Sen. Mike Braun (R-IN) is rallying support for his and Sen. Bernie Sanders’s (I-VT) Health Care PRICE Transparency Act 2.0 (S. 3548) to combat the country’s soaring hospital costs, purportedly driven by provider consolidation and exacerbated by widespread pricing ambiguity in the industry.
The bipartisan duo’s landmark price transparency bill, positioned as a comprehensive successor to the House-passed Lower Costs, More Transparency Act (H.R. 5378), would require hospitals, clinical diagnostic laboratories, imaging service providers, and ambulatory surgical centers to publicly disclose detailed pricing information for all their services in a consumer-friendly format.
Under the legislation, the HHS secretary would be responsible for setting up and monitoring compliance procedures and enforcing penalties for violations.
The Health Care PRICE Transparency Act 2.0 is currently stalled in the Senate’s health committee, and it remains unclear when Sanders will schedule a markup. Braun called for movement on the legislation during a Senate Aging Committee hearing Thursday (July 11).
“I look forward to continuing to work with my colleagues on both sides of the aisle to get the Health Care Price Transparency Act 2.0 to the President’s desk,” Braun, the Senate Aging Committee’s ranking Republican, said in his opening statement. “It is time to deliver for our seniors, families and Americans all across the country.”
Health care spending in America, notoriously more than twice those of peer nations despite having no better health outcomes to show for it, accounted for 17.3% of the country’s Gross Domestic Product (GDP) in 2022 and is expected to reach nearly 20% in 2032, according to the latest estimates from the National Health Expenditure Accounts (NHEA).
During the Senate Aging Committee’s health care transparency hearing, Braun said that steadily rising costs are due to the health care industry pretending to be part of a ‘free enterprise’ system, which should promote transparency and competition. But these principles don’t apply to today’s industry, he said.
Federal law already requires hospitals to post all prices online in an accessible format. But as of March 2024, only 34.5% of the 2,000 sampled hospitals are fully compliant with these regulations, according to a new ‘health care price transparency’ report unveiled by Braun on the same day as the hearing.
“Our bill puts the power back in the hands of Americans,” Braun said during the hearing. “It starts to make it consumer-driven, and it starts to break up the oligopoly — the monopoly, nearly — of how health care is provided.”
Thursday’s transparency hearing follows several letters from health care coalitions sent last month, urging the Senate Finance Committee to advance the site-neutrality and honest billing provisions in the Lower Costs, More Transparency Act — which passed the House last December with sizable bipartisan support but has since stalled in the upper chamber.
Although Thursday’s hearing was held by a different committee than requested, it’s still important that multiple committees are discussing health care costs and transparency, according to Darbin Wofford, a senior health policy advisor at the left-leaning Third Way.
The Senate Aging Committee had been planning its own price transparency hearing for quite some time, and it’s significant that committee Chairman Sen. Bob Casey (D-PA) is also a member of the Senate Finance and health committees, Wofford added.
The nonprofit think tank, Third Way, was one of many organizations that signed onto multiple coalition letters as part of an organized pressure campaign for Senate action on the House-passed transparency bill.
The Congressional Budget Office (CBO) estimated that the House’s full transparency package would save taxpayers $715 million from 2024 to 2033. Most of the bill’s transparency measures, which mandate an ‘estimated amount of cost-sharing of prices’ instead of the actual list prices, wouldn’t impact the budget because they essentially codify existing requirements, according to CBO.
The only transparency provision that would save taxpayer money is the one requiring off-campus hospital outpatient departments to have a separate provider identification number, as this would help insurers who have a policy of not paying for hospital facility fees for off-campus providers and might encourage more insurers to adopt similar policies, the CBO said March 22 in response to questions submitted for the record from the House Energy & Commerce’s health panel members.
Sophia Tripoli, senior director of health policy at Families USA and a witness at Thursday’s hearing, told Inside Health Policy afterward that the Senate’s price transparency bill improves on the House-passed bill by requiring negotiated rates to be presented in dollar amounts and increasing fines for non-compliance.
The witnesses at the hearing—including industry experts, a consumer advocate, and a former state health care administrator—argued that health care monopolies, especially those owned by private equity firms, exploit the industry’s lack of price transparency to inflate costs and degrade the quality of patient care.
Chris Whaley, the associate director of the Center for Advancing Health Policy through Research, said during the hearing that over 2,000 hospital mergers have occurred in the country over the past two decades.
The witnesses collectively urged Congress to enhance employers’ and unions’ access to health care claims data, increase transparency in health care provider ownership, and address anti-competitive contract terms between providers and insurers—all provisions outlined in Sens. Braun and Sanders’ bill.
Zach Riddle, Braun’s communications director, told IHP in a written statement on Thursday that the primary focus is garnering member support for the legislation while evaluating any opportunities to advance the bill as they become available.
To further fulfill Atlantic Health System’s commitment to providing the highest-quality care to every patient at the time or place most convenient to them, Atlantic Health is pleased to announce the creation of a joint venture with Premier Health Associates, LLC.
Premier Health is a leading multi-specialty physician group, focused on primary-care delivery across 16 locations in Sussex, Warren and Morris Counties and Pike County in Pennsylvania.
Premier Health will join the Atlantic Health System network of care, expanding Atlantic Health’s ability to provide comprehensive primary care services to the region. Premier Health offers eleven different specialists representing eight different specialties of care including gastroenterology, orthopedics/sports medicine, endocrinology, pulmonology, rheumatology, general/colorectal surgery, interventional pain management, chiropractic medicine, acupuncture, and imaging.
