Ivy K. Miller

Associate

imiller@rc.com

Boston, MA — 617.305.5449

Ivy K. Miller

Associate

imiller@rc.com

Boston, MA — 617.305.5449

Ivy K. Miller provides counsel on the full spectrum of health law matters to health care organizations, including health systems, physician groups, hospitals, and other health care providers and suppliers. Ivy regularly advises clients on corporate and transactional matters, privacy and security issues, and federal and state health care fraud and abuse compliance, helping them navigate a complex and ever-evolving legal and regulatory environment.

Ivy contributes to the firm’s Health Care and Life Sciences blog Health Law Diagnosis, highlighting health care market issues within the legislative landscape, as well as to scholarly and public interest publications. She has a proven ability to synthesize complex legal constructs and policy issues and has research experience with reproductive rights and health care access issues. Previously, as a health law intern at Robinson+Cole, Ivy conducted research on compliance issues, including HIPAA, 42 CFR Part 2, and provider licensure and tracked state-level legislation affecting health care providers.

In law school, Ivy was a legal intern for the Honorable Judge Margaret R. Guzman of the U.S. District Court for the District of Massachusetts, and she interned in health and reproductive justice initiatives in Boston, Minneapolis, and New York. Ivy holds dual degrees (J.D. and Master of Public Health) that allow her to draw on a strong health policy background to advise clients on new legislative initiatives and regulatory priorities.

Northeastern University School of Law (Juris Doctor)
- Rappaport Center for Law and Public Policy, Fellow
- Northeastern University Law Review
- Massachusetts Supreme Judicial Court Pro Bono Honor Roll
Tufts University School of Medicine (Masters)
- Public Health
University of California, Irvine (Bachelors)
- B.A., Public Health Policy, Sociology Minor

Commonwealth of Massachusetts

Massachusetts Bar Association Health Law Section Council

Publications

July 1, 2026

Massachusetts HPC Expands Reporting Requirements and Oversight Authority in New Material Change Regulations

Health Law Diagnosis

July 1, 2026

Connecticut Updates its Medical Orders for Life-Sustaining Treatment Program

Health Law Diagnosis

July 1, 2026

Connecticut Expands Penalties for Unlicensed Health Care Operations

Health Law Diagnosis

July 1, 2026

Massachusetts HPC Expands Reporting Requirements and Oversight Authority in New Material Change Regulations

Health Law Diagnosis

July 1, 2026

Connecticut Updates its Medical Orders for Life-Sustaining Treatment Program

Health Law Diagnosis

July 1, 2026

Connecticut Expands Penalties for Unlicensed Health Care Operations

Health Law Diagnosis

June 29, 2026

Connecticut Disbands Office of Health Strategy and Reassigns Health Care Oversight and Policymaking Authority Across State Agencies

Health Law Diagnosis

March/April 2026

How PBM Reform Suddenly Got Rolling

Massachusetts Bar Association Section Review

March 5, 2026

Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

Health Law Diagnosis

March/April 2024

Implications of Biden’s Proposed LTC Nurse Staffing Rule

Massachusetts Bar Association Section Review

The article covers proposed staffing standards for long-term care (LTC) facilities, potential added staff compensation reporting and compliance implications, and the impact the proposed rule would have on Massachusetts and Connecticut LTC facilities, if enacted. “The Proposed Rule would establish national, quantitative minimum nurse staffing standards for all LTC facilities,” they write. “CMS cites the link between consistent nurse staffing and quality and safety metrics as the driver for establishing these standards, with the ultimate goal of decreasing nationwide variability in nurse staffing and increasing quality and safety overall.” To read the article in full, click here.

April 2024

HHS Proposes to Combat Abortion Bans by Protecting Reproductive Health Records

Northeastern University Law Review Online Forum

Read the article.

June 29, 2026

Connecticut Disbands Office of Health Strategy and Reassigns Health Care Oversight and Policymaking Authority Across State Agencies

Health Law Diagnosis

March/April 2026

How PBM Reform Suddenly Got Rolling

Massachusetts Bar Association Section Review

March 5, 2026

Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

Health Law Diagnosis

March/April 2024

Implications of Biden’s Proposed LTC Nurse Staffing Rule

Massachusetts Bar Association Section Review

April 2024

HHS Proposes to Combat Abortion Bans by Protecting Reproductive Health Records

Northeastern University Law Review Online Forum

Read the article.

Health Law Diagnosis

Below is an excerpt of the Health Law Diagnosis blog posts authored by Ivy.

Connecticut Expands Penalties for Unlicensed Health Care Operations

Connecticut Governor Ned Lamont recently signed into law Public Act No. 26-68 (the Act), which makes targeted but significant changes to the Department of Public Health’s (DPH) enforcement authority for health care licensure and certification violations by increasing potential fines and creating criminal liability for certain unlicensed operation of health care institutions and unlicensed provision of professional health care services. These changes take effect October 1, 2026. Expanded Penalties for Operating Without Required Licensure or Certification The Act revises the penalty framework for a person who establishes, conducts, manages or operates a health care institution (such as a hospital, urgent care center or nursing home) without the required license or certificate. Beginning October 1, 2026, such conduct will be a class D felony, and violators may be fined up to $5,000 per day, an increase from the current maximum of $100 per day. The Act creates a new penalty for property owners on whose property a health care institution is established, conducted, managed, or operated without the required license or certificate. These property owners may be fined up to $100 per day. There is a narrow exception to the above penalties for any institution that applied for a license renewal within 60 days after its license lapsed. Increased Civil Penalties The Act adds a separate civil penalty mechanism, under which DPH may, after a hearing, impose a civil penalty of up to $25,000 per day on any person establishing, conducting, managing or operating a health care institution without the required license or certificate. Under current law, DPH may, upon the advice of the Attorney General, seek an injunction to restrain the offending institution’s operation. The Act also authorizes DPH (or the applicable health care service licensing board or commission) to issue a temporary order to stop a person performing unlicensed activities while a formal order is pending if such activities pose an imminent risk to public health, safety or welfare. After a hearing, DPH may also impose a civil penalty of up to $25,000 for each day that a person provides professional health care services without the required DPH license or certificate. Key Takeaways Under the Act, DPH has much greater authority to enforce its institution and individual licensing and certification requirements. Institutions and individuals licensed or certified by DPH should review their current licenses, certificates, and renewal tracking processes before October 1, 2026.

