Health Care Checkup: November 3, 2023

Health Care Checkup

November 3, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Thursday night, the House passed a supplemental funding bill to provide $14.3 billion in aid to Israel. The Senate continues to work on its own aid package that includes aid to Israel, Ukraine, and Taiwan.

On Monday, President Biden signed a sweeping executive order on artificial intelligence that establishes standards for security and privacy protections and requires developers to safety-test new models. The order will broadly impact companies as leading developers must submit test results on their new models to the government before releasing them to the public.

On Thursday, CMS issued the calendar year (CY) 2024 Medicare Physician Fee Schedule (PFS) final rule, which decreases Medicare payments to physicians and clinicians in 2024 by an average of 1.25%.

What to Expect Next Week: The Senate HELP Committee will hold a hearing on AI in health care, and the Senate Finance Committee is expected to markup a slate of bills encompassing policies aimed at expanding mental health care under Medicaid and Medicare, reducing prescription drug costs, and reforming pharmacy benefit managers (PBMs). The Senate also continues to work on their version of an aid package for Israel, Ukraine, and Taiwan.

The House will continue to work on passing the Transportation-HUD funding measure.

DEEP DIVE

Congressional:

Senate Offers FDA $20 Million Boost for 2024

On Wednesday, the Senate passed the minibus (H.R. 4366), the Agriculture-FDA, Military Construction-VA, and Transportation-HUD appropriations for fiscal 2024 in an 82-15 vote. In the package, the FDA would receive a $20 million net spending increase, with total FDA funding at $6.625 billion, which includes $3.55 billion in base funding as well as revenue from industry-paid user fees. The legislation also includes targeted increases for drug and device shortages. The House passed its version of this bill earlier this year. Reconciliation of the bills will be part of the larger FY 2024 spending discussion between House and Senate leadership.

House Introduces Revised Labor-HHS-Education Funding Bill

On Tuesday, House Republicans released a revised version of their Labor-HHS-Education appropriations bill that includes several new conservative social policy riders related to abortion, gun control, and diversity. An amendment from Rep. Greg Murphy (R-NC) would prohibit funding for finalizing the Biden administration's proposed rule to set minimum staffing levels in nursing homes. Murphy also introduced an amendment to transfer $2 million from the office of the HHS secretary to the Substance Abuse and Mental Health Services Administration for grants to prevent opioid overdoses. The House could take up the revised bill the week of November 13. Read the bill and amendments here.

Senate Finance Plans Markup on PBMs, 'Ghost Networks'

On Thursday, the Senate Finance Committee announced they will hold a markup next week, on Wednesday, November 8, on legislation aimed at expanding access to mental health in Medicare, pharmacy benefit managers (PBMs), and lowering drug costs. The legislation discussion draft aims to stop a phenomenon Wyden and mental health advocates refer to as "ghost networks" in Medicare Advantage plans. The discussion draft would require Medicare Advantage plans to maintain accurate provider directories that are verified at least every 90 days and would require plans to remove listings within five days of finding a provider that is no longer participating in the network. It also includes several Medicare and Medicaid extenders, including one extending incentive payments for providers to participate in alternative payment models and a program that helps beneficiaries receive primary care in their homes. Additionally, the bill would extend a transition to lower lab payments under Medicare from 2026 to 2027, delay Medicaid disproportionate share hospital cuts, and mitigate the administration's proposed cuts to the Physician Fee Schedule. Read the discussion draft here.

Senate Appropriations Committee to Hold HHS, DHS Supplemental Hearing

On Tuesday, Senate Appropriations Chair Patty Murray (D-WA) said the committee will call HHS Secretary Xavier Becerra and DHS Secretary Alejandro Mayorkas before the panel on November 8, and signaled openness to addressing both foreign and domestic issues. Murray stated, “if we can pass our domestic priorities right alongside our national security priorities, we absolutely should.” Sen. Bernie Sanders (I-Vt.) and five Democrats called on Senate leadership in a letter to match the emergency supplemental for Israel and Ukraine with funding for domestic programs, including the opioid crisis and boosting primary care, which the White House did not ask for. Read the letter here, and Sen. Murray’s statement here.