“Atlantic Health System and Premier Health share a common view of how we can best serve our patients – by reaching them at the right place, at the right time and for the right cost,” said Kevin Lenahan, Executive Vice President, Chief Business and Strategy Officer, Atlantic Health System. “Together we can make the best parts of our organizations even better on behalf of the communities in northwestern New Jersey, who can visit their trusted, primary care physician knowing the strength of the entire Atlantic Health network of care is in support.”
Premier Health’s 38 health care professionals conduct approximately 177,000 patient visits annually at 15 physicians offices and one ambulatory surgery center, making it a critical health care resource to the community.
Further deepening its ties to Atlantic Health, Premier Health will implement Atlantic Health’s instance of the Epic electronic health record (EHR) platform at the beginning of 2025. Epic securely keeps patients’ complete and up-to-date medical records, allowing physicians and patients to share information throughout the Atlantic Health System network seamlessly, regardless of the location where care is provided.
“A personalized relationship between patient and physician is the cornerstone of building the health and wellness of a community,” said Steven Sheris, MD, Executive Vice President, Chief Physician Executive, Atlantic Health System. “The physicians of Atlantic Health System and Premier Health will bring their patient-centered focus to this new venture, helping ensure doctors enjoy the life-improving work of their practice while patients benefit from superior outcomes.”
Premier Health’s mission is to establish comfortable and trusting relationships with the physician or caregiver of their choice, approaching healthcare from a family-centered perspective in a collaborative setting. By joining Atlantic Health, they will be able to continue reaching new patients while offering seamless access to new levels of care.
“We have always had a strong working and clinical relationship with our new partners at Atlantic Health System. By working to create a new entity that includes physician ownership within the venture, we felt it would be a perfect vehicle for us to achieve clinical integration within Atlantic Health,” said David Bollard, DO, President, Premier Health. “This JV will attract providers who wish to access the extensive benefits of a large partner like Atlantic Health, while still offering an opportunity for practice ownership within their community. It was this model that attracted all of our present physicians and will undoubtably attract many more in the future.”
Under the terms of the joint venture, Atlantic Health System will be the majority owner of the new organization, which will retain the title of Premier Health Associates.
The Centers for Medicare and Medicaid Services proposed payment updates for hospitals and physicians. House appropriators advanced legislation to fund the federal health department next year. But first …
State and local governments are buying up — and retiring — residents’ medical debt.
Medical debt is a growing burden for millions of people around the country, from parents in Illinois to immigrants in Colorado to residents of the “Diabetes Belt” across the South, and it’s now being recognized as a health-care problem. People often forgo care or prescriptions if they have debt, according to a KFF Health News investigation, and the psychological toll can be steep, too.
The Biden administration proposed barring medical debt from credit reports. This morning, Senate Health Committee Chair Bernie Sanders (I-Vt.) will convene a hearing in D.C. on medical debt.
Now local governments are looking at how they can assist residents by buying up medical debt on the cheap and retiring it.
Under a measure the Los Angeles County Board of Supervisors approved unanimously last month, the county will enter into a pilot program with Undue Medical Debt (previously known as RIP Medical Debt), a national organization that turns the debt collection process on its head. Instead of buying outstanding debt from hospitals and pursuing patients for payment, as commercial debt collectors do, Undue Medical Debt looks to buy debt, usually for pennies on the dollar, then retire it.
Los Angeles County’s $5 million investment is expected to allow Undue Medical Debt to help 150,000 low-income residents and eliminate $500 million in debt. It’s one component of the county’s larger medical debt plan, which includes tracking hospitals’ role in feeding the $2.9 billion problem, boosting bill retirement for low-income patients and monitoring debt collection practices.
Four in 10 adults in the United States struggle with health-care debt, and Los Angeles County has labeled it a public health issue on par with diabetes and asthma.
The logic behind the effort is simple. “Getting health care should never make anyone sicker,” said Naman Shah, medical and dental affairs director at the county public health department.
Undue Medical Debt has contracted with more than a dozen city, county and state governments across the country to provide local debt relief, including Cook County, Ill. (home to Chicago); Toledo; Arizona and New Jersey.
Since its inception, Undue Medical Debt has relieved almost $12 billion in medical debt across the country.
Beginning in 2022, Cook County has leveraged American Rescue Plan dollars — federal emergency funds made available during the coronavirus pandemic — to wipe out over $382 million in medical debt for more than 213,000 residents. About 15 other state or local governments have also used American Rescue Plan funds to retire medical debt, according to Undue Medical Debt, and other jurisdictions are developing similar plans.
Mona Shah of Community Catalyst, a national health equity and policy organization, applauds the local government moves but cautions that one-time debt relief goes only so far. She endorsed Los Angeles County’s approach: pairing debt relief with a longer-term effort to understand and address the root causes of medical debt, in part by getting a better handle on debt collection practices and helping hospitals improve their financial assistance programs.
“We don’t want to ever deny that relief, but we really need to focus on preventing medical debt from happening in the first place,” Shah said.
Nearly two years since Medicare first implemented a program requiring drug companies pay back the government when they raise the prices for drugs covered under Medicare Parts B and D faster than the rate of inflation, CMS is proposing to update its efforts and codify policies to adjust how 340B drugs and drugs currently in shortage are considered when calculating total inflation rebate amounts, the proposed rule for the calendar year 2025 physician fee schedule released Wednesday (July 10) says.
A fact sheet provided by CMS also shares how the agency seeks to update its invoicing process for inflation rebates and proposes creating a process to reconcile rebate amounts when new or revised information emerges.