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Connecticut Updates its Medical Orders for Life-Sustaining Treatment Program

Connecticut Governor Ned Lamont recently signed Public Act No. 26-68 (the Act), which includes changes to the state’s medical orders for life-sustaining treatment (MOLST) program. Shortly after the Act was signed into law, the Connecticut Department of Public Health (DPH) issued policies and procedures regarding the MOLST program, which will operate as regulations in the interim until DPH promulgates final regulations. The statutory changes to the MOLST program became effective May 26, 2026, and the DPH policies and procedures became effective June 8, 2026. Background MOLST is Connecticut’s framework for documenting medical orders concerning life-sustaining treatment for individuals who are approaching the end stage of a serious, life-limiting illness or who are in a condition of advanced chronic progressive frailty. The purpose of the program is to support patients’ preferences regarding treatment at such point in their disease progression. MOLST is implemented through medical orders that can guide treatment decisions across care settings. Statutory Changes to the MOLST Program The Act redefines a “medical order for life-sustaining treatment” to now mean a set of orders established by DPH and specific to the MOLST program. Previously, a MOLST was an order made by a physician, advanced practice registered nurse (APRN) or physician assistant. The Act further specifies that a MOLST will be valid only if it is completed on a form prescribed by DPH. Pursuant to this change, DPH published a form which providers must now use to effectuate patients’ wishes for life-sustaining treatment. The Act also allows physician assistants, in addition to APRNs and physicians, to determine that a patient’s condition has progressed to the point appropriate for a MOLST. MOLST Policies and Procedures DPH’s policies and procedures operationalize the MOLST changes made by the Act. The policies include training-related requirements for providers who are authorized to execute a MOLST form. Each eligible provider must complete DPH-approved MOLST training, which will focus on conditions that qualify a patient for participation in the MOLST program. No provider may sign a MOLST form without first completing the required DPH-approved training. The new DPH policies require that a provider conduct a MOLST discussion with the patient or the patient’s legally authorized representative before executing a MOLST form. During this discussion, the provider must discuss the patient’s goals for care and treatment and the benefits and risks of various methods for documenting the patient’s wishes for end-of-life treatment. The MOLST discussion must be completed again as clinically appropriate to review goals of care and treatment preferences according to disease progression, when the patient is transferred to a different care setting or level of care, or if the patient’s preferences change. The provider must document these discussions in the patient’s medical record. Once the MOLST form is executed, it must be made available for the patient to review. The policies also address revocation, amendment and treatment requests that differ from a valid MOLST form. A patient or their legally authorized representative may request and receive treatment that differs from the patient’s valid MOLST form at any time, without revoking the MOLST form. A patient or legally authorized representative may revoke or amend a valid MOLST form at any time. Each health care provider must follow the orders on a valid MOLST form, unless instructed otherwise by the patient or legally authorized representative. The policies also provide that valid MOLST forms must be recognized by any receiving health care provider or institution. Key Takeaways The Act and related DPH policies result in a more detailed and standardized operational framework for the MOLST program, and place new training requirements on providers. Health care providers involved in end-of-life care should be aware of these new changes to the MOLST program and may need to update their processes and forms to comply with the new state-mandated MOLST program requirements.

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Massachusetts HPC Expands Reporting Requirements and Oversight Authority in New Material Change Regulations

