Stevens, sent a letter to party leadership Wednesday urging negotiations be included in the final bill.
Democrats say reducing what Medicare pays for drugs would yield substantial savings to help finance other pieces of the reconciliation package; the CBO has previously estimated the price negotiation provisions of the House-passed bill would save roughly $500 billion. Sanders said he expects the final measure to include price negotiation provisions.
âPeople are tired of paying the highest prices in the world for prescription drugs,â he said. âTheyâre tired of the greed of the pharmaceutical industry and they want the Congress to act.â
Democrats also say they will assume savings from repealing a rule finalized under the Trump administration that would have required discounts negotiated by drugmakers and pharmacy benefit managers — who manage insurers’ prescription drug benefits — to be passed through directly to the pharmacy and reflected in consumer prices.
The CBO estimated that if the rule took effect, Medicare spending could increase by as much as $170 billion. Among other reasons, pharmacy benefit managers would no longer be able to use rebates negotiated with drugmakers to reduce premiums for plan members. That in turn would increase Medicare Part D premiums and require more federal subsidies, the CBO said.
The rule was blocked in court and never formally took effect, so repealing it likely would only create savings on paper. But future litigation could always undo the prior ruling.
The prescription drug lobby’s main trade group on Thursday came out swinging against the Democratic plan, citing the potential use of drug price savings to offset other programs, as well as repeal of the Trump-era rule.
“This plan puts in motion a system that will allow government bureaucrats to tell seniors which medicines they can have while repealing a policy that would immediately lower what they pay at the pharmacy counter,” said Debra DeShong, executive vice president for public policy at the Pharmaceutical Research and Manufacturers of America. “This isnât about lowering costs for prescription drugs. The real goal of this budget is to upend Medicare to help pay for Tesla tax credits and other government programs at seniorsâ expense.”
DeShong is a longtime Democratic operative who worked for former New Jersey Sen. Robert Torricelli, as well as the Democratic National Committee and former Massachusetts Sen. John Kerry’s 2004 presidential campaign.
Another provision Democrats may want to see more details on before committing to vote for a budget resolution is a proposed border carbon adjustment, effectively a tariff or tax on imported goods that don’t meet stringent emissions standards.
The fee, whose cost could be passed on to consumers, could leave Democrats open to criticism that they are raising taxes on working families.
House Republicans in 2017 were forced to shelve a broader policy that would have taxed imports at the corporate rate while exempting exports from the tax, after a lobbying blitz by affected industries objecting to what was dubbed a “border adjustment tax.”
Biden has pledged not to raise taxes on anyone making less than $400,000 a year, but top Democrats say they will figure out a way to shield lower- and middle-income consumers.
âOn my watch, there is not going to be carbon policy that hurts workers and their families,â Wyden said Thursday. âThat means honoring the Biden pledge.â
But Wyden said he would need more time to consider the mechanics of implementation. Other Democrats dismissed the criticism outright, saying a border fee should not be considered a tax.
The care was ordinary. A hospital in Modesto, California, treated a 30-year-old man for shoulder and back pain after a car accident. He went home in less than three hours.
The bill was extraordinary. Sutter Health Memorial Medical Center charged $44,914 including an $8,928 âtrauma alertâ fee, billed for summoning the hospitalâs top surgical specialists and usually associated with the most severely injured patients.
The case, buried in the records of a 2017 trial, is a rare example of a courtroom challenge to something billing consultants say is increasingly common at U.S. hospitals.
Tens of thousands of times a year, hospitals charge enormously expensive trauma alert fees for injuries so minor the patient is never admitted.
In Florida alone, where the number of trauma centers has exploded, hospitals charged such fees more than 13,000 times in 2019 even though the patient went home the same day, according to a KHN analysis of state data provided by Etienne Pracht, an economist at the University of South Florida. Those cases accounted for more than a quarter of all the stateâs trauma team activations that year and were more than double the number of similar cases in 2014, according to an all-payer database of hospital claims kept by Floridaâs Agency for Health Care Administration.
While false alarms are to be expected, such frequent charges for little if any treatment suggest some hospitals see the alerts as much as a money spigot as a clinical emergency tool, claims consultants say.
âSome hospitals are using it as a revenue generator,â Tami Rockholt, a registered nurse and medical claims consultant who appeared as an expert witness in the Sutter Health car-accident trial, said in an interview. âItâs being taken advantage ofâ and such cases are âway more numerousâ than a few years ago, she said.