CMS is proposing to remove 340B drugs units for professional claims that were submitted by Medicare suppliers associated with 340B-covered entities with dates of service during 2024 and 2023. This would align with revised guidance published in December for the Part B inflation rebate program that separates and excludes the units of drugs for which a drug maker provides a discount associated with the federal drug discount program from the units of drugs for which a manufacturer may be liable to pay a Part B inflation rebate.
Additionally, according to the fact sheet, CMS is proposing to:
CMS is proposing similar policy adjustments for the Part D inflation rebate program. The agency wants to establish a process to estimate the total number of units of a Part D rebatable drug that are provided a 340B discount and exclude these drug units from the total number of units used to calculate the total rebate amount for a Part D rebatable drug. This would apply for claims with dates of service on or after Jan. 1, 2026.
CMS is also proposing new policies that would identify a payment amount benchmark period for a Part D rebatable drug in certain instances of a missing Average Manufacturer Price (AMP), establish a method and process for reconciliation when new information surfaces regarding inflation rebate amounts, and set up civil money penalties for when drug makers are late to pay inflation rebate amounts in full in a timely manner.
CMS also wants to establish a standard method and process for issuing rebate reports to drug makers that may include the use of an online portal. CMS would first provide a preliminary rebate report and a suggestion of error period for drug makers to review the preliminary rebate amount and identify certain mathematical errors. Following the suggestion of error period, CMS will provide the official rebate report, which will include the rebate amount.
The rebate amount may be reduced for drugs currently in shortage, facing a severe supply chain disruption, or likely to be in shortage, or adjusted in the program’s reconciliation process.
When reconciling rebate amounts, CMS says it would provide drug makers with reconciled inflation rebates one full year after a company receives its rebate report. For inflation rebates under Part D, the agency is specifically proposing two regular reconciliations of a rebate amount to occur at 12 months and 36 months after the receipt of the rebate report.
“CMS is proposing to conduct two Part D reconciliations to ensure there is enough time to capture the relevant data for an accurate rebate amount. The 12-month reconciliation would provide sufficient time to capture the majority of updates to the data that encompass the rebate amount. The 36-month reconciliation would be sufficient to capture the remainder of the run-out for MDRP AMP restatements,” CMS says.
The fact sheet also clarifies how CMS plans to calculate inflation rebates for Part B and Part D drugs that are currently in shortage, facing a severe supply chain disruption or likely to be in shortage. The agency will first determine the number of days a drug has been described as “currently in shortage” on an FDA shortage list during the period when the inflation rebate is being assessed. CMS will then divide that number by the total number of days in the calendar quarter or applicable period for the rebate, and then multiply that amount by a percentage that is decreased over time.
For a Part B or Part D rebatable biosimilars or generic Part D rebatable drugs facing a severe supply chain disruption, or a generic Part D rebatable drug likely to be in shortage, drug makers will have to submit to CMS a request for a rebate reduction along with supporting documentation.
“If the drug company submits a timely and complete request and CMS determines that a reduction should be granted based on its review of the request and supporting documentation, CMS will reduce the rebate amount by 75 percent for one year regardless of whether the drug subsequently goes on an FDA shortage list during that year,” CMS says. “If a severe supply chain disruption or likely shortage is not resolved in the first year, the drug company may apply for an extension of the rebate reduction for a second year. Reductions for a severe supply chain disruption or likely shortage are limited to two consecutive years.”
This myriad of policy fixes and adjustments comes months after CMS released draft guidance for how it expects to implement the next round of its drug price negotiation program in Medicare, possibly the most controversial price control under the Inflation Reduction Act alongside inflation rebates, a $35 cap on monthly copay costs for insulin products and a complete redesign of the Part D benefit that includes a $2,000 cap on all out-of-pocket drug spending starting in 2025.
Republican lawmakers and the drug industry are primarily against further implementation of a policy permitting the government to negotiate lower drug prices for Medicare beneficiaries.
The agency is also taking input on its idea to establish a Part D claims data repository in future years of the Part D inflation rebate program, which would require 340B covered entities to submit certain data elements from 340B-identified Part D claims to the repository so CMS can identify 340B drug units to exclude from Part D inflation rebate calculations.
CMS is soliciting comments on its proposed changes until Sept. 9.
Hospitals quickly blasted CMS’ calendar year 2025 proposal to boost pay for hospital outpatient and ambulatory surgical centers by a net 2.6% increase as inadequate and also pushed back on efforts to use Medicare Conditions of Participation to drive policy changes, including by setting baseline requirements for obstetric services for the first time. Medical device stakeholders, however, were pleased with the agency’s proposals to improve pay for radiopharmaceuticals.
The draft CY 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) rule also codifies the 12-month CHIP/eligibility for children, expands coverage for formerly incarcerated people, adds new measures to the quality reporting program to advance equity and provides an add-on payment for high-cost drugs and biologics covered by the Indian Health Service (IHS).
It proposes several new measures for the quality reporting programs and would alter the process for removing measures that are not improving outcomes. CMS also seeks comments on proposed changes to the Star Quality Rating System.
In a release on the rule, CMS highlights the maternal health proposal aiming to reduce maternity-related deaths that disproportionately affect racial and ethnic minorities, most of which are preventable.
CMS has broad authority to establish health and safety regulations, including those for maternal care. However, the agency says there are currently no baseline requirements for hospitals and Critical Access Hospitals regrading organization, staffing, training, maternal health quality assessments and performance improvement (QAPI) and delivery of obstetrical services.
Therefore, CMS proposes for the first time, to revise the Conditions of Participation for OB services to add those baseline requirements and ensure all hospitals participating in Medicare are held to a consistent standard. The rules also propose changes to the CoP for hospitals and CAHs that provide emergency services, discharge planning for all hospitals and to CAH transfer protocols.