On April 16, 2026, the Massachusetts Health Policy Commission (HPC) approved amendments to its Material Change Notice (MCN) regulations at 958 CMR 7.00 (the Amended Regulations), which went into effect on May 8, 2026. As background, following the 2025 passage of health care legislation that expanded the HPC’s health care market oversight responsibilities, the HPC proposed amended MCN regulations in February 2026 for review and comment that broadened the MCN process and gave the HPC greater latitude to conduct Cost and Market Impact Reviews (CMIRs) (see our analysis here). The Amended Regulations are largely consistent with the proposed regulations, but include a few changes apparently influenced by stakeholder comments. The Amended Regulations include the newly defined thresholds for filing MCNs, new categories of investors subject to MCN filing requirements, an expanded scope of review and authority for the HPC, and additional post-transaction review processes. At an April 16 Public Meeting to review the proposed regulations, the HPC sought to address concerns from commenters by explaining the agency’s rationale for certain changes and making adjustments. The HPC also noted that it would promulgate sub-regulatory guidance on certain issues, including how pharmacy revenue should be counted for the purpose of Net Patient Service Revenue, as well as further describing the definition of “control” for purposes of charitable relationships. Notably, in connection with the finalization of the Amended Regulations, the HPC has already issued sub-regulatory guidance on the MCN Amended Regulations on May 21, 2026 (available here), as well as an updated MCN Form (available here) for use starting May 19, 2026. Below, we summarize the key provisions of the Amended Regulations approved by the HPC, including in bold italics any departure from the language of the amendments as previously proposed by the HPC: New MCN definitions: The Amended Regulations add new definitions that impact MCN filing obligations, including the following definitions allowing for regular adjustment of monetary filing thresholds by the HPC and establishing the type of owners/investors now subject to the MCN filing requirement, and any exceptions thereto: MCN Filing Threshold and Revenue Increase Threshold: Prior regulations applied MCN reporting requirements to providers/provider organizations with more than $25 million in Net Patient Service Revenue (NPSR) as well as to certain transactions that would result in an increase of more than $10 million in NPSR. The Amended Regulations formally define these monetary thresholds, setting $25 million in NPSR as the “MCN Filing Threshold” (applicable to MCN reporting associated with clinical affiliations) and $10 million in NPSR as the “Revenue Increase Threshold” (applicable to MCN reporting associated with mergers, acquisitions, certain other affiliations, and significant capacity increases). These monetary thresholds will now be subject to annual adjustment by the HPC. Private Equity Company and Significant Equity Investor: The Amended Regulations newly define the term “Private Equity Company” in broad terms to refer to any entity that collects capital investments, however organized, and which purchases directly or through another owned or controlled entity, a direct or indirect ownership share of a provider, provider organization, or management services organization (MSO). The Amended Regulations separately define “Significant Equity Investor” as a Private Equity Company that holds—or would hold, following a proposed transaction—any financial interest in a provider, provider organization, or MSO; or any investor that holds—or would hold, following a proposed transaction—equity amounting to more than 10 percent of a provider, provider organization, or MSO. Both defined terms include narrow exceptions for venture capital firms exclusively engaged in funding start-ups and early stage businesses; and Significant Equity Investors exclude individual licensed health care providers who practice medicine, dentistry or another health care profession as a full or partial owner of the provider or provider organization. MCN-triggering transactions: The Amended Regulations clarify the scope of certain transactions already subject to the MCN process, including: Mergers or affiliations involving both a provider or provider organization and an insurance carrier, and acquisitions of a provider or provider organization by an insurance carrier (and vice versa). Mergers with or acquisitions of hospitals or hospital systems. The final Amended Regulations removed additional language here that would have also referenced mergers with or acquisitions of a provider or provider organization by a hospital or hospital system, which per the HPC was done because such transactions are already captured elsewhere as material changes. Mergers, acquisitions, or affiliations (including corporate affiliations, contracting affiliations, and employment of health care professionals) where: (a) the arrangement is between providers, or involves one of the following: a provider organization, an MSO that establishes contracts with insurance carriers or third-party administrators, or an entity that represents health care providers (including out-of-state providers) in contracting with payers for health care services; and (b) such arrangement would result in an increase in one party’s NPSR equal to or greater than the Revenue Increase Threshold (defined above), or in one party gaining a dominant market share (as such term is defined in these regulations) in a given service area or region. The final Amended Regulations added a carveout here for entities representing out-of-state providers to clarify that this will only require the MCN if the proposed transaction is with or on behalf of a Massachusetts provider, provider organization, or MSO. Clinical affiliations between two or more providers or provider organizations that each have an NPSR greater than the MCN Filing Threshold. The Amended Regulations specify arrangements that explicitly constitute clinical affiliations covered under this requirement, as follows: co-branding, co-located services, complete or substantial staffing of an acute hospital service line, funding EHR interconnectivity, regular and ongoing provision of telemedicine services, preferred provider relationships, and discount arrangements. The Amended Regulations maintain the pre-existing exclusion for affiliations solely related to clinical trials or graduate medical education programs. Any form of partnership, joint venture, accountable care organization, parent corporation, MSO, or other organizational structure created to administer contracts with insurance carriers, third party administrators, or other contractors. The Amended Regulations also add new categories of transactions subject to MCN review, with minor changes from the regulations as proposed, as noted below: Any significant increase to a provider or provider organization’s capacity, including: Any increase to capacity that would trigger the Determination of Need (DoN) process due to a Substantial Capital Expenditure (as defined in the DoN regulations at 105 CMR 100.000). The Amended Regulations narrowed this requirement—as proposed, this category would also have included any other basis meeting the monetary criteria for a Substantial Capital Expenditure. Any increase to capacity that would result in an increase to the provider’s NPSR equal to or greater than the Revenue Increase Threshold (set at $10 million currently) based on expected revenue from the planned capacity (e.g., any increases to operational capacity that do not meet the DoN monetary thresholds for Substantial Capital Expenditures but will result in NPSR increasing at least $10 million). Any transaction involving a Significant Equity Investor, including a Private Equity Company (as each are defined above), that results in a partial or complete change of ownership or control of a provider, provider organization, or MSO that provides support for negotiating or establishing contracts with carriers or third-party administrators. Any real-estate lease backs involving the sale of real property used to deliver healthcare services, as well as other significant acquisitions, sales, or transfers of assets to be specified by the HPC in forthcoming guidance. The Amended Regulations deferred to the HPC to further define this category, in response to commenters’ concerns about its broad scope as proposed. Any conversion of a provider or provider organization from a non-profit entity to a for-profit entity. Additional CMIR authority: In addition to its expanded MCN scope, the HPC is authorized under the Amended Regulations to conduct a CMIR if a proposed material change is “likely to have a significant impact” on the competitive market or on the Commonwealth’s ability to meet its financial goals pursuant to the Health Care Cost Growth Benchmark, a metric for cost containment established and updated annually by the HPC. The Amended Regulations also give the HPC discretion to conduct a CMIR on any provider organization that exceeded the Health Care Cost Growth Benchmark in the previous year, as reported by CHIA. No changes were made to the amendments as proposed. Expanded review and enforcement authority relevant to the MCN and CMIR processes: Under the Amended Regulations, the HPC has expanded authority to request information from parties to a transaction and certain other market participants. While the authority to request documents and other materials is not new, the Amended Regulations add Significant Equity Investors to those parties from whom information may be requested, including information about the entity’s capital structure, general financial condition, ownership and management, and audited financial statements. HPC may also request information from payers related to a particular MCN. No changes were made to the amendments as proposed. Post-transaction review of material changes: The Amended Regulations allow the HPC to conduct post-transaction reviews of material changes for up to five years, at its discretion. Under its post-transaction review authority, the HPC would be able to require parties to a material change to submit any data and information it deems necessary to assess the post-transaction impacts, and to make referrals to the Attorney General or other state or federal agencies as appropriate. No changes were made to the amendments as proposed. MCN Filing Deadline: Where a proposed transaction or other arrangement requires the filing of an MCN and a DoN, the Amended Regulationsclarify that the MCN must be filed with the HPC no later than the date of filing of the DoN application. The Amended Regulations maintain the current requirement that all MCNs be filed not less than 60 days prior to the proposed effective date of a material change. In its proposed amendments, the HPC had sought to require concurrent filing of the MCN and the DoN application. Key Takeaways The Amended Regulations preserve the core expansion of scope and authority proposed by the HPC in February, 2026, which entities have already been subject to in large part since the HPC’s Bulletin HPC-2025-01 guidance that went into effect on April 8, 2025. Health care organizations and investors should carefully review any upcoming organizational changes that may newly trigger MCN requirements or a CMIR process under the Amended Regulations. Of note, recent MCN filings show a significant increase in filings by significant equity investors. We will continue to monitor the HPC’s implementation of the Amended Regulations and the agency’s guidance.