Hospitals can charge trauma activation fees when a crack squad of doctors and nurses assembles after an ambulance crew says itâs approaching with a patient who needs trauma care. The idea is that life-threatening injuries need immediate attention and that designated trauma centers should be able to recoup the cost of having a team ready â even if it never swings into action.
Those fees, which can exceed $50,000 per patient, are billed on top of what hospitals charge for emergency medical care.
âWe do see quite a bit of non-appropriate trauma charges â more than youâd see five years ago,â said Pat Palmer, co-founder of Beacon Healthcare Costs Illuminated, which analyzes thousands of bills for insurers and patients. Recently âwe saw a trauma activation fee where the patient walked into the ERâ and walked out soon afterward, she said.
The portion of Florida trauma activation cases without an admission rose from 22% in 2012 to 27% last year, according to the data. At one Florida facility, Broward Health Medical Center, there were 1,285 trauma activation cases in 2019 with no admission â almost equal to the number that led to admissions.
âTrauma alerts are activated by EMS [first responders with emergency medical services], not hospitals, and we respond accordingly when EMS activates a trauma alert from the field,â said Jennifer Smith, a Broward Health spokesperson.
Florida regulations allow hospitals themselves to declare an âin-hospital trauma alertâ for âpatients not identified as a trauma alertâ in the field, according to standards published by the Florida Department of Health.
At some hospitals, few patients whose cases generate trauma alerts are treated and released the same day.
At Regions Hospital, a Level I trauma center in St. Paul, Minnesota, patients who are not admitted after a trauma team alert are âvery rareâ â 42 of 828 cases last year, or about 5%, said Dr. Michael McGonigal, the centerâs director, who blogs at âThe Trauma Pro.â
âIf youâre charging an activation fee for all these people who go home, ultimately thatâs going to be a red flagâ for Medicare and insurers, he said.
In the Sutter case in Modesto, the patient sued a driver who struck his vehicle, seeking damages from the driver and her insurer. Patient âlooks good,â an emergency doctor wrote in the records, which were part of the trial evidence. He prescribed Tylenol with hydrocodone for pain.
âIf someone is not going to bleed out, or their heart is not going to stop, or theyâre not going to quit breathing in the next 30 minutes, they probably do not need a trauma team,â Rockholt said in her testimony.
Like other California hospitals with trauma center designations, Sutter Health Memorial Medical Center follows âcounty-designated criteriaâ for calling an activation, said Sutter spokesperson Liz Madison: âThe goal is to remain in position to address trauma cases at all times â even in the events where a patient is determined healthy enough to be treated and released on the same day.â
Trauma centers regularly review and revise their rules for trauma team activation, said Dr. Martin Schreiber, trauma chief at Oregon Health & Science University and board chair at the Trauma Center Association of America, an industry group.
âIt is not my impression that trauma centers are using activations to make money,â he said. âActivating patients unnecessarily is not considered acceptable in the trauma community.â
Hospitals began billing trauma team fees to insurers of all kinds after Medicare authorized them starting in 2008 for cases in which hospitals are notified of severe injuries before a patient arrives. Instead of leaving trauma team alerts to the paramedics, hospitals often call trauma activations themselves based on information from the field, trauma surgeons say.
Reimbursement for trauma activations is complicated. Insurers donât always pay a hospitalâs trauma fee. Under rules established by Medicare and a committee of insurers and health care providers, emergency departments must give 30 minutes of critical care after a trauma alert to be paid for activating the team. For inpatients, the trauma team fee is sometimes folded into other charges, billing consultants say.
But, on the whole, the increase in the size and frequency of trauma team activation fees, including those for non-admitted patients, has helped turn trauma operations, often formerly a financial drain, into profit centers. In recent years, hundreds of hospitals have sought trauma center designation, which is necessary to bill a trauma activation fee.
âThere must have been a consultant that ran around the country and said, âHey hospitals, why donât you start charging this, because you can,ââ said Marc Chapman, founder of Chapman Consulting, which challenges large hospital bills for auto insurers and other payers. âIn many of those cases, the patients are never admitted.â
The national number of Level I and Level II trauma centers, able to treat the most badly hurt patients, grew from 305 in 2008 to 567 last year, according to the American College of Surgeons. Hundreds of other hospitals have Level III or Level IV trauma centers, which can treat less severe injuries and also bill for trauma team activation, although often at lower rates.https://datawrapper.dwcdn.net/uhe6r
Emergency surgeons say they walk a narrow path between being too cautious and activating a team unnecessarily (known as âovertriageâ) and endangering patients by failing to call a team when severe injuries are not obvious.
