Tag: HHS

HHS Replaces ACIP Members, Future Vaccine Policy Unclear

Member News

The U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. announced June 9 the removal of all 17 members of the Advisory Committee on Immunization Practices (ACIP). This independent body is comprised of experts in infectious disease, epidemiology, pediatrics, internal medicine and public health. ACIP plays a central role in guiding U.S. vaccine policy through the evidence-based recommendations it puts forth to the Centers for Disease Control and Prevention (CDC), which directly influences vaccine schedules, insurance coverage, provider reimbursement and programs such as Vaccines for Children.

Kennedy announced eight replacements June 11 on social platform X. The appointments mark a potential significant change in the future of federal vaccine policy. While past ACIP recommendations and resources remain available through the CDC, it remains unclear how the new members and administration will guide national immunization practices.

The MHA remains committed to assisting members in increasing vaccine uptake and avoiding the spread of vaccine preventable diseases, as the evidence is indisputable that vaccines are the best tool available to prevent severe illness and save lives. The association continues to monitor the potential impacts that may result from the changes to ACIP.

Members are encouraged to share feedback on the impact of these changes to existing organizational vaccine policies with Kelsey Ostergren at the MHA.

Federal Agencies Pause Enforcement of 2024 Mental Health Parity Rule

Member News

The Department of Labor, Health and Human Services, and the Treasury recently announced that the 2024 final rule on the Mental Health Parity and Addiction Equity Act (MPHAEA) will not be enforced, following a legal challenge by the ERISA Industry Committee (ERIC).

The 2024 rule expanded upon 2013 regulations by introducing new requirements for nonquantitative treatment limitation analyses, designed to strengthen parity between mental health and medical or surgical benefits. In January 2025, ERIC filed a suit arguing the new rule is arbitrary and unlawful.

In response, the departments asked the courts to pause enforcement and indicated they may revisit the rule through future rulemaking. Citing executive order 14219, which directs agencies to reduce regulatory burdens, the departments confirmed they will not enforce the 2024 provisions for violations occurring before a final court decision and for 18 months thereafter.

The enforcement pause applies only to the new provisions introduced in the 2024 rule. The 2013 final rule and the underlying Mental Health Parity and Addiction Equity Act statute, including amendments from the Consolidated Appropriations Act of 2021, remain in effect.

The Department of Health and Human Services is encouraging states, which are the primary enforcers of parity requirements for health insurance issuers, to adopt a similar approach. States that pause enforcement of the 2024 provisions but continue enforcing the 2013 rule and statute will not be considered out of compliance by HHS.

Members with questions may contact Lenise Freeman at the MHA.

HHS Renews Ongoing Opioid Crisis PHE

Member News

U.S. Secretary of Health and Human Services (HHS) announced March 18 the renewal of the public health emergency (PHE) declaration addressing the ongoing opioid crisis. This extension, which lasts for 90 days, allows continued federal coordination efforts and preserves essential flexibilities to facilitate key actions in combating the opioid overdose crisis. Secretary Robert F. Kennedy, Jr. reaffirmed the administration’s commitment to treating the crisis as a national security emergency.

The public health emergency declaration, initially made under the Trump administration in 2017, provides HHS with special authorities, enabling expedited treatment projects, voluntary information collections and research support for opioid use disorder treatments. These actions ensure efficient multi-sector collaboration to save lives.

Opioids, particularly fentanyl, continue to claim approximately 150 lives each day in the U.S., despite a 25.5% drop in overdose deaths. Opioid overdoses remain the number one cause of death among those aged 18-44. The continuation of the public health emergency supports ongoing efforts to combat substance use, prevent overdose fatalities and provide crucial assistance to individuals in recovery from substance use disorders.

Members with questions may contact Lauren LaPine at the MHA.

MHA Monday Report March 17, 2025

Member News, Monday Report

Legislative Policy Panel Acts on Opioid Treatment Policies

The MHA Legislative Policy Panel met virtually March 12 to develop recommendations on legislative and policy issues impacting Michigan hospitals. The MHA advocacy team provided important updates to the panel on healthcare activities at both …

MHA Member Supply Chain Leaders Share Insights and Resources

MHA staff recently attended the Navigating Supply Chain Challenges in the Current Healthcare Environment event hosted March 4 by the Great Lakes Chapter of the American College of Healthcare Executives. This participation represents the MHA’s …