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Connecticut Disbands Office of Health Strategy and Reassigns Health Care Oversight and Policymaking Authority Across State Agencies

Connecticut Governor Ned Lamont recently signed Public Act No. 26-68 (“the Act”), which includes the elimination of the Office of Health Strategy (OHS) and reassignment of its statutory authority over the health care delivery system in Connecticut. The Act’s repeal of OHS’s enabling statute and the transfer of its authority to other state agencies are scheduled to take effect on July 1, 2026. The Act allocates functions related to the oversight of health care in Connecticut previously assigned to OHS among several state agencies and offices, including the Department of Public Health (DPH), the Office of Policy and Management (OPM), the Department of Social Services (DSS) and the Office of the Healthcare Advocate (OHA). The impact of the dissolution of OHS and corresponding reshuffling of authority is summarized below. Certificates of Need Previously, OHS oversaw the Connecticut Certificate of Need (CON) program; however, under the Act the CON program will move to DPH. We have previously written about the Act’s changes to the CON program. Please see here for our analysis of the Act’s changes to the CON process, and here for our analysis of the new process for hospitals seeking to pause or terminate service lines. For now, it is important for CON applicants and parties to understand that from July 1, 2026, until July 1, 2027, DPH will oversee the CON program in its current state until the newly established CON processes go into effect July 1, 2027. Functions Moving to DPH Aside from authority over the CON process, several notable functions previously vested in OHS shift to DPH: Health Systems Planning Unit – The Act re-establishes the Health Systems Planning Unit within DPH, under the direction of the Commissioner of Public Health, rather than within OHS. Nonprofit hospital transactions and related health care market reporting – The Act moves several hospital and group practice transactions and other reporting functions from OHS to DPH. For nonprofit hospital sales, all authority previously conferred to the Commissioner of Health Strategy is now granted to the Commissioner of Public Health. Hospital, hospital system, and group practice reporting also shifts to DPH, including written notices after certain transactions and health care entity annual reporting. Health care facility oversight and reporting – DPH will now oversee all facility fee requirements, including hospital, health system, and hospital-based facility reporting requirements, and will hold enforcement authority arising from such reporting requirements. Patient billing and financial assistance provisions – Hospitals must now report charity care and reduced-cost service policies to the Health Systems Planning Unit of DPH, and hospitals must provide detailed patient bills upon request of DPH or a patient. Health data functions – Short-term acute care general and children’s hospitals will need to submit patient-identifiable inpatient discharge data and emergency department data to DPH, and outpatient surgical facilities and certain hospital outpatient surgery departments must submit such data to DPH. Community Health Worker Advisory Body – DPH now has jurisdiction over the Community Health Worker Advisory Body. Functions Moving to OPM The Act transfers key health care data reporting authorities to OPM, including: Core health information technology responsibilities – OPM will now oversee implementation and revision of the statewide health information technology plan, adoption of electronic data standards, oversight of the Statewide Health Information Exchange (discussed further below), and associated legislative committee reporting. Statewide Health Information Exchange – The Act gives OPM administrative authority over the Statewide Health Information Exchange, known as Connie. The Secretary of OPM is responsible for designating and posting the systems, technologies, entities, and programs that constitute the exchange. OPM also receives authority to adopt regulations and implement interim policies and procedures for Connie, including public hearing and notice requirements. State Health Information Technology Advisory Council – This council, tasked with policy recommendations for health information technology and exchange efforts, is reoriented to advise the Secretary of OPM and the health information technology officer. All-payer claims database – OPM becomes the successor agency for the all-payer claims database program, now overseeing the planning, implementation, and administration of the all-payer claims database program, securing data collection and storage, auditing reporting entity data, and maintaining written administrative procedures in consultation with the Health Information Technology Advisory Council. Consumer health information website – The Secretary of OPM receives responsibility for posting consumer-facing health cost and quality information, making specified lists of frequent services and procedures publicly available, and issuing reports on billed and allowed amounts and out-of-pocket costs. Health care cost growth and quality benchmark authority – The Act redesignates the agency responsible for establishing the health care cost growth and health care quality benchmarks every five years to OPM. The Act also confers authority in OPM for monitoring and identifying entities exceeding benchmarks or failing targets and informing the public as such. Functions Moving to DSS The authorities reallocated to DSS include: Hospital financial health reporting – Hospitals must submit semiannual financial health reports to the Commissioner of Social Services, rather than the Commissioner of Health Strategy. DSS may require additional information if a hospital reports two consecutive quarters of 60 days or less of cash on hand, and DSS must contact a hospital to offer assistance if a report reflects two consecutive quarters of 45 days or less of cash on hand. Covered Connecticut and waiver-related provisions – The Commissioner of Social Services remains responsible for seeking Section 1115 waivers, but the Act removes the requirement for prior consultation with the Insurance Commissioner and OHS from that provision. The Act also permits DSS, rather than OHS, to seek Section 1332 waivers from the federal government. Community Benefit Program Reporting Moves to OHA The Act reassigns hospital community benefit program reporting, which includes hospitals’ community health needs assessments, implementation strategies, and annual reports, from OHS to OHA. Hospitals must submit community benefit reporting to OHA or to a designee selected by the Healthcare Advocate. The annual summary and analysis of community benefit program reporting is assigned to the Healthcare Advocate, who must post the summary and analysis on the OHA website and solicit stakeholder input through a public comment period. OHA uses that reporting and stakeholder input to identify additional stakeholders, determine how those stakeholders could assist in addressing community health needs, determine whether to make recommendations to DPH in developing the state health plan, and inform the statewide health care facilities and services plan. Key Takeaways Broadly, the above-discussed sections of the Act eliminate OHS as a statutory office and distribute its principal functions among multiple agencies. DPH becomes the key successor for the Health Systems Planning Unit, CON authority, nonprofit hospital transaction authority, and multiple health facility oversight functions. OPM becomes the key successor for statewide health information technology, the Statewide Health Information Exchange, the all-payer claims database, consumer health information tools, and benchmark programs. DSS becomes the successor for hospital financial health reporting and receives Covered Connecticut waiver authority. OHA becomes the successor for community benefit program reporting. Despite administrative authority being distributed across multiple state agencies, the substantive reporting and administrative requirements for health care entities remain largely unchanged. Health care entities should be aware of the different agencies to which they must make reports and disclosures. We will continue to monitor implementation of these administrative changes.