Ranking Member Cassidy, Warner, Colleagues Launch Bipartisan Senate Health Care Cybersecurity Working Group

On Thursday, Senators Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (D-NH) launched a bipartisan working group to examine and propose potential legislative solutions in the HELP Committee jurisdiction to strengthen cybersecurity in the health care and public health sector. This effort comes at a time of record cybersecurity attacks on healthcare entities. Read the press release here.

House Republicans Subpoena HHS Official in Investigation on COVID-19 Origins

On Thursday, Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH), Oversight and Accountability Chairman James R. Comer (R-KY), Energy and Commerce Chair Cathy McMorris Rodgers (R-WA), and Energy and Commerce Oversight and Investigations Subcommittee Chairman Morgan Griffith (R-VA) issued a subpoena for HHS Assistant Secretary for Legislation Melanie Egorin following months of negotiations about her testimony. The lawmakers stated in the letter, "Our accommodations have not been met with reciprocal actions from the Department, and its efforts to produce documents are deficient." An HHS spokesperson responded in a statement that the department "has provided to Congress thousands of pages of documents and made available federal officials relevant to the Committee's inquiry." Read the member’s letter here.

Reps. Smith, McMorris Rodgers, Crapo Press Biden Administration to Withdraw Federal Nurse Staffing Mandate

On Tuesday, in a letter to Health and Human Services (HHS) Secretary Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Brooks-LaSure, House Ways and Means Committee Chairman Jason Smith (R-MO), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), and Senate Finance Committee Ranking Member Mike Crapo (R-ID) called on the Administration to immediately withdraw the proposed minimum staffing rule and provide justification for its $40.6 billion unfunded mandate that the members say could force many nursing homes to close. Under the Biden Administration’s proposal, nursing homes would have limited flexibility to distribute direct care staff and meet individual resident needs. CMS data indicates that 79 percent of nursing facilities across the country would need to hire additional nursing staff to comply with the Biden Administration’s proposed mandate. Read the letter here.

Pallone and Neal Urge CMS to Increase Oversight of Medicare Advantage Market

On Wednesday, Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) joined with Ways and Means Committee Ranking Member Richard E. Neal (D-MA) in a letter to CMS Administrator Chiquita Brooks-LaSure urging increased oversight and transparency of broker participation and compensation in the Medicare Advantage market. The Democratic health leaders encouraged the Biden Administration to build on recent efforts to address deceptive marketing practices and broker compensation to protect Medicare beneficiaries and the program better overall. In addition to requiring reporting of total broker compensation, the Democratic Committee leaders urged the Administration to reform the total amount brokers can receive in compensation per enrollee. Read the press release here and the letter here.

Sanders’ Primary Care Boost Bill Gets Push from Health Groups

On Monday, more than 500 health groups urged House and Senate leaders to reauthorize the Community Health Center Fund at the increased level Sens. Bernie Sanders (I-VT) and Roger Marshall (R-KS) proposed in a bill released last month (S. 2840). Community health centers would receive $5.8 billion annually for three years under the bill, a nearly $2 billion yearly increase. Advocates for Community Health sent the letter calling for the funding boost, stating, “This investment of $5.8 billion per year for three years has the greatest potential to sufficiently support patient care, shore up struggling health centers, and set our country on a path to improved health for all communities.” Read the letter here.

Senate Adopts Ambulance, Telehealth Amendments to VA Spending Bill

Last Wednesday, October 25, the Senate adopted several amendments to a three-bill spending package (H.R. 4366), including a measure blocking the Department of Veterans Affairs from lowering ambulance payment rates. Senators are set to wrap up amendments next week on the package, which includes the Military Construction-VA, Transportation-HUD, and Agriculture bills. The Senate passed by voice vote an amendment from Veterans' Affairs Committee Ranking Member Jerry Moran (R-KS) and Chairman Jon Tester (D-MT) that would block a February VA rule to lower ambulance payments to the Medicare rate rather than the higher rate that ambulances charge in FY2024. The Senate also passed by voice vote amendments to dedicate $5.2 billion in VA funds to increasing telehealth capacity and to prioritize telehealth and mental health funding in states with the highest veteran suicide rates. An amendment to require a review of toxic exposure effects on servicemembers who served in Kosovo and another mandating data sharing with state cancer registries also passed by voice vote.