“The proposed hospital outpatient rule builds on the Biden-Harris Administration’s commitment to reducing the nation’s high maternal mortality rate and actions outlined in the White House Blueprint for Addressing the Maternal Health Crisis, increasing access to services in tribal, rural, and other underserved communities, and addressing barriers to Medicare coverage for those recently incarcerated. This proposed rule is proof that we are committed to ensuring people aren’t just covered, but that coverage is meaningful,” CMS Administrator Chiquita Brooks-LaSure said in a statement.
Hospitals quickly blasted the pay rate, which includes a 3.0% market basket increase net a 0.4% productivity adjustment. “It is no secret that the financial pressures hospitals are facing are being compounded by inflation, stubborn labor shortages and an aging demographic,” Premier said in a statement. “Payment policies should empower hospitals to deliver exceptional, patient-centric care, but the proposed update falls short on this objective.”
Premier says CMS can course correct by using better methodologies and new data sources to accurately gauge hospitals’ true costs, including comprehensive labor expenses.
The American Hospital Association says the inadequate update comes even as many hospitals are operating on negative or very thin margins. ‘Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, and we urge CMS to provide additional support in the final rule,” the lobby says.
AHA further says that while it shares CMS goal of improving maternal health outcomes and reducing inequities in maternal care, the lobby worries about CMS’ “continued and excessive” use of CoPs to drive its policy agenda. “We believe a less punitive and more collaborative and flexible approach is far superior. We will carefully review CMS’ proposals to determine whether they are feasible, sufficiently flexible for the wide variety of hospitals to which they would apply and do not inadvertently exacerbate maternal care access challenges.”
Premier is also disappointed CMS moved forward with the new CoP around obstetrics, saying while it supports the standardization of data collection and measures and agrees care delivery standard can help address maternal mortality, any policy change must ensure that it does not reduce access to care. “An obstetric services CoP that results in the loss of Medicare certification for compliance failure is far too harsh a penalty, resulting in further limits to obstetrical care and potentially higher rates of maternal morbidity and mortality. In trying to address the maternal crisis, the last thing we want to do is intensify disparities we know are already present in obstetrical care,” Premier says.
Premier notes that the HHS’ Office of Women’s health has tapped into Premier’s data to help understand why disparate outcomes occur and urges CMS to hold off on the creation of a CoP until the results of HHS’ work are available and instead focus on how it can improve data collection, standards, and other elements of obstetrical care.
Diagnostic Radiopharmaceuticals.
CMS is proposing to pay separately for higher-cost diagnostic radiopharmaceuticals that are packaged into the payments for nuclear tests, a move applauded by medical device stakeholders who have been lobbying for adjustments. The agency says that while packaging the payments generally works, there are some situations where the package fails to account for the costs of certain products, even if they’re the most clinically appropriate.
The agency proposes to pay separately for any radiopharmaceutical with a per-day cost that is greater than $630, and to remove their costs from the payment amounts for the nuclear medicine tests. Any diagnostic radiopharmaceutical with a per-day cost equal to or below that threshold would continue to be policy-packaged, with costs incorporated into the payment rates for the nuclear medicine tests, CMS notes.
Patrick Hope, executive director of AdvaMed Imaging, says the proposal is welcome news for patients and their families. “With this proposal, CMS is recognizing the value of diagnostic radiopharmaceuticals and the importance of expanding access of these diagnostic imaging agents to more patients so that they might receive better treatment and care,” he says. “Achieving separate payment for diagnostic radiopharmaceuticals continues to be a top priority for AdvaMed — millions of patients and their family members applaud this positive step in the right direction. We look forward to working with all stakeholders in support of this proposal to being finalized beginning in 2025.”
CMS also proposes to establish a $10 add-on payment for radiopharmaceuticals that use a certain isotope (Tc-99m) that is derived from domestically produced MO-99 starting Jan. 1, 2026. The policy would help counteract the effect of foreign governments subsidization of those products that disincentives domestic investments in MO-99 production infrastructure, the agency says. “We believe the $10 add-on payment for domestically produced Tc-99m would ensure equitable payments by paying providers who use domestically produced Tc-99m radiopharmaceuticals when available, an amount that reflects the anticipated higher cost of these products.”
Formerly Incarcerated Individuals. The draft rule would narrow the definition of custody so that it excludes people on parole, probation or home detention, and thus allows Medicare to pay for those services/items. The agency also proposes a special enrollment period for those individuals and seeks comments on how the policies should apply to people living in halfway houses.
Quality Reporting Programs. The agency proposes several updates to the various Quality Reporting programs.
For the Hospital Outpatient and the Rural Emergency Hospital reporting programs, CMS proposes three measures, including the Hospital Commitment to Health Equity measure, starting in 2025, the Screening for Social Drivers of Health (SDOH), starting with voluntary reporting in 2026, and Screen Positive Rate for SDOH, starting with voluntary reporting in 2025 that will be mandatory in 2026.
For the ASC QR program, CMS proposes to adopt the Facility Commitment to Health Equity (FCHE) measure starting with the CY 2025 reporting period and the two SDOH measures, starting with the hospital and rural emergency programs.
For hospitals, CMS seeks to adopt the Patient Understanding of Key Information Related to Recovery After a Facility-Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance measure (Information Transfer PRO-PM) beginning with voluntary reporting in the CY 2025 reporting period followed by mandatory reporting beginning with the CY 2026 reporting period. This would provide insight into the communication of recovery information and enable hospital outpatient departments to improve patient understanding of such information, CMS says.