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How PBM Reform Suddenly Got Rolling

Below is an excerpt of an article published in the Massachusetts Bar Association’s Section Review. Recent months have seen a significant shift in how pharmacy benefit managers (PBMs) are regulated at both the state and federal levels. PBMs are hired by health plans to manage administrative and other duties, while also serving as intermediaries by negotiating rates with drug companies. However, unlike most players in the health care system whose financial arrangements are heavily regulated and often subject to public scrutiny, PBMs have historically been permitted to operate with few disclosure or transparency requirements. PBMs wield substantial leverage to bargain with drug companies and influence drug prices. One service that PBMs provide is to negotiate rebates that the drug companies pay to health plans. In exchange for a larger rebate, PBMs may offer drug manufacturers a benefit, such as a more favorable position (typically meaning a lower patient copay) on a drug formulary: the list of drugs that the health plan covers, along with the pricing structure for those drugs. PBMs may, in some cases, retain portions of those rebates before passing them on to the health plan. While lower co-pays may, in the short term, be a benefit to patients, high rebates typically result in drug companies raising the list price of the drug over time, which means higher consumer costs. Read the full article, here.

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Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

On February 5, 2026, the Massachusetts Health Policy Commission (HPC) published proposed amendments to its Material Change regulations at 958 CMR 7.00 (the Proposed Amendments). Among other things, the Proposed Amendments broaden the HPC’s market review authority by subjecting more transactions to the HPC’s Material Change Notice (MCN) process and provide the HPC greater latitude to conduct Cost and Market Impact Reviews (CMIRs) of proposed transactions. Below, we summarize the background and timing for public hearing and adoption, and major provisions of the Proposed Amendments. Background & Timing In January 2025, Massachusetts enacted Chapter 343 of the Acts of 2024, “An Act Enhancing the Market Review Process” (the Act), which expanded the HPC’s health care market oversight role, including by authorizing the agency to review a wider range of transactions. The Act (which we discussed here) aimed to strengthen regulatory oversight of health care market transactions, conferring more authority not just on the HPC, but also on the Center for Health Information and Analysis (CHIA) and the Attorney General’s Office. The Act focuses on transactions involving private equity, pharmacy benefit managers, real estate investment trusts, and management service organizations, in order to expand the types of transactions subject to the MCN requirement. The Proposed Amendments seek to codify a number of changes included in the HPC’s Bulletin HPC-2025-01 guidance that went into effect on April 8, 2025. The HPC’s Bulletin provided guidance to providers and provider organizations concerning implementation of the Act. The Bulletin included several new categories of transactions subject to the MCN requirement, new definitions affecting MCNs, as well as changes to the review process for MCNs. The Proposed Amendments are consistent with the Bulletin, with some additional clarifications, as described below. When adopted, the Proposed Amendments will supersede Bulletin HPC-2025-01. The HPC will conduct a virtual public hearing on the Proposed Amendments at 1:00 PM on March 12, 2026. Interested parties are encouraged to submit either oral or written testimony and comments, and parties may request to provide live testimony during the hearing. The HPC will accept testimony and comments until 5:00 PM on March 20, 2026, and is expected to vote on the final adoption of the Proposed Amendments at its board meeting on April 16, 2026. Proposed Amendments The major provisions of the Proposed Amendments are as follows: New definitions: The Proposed Amendments add new definitions, including the following definitions allowing for regular adjustment of monetary filing thresholds by the HPC and establishing the type of investors now subject to the Act and any exceptions thereto: MCN Filing Threshold and Revenue Increase Threshold: Current regulations apply MCN reporting requirements to providers/provider organizations with more than $25 million in Net Patient Service Revenue (NPSR) as well as to certain transactions that would result in an increase of more than $10 million in NPSR. The Proposed Amendments formally define these monetary thresholds, setting $25 million in NPSR as the “MCN Filing Threshold” (applicable to MCN reporting associated with clinical affiliations) and $10 million in NPSR the “Revenue Increase Threshold” (applicable to MCN reporting associated with mergers, acquisitions, certain other affiliations, and significant capacity increases). These monetary thresholds are subject to annual adjustment by the HPC. Private Equity Company and Significant Equity Investor: The Proposed Amendments newly define the term “Private Equity Company” in broad terms to refer to any entity that collects capital investments, however organized, and which purchases directly or through another owned or controlled entity, a direct or indirect ownership share of a provider, provider organization, or management services organization (MSO). The Proposed Amendments separately define “Significant Equity Investor” as a Private Equity Company that holds—or would hold, following a proposed transaction—any financial interest in a provider, provider organization, or MSO; or any investor that holds—or would hold, following a proposed transaction—equity amounting to more than 10 percent of a provider, provider organization, or MSO. Both defined terms include narrow exceptions for venture capital firms exclusively engaged in funding start-ups and early stage businesses; and Significant Equity Investors exclude individual licensed health care providers who practice medicine, dentistry or another health care profession as a full or partial owner of the provider or provider organization. Expanded scope of MCN-triggering transactions: The Proposed Amendments would clarify the scope of review for transactions currently subject to the MCN process. These transactions include: Mergers or affiliations involving both a provider or provider organization and an insurance carrier, and acquisitions by an insurance carrier of a provider or provider organization (and vice versa). Mergers with or acquisitions of hospitals or hospital systems, or of a provider or provider organization by a hospital or hospital system. Mergers, acquisitions, or affiliations (including corporate affiliations, contracting affiliations, and employment of health care professionals) where: (a) the arrangement is between providers, or involves one of the following: a provider organization, an MSO that establishes contracts with insurance carriers or third-party administrators, or an entity that represents health care providers (including out-of-state providers) in contracting with payers for health care services; and (b) such arrangement would result in an increase in one party’s NPSR equal to or greater than the Revenue Increase Threshold (defined above), or in one party gaining a dominant market share (as such term is defined in these regulations) in a given service area or region. Clinical affiliations between two or more providers or provider organizations that each have a NPSR greater than the MCN Filing Threshold. The Proposed Amendments specify arrangements that explicitly constitute clinical affiliations covered under this requirement, as follows: co-branding, co-located services, complete or substantial staffing of an acute hospital service line, funding EHR interconnectivity, regular and ongoing provision of telemedicine services, preferred provider relationships, and discount arrangements. The Proposed Amendments maintain the pre-existing exclusion for affiliations solely related to clinical trials or graduate medical education programs. Any form of partnership, joint venture, accountable care organization, parent corporation, MSO, or other organizational structure created to administer contracts with insurance carriers, third party administrators, or other contractors. The Proposed Amendments would also add new categories of transactions subject to MCN review: Any significant increase to a provider or provider organization’s capacity, including: Any increase to capacity that would trigger the Determination of Need (DoN) process due to a Substantial Capital Expenditure (as defined in the DoN regulations at 105 CMR 100.000) or any other basis meeting the monetary criteria for a Substantial Capital Expenditure, and any increase to capacity that would result in an increase to the provider’s NPSR equal to or greater than the Revenue Increase Threshold (set at $10 million currently) based on expected revenue from the planned capacity (e.g., any increases to operational capacity that do not meet the DoN monetary thresholds for Substantial Capital Expenditures but will result in NPSR increasing at least $10 million). Any transaction involving a Significant Equity Investor, including a Private Equity Company (as each are defined above), that results in a partial or complete change of ownership or control of a provider, provider organization, or MSO. A significant acquisition, sale, or transfer of provider/provider organization assets, including real estate lease-backs involving the sale of real property used to deliver healthcare services. Any conversion of a provider or provider organization from a non-profit entity to a for-profit entity. Additional CMIR authority: The Proposed Amendments would additionally allow the HPC to conduct a CMIR if a proposed material change is “likely to have a significant impact” on the competitive market or on the Commonwealth’s ability to meet its financial goals pursuant to the Health Care Cost Growth Benchmark, a metric for cost containment established and updated annually by the HPC. The Proposed Amendments would also give the HPC discretion to conduct a CMIR on any provider organization that exceeded the Health Care Cost Growth Benchmark in the previous year, as reported by CHIA. Expanded review and enforcement authority relevant to the MCN and CMIR processes: Under the Proposed Amendments, the HPC would have expanded authority to request information from parties to a transaction and certain other market participants. While the authority to request documents and other materials is not new, the Proposed Amendments add Significant Equity Investors to those from whom information may be requested, including information about the entity’s capital structure, general financial condition, ownership and management, and audited financial statements. HPC may also request information from payers related to a particular MCN. Post-transaction review of material changes: The Proposed Amendments would allow the HPC to conduct post-transaction reviews of material changes for up to five years, at its discretion. Under its post-transaction review authority, the HPC would be able to require parties to a material change to submit any data and information it deems necessary to assess the post-transaction impacts, and to make referrals to the Attorney General or other state or federal agencies as appropriate. Key Takeaways For health care organizations, the Proposed Amendments reinforce the significantly expanded authority of the HPC to oversee healthcare market transactions and arrangements, and will require close vetting to ensure future transactions and arrangements are appropriately reported. The Proposed Amendments also shed light on how the HPC might exercise its authority to review transactions, particularly those transactions involving private equity investors and MSOs, and those meeting certain financial thresholds. Stakeholders are encouraged to provide public comments on the Proposed Amendments as soon as practicable, and before March 20, 2026, in order to be heard prior to the HPC’s vote on the Proposed Amendments. We will continue to monitor the HPC’s rulemaking and guidance, as well as its implementation of the Proposed Amendments (once approved) and any resulting changes to the MCN process.