Often âwe donât know if patients are seriously injured in the field,â said Dr. Craig Newgard, a professor of emergency medicine at Oregon Health & Science University. âThe EMS providers are using the best information they have.â
Too many badly hurt patients still donât get the care they need from trauma centers and teams, Newgard argues.
âWeâre trying to do the greatest good for the greatest number of people from a system perspective, recognizing that itâs basically impossible to get triage right every time,â he said. âYouâre going to take some patients to major trauma centers who donât really end up having serious injury. And itâs going to be a bit more expensive. But the trade-off is optimizing survival.â
At Oregon Health & Science, 24% of patients treated under trauma alerts over 12 months ending this spring were not admitted, Schreiber said.
âIf this number gets much lower, you could put patients who need activation at risk if they are not activated,â he said.
On the other hand, rising numbers of trauma centers and fees boost health care costs. The charges are passed on through higher insurance premiums and expenses paid not just by health insurers but also auto insurers, who often are first in line to pay for the care of a crash victim.
Audits are uncommon and often the system is geared to paying claims with little or no scrutiny, billing specialists say. Legal challenges like the one in the Sutter case are extremely rare.
âMost of these insurers, especially auto insurance, do not look at the bill,â said Beth Morgan, CEO of Medical Bill Detectives, a consulting firm that helps insurers challenge hospital charges. âThey automatically pay it.â
And trauma activation charges also can hit patients directly.
âSometimes the insurance companies will not pay for them. So people could get stuck with that bill,â Morgan said.
A few years ago, Zuckerberg San Francisco General Hospital charged a $15,666 trauma response fee to the family of a toddler who had fallen off a hotel bed. He was fine. Treatment was a bottle of formula and a nap. The hospital waived the fee after KHN and Vox wrote about it.
Trauma alert fatigue can add up to a nonfinancial cost for the trauma team itself, McGonigal said.
âEvery time that pager goes off, youâre peeling a lot of people away from their jobs only to see [patients] go home an hour or two later,â he said.
âSome trauma centers are running into problems because they run themselves ragged. And there is probably unneeded expense in all the resources that are needed to evaluate and manage those patients.â
The Biden administration is looking at the idea of expanding Medicareâs definition of medically-necessary dental coverage, according to a senatorâs office, and such a move potentially could bring down the cost of congressional Democratsâ plan to add a new dental benefit to Medicare as part of a broad budget reconciliation package later this year. However, the administration has not committed to any action and whether the move would bring down costs depends on several factors, stakeholders said.
A spokesperson for Sen. Ben Cardin (D-MD), a long-standing Medicare dental coverage advocate, said the senator has supported expanding the medically-necessary dental services definition to cover additional medically necessary conditions, and continues to encourage the administration to make this change. The spokesperson said the request is on the administrationâs radar.
CMS and the White House did not respond to a request for comment.
Medicare Part A currently covers a narrow set of medically-necessary dental services received in a hospital, and some Medicare Advantage plans offer dental benefits. Medicare statute prohibits coverage of routine dental care and dental prostheses.
Consumer advocates and progressive lawmakers have led a push for expanding Medicare benefits to include dental care, along with hearing and vision, and they hope to accomplish this through the budget reconciliation package. Senate Majority Leader Chuck Schumer (D-NY) announced Tuesday night that he intends to fully fund Medicare dental, hearing and vision care through the $3.5 trillion Senate budget resolution that budget committee Democrats agreed to earlier this week.
Schumer didnât say how much money could be devoted to the new benefits. But draft Senate budget documents circulating in June put the cost at $299.6 billion over 10 years, with $233.6 billion of that to pay for dental care.
The Congressional Budget Office score of a new Medicare dental benefit might be driven down if CMS expanded the definition of medically-necessary dental coverage, said Meredith Freed, a policy analyst at Kaiser Family Foundation.However, the impact would depend on what services CMS moved to consider medically-necessary and which would be covered under a new law, among other things, Freed added.
Melissa Burroughs, associate director for strategic partnerships at Families USA, said itâs unclear how much an expanded definition of medically-necessary dental coverage would bring down the CBO score for a dental benefit, but she said research shows covering dental services would bring down other health care costs.