CMS also proposes to remove two reporting measures, one — the MRI Lumber Spine for Low Back Pain — because studies show that performance or improvement on the measures doesn’t result in better outcomes — and the Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-Risk Surgery measure, because it does not provide meaningful data.
CMS is also proposing to modify the immediate measure removal policy across the REH, HOPD and ASC reporting programs. Currently, CMS may immediately remove a measure if the agency believes its continued use would raise safety concerns. The draft rule would modify the policy to allow the agency to suspend, instead of removing, the measure, and then proposed to retain modify or remove it in the next payment cycle, which would increase transparency and allow the public voice in the rulemaking process.
CMS Is also considering changes to the Star Quality rating program and seeks feedback on whether hospitals that perform in the bottom quartile should be eligible for receiving a 5- star rating.
Medicaid:
The rule also proposes to amend Medicaid service regulations to allow reimbursement for services furnished outside of the “four walls” of freestanding IHS/Tribal-run clinics. Federal reimbursement will also be available for services provided by behavioral health clinics in rural areas. The agency is not proposing a definition of “rural” but seeks comments on definitions.
The rule also codifies the requirement for states to provide one year of continuous coverage for children on Medicaid/CHIP. The agency further seeks to remove a failure to pay premiums as an optional exception to continuous eligibility.
In a sweeping loss for telehealth stakeholders, CMS outlined in the proposed calendar year 2025 Physician Fee Schedule plans to repeal crucial telehealth flexibilities that would subject most digital care to pre-pandemic regulations unless Congress extends the flexibilities before they expire at the end of the year. It is currently unclear how the codes would be modified if lawmakers pass an extension after the PFS is finalized.
Although CMS will continue to examine telehealth and its impact on access and quality, the agency will only allow limited flexibilities where possible and “reflect CMS’ goal to maintain and expand the scope of and access to telehealth services where appropriate.”
However, absent congressional action, beginning Jan. 1, 2025, the statutory restrictions on geography, site of service and practitioner type that existed prior to the COVID-19 public health emergency will go back into effect. In the new year, beneficiaries will need to be in a rural area and a medical facility to receive non-behavioral health services via telehealth.
Fraud concerns, a high Congressional Budget Office score and a canceled mark up have plagued the leading two-year telehealth extension bill that stakeholders are still hopeful will be wrapped into a health package passed during the lame duck session. Sources say the cost of the two-year telehealth extension bill could reach $4.3 billion, coming as House staffers work to organize payfors to offset high costs.
Consultants previously flagged that CMS is at risk of creating misalignment between telehealth reimbursement policies in its upcoming PFS and Congress’ potential extension of pandemic telehealth waivers.
But there are smaller provisions included in the draft PFS that expand access to telehealth, including permanently adding audio-only services to the schedule.
Removal of frequency limitations. CMS proposed to continue the suspension of frequency limitations for subsequent inpatient visits, subsequent nursing facility visits and critical care consultations for 2025.
Flexibility for providers’ home addresses. Through 2025, CMS proposed to continue to permit the distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home.
Direct supervision. CMS proposed for certain services that are required to be furnished under the direct supervision of a physician or other supervising practitioner to permanently adopt a definition of direct supervision that allows practitioners to provide supervision through real-time audio-visual telehealth.
Supervision of residents in teaching settings. The agency proposed to continue the current policy to allow teaching physicians virtually supervise residents in all teaching settings, but only in clinical instances when the service is furnished via telehealth visit, with the patient, resident and teaching physician through December 2025. CMS is also requesting information to consider whether and how best to expand the array of services included under the primary care exception in future rulemaking.
Even though lawmakers will likely tackle most of their health care policymaking after the November election, Congress has plenty on its agenda before its August recess.
Many eyes are on Democrats returning to the Capitol this week for the first time since President Joe Biden’s debate performance, and they’re facing reporters asking whether Biden should stay in the race. As one lobbyist quipped to us, health care is “whispering, hoping to be heard in a hurricane.”
But they’ll also deal with appropriations for health care agencies and the future of telehealth in the Medicare program among other issues.
Here’s what to expect in the coming weeks:
Appropriations: Lawmakers will likely have to pass a stopgap spending measure to avoid a government shutdown at the end of September, but they’re moving forward on a number of appropriations bills impacting health care agencies.
The House Appropriations Committee is set to mark up the Labor-HHS-Education package after it advanced through a subcommittee on party lines last week. That bill would cut HHS’ fiscal 2025 budget by 7 percent, but it isn’t likely to become law in its current form, given opposition from Senate Democrats. The full committee will also mark up the Agriculture-FDA measure that advanced last month on party lines.
In the upper chamber, the Senate Appropriations Committee is slated to mark up the Agriculture-FDA package and the Military Construction, Veterans Affairs, and Related Agencies package on Thursday.
Telehealth: Legislation that would extend loosened virtual care rulesin Medicare for two years was supposed to get a full committee markup at the end of June, but it fell victim to tensions over an unrelated privacy bill that forced Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, to cancel the markup.
The pandemic-era rules expire at the end of the year. Rodgers has said she hopes to advance a fully paid-for package before the August recess.
Pediatric rare disease priority review vouchers: Rodgers said last month that legislation to reauthorize the pediatric rare disease priority review voucher program remains a top priority. It was also supposed to be marked up late last month in the markup that was ultimately canceled.
The program intends to incentivize the development of treatments for rare pediatric diseases by speeding up the regulatory process and is set to expire at the end of September.
THE 2016 REPUBLICAN PLATFORM VS. 2024 — The many substantive differences between the Republican’s 2016 platform and its likely 2024 version underscore how former President Donald Trump has moved the party away from traditional conservative positions on health care.