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HRSA Requests Comments on Second Iteration of 340B Rebates

On February 17, 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) regarding the use of rebates within the 340B Program. After an unsuccessful first attempt at deploying a rebate model late last year (as we previously wrote about here and here), HRSA is now seeking “input from interested parties regarding the potential use of rebates” by drug manufacturers, “including the standards and procedures” that HRSA should use in implementing rebates for purchases of certain drugs by 340B hospitals and other providers. Background and Precipitating Litigation Under HRSA’s 340B Program, drug manufacturers must sell their products to certain safety-net health care providers at a discount, also known as the 340B ceiling price. Until last year, HRSA’s decades-long practice had been to require that discounts be offered to providers upfront (i.e., applied to the purchase price for the product). But in August 2025, HRSA proposed to change course starting in 2026, launching a 340B Rebate Model Pilot Program (the “Rebate Program”), under which qualifying drug manufacturers could charge 340B covered entities a higher price upfront and offer the difference between that price and the 340B ceiling price as a rebate. The initial rollout of the Rebate Program prompted litigation. In December 2025, several trade groups and safety-net providers sued the federal government, alleging that the Rebate Program’s launch bypassed certain requirements under the federal Administrative Procedure Act (APA), including by failing to reasonably explain the basis and design of the Rebate Program. As we wrote about here and here, the Rebate Program was put on pause pursuant to a preliminary injunction just three days before it was set to begin, and the District Court ultimately granted the parties’ joint motion to vacate and remand the Rebate Program back to HRSA for reconsideration. HRSA’s Request for Information The RFI, published promptly following conclusion of the suit described above, shows HRSA’s continued interest in implementing a rebate program that is “in the public’s interest” for 340B drug purchases. Importantly, the RFI invites comments by stakeholders on a wide range of issues, including: “[A]dministrative, operational, financial, and medication access concerns” that rebates may cause; Whether and to what extent 340B covered entities have “reasonable . . . reliance interests” in maintaining an upfront discount structure; Cash-flow implications of rebate payment timing for 340B covered entities; and Any “proposed alternatives and scope-limiting measures” that may “promote the integrity of the 340B Program” and avoid issues with duplicate discounts, particularly in light of the Medicare Drug Price Negotiation Program’s launch on January 1, 2026. To inform these priorities, HRSA asks for detailed and specific information from stakeholders. Such information includes current and projected costs of upfront versus rebate discounts, how stakeholders interact with contract pharmacies and third-party vendors, and what data collection practices stakeholders use. HRSA also asks commenters to weigh in on balancing concerns from stakeholders “across the continuum of the drug supply chain,” how to gather and generate data for future analysis, and how to promote transparency within the rebate model. Key Takeaways In its RFI, HRSA appears set on addressing the Rebate Program deficiencies under the APA as identified in the litigation mentioned above – affirming its intention to “undertak[e] a methodical and deliberate approach” in crafting a new rebate model, including “analyzing the comments received prior to pursuing the implementation” of a new rebate model. HRSA will be accepting comments on the RFI until March 19, 2026. Covered entities under the 340B Program and other stakeholders are encouraged to comment reflecting their organizations’ experiences, challenges, and cost estimates in response to the specific questions above. We will continue to monitor the comments and the future of rebates under the 340B Program.