House Energy and Commerce Committee Holds Long-term Care Workforce Shortage Hearing

Last Wednesday, October 25, the House Energy and Commerce Health Subcommittee held a hearing on the Nursing Home and Home Health Workforce Shortage, examining proposed regulations for long-term services and supports (LTSS), which includes nursing home care and home and community-based services (HCBS). During the hearing, there was consensus from both Republicans and Democrats that the healthcare industry is facing unprecedented healthcare worker shortages. Republicans opposed the CMS proposed rules, stating they were well-intended but likely to cause further staffing exacerbations and would hurt state Medicaid budgets. Most Democrats supported the proposed rules, citing long-standing workforce and quality care issues in LTSS that would benefit from further regulation. Read the hearing memo here and the Mehlman hearing summary here.

Senate HELP Committee Advances NIH Nominee Monica Bertagnolli in Nominations Markup

Last Wednesday, October 25, Senators on the Health, Education, Labor, and Pensions (HELP) Committee held a nominations markup and voted to advance the nomination of Monica Bertagnolli to lead the National Institutes of Health. The 15-6 vote was far from typical, with ranking member Bill Cassidy (R-LA) voting for Biden's nominee and Chairman Bernie Sanders (I-VT) opposing her nomination. All other Democrats besides Sanders voted to confirm her, while six committee Republicans voted against doing so. Her vote moves to the full Senate, where she will likely face Republican opposition. Read Sanders’ opening remarks here, and Cassidy’s here.

Senate HELP Holds Hearing on Nursing Shortage Without Hospital Executives

Last Friday, October 27, Senate HELP Chairman Bernie Sanders (I-VT) held a field hearing in New Jersey, highlighting an ongoing strike of 1,700 nurses at Robert Wood Johnson University Hospital in New Brunswick. Sanders said Thursday that Mark Manigan, CEO of RWJ Barnabas Health, and Alan Lee, the CEO of Robert Wood Johnson University Hospital, declined his invitation to testify. National Nurses United President Nancy Hagans, Health Professionals and Allied Employees President Debbie White, and striking nurses testified at the hearing. Committee ranking member Bill Cassidy (R-LA), the health system, and the hospital argued Sanders was interfering in a labor dispute. Cassidy has suggested the hearing would violate Senate rules and ethics, which state committee funds can only be used for official legislative purposes. Read Sanders’ statement here, and Cassidy’s statement here.

House Budget Health Task Force Meets with CBO on Medicare Drug Negotiation

Last Thursday, October 26, the House Budget Committee's health task force on Thursday met with Congressional Budget Office Director Phillip Swagel to discuss how the government scorekeeper calculated the impacts of the Inflation Reduction Act that was passed into law in 2022 and provides direct price negotiations between Medicare and drugmakers. The meeting also included American Action Forum President and former CBO Director Douglas Holtz-Eakin; Duane Schulthess, CEO of healthcare consultant firm Vital Transformation; and Peter Kolchinsky, founder of RA Capital. In the fall of 2022, CBO estimated, with uncertainty, that the law would result in 13 fewer drugs coming to market over the next 30 years out of an estimated 1,300 drug approvals. Republicans have argued that CBO's budgeting limitations do not allow it to capture the law's full impact. During the meeting, Swagel said CBO would continue work on the law's impact, such as the difference between the minimum nine years traditional drugs would have to be on the market versus the longer 13-year timeline for biologics before negotiated prices could kick in.