The Republican National Committee platform committee agreed to Trump’s platform Monday, which is set to be finalized next week. The GOP didn’t release a platform in 2020 when Trump lost to President Joe Biden.
The RNC didn’t return a request for comment on this year’s changes.
Here are some key differences:
Obamacare: After a protracted and failed GOP bid in Congress to repeal the Affordable Care Act under the Trump administration, the 2024 platform makes no mention of the health care law.
Trump said late last year that he was “seriously looking at alternatives” to Obamacare and that the 2017 repeal and replace bid was a “low point” for the party. The 2016 platform pledged that a Republican president would sign its repeal with unanimous GOP support.
The 2024 platform also doesn’t mention Medicaid, while the 2016 platform proposed turning it into a block grant program.
Medicare: Republicans’ traditional fiscal conservatism is in nearly every corner of the 2016 platform, including on the federal health insurance program benefiting older adults.
In stark contrast, the 2024 platform pledges not to slash “one penny” from Medicare.
In 2016, Republicans called for a substantial overhaul of Medicare to preserve its solvency, pointing to an aging population, suggesting a premium support system and guaranteeing a contribution toward plans dependent on income. That platform also floated changing the eligibility age, though it pledged not to make changes for those 55 and older.
Although light on details, 2024’s platform proposes border security as a way to shore up Medicare’s finances by preventing “tens of millions of new illegal immigrants” from being added to the program’s rolls. Undocumented people are not eligible for Medicare, but some noncitizens are eligible, with restrictions.
Abortion: Trump has ushered in a significant softening of the party’s position on abortion in a post-Roe America.
Unlike the 2016 edition, the platform doesn’t call for a 20-week federal abortion ban, instead saying the party opposes “late term abortion” and supports access to birth control and in vitro fertilization.
The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), today released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment. The HTI-2 proposed rule reflects ONC’s focused efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.
“The Biden-Harris Administration has been working to expand interoperability and improve transparency when it comes to electronic health information,” said HHS Secretary Xavier Becerra. “Now we are building on that work to ensure that the entire system that supports patients and providers utilizes the best technology available in a safe and responsible way.”
“The HTI-2 proposed rule is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” said Micky Tripathi, Ph.D., national coordinator for health information technology. “As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead.”
In firsts of their kind, the HTI-2 proposed rule has two sets of new certification criteria designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program. These new certification criteria, which would improve public health response and advance the delivery of value-based care, focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers and public health organizations or payers). The health IT for public health-oriented certification criteria were developed in tandem with the Centers for Disease Control and Prevention (CDC) to support its ongoing Data Modernization Initiative. Similarly, the health IT for payer-oriented certification criteria were developed in coordination with the Centers for Medicare & Medicaid Services (CMS) to support technical requirements included in the CMS Interoperability and Prior Authorization final rule (89 FR 8758).
The proposed rule also includes several proposed technology and standards updates that build on the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, published in January 2024, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support. The HTI-2 proposed rule also proposes to require the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, which builds on HTI-1 USCDI requirements to give industry longer term planning clarity. The proposed rule also proposes to implement section 119(b)(3) of the Consolidated Appropriations Act, 2021 by including a new, real-time prescription benefit tool certification criterion, which would empower providers and their patients to make more informed decisions with more transparent information comparing the patient-specific cost of drugs and suitable alternatives.
The HTI-2 proposed rule continues ONC’s commitment to further clarifying the information blocking regulations and the ways in which they apply. The proposed rule includes proposed revisions to certain information blocking “exceptions” to address additional scenarios that have recently been identified by the regulated community. This rule also proposes a new “Protecting Care Access” information blocking exception, which would address concerns about potential information blocking consequences if an entity chooses to limit sharing of a patient’s reproductive health care information in certain circumstances. This proposal would build on other key steps HHS has taken to strengthen patient and provider privacy, including for those seeking or providing lawful reproductive care.
Completing the full suite of HTI-2 proposals is the proposal to establish certain Trusted Exchange Framework and Common AgreementTM (TEFCATM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.
The HTI-2 proposed rule is available at healthit.gov/proposedrule and will be published in the Federal Register in the coming days, at which point it will be available for public comment for 60 days.
ONC will be hosting a series of information sessions about the proposed rule in the coming weeks. More information can be found at healthit.gov/proposedrule and via ONC’s X account, @ONC_HealthIT .
Medicare and Medicaid Programs:
This proposed rule would revise the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on our continuing experience with these systems. In this proposed rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program.
This proposed rule would request information on options being considered for future changes to the Overall Hospital Quality Star Rating methodology. The proposed rule would narrow the description of “custody” for purposes of Medicare’s no legal obligation to pay payment exclusion. The proposed rule would revise the eligibility requirements in the special enrollment period (SEP) for formerly incarcerated individuals to tie the eligibility for this SEP to the determination made by the Social Security Administration that they are no longer incarcerated for releases that occur on and after January 1, 2025. This rule also proposes to codify the requirement in the Consolidated Appropriations Act, 2023 (CAA, 2023) to provide 12 months of continuous eligibility to children under the age of 19 in Medicaid and CHIP, with limited exceptions.
Further, this proposed rule would provide updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum patients. This rule proposes to separately pay IHS and tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the AIR under the authorities used to calculate the AIR starting January 1, 2025. This rule also requests further information related to a Tribal Technical Advisory Group request to apply the Indian Health Service encounter rate to all outpatient tribal clinics. Further, this proposed rule would provide updates to the CoPs for hospitals and CAHs in an effort to advance the health and safety of pregnant, birthing, and postpartum women. Finally, the proposed rule would provide exceptions to the Medicaid clinic services benefit four walls requirement for Indian Health Service and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.