A community statement from over 150 medical and beneficiary organizations — including Families USA, the Center for Medicare Advocacy, AARP and the American Medical Association — points out that untreated oral infections are linked to many chronic conditions, which disproportionately affect Medicare beneficiaries and thus pose significant costs to the program. The statement implores Congress and the administration to look at options for extending dental coverage to Medicare beneficiaries.
Consumer advocates have called on CMS to expand the medically-necessary dental coverage definition for years and across administrations, saying the agency already has the authority to do so, but no action has been taken by CMS in the past. Then-CMS Administrator Seema Verma said in early 2019 that the agency was looking closely at medically-necessary dental benefits but worried the agency didnât have the authority to cover expanded care.
The Center for Medicare Advocacy believes the statutory exclusion of dental care in Medicare doesnât apply when the dental care is primarily for the purpose of preventing risks from other medical conditions or treatment, like when oral infections need to be addressed before heart surgery or chemotherapy, said Center for Medicare Advocacy Policy Attorney Kata Kertesz.
âAuthorizing dental coverage in such circumstances does not require legislation, but could be accomplished by CMS more quickly, through a national coverage determination or policy guidance,â Kertesz said in an email.
The Biden administration hasnât made any commitment towards expanding medically-necessary dental coverage, Kertesz said. But she added the Center for Medicare Advocacy has sensed some administration interest in and an understanding of the benefits of expanding the definition. CMA remains hopeful the issue will be addressed, Kertesz added. — Maya Goldman
Hospitals, doctors, hospices, home health agencies and others are asking Senate leadership in both parties not to extend Medicare sequestration to pay for some of the bipartisan infrastructure deal, but one lobbyist says there are a number of unanswered questions about how Medicare sequester cuts could factor into both the infrastructure bill and the Senate budget resolution deal announced earlier this week.
The American Hospital Association, American Medical Association, American Health Care Association, National Association for Home Care & Hospice, National Hospice and Palliative Care Organization and Association for Clinical Oncology asked Senate Majority Leader Chuck Schumer (D-NY) and Senate Minority Leader Mitch McConnell (R-KY) in a July 15 letter not to use Medicare cuts — through an extension of sequestration — to pay for the bipartisan infrastructure package.
Hospital groups had previously urged lawmakers to avoid using Medicare cuts to pay for non-Medicare projects last month when a document surfaced listing a sequester extension as an offset. But lawmakers continue to discuss how to pay for the infrastructure deal and reportedly are looking at changing some offsets, spurring health care providers to step up their lobbying to keep a sequester extension out of the package. Time is of the essence as Schumer has indicated he wants to move the infrastructure package as soon as this month.
AHA separately on Friday (July 16) also urged lawmakers not to take back COVID-19 provider relief funds to offset unrelated spending, and asked Congress to push HHS to release the rest of that funding.
On the sequester, the provider groups say they donât believe Medicare funds should be used to pay for non-health care programs.
âAmericans rely on hospitals and health systems, physicians, skilled nursing facilities, hospice and home care to care for them and maintain their health. We understand that addressing core infrastructure needs can allow us to continue to serve our communities and our patients,â the letter from the various provider groups about the sequester says.
âHowever, we are opposed to the use of an extension of mandatory Medicare sequestration as a pay-for in any infrastructure package. Additionally, we do not believe that Medicare funds should be used to pay for non-health care programs.â
The groups also say that extending sequestration adds a âdestabilizing element to health care accessâ as experience has shown that Medicare pay bumps already donât account for cost increases.
Lobbyists say that without infrastructure bill text, itâs not clear exactly how changes to sequestration cuts could play out in the infrastructure package, but the groups say the cuts should be taken off the list of possible pay-fors.
Schumerâs office did not respond to questions about the groupsâ letter, or to questions on whether additional sequestration cuts coming down the pike due to the cost of the American Rescue Plan might be averted through either the infrastructure or budget resolution deals.
One lobbyist also said stakeholders will be watching to see how lawmakers handle the cost of the new packages, if they arenât completely paid for, or whether any additional costs that could lead to more sequestration cuts might be kept from the so-called PAY-GO scorecard.
The lobbyist said those questions have all been asked, but nothing is clear at the moment.
Schumer has said the budget resolution deal could be fully paid for and such an option is âon the table.â
âOne of the things that was presented in our caucus is that we could fully pay for the bill, that is one of the options on the table, that is doable,â Schumer said at a recent press conference.
The Medicare sequester is currently on hold until 2022.
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