Senators Wyden, Finance Democrats Urge Further Action from CMS to Protect Seniors from Deceptive Marketing Scams in Medicare Advantage

Last Thursday, October 26, Senate Finance Committee Chairman Ron Wyden (D-Ore.) led Senate Finance Committee Democrats in sending a letter pressing the Centers for Medicare & Medicaid Services (CMS) to take additional steps to protect seniors from deceptive practices used by marketing middlemen in Medicare Advantage. In their letter to CMS Administrator Chiquita Brooks-LaSure, Wyden and Finance Committee Democrats urged the agency to limit third-party marketing organizations from selling seniors’ personal information, as well as increase transparency around marketing spending in the Medicare Advantage program and ensure a level playing field for plan participants within Medicare Advantage. Read the press release here and the letter here.

Senators Grassley and Warren Push for FDA to Include Device Identifier Data on Medicare Claims Forms

Last Thursday, October 26, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) asked FDA Commissioner Robert Califf for the FDA’s support to include device identifier data on Medicare claims forms after the National Committee on Vital and Health Statistics recommended the FDA review feedback it received on the proposal. Warren and Grassley have been pushing for the policy for years, stating in the letter, “The inclusion of DIs on claims transactions would greatly improve our health care system’s ability to identify risks and reach patients who may be affected by device failures, which contribute to serious health problems and impose significant financial costs.” Read the letter here.

Senator Sanders Urges Investigation of Patent for NIH-Funded Cancer Therapy

Last Monday, October 23, Senate HELP Committee Chair Bernie Sanders (I-VT) urged the Department of Health and Human Services (HHS) to investigate the NIH after they proposed an exclusive patent license to a company with agency ties for its cervical cancer therapy. On September 21, the NIH proposed granting an exclusive license to Scarlet TCR for a cervical cancer treatment, which was invented, manufactured, and tested at the NIH. Sanders alleges that one of the leading researchers for this treatment "may stand to gain a massive financial windfall as a result of this exclusive patent license,” and the NIH should offer non-exclusive licenses for the drug so multiple manufacturers can make it. Read the letter here.

Members of Congress Criticize Proposed Set Minimum Nursing Home Staff Standards

On October 20, more than a hundred members of Congress spoke out against a proposed rule to set a minimum federal staffing standard in nursing homes. A bipartisan letter sent from nearly a hundred members, led by Rep. Greg Pence (R-IN), urged HHS Secretary Xavier Becerra to reconsider the proposal, which the lawmakers say would limit care for older adults, drive up state Medicaid costs and lead to nursing home closures. The nursing home industry has also stated strong disapproval of the rule for being too stringent. The letter follows major care advocates, labor groups, and nursing home workers publishing a full-page ad in The Washington Post urging Congress to support the proposed rule. Read the letter here.

Notable Bills Introduced:

Senators Whitehouse, Murkowski, Warner, Blackburn Reintroduce Bipartisan Legislation to Expand Telehealth Treatment for Opioid Use Disorder

On Wednesday, Senators Sheldon Whitehouse (D-RI), Lisa Murkowski (R-AK), Mark Warner (D-VA), and Marsha Blackburn (R-TN) reintroduced the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, legislation to increase access to telehealth services for opioid use disorder. The TREATS Act would make the changes permanent, allowing providers to waive the in-person visit requirement and instead use audio-only or audio-visual telehealth technology. Representatives David Trone (D-MD), Jay Obernolte (R-CA), and Brian Fitzpatrick (R-PA) led the introduction of the identical legislation in the House. Read the press release here and the bill here.

Senators Tillis, Wyden, & Bennet Introduce Bill to Improve Health Care Access, Protect Seniors from Unexpected Costs

On Monday, Senators Thom Tillis, Ron Wyden (D-OR), and Michael Bennet (D-CO) introduced the bipartisan Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act. The bill is included in the Senate Finance Committee’s discussion draft for its November 8 markup. The bill would (1) strengthen requirements for Medicare Advantage plans to maintain accurate and updated provider directories; (2) ensure patients do not pay out-of-network costs for appointments with providers that were incorrectly listed in their plan’s provider directory as in-network; and (3) Direct Centers for Medicare and Medicaid to publish guidance for plans to maintain accurate provider directories. Read the press release here and the bill here.