This proposed rule would revise the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on our continuing experience with these systems.
The United States Department of Health and Human Services has handed down a hefty fine to the Pennsylvania-based Heritage Valley Health System over violations of the Health Insurance Portability and Accountability Act (HIPAA).
The fine follows an investigation into a ransomware attack on the healthcare provider in 2017.
The Department of Health and Human Services found that the Heritage Valley Health System failed to conduct a proper risk analysis of the data it was holding and how it was stored and did not have a proper contingency plan in place in case of such an attack. Nor did the organisation have a properly implemented user access policies in place.
In addition to the fine, Heritage Valley will be required to develop proper security policies in line with HIPAA rules, implement a risk management plan, and conduct a “thorough risk analysis” program.
The organisation’s progress will also be monitored by the Department of Health and Human Services’ Office for Civil Rights for a period of three years.
“Hacking and ransomware are the most common type of cyber attacks within the healthcare sector. Failure to implement the HIPAA Security Rule requirements leaves healthcare entities vulnerable and makes them attractive targets to cyber criminals,” Melanie Fontes Rainer, the director of the Office of Civil Rights, said in a statement.
“Safeguarding patient-protected health information protects privacy and ensures continuity of care, which is our top priority. We remind and urge health care entities to protect their records systems and patients from cyber attacks.”
According to the Department of Health and Human Services, there has been a 264 per cent increase in ransomware reports filed with the Office of Civil Rights since 2018.
Former President Trump says he “will not cut one penny” from Medicare and Social Security and steps back from calls for broad national abortion restrictions, according to a summary of the Republican election platform released Monday ahead of the party’s national convention.
The 16-page document skims over health topics, focusing more on Trump’s proposals to restrict immigration and boost the economy. But the few policy stances laid out reflect the growing national discord over health care access, and potential GOP angst over revisiting the resounding failure of the fight to repeal and replace the Affordable Care Act. Trump has also softened his stance on abortion law as polls and state ballot votes show voters’ apprehension toward broad bans.
But while Trump and the Republican party are scaling back some of their less popular stances, they also signaled a plan to dramatically intensify a battle against transgender people’s health care. The platform says that Trump intends to bar federal funds from supporting gender-affirming surgeries, regardless of age, nodding to a stance that has inflamed GOP voters in recent years.
Half of U.S. states have passed bans or restrictions on gender-affirming care, particularly for minors, in recent years, according to the Human Rights Campaign. House Republicans last year attempted to insert language into spending and authorization bills that would bar federal funds for gender-affirming care, restrict minors’ access, and put limits on global nonprofits’ work in the area.
The Republican National Committee in 2020 simply renewed its 66-page, 2016 platform, so this new platform represents a small if incomplete glimpse into pivots the party is making to appeal to voters.
Here is how the platform has shifted on health care.
While Trump and the Republican party are still boasting that his Supreme Court appointments led to the fall of Roe v. Wade’s national abortion protections, the former president has scaled back his rhetoric calling for broad restrictions to the procedure.
Some conservative advocates have called for federal abortion restrictions, but that language did not make it into the platform. The national committee underscored Trump’s belief that the decision should be left up to the states, though it said the party “will oppose Late Term Abortion,” using a phrase that is not recognized by major medical organizations.
The party said it would also support policies that advance prenatal care, access to birth control, and in-vitro fertilization. IVF recently became enmeshed in the fight over abortion, after Alabama’s Supreme Court issued a ruling that effectively made the fertility procedure illegal in the state.
The 2016 platform explicitly called on Congress to enact a 20-week abortion ban. It also said GOP lawmakers should bar minors from traveling across state lines for the procedure without parental consent, and called for reinstituting the so-called Mexico City Policy, which prohibits federal funding for nonprofits that provide or promote abortion services in other countries.
Sixty-three percent of Americans believe abortion should be legal in “all or most cases,” according to May polling from Pew Research Center.
The new platform seems to reflect growing concerns that Republicans could raise retirement ages and alter benefits, as the Republican Study Committee recommended in a proposal this year.
The party in 2016 wrote that “[t]o preserve Medicare and Medicaid, the financing of these important programs must be brought under control before they consume most of the federal budget, including national defense,” and “Medicare’s long-term debt is in the trillions.” The 2016 platform called for raising the age of Medicare eligibility.
The platform released Monday vows that President Trump will not cut Medicare funding but will “ensure Economic Stability.” It does not go into detail on those stability provisions, but promises no cuts and no changes to the retirement age.
Medicare’s hospital fund is projected to reach insolvency in 2036, which is five years later than the previous projection.
Health care and prescription drug costs “are out of control” according to the platform, which does not engage with the Biden-era law allowing Medicare to directly negotiate drug prices.
Republicans “will increase Transparency, promote Choice and Competition, and expand access to new Affordable Healthcare and prescription drug options,” according to the platform.
Trump and Biden sparred over drug pricing policies in the June debate — both taking credit for insulin cost caps passed broadly during Biden’s presidency — while avoiding the ultimate question of what Trump would do with the nascent Medicare negotiation program in a second term. If Republicans were to roll back parts of the Medicare drug price negotiation program, it would likely cost the federal government money.
Though it wasn’t mentioned in this year’s GOP platform, Trump promised a year ago to sign an executive order that “will tell Big Pharma that we will only pay the best price they offer to foreign nations, who have been taking advantage of us for so long — the United States is tired of getting ripped off.”