MHA Upcoming PFE Webinars Focus on Advancing Patient-Centered Care

The MHA, in conjunction with its statewide Person & Family Engagement (PFE) Advisory Council, is excited to offer the PFE Improvement Sprints, a webinar series designed to help hospitals and health systems amplify PFE efforts. …

Applications Open for 2025-2026 Excellence in Governance Fellowship

Applications for the 2025-2026 Excellence in Governance Fellowship are now open for healthcare board members seeking innovative and effective ways to lead their organizations as hospitals and health systems navigate financial strain and labor challenges. …

Balancing the Complexities of the Healthcare Workforce in Rural Markets

MHA Endorsed Business Partner AMN Healthcare will host the webinar Balancing the Complexities of the Healthcare Workforce in Rural Markets from 11 a.m. to 12 p.m. ET April 10. Speakers John Higgins, vice president of Essentia Health, a …

Keckley Report

DOGE Healthcare Targets prompt Uncomfortable Questions

In the President’s 99-minute address to Congress last Tuesday, not a mention of healthcare. None. Nada. Go figure.

It’s not surprising but totally regrettable. Politicians on both sides of the aisle know it’s a vital industry to the population’s well-being and the economy’s overall stability. It accounts for a fourth of all job gains in monthly Bureau of Labor jobs reports. It also represents 28% of total federal spending (includes HHS + Veterans Health) with the CBO forecasting 5.5% annual growth through 2032. Thus, it’s not surprising it’s a target of ongoing DOGE federal spending cuts and prominent in this week’s budget reconciliation vote by Congress to avoid a shut down.

Two programs are initial targets: Medicaid and Veterans Affairs. Each is big and serves unique populations …

The impact of proposed Medicaid and VA cuts will draw attention to the overall health system, prompting its critics to argue its wastefulness and its defenders to blame inadequate funding or unfair regulation.”

Paul Keckley, March 10, 2025

New to KnowNews to Know

  • Registration is open for the highly anticipated MHA Keystone Center Safety & Quality Symposium, scheduled for April 28 and 29, 2025, at the Kellogg Conference Center & Hotel, East Lansing.
  • Lenise Freeman, a current Government Relations and Public Policy Fellow, was recently selected to participate in The Center for Health and Research Transformation (CHRT) at the University of Michigan Health Policy Fellowship.

MHA in the News

The MHA received media coverage the week of March 10 on the 340B program and potential federal Medicaid funding cuts with outlets including MichMash, Crain’s Grand Rapids Business and 9&10 News. MHA CEO Brian Peters appeared on the March 14 episode …

MHA Monday Report March 10, 2025

Member News, Monday Report

Senate Passes 340B Hospital Protections & IMLC Clears House

The Michigan Senate passed legislation that protects 340B hospitals with bipartisan support while the Michigan House of Representations voted through legislation that removes the sunset on the Interstate Medical Licensure Compact (IMLC) during the week …

Hospital Medicaid Communications Toolkit Available

The MHA recently released a toolkit of communications resources to support hospitals in advocating against potential Medicaid funding cuts in their local communities. The toolkit includes: Talking points Template letter-to-the-editor Template press release Social media …

HHS Rescinds Richardson Waiver Policy on Public Participation

The Department of Health and Human Services (HHS) recently announced the rescinding of the Public Participation in Rule Making (Richardson Waiver), which invited public participation in rulemaking related to federal rules and regulations. HHS Secretary …

MDHHS Medicaid Provider Manual Available April 1

The Michigan Department of Health and Human Services (MDHHS) recently completed the April 2025 update to the MDHHS Medicaid Provider Manual, which will be available online April 1, 2025. This update aims to clarify coverage …

MHA Keystone Center Safety & Quality Symposium Approved for CE Credits

Registration is open for the highly anticipated MHA Keystone Center Safety & Quality Symposium, scheduled for April 28 & 29, 2025, at the Kellogg Conference Center & Hotel, East Lansing. The symposium, offering continuing education …

Regional Training April 23 for Maternal Health Providers on Hypertension Safety

The Michigan Alliance for Innovation on Maternal Health is offering regional training sessions for inpatient maternal health providers focused on implementing the hypertension safety bundle and addressing common challenges with implementation. The one-hour …

Keckley Report

The Four Unwritten Rules for Engaging the Nashville Healthcare Industry

“This year, the Nashville Heath Care Council is celebrating its 30th anniversary. Its 900 members employ 333,000 and contribute $68 billion to the local economy. It hosts global conferences (VIVE, Sessions) among its 80+ events annually and promotes Nashville as the healthcare innovation hub of the planet. It is dominated by publicly traded health services companies and the armies of advisors, lawyers, accountants and analysts they employ. …

The Nashville healthcare community will not attempt to transform the industry: that’s for others. It will engage on industry challenges that require technology-enabled solutions, private capital and experienced operators. It is not paralyzed by regulation, industry norms, trade association affiliations or tradition. It is prone to think of healthcare as a opportunistic market, celebrate its profitability and leave systemic issues for others to fix.