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Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift

The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court on January 12, 2026—the deadline for briefing regarding the preliminary injunction—stating that the government was considering “returning the approvals challenged [in the lawsuit] to [the Health Resources and Services Administration] for reconsideration,” and that the parties “plan to dismiss the appeal in short order.” The government formally moved to dismiss its appeal on January 16, 2026, and the First Circuit dismissed the appeal on January 20, 2026. By way of background, just three days before the Rebate Program was set to go into effect, a U.S. District Court issued a preliminary injunction blocking its implementation, which we previously wrote about here. The government swiftly appealed the preliminary injunction to the First Circuit, requesting an administrative stay of the District Court’s decision while the First Circuit deliberated on the preliminary injunction. The First Circuit declined to issue an administrative stay, finding that the federal government had “not carried its burden to justify a stay”—noting specifically that the government did not make a strong showing that it is likely to success on the merits and did not demonstrate that it would suffer irreparable injury should the Court decline to grant the stay. The Court agreed with the District Court’s findings that “the administrative record . . . is devoid of evidence that the federal government considered the hospitals’ significant reliance interests — a critical factor in the analysis of an arbitrary-and-capricious claim.” Absent the stay, the First Circuit requested further briefing on the appeal of the preliminary injunction. As of this writing, the case will continue to move forward at the District Court level, as the parties have not yet submitted any filings to indicate otherwise, and the District Court’s preliminary injunction prohibiting implementation of the Rebate Program will remain in effect until that litigation is resolved. As discussed in our original post, under the 340B statute, the government can decide to use rebates, but may not bypass APA requirements when modifying the 340B program to implement those rebates. In issuing the preliminary injunction, the District Court indicated that, among other things, the government failed to provide a reasonable explanation for the costs and benefits of the program and the deviation from decades of industry reliance on upfront discounts. Therefore, if the government elects not to pursue reconsideration of the injunction in the First Circuit, the Rebate Pilot Program, as currently contemplated by the government, may not proceed until litigation at the District Court level concludes. As noted by the District Court, the government would need to satisfy APA requirements to implement a rebate program under the 340B statute, including developing a full administrative record addressing the costs and benefits to the parties. However, it is unclear to what extent the government would incorporate commenters’ suggestions for managing 340B Covered Entities’ implementation costs, which include, for example, delaying the program’s start date to better equip Covered Entities to handle the increased administrative burden, implementing a dispute resolution mechanism that better protects 340B Covered Entities in the event that manufacturers fail to provide timely rebates, and limiting the scope of a future pilot program (as designed, the Rebate Program would apply to all 340B Covered Entities). We will continue to monitor this litigation and developments concerning the Rebate Program.

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Court Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot Program

On December 29, 2025—just three days before the 340B Rebate Model Pilot Program (the Rebate Program) was set to begin—the U.S. District Court for the District of Maine issued an order granting a preliminary injunction to block the government’s implementation of the Rebate Program on January 1, 2026, after determining that the Health Resources and Services Administration (HRSA) likely violated the Administrative Procedure Act (APA) during the Rebate Program’s rollout. Background Under the 340B Program, drug manufacturers are required to offer their products for sale to certain safety-net health care providers at a discounted price. Since the 340B Program was established, HRSA has required that the discounts be offered to providers as “upfront” price concessions. Safety-net providers often rely on savings achieved from the upfront discounts to support programs to ensure access for the vulnerable patient populations they serve. On July 31, 2025, HRSA announced the Rebate Program, which would permit an approved group of drug manufacturers to offer 340B drug price reductions in rebate form rather than as an upfront discount. The Rebate Program would require safety-net providers to pay the full market cost of the drug and then claim a rebate to realize the discount. HRSA in part contends that the Rebate Program is intended to “de-duplicate” price concessions that certain safety-net providers may obtain via the 340B Program and the Inflation Reduction Act’s Drug Price Negotiation Program. Although only nine drug manufacturers were approved to participate in the Rebate Program, and the Rebate Program covers ten drugs, those manufacturers would be permitted under the Rebate Program to implement the rebate model with respect to all 340B safety-net providers—meaning, all 340B safety-net providers would be required to pay full price and implement the rebate model with respect to the ten drugs. Importantly, the announcement of the Rebate Program appeared to be a reversal of the 340B Program’s prior use of upfront discounts since the 340B Program’s inception in 1992. In fact, late in 2024, HRSA sent violation letters regarding proposed rebate models to some of the very same drug manufacturers who were subsequently approved for participation in the Rebate Program. Complaint On December 1, 2025, the American Hospital Association (AHA), the Maine Hospital Association (MHA), and four safety-net providers (collectively, the Plaintiffs) sued the federal government, alleging in their complaint that the rollout of the Rebate Program bypassed the requirements of the APA. The Plaintiffs claimed that HRSA did not address the issues raised by affected stakeholders during the statutorily required comment period, instead going ahead with the implementation of the Rebate Program as planned. On that same day, the Plaintiffs urged the court to temporarily block the January 1 start date for the Rebate Program, citing the potential for “hundreds of millions of dollars in costs” to 340B Program participants as a result of the Rebate Program, as well as “inevitable disruptions to patient care.” On December 10, 2025, several drug manufacturers, including AbbVie, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), moved to intervene in the suit as a matter of right, claiming the government could not adequately represent their interests in the case—namely, the potential for financial losses from duplicative discounts, as well as the government’s contrary position regarding 340B rebate models in other ongoing litigation. The Court, however, rejected the drug manufacturers’ bid to intervene in the case, noting that because the case (which consists of five alleged violations of the APA) “turns entirely” on the administrative record, the drug manufacturers would not feasibly be able to illuminate that record better than the government. Additionally, the Court stated that although the government does not itself face the financial implications alleged by the drug manufacturers, this does not inherently mean that the government cannot adequately represent the drug manufacturers’ interests. Court’s Decision In its decision to grant the preliminary injunction, the Court examined whether HRSA adhered to the APA’s arbitrary and capricious standard in its rollout of the Rebate Program. The Court explained that when a federal agency introduces new programs or policies impacting the rights and privileges of the public, those actions must be “reasonable and reasonably explained” in order to satisfy the arbitrary and capricious standard. The Court noted that the Rebate Program represented a “departure from [HRSA’s] decades-long practice of requiring upfront discounts on 340B eligible drugs” and that the administrative record—which is central to the issue of whether HRSA violated the APA—was “rather threadbare.” The decision went on to conclude that the government “failed to follow the APA’s basic blueprint in assembling” the Rebate Program, thereby warranting a preliminary injunction to prevent its implementation nationwide. The Court’s analysis centered on the following factors: Substantial Likelihood of Success on the Merits. The Court noted that there was a paucity of information in the administrative record. In reviewing what information was produced, the Court indicated that HRSA must stand by its reasoning at the time it decided to establish the Rebate Program rather than relying on post-hoc rationalizations or documentation from manufacturers—i.e., they must “do their own homework” vis-a-vis building an administrative record demonstrating the thought process behind the Rebate Program. The Court also found that HRSA failed to provide a reasonable explanation regarding the design of the Rebate Program, and that there was no evidence that HRSA weighed the Plaintiffs’ decades of industry reliance on the upfront discount model against the stated goals of the Rebate Program and approach favored by manufacturers, or evaluated Plaintiffs’ costs to float the full cost of the drugs until receiving the 340B rebate. Further, the Court found “fatal” the HRSA’s failure to consider the costs and benefits of the Rebate Program, as it was only now reviewing administrative costs of the Rebate Program. High Likelihood of Irreparable Harm. The Court concluded that Plaintiffs demonstrated irreparable harm if the Rebate Program were to be implemented, even without relying on “speculative concerns” about delays and denials of rebates for claims involving 340B drugs. Instead, the Court relied on Plaintiffs’ “estimate[d] $400 million in compliance costs, the downstream effect causing them to cut back services and suspend partnerships with drug distributors.” Balance of Equities/Public Interest. The Court found that there was strong public interest in preserving the status quo and the reach of 340B covered entities to provide critical medical services, particularly in light of the Court’s conclusion that Plaintiffs would likely succeed on the merits of their APA claims. Implications and Next Steps Importantly, the Rebate Program is not impermissible under this Order, and in fact, the government has discretion under the 340B Program to opt for 340B rebates. However, any Rebate Program imposed on the public as a final agency action must withstand the requirements of the APA. In this regard, the decision indicates a more fulsome administrative record would need to be established addressing the basis for the Rebate Program compared to the prior policy, its design, and how it weighed Plaintiffs’ reliance interests and administrative costs of compliance. Although the Court declined to weigh in on policy arguments related to what would be less costly alternatives, dispute resolution mechanisms for rebate models, and the use of the rebate database, these questions will also likely need to be addressed in any future iteration of the Rebate Program. Finally, the Court was clear that the preliminary injunction is not limited to the Plaintiffs, and that the Court was authorized to preliminarily enjoin the whole agency action on a national level. The federal government immediately appealed the order to the First Circuit seeking an emergency stay of the preliminary injunction, and it remains to be seen whether that appeal will prove successful on such a short timeline, as the Rebate Program was to begin January 1, 2026. The drug companies have separately appealed the denials of their motions to intervene, the resolutions of which may impact the suit’s timeline and progression. We will continue to monitor the Rebate Program litigation and implications for 340B compliance.