Notably, the platform doesn’t mention Medicaid or the Affordable Care Act at all. In 2016, Trump ran on calls to repeal the ACA, and his platform advocated for Medicaid block grants, a method of funding the program that could lead to significant cuts.
The Republican platform reflects a yearslong effort to restrict or fully bar gender-affirming care. It pledges to ban taxpayer funding for gender-affirming surgeries, and mentions restrictions on transgender people in sports and education.
While many state laws in recent years aim at limiting minors’ access to transition-related care, the 2024 platform lays out no age restrictions, seeking to prohibit federal funding regardless of patients’ age. (In the 2016 platform, the word “gender” does not appear at all.)
The Supreme Court last month agreed to hear a case on state bans on care for transgender minors; it could hear arguments as early as this fall.
More than 60% of American voters oppose bans on gender-affirming care for minors, according to Gallup polling this year.
The shortened, 2024 platform also removes language condemning same-sex marriage. It instead says that “Republicans will promote a culture that values the sanctity of marriage” and “the foundational role of families.”
More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.
About 47% of 1,134 people surveyed said they would choose hospital-level care at home, according to a study published Monday in JAMA Network. Around 17% said they would decline home-based hospital care. Approximately 40% of respondents thought hospital-at-home can be as good as in-facility care, while roughly a quarter said it was not. Nearly two-thirds of the adults surveyed said they would feel safe being treated at home.
Respondents also said they would be willing to assist in providing medical care to a loved one getting hospital care at home. About 82% said they would be able to manage medication on a schedule, more than two-thirds said they would provide wound care to a patient and nearly half said they would change a catheter.
The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.
The Congressional Budget Office estimates a two-year telehealth extension would cost the federal government $4 billion, sources told Inside Health Policy, but is still collecting additional research to adjust the final score. Sources say the bill could reach $4.3 billion, coming as House staffers work to organize payfors to offset high costs.
The House Energy & Commerce Committee recently received the CBO score for the Telehealth Modernization Act, which passed out of E&C’s health subcommittee in May, sources say. The earlier absence of a CBO score was the key reason the bill was not included in a full committee mark up in early June that featured two smaller telehealth bills.
Although the full committee was supposed to mark up the Telehealth bill on June 27, squabbles over a separate high-profile privacy bill that was also on the mark up slate led to an abrupt cancelation of the committee meeting. But lobbyists and lawmakers said they anticipate the bill to be marked up this month.
CBO signaled on July 1 that it needs additional information to accurately score the cost to the federal government of extending telehealth flexibilities. CBO is searching for more information on how providers respond to a change in prices paid for telehealth service to further inform cost of payment rates.
The office also would like to see more research on the substitution effects of telehealth and in-person care, and tracking telehealth downstream spending per service. Specifically, it wants to assess whether the effects on downstream spending are more or less likely for certain types of telehealth services and the mechanisms underlying those effects.
Class-action plaintiffs are asking a federal district court to reject arguments by healthcare insurance giant Humana that the Medicare Act’s administrative appeals process should block litigation over its use of artificial intelligence to process coverage claims.
“Humana argues this Court lacks jurisdiction over Plaintiffs’ claims, asserting that Plaintiffs’ claims arise under the Medicare Act, which requires them to exhaust administrative remedies,” the plaintiffs tell the U.S. district court for western Kentucky in their June 27 opposition to the company’s motion for dismissal of the case.
“Humana is wrong and overstates the jurisdictional nature of the exhaustion analysis,” the plaintiffs argue, saying the Medicare appeals process should be waived because plaintiffs face “irreparable” harm while awaiting the outcome of what can be a lengthy process overseen by the secretary of Health and Human Services.
According to the filing, “Humana’s conduct puts Plaintiffs at risk of irreparable harm if they were required to exhaust administrative remedies” and “exhaustion would be futile because Humana abuses the appeals process and the Secretary lacks the authority to grant the relief sought by Plaintiffs via administrative appeal.”
The plaintiffs’ request for the court to reject Humana’s motion for dismissal filed June 6 is the latest development in a high-profile case that could have impacts for the entire healthcare sector by setting new legal standards for the use of AI by insurance providers.
“This putative class action arises from Humana’s unlawful and undisclosed use of artificial intelligence to wrongfully make coverage determinations for elderly patients’ post-acute care without sufficient individualized review by doctors,” says the plaintiffs’ opposition to the motion for dismissal.
“Humana uses an AI Model known as nH Predict to make claims determinations and override real treating physicians’ determinations as to medically necessary care patients require,” the plaintiffs allege, saying the company knows the AI model’s results “are highly inaccurate and are not based on patients’ individual medical needs but continues to use nH Predict to make coverage determinations to the detriment of its insureds.”
Humana last month asked the court to “seal” its response to an amended complaint claiming the Health Insurance Portability and Accountability Act requires protecting sensitive information contained in the response.
Humana “simply asks this Court to allow the redacted portions of both documents (along with the unredacted versions of those documents) to remain permanently under seal,” the company said in its June 6 motion for a sealed submission to the complaint.
The revised complaint was filed after the court and parties in the case agreed that plaintiffs would submit an amended lawsuit on April 22 after Humana filed a motion for dismissal of the initial complaint.
The plaintiffs’ latest filing is in response to Humana’s motion last month for dismissal of the case.
“Now, Humana brings their Motion to Dismiss (‘MTD’) arguing that Plaintiffs’ claims should be dismissed because: (1) this Court lacks jurisdiction because Plaintiffs were required to exhaust administrative remedies and failed to do so; and (2) that Plaintiffs’ claims are preempted by the Medicare Act,” says the latest filing by plaintiffs. “Both arguments fail,” they tell the court.
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