The Nashville healthcare community is a fast follower: the bleeding edge is for others.  But in following fast, it has emerged as a key influencer in Trump healthcare policies and their execution.”

Paul Keckley, March 3, 2025

New to KnowNews to Know

  • The MHA Human Resources Conference is quickly approaching on March 25, 2025 from 8:30 a.m. to 3:30 p.m. at the Crowne Plaza Lansing.
  • In order to continue sharing with key stakeholders the important impact hospitals make to their communities, the MHA invites members to share examples of strong community impact programming through a brief survey.

Elizabeth KutterMHA in the News

The MHA received media coverage the week of March 3 on the Michigan Senate passing legislation that protects the 340B program, the potential impact of tariffs on hospitals and healthcare costs, as well as a …

HHS Rescinds Richardson Waiver Policy on Public Participation

Member News

The Department of Health and Human Services (HHS) recently announced the rescinding of the Public Participation in Rule Making (Richardson Waiver), which invited public participation in rulemaking related to federal rules and regulations. HHS Secretary Robert F. Kennedy Jr. announced the repeal in a policy memo, emphasizing that this decision aligns the Department with the Administrative Procedure Act (APA). Effect immediately, the HHS will no longer apply additional notice and comment requirements beyond what the APA mandates.

The APA established procedures for federal rulemaking, requiring agencies to provide public notice and solicit feedback before implementing certain regulations. However, it also allows exemptions for certain areas, including public property, loans, grants, benefits and contracts. The Richardson Waiver voluntarily extended public participation to these areas within HHS, ensuring transparency and accountability in policymaking. By rescinding the waiver, HHS is removing these safeguards, making it easier to change policies without consulting the public or affected stakeholders.

While this repeal does not affect the Medicare payment rule processes, it may impact public participation in policymaking related to National Institutes of Health research funding and Medicaid regulations. Without a mandatory public comment period, HHS can now make sweeping changes with minimal oversight, potentially altering hospital reimbursement rates, research funding allocations and healthcare compliance regulations without input from medical professionals or patient advocacy groups.

The MHA encourages healthcare stakeholders to increase direct engagement with policymakers, strengthen advocacy efforts and collaborate with professional organizations to ensure their concerns are still represented. It will be more critical than ever for hospitals and advocacy groups to remain vigilant, track policy changes closely and actively seek alternative ways to impact healthcare regulations.

Members with questions may contact Lauren LaPine at the MHA.

HHS Submits New HIPAA Security Proposed Rule

Member News

The U.S. Department of Health and Human Services (HHS) recently submitted a proposed rule to update the HIPAA Security Rule and enhance the protection of electronic protected health information. The changes aim to address the growing number of breaches and cyberattacks in healthcare, as well as common deficiencies identified during Security Rule investigations.

The HIPAA Security Rule currently allows entities to bypass “addressable” implementation specifications, if deemed unreasonable due to factors such as risk or cost. The proposed modifications will require entities to meet all standards and implementation specifications and not allow an entity to avoid an addressable implementation specification. The proposed rules also seek to clarify existing standards and provide detailed guidance on compliance.

The MHA is reviewing the proposed changes and will submit comments to HHS. Public comments are open until March 7, 2025. Members with questions may contact Jim Lee at the MHA.

DEA Extends Telemedicine Rule for Controlled Substances Through 2025

Member News

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) recently issued a rule extending telemedicine prescribing flexibilities for controlled substances through Dec. 31, 2025. This extension continues pandemic-era provisions, allowing controlled substances to be prescribed via telemedicine without requiring a prior in-person visit, which is crucial for Michigan hospitals, particularly in rural and underserved communities.

The rule will:

  • Extend the ability to prescribe Schedule II-V controlled substances, including medications like buprenorphine for opioid use disorder, via telemedicine.
  • Allow flexibilities to apply to all practitioner-patient relationships, not just those established during the COVID-19 public health emergency.
  • Serve as an effort to ensure continued access to essential healthcare, reduce requirement of in-person evaluations and provide critical medications, especially for opioid use disorder.