Senators Hassan, Blackburn Introduce Bipartisan Bill to Expand Access to Medication-Assisted Treatment for Substance Use Disorder

On Monday, Senators Maggie Hassan (D-NH) and Marsha Blackburn (R-TN) introduced the Extending Access to Addiction Treatment Act, which would permanently expand coverage for medication-assisted treatment for substance use disorder under Medicaid, which currently goes through 2025. Read the press release here and the bill here.

Padilla, Markey Introduce Legislation to Strengthen Health and Homelessness Services Coordination

On Monday, Senators Alex Padilla (D-CA) and Edward J. Markey (D-MA) introduced the Homelessness and Behavioral Health Care Coordination Act of 2023. The legislation would establish a grant program through the Department of Health and Human Services (HHS) that would award five-year grants of up to $500,000 to eligible entities to improve their capacity to coordinate culturally competent, trauma-informed behavioral and homelessness services. Rep. Madeleine Dean (D-PA) introduced companion legislation in the House. Read the press release here and the bill here.

Executive Branch:

Biden Signs Sweeping Order Regulating Artificial Intelligence

On Monday, President Biden signed a sweeping executive order on artificial intelligence that establishes standards for security and privacy protections and requires developers to safety-test new models. The order will have broad impacts on companies developing powerful AI tools that could threaten national security. Leading developers will need to submit test results on their new models to the government before releasing them to the public. In the healthcare sector, the order calls on HHS to:

Create an AI task force to develop a “strategic plan” within a year on “responsible” use of AI, including generative AI, real-world performance monitoring, equity and reducing burden.
Directs HHS to craft a strategy to determine whether such technology is sufficiently high-quality for use in health care in the next 180 days. An “AI assurance policy” would include performance evaluation and infrastructure needs for pre- and post-market oversight.
Directs HHS to consult with relevant agencies to weigh how nondiscrimination laws might intersect with AI and to create an AI safety program with a common framework for detecting errors, including “specifications” for a “central tracking repository” for harm-related incidents.
Directs on HHS in consultation with the Secretary of Defense and the Secretary of Veterans Affairs to work through grants and other means to advance AI technology for crafting personalized immune response profiles for patients and veterans’ health care, among other priority areas, including improving data quality.
Calls on HHS to identify areas where public/private partnerships could be helpful in product development and for the agency to create a plan to regulate AI in such applications.
Calls on the White House Office of Science and Technology Policy to consult with HHS and other agency heads on creating a framework to encourage providers to “implement comprehensive, scalable, and verifiable synthetic nucleic acid procurement screening mechanisms, including standards and recommended incentives.”

Read the executive order here and the fact sheet here.

OMB Proposes Additional Steps on Biden’s AI Executive Order

On Wednesday, the White House’s Office of Management and Budget (OMB) published additional details of how President Biden’s artificial intelligence plan will look in practice and seeks comments from the public. OMB’s proposed memorandum for agency and executive department heads stated agencies, including HHS, have until August 1, 2024, to implement minimum guardrails for AI that impacts rights or safety. If they don’t meet those benchmarks, the agencies must stop using the technology. According to OMB, AI impacts rights when it affects access to health care and social services, including decisions on diagnosis, health risk assessments, and insurance processes. If AI falls under those categories, whether the technology is new or already in use, agencies must undertake an AI impact assessment, including testing it in the real world and ensuring it will “advance equity, dignity, and fairness” by the deadline. Read the OMB memo here.

CMS Issues Final Rule for CY24 Medicare Hospital Outpatient Prospective Payment, Ambulatory Surgical Center Payment Systems, and 340B Remedy

On Thursday, the Centers for Medicare & Medicaid Services (CMS) finalized Medicare payment rates for Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) services for calendar year (CY) 2024. Acute-care hospitals will receive nearly $89 billion in Medicare payments for outpatient services in 2024, or 3.1% more than this year. The rule also finalizes a 3.1%, or $207 million, increase in Medicare payments for ambulatory surgical centers next year. Total payments to the centers are expected to reach $7.1 billion next year under the rule. An estimated 3,500 general acute care hospitals, children’s hospitals, cancer hospitals, and community mental health centers will be affected by the payment rule, along with approximately 6,000 surgical centers. Read the fact sheet here.