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CMS Adds New Requirements to Hospital Price Transparency Reporting

On November 21, 2025, the Centers for Medicare & Medicaid Services (CMS) published the CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule (the Rule), which includes several significant changes to hospital price transparency regulations. The changes follow from Executive Order 14221, entitled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information,” which directs the Department of Health & Human Services (HHS) to take steps to require more uniform, accurate pricing information from hospitals. Key provisions of the Rule’s new requirements are summarized below. Although these new requirements become effective on January 1, 2026, CMS is delaying enforcement until April 1, 2026. New MRF Data Reporting Requirements Allowed Amounts Currently, where a hospital’s standard charge is based on an algorithm or percentage, CMS requires hospitals to report an “estimated allowed amount” in their machine-readable file (MRF). The Rule removes this requirement and instead requires hospitals to report the following four elements: Median allowed amount (which replaces estimated allowed amount); The 10th percentile allowed amount; The 90th percentile allowed amount; and The number of allowed amounts used to calculate the prior three amounts. The median allowed amount and the 10th– and 90th-percentile allowed amounts must be calculated based on amounts the hospital has historically received from a third-party payer (less certain contractual adjustments) over the 12 to 15 months prior to posting the MRF. If an allowed amount falls between two amounts, hospitals are required to report the higher amount. To calculate these data points, hospitals must use electronic data interchange (EDI) 835 electronic remittance advice (ERA), or an equivalent, alternative source of remittance data. Hospital NPI The Rule also adds a requirement that hospitals encode in their MRF their organizational (i.e., Type 2) National Provider Identifier or NPI. Modification of MRF Attestation Statement Current regulations require each hospital to attest to the accuracy and completeness of the information encoded in its MRF. Beginning January 1, 2026, the Rule replaces the existing affirmation statement with a new, strengthened requirement at 45 C.F.R. § 180.50(a)(3)(iii) (reproduced below). To the best of its knowledge and belief, this hospital has included all applicable standard charge information in accordance with the requirements of 45 CFR 180.50, and the information encoded is true, accurate, and complete as of the date in the file. This hospital has included all payer-specific negotiated charges in dollars that can be expressed as a dollar amount. For payer-specific negotiated charges that cannot be expressed as a dollar amount in the machine-readable file or not knowable in advance, the hospital attests that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a dollar amount and has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula. The Rule also adds a requirement that hospitals include with the attestation statement the name of the hospital’s CEO, president, or senior official designated to oversee the data encoding process for the MRF. Changes to Civil Monetary Penalties Finally, the Rule makes available a 35% reduction to Civil Monetary Penalties (CMP) imposed for certain violations of hospital price transparency requirements, which hospitals can request in exchange for the hospital waiving its right to an administrative hearing. However, the 35% reduction will not apply if the CMP is imposed due to the hospital failing to make its MRF or any shoppable services public. Conclusion Hospitals would be well advised to proactively assess their price transparency practices and update their processes and disclosures to align with the enhanced requirements of the new Rule.

Ivy K. Miller

Ivy K. Miller

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Massachusetts HPC Expands Reporting Requirements and Oversight Authority in New Material Change Regulations

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Connecticut Expands Penalties for Unlicensed Health Care Operations

Connecticut Updates its Medical Orders for Life-Sustaining Treatment Program

Massachusetts HPC Expands Reporting Requirements and Oversight Authority in New Material Change Regulations

Connecticut Disbands Office of Health Strategy and Reassigns Health Care Oversight and Policymaking Authority Across State Agencies

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Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

HRSA Requests Comments on Second Iteration of 340B Rebates

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift

Court Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot Program

CMS Adds New Requirements to Hospital Price Transparency Reporting

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