While the rule extends telemedicine prescribing flexibilities, certain conditions remain in place:

  • The prescription must be issued for a legitimate medical purpose and within the usual course of professional practice.
  • The prescription must be issued through an interactive telecommunications system, ensuring that the patient and practitioner are engaged in a real-time communication.
  • The practitioner must be authorized to prescribe the controlled substance under their DEA registration or be exempt from the need for a registration.
  • The prescription must comply with all relevant legal and regulatory requirements for controlled substances.

This extension provides the DEA and HHS more time to continue reviewing and evaluating telemedicine and controlled substance policies. The MHA submitted a comment letter advocating for expanded access to telehealth and will remain actively involved in these efforts throughout 2025.

Members with questions may contact Kelsey Ostergren at the MHA.

CMS Finalizes Medicare Appeals Process for Beneficiary Status Change

Member News

The Centers for Medicare & Medicaid Services (CMS) and the United States Department of Health and Human Services (HHS) recently released a final rule, effective Oct. 11, 2024, implementing a federal district court order that requires the HHS to establish appeals processes for Medicare beneficiaries initially admitted as hospital inpatients, but who are subsequently reclassified as outpatients receiving observation services during their hospital stay.  The change in status from inpatient to outpatient results in a denial of coverage for the hospital stay under Medicare Part A.

The processes include:

  • Expedited appeals – Beneficiaries will be entitled to request an expedited appeal prior to hospital discharge when they disagree with the hospital’s decision to reclassify their status from inpatient to outpatient receiving observation services. Appeals will be conducted by a Beneficiary & Family Centered Care – Quality Improvement Organization.
  • Standard appeals – This process will be available to beneficiaries who file an appeal after hospital discharge. These standard appeals will follow procedures similar to expedited appeals, but without the expedited filing and decision timeframes.
  • Retrospective appeals – This process is available for beneficiaries to appeal denials of Part A coverage for specific inpatient admissions involving status changes that occurred back to Jan. 1, 2009. Medicare Administrative Contractors will perform the first level of appeal, followed by Qualified Independent Contractor reconsiderations, Administrative Law Judge hearings, review by the Medicare Appeals Council and judicial review. Eligible beneficiaries have 365 calendar days from the implementation date of this rule to request a retrospective appeal.

The CMS updated regulations and appeal procedures based on the final rule to include:

  • Increasing the timeframe for providers to submit a claim following a favorable decision from 180 to 365 calendar days.
  • Extending the timeframe for submission of provider records as requested by a contractor from 60 to 120 calendar days.

The rule clarifies the effect of a favorable appeal decision in various instances:

  • The hospital must refund any payments received for the Part B outpatient claim before submitting the Part A inpatient claim. If a Part A claim is submitted, the previous Part B outpatient claim will be reopened and canceled, with any Medicare payments recouped to prevent duplicate payment.
  • The hospital must refund any payments collected for the outpatient services if the hospital chooses not to submit a Part A claim for a beneficiary who was not enrolled in Medicare Part B at the time of hospitalization.
  • The hospital must refund any payments collected for the outpatient hospital services only if the hospital chooses to submit a Part A claim for beneficiaries who were enrolled in Medicare Part B at the time of hospitalization.
  • Out-of-pocket payments made by a family member on behalf of a beneficiary for skilled nursing facility services may include payments made by individuals who are not biologically related to the beneficiary such as a close friend, roommate or former spouse.

Members with questions regarding the Medicare appeal process should contact Vickie Kunz at the MHA.

Favorable Federal Court Ruling Allows Hospitals to Continue to Offer Unaltered Public Websites

Member News

A United States District Court Judge in Texas issued a ruling June 20 on recent Department of Health and Human Services (HHS) bulletins that restrict healthcare providers from using standard third-party web technologies that partially capture IP addresses on public-facing webpages.

This ruling was in favor of the American Hospital Association (AHA), Texas Hospital Association (THA) and hospital plaintiffs. The AHA and THA sued the HHS Office for Civil Rights, claiming that the bulletins did not follow proper rulemaking processes because no notice-and-comment opportunity was provided. Additionally, the prohibited activity would negatively affect providers who use common web technology to communicate reliable, accurate health information to the general public.

This favorable ruling, which the MHA and many other state hospital associations supported with a joint amicus brief, means that hospitals do not need to alter or discontinue their public-facing websites to comply with the rule and subsequent bulletins issued by the HHS-OCR limiting such technologies.

Members with questions may contact Amy Barkholz at the MHA.