Additionally, the OPSS final rule outlines the remedy for the invalidated OPPS 340B-acquired drug payment policy for Calendar Years 2018-2022, in light of the Supreme Court’s decision in American Hospital Association v. Becerra, which ruled the pay cuts to be unlawful. CMS will pay $9.0 billion to affected 340B providers for claims covering CYs 2018 through 2022, in a one-time lump-sum payment to each of the approximately 1,700 affected 340B covered entity hospitals. Read the fact sheet here.

CMS Issues Final Rule for CY24 Medicare Physician Fee Schedule

On Thursday, CMS issued the calendar year (CY) 2024 Medicare Physician Fee Schedule (PFS) final rule that includes changes to other Medicare Part B issues, and the Medicare Shared Savings Program. Overall, Medicare payments to physicians and clinicians in 2024 would fall by an average of 1.25% next year. In the final 2024 Medicare Physician Fee Schedule, the multiplier, or “conversion factor,” used to determine provider reimbursement in traditional Medicare, would drop to $32.73 in 2024, down $1.15, or 3.4%, from $33.88 in 2023. Changes to the Shared Savings Program include moving Accountable Care Organizations (ACOs) toward digital measurement of quality by establishing a new Medicare Clinical Quality Measure (CQM) collection type for ACOs and aligning Shared Savings Program and Merit-based Incentive Payment System (MIPS) Promoting Interoperability requirements starting January 1, 2025. Read the PFS fact sheet here and the Shared Savings fact sheet here.

HHS Proposes Rule to Establish Disincentives for Health Care Providers that have Committed Information Blocking

On Monday, the Department of Health and Human Services (HHS) released a proposed rule for public comment that would establish disincentives for healthcare providers found by the HHS Office of Inspector General (OIG) to have committed information blocking – when a provider knowingly and unreasonably interferes with the access, exchange, or use of electronic health information except as required by law or covered by a regulatory exception. The proposal would only apply to a small subset of healthcare providers that participate in Medicare interoperability programs and the Medicare Shared Savings Program, with typical penalties for hospitals being $394,000, and $686 for individual clinicians. The agency requested information on if and how it should broaden the penalties to include other providers, with the comment period ending January 2. Read the press release here and the proposed rule here.

HHS Issues 2024 Home Health Prospective Payment System Final Rule

On Wednesday, CMS issued the calendar year (CY) 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule, which updates Medicare payment policies and rates for Home Health Agencies (HHAs). HHA rates will increase by 0.8%, or $140 million, in 2024. The payment rule also calls for an inflationary increase of 3%, or $525 million, next year, while imposing a 2.6% permanent pay cut of $455 million based on the assumption that home health agencies will alter their future billing and coding activity to maximize reimbursements. The rule also finalizes a 0.4%, or $70 million, increase in the fixed-dollar loss ratio for outlier payments, in which Medicare helps offset provider losses due to extraordinarily expensive cases. Read the fact sheet here and the rule here.

CMS Kicks Off Medicare Drug Price Negotiations Public Listening Sessions

On Monday, CMS held its first public listening session for Bristol Myers Squibb’s blood-clotting drug Eliquis, one of the 10 medications selected for Medicare drug price negotiations. There will be a total of 10 listening sessions; one will take place each day from Monday through November 15. Members of the public had to register to speak at the sessions by Oct. 15. The Centers for Medicare and Medicaid Services expects 20 people to be selected randomly for each session. Individuals could talk about their day-to-day experiences living with the conditions treated by the drugs selected for negotiation, how the drug impacts them, and affordability or access issues. The pharmaceutical industry trade group PhRMA was critical of the listening sessions, stating they were a “box-checking exercise” with limited utility because CMS will not respond to feedback in real-time. See the list of listening sessions here.

CDC Launches New Campaign Offering Hospital Leaders Resources to Prevent Burnout

This week, the CDC launched a new campaign offering hospital leaders resources to prevent provider burnout, which the CDC has stated is at crisis levels. The campaign comes after a new CDC report found that, between 2018 and 2022, the number of providers who reported feeling burnt out increased from 11.6 to 19 percent. The CDC’s Impact Wellbeing campaign, a response to the report, includes a questionnaire template in which hospital workers can identify how they feel, a guide leaders can use to encourage workers to seek help for mental health concerns, and a list of training strategies for supervisors to help them prevent burnout. See the campaign here.

Biden-Harris Administration Releases Proposed Rule to Improve Surprise Billing Payment Dispute Process

Late last week, on October 27, the Biden-Harris Administration (the Administration), through the Departments of Health and Human Services (HHS), Labor, and the Treasury (the Departments), along with the Office of Personnel Management (OPM), released a proposed rule on the No Surprises Act’s Federal independent dispute resolution (IDR) process. The Federal IDR process is a mechanism that providers (including air ambulance providers), facilities, and health plans can use to resolve payment disputes for certain out-of-network charges. The proposed rule, if finalized, would improve communications between payers, providers, and certified IDR entities who make payment determinations; adjust Federal IDR timelines; establish new batching criteria; create a more efficient Federal IDR process; and change the administrative fee structure to improve accessibility of the process. Read the press release here and the fact sheet here.

Legal & Other:

AHA Sues Biden Administration Over Use of Online Tracking Technologies

On Thursday, a group of hospital associations and hospitals filed a lawsuit against the Biden administration challenging a "bulletin" released last year by the Health and Human Services (HHS) department related to privacy and information sharing. The bulletin has spurred more than 100 letters from HHS and the Federal Trade Commission to health systems and telehealth companies, warning that their use of online tracking technologies could violate health privacy laws. The associations and hospitals argued in their complaint that the technologies are necessary to analyze use of their websites and to communicate effectively with the public. AHA also noted that Medicare.gov and other websites managed by the federal government use similar technologies. The lawsuit claims HHS exceeded its statutory law under HIPAA and is asking the court to bar its enforcement.

HHS’ Office for Civil Rights Settles Ransomware Case

On Tuesday, a company that provides medical management services, including billing, settled with HHS Office of Civil Rights (OCR) after a large ransomware attack, marking the first time OCR has settled a ransomware case. The settlement is for $100,000 after the attack that affected the protected health information of more than 206,000 people. According to the settlement, OCR will continue to monitor the company over the next three years to ensure HIPAA compliance and require a corrective action plan. Doctors’ Management Services did not have to admit guilt in the settlement. According to OCR, ransomware attacks reported to the office have increased by 278 percent in the past four years, with hacking accounting for 77 percent of large breaches reported to OCR. Read the press release here.

‘No Surprises’ Restrictions Challenged by Agencies

Last week, on October 27, the Departments of Health and Human Services, Labor, and the Treasury, along with the US Office of Personnel Management, submitted a notice that they are preparing to file a consolidated appeal in the US Court of Appeals for the Fifth Circuit. The appeal will challenge an August decision by Judge Jeremy Kernodle of the US District Court for the Eastern District of Texas that removed provisions in the agencies’ regulations for determining the qualifying payment amount (QPA) in No Surprises Act arbitration (H.R. 133). Read the appeal here.

CONGRESSIONAL HEARINGS & EVENTS

House Hearings: No health hearings have been announced for next week yet.

Senate Hearings:

Appropriations Committee – Full Committee Hearing

“A Review of the President’s Supplemental Request for the Departments of Health and Human Services and Homeland Security”

Wednesday, November 8, at 9:00 AM

Senate Finance Committee – Markup

Markup of legislative proposals for expanding mental health care under Medicaid and Medicare, addressing pharmacy benefit managers, and Medicare and Medicaid reauthorizations.

Wednesday, November 8, time TBD

Health, Education, Labor, and Pensions Committee Subcommittee on Primary Health and Retirement Security - Hearing

“Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care.”

Wednesday, November 8, at 2:30 PM