Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
Articles by Regina DeSantis
HHS and Congress Push to Streamline and Onshore Clinical Trials
Conducting first-in-human clinical trials in the United States is often associated with significant cost, complexity and delay. There is a growing consensus among policymakers that the current US requirements are unnecessarily rigid and burdensome for early-stage clinical development. Companies often view foreign jurisdictions, such as Australia and China, as offering faster, more flexible pathways for initiating clinical trials.
FDA Seeks Venture Capital Firm Input on New Contracting Approach | JD Supra
On December 19, 2025, the Food and Drug Administration (FDA), part of the US Department of Health and Human Services, released a request for information (RFI) seeking input from venture capital firms on how the FDA can better access innovative early-stage companies through creative contracting methods in order to spur advancements in public health.
Sweeping Changes In Store For Federal Healthcare Programs After The Enactment Of The "One Big Beautiful Bill Act"
The One Big Beautiful Bill Act will create a sea change in the healthcare landscape. This law will make significant changes to federal healthcare programs, especially Medicaid's financing and eligibility requirements. With large reductions in healthcare funding anticipated for providers and millions of people expected to lose their health coverage, stakeholders should become familiar with the changes and develop strategies for navigating the expected impacts.
Sweeping Changes in Store for Federal Healthcare Programs After the Enactment of the "One Big Beautiful Bill Act" | JD Supra
Key Takeaways: The One Big Beautiful Bill Act will create a sea change in the healthcare landscape. This law will make significant changes to federal healthcare programs, especially Medicaid’s financing and eligibility requirements. With large reductions in healthcare funding anticipated for providers and millions of people expected to lose their health coverage, stakeholders should become familiar with the changes and develop strategies for navigating the expected impacts.
New Lawsuit Challenges Maryland Cannabis Administration's Social Equity Program Under 'Dormant Commerce Clause,' Seeks Injunction Against Issuing Licenses
According to a Complaint filed on January 26, 2024, in the United States District Court for the District of Maryland, Maryland's adult-use cannabis licensing program, which is currently limited to applicants who qualified for the Social Equity Program, violates the "dormant Commerce Clause" of the Constitution by discriminating against out-of-state applicants.
Litigation Update: Maryland District Court Finds That 'Dormant Commerce Clause' Does Not Apply To Adult-Use Cannabis In Maryland, Denies Injunction
We have an update about the recent lawsuit challenging the constitutionality of the Maryland Cannabis Administration's (MCA's) Social Equity Program.
The DEA's Rule To Reschedule Cannabis To Schedule III: Process And Timeline
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More specifically, the Department of Justice (DOJ), which has authority over the DEA, submitted a formal rescheduling recommendation to the White House following an August 2023 recommendation from the Department of Health and Human Services (HHS) to the DEA to reschedule cannabis.
Medina v. Planned Parenthood South Atlantic: Oral Arguments Focus On Statutory 'Magic Words'
On April 2, 2025, the U.S. Supreme Court heard oral arguments in Medina v. Planned Parenthood South Atlantic. At issue in Medina is § 1902(a)(23) of the Social Security Act (the Act),1 or the "free-choice-of-provider" provision, which allows Medicaid beneficiaries to seek care from any qualified provider.
Medina v. Planned Parenthood South Atlantic: Oral Arguments Focus on Statutory ‘Magic Words’ | JD Supra
On April 2, 2025, the U.S. Supreme Court heard oral arguments in Medina v. Planned Parenthood South Atlantic. At issue in Medina is § 1902(a)(23) of the Social Security Act (the Act),1 or the “free-choice-of-provider” provision, which allows Medicaid beneficiaries to seek care from any qualified provider.
HHS Under The Second Trump Administration
On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President's "Department of Government Efficiency" Workforce Optimization Initiative, which instructed the newly formed Department of Government Efficiency ("DOGE") to make changes to the federal workforce, such as restructuring agencies and eliminating certain positions.
HHS Under the Second Trump Administration | JD Supra
On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of Government Efficiency (“DOGE”) to make changes to the federal workforce, such as restructuring agencies and eliminating certain positions.
Department of Health and Human Services Seeks to Revise Rulemaking Policies | JD Supra
While the APA generally requires agencies to engage in notice-and-comment rulemaking before issuing regulations, there are exceptions for matters related to “agency management or personnel or to public property, loans, grants, benefits, or contracts,” or if an agency “for good cause” determines “that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” Since 1971, however, HHS has taken the position that matters within the agency’s...
Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation | JD Supra
Key Takeaways: FDA released a Revised Draft Guidance document with recommended practices for combatting misinformation online. Firms may wish to issue tailored responsive communications to combat specific instances of internet-based misinformation as defined by FDA. FDA establishes an enforcement policy regarding tailored responsive communications which must fall within an outlined scope and include certain disclosures and disclaimers.
Want To Say It Ain't So? FDA Guides Firms On How To Respond To Misinformation
FH Foley Hoag LLP More Foley Hoag provides innovative, strategic legal services to public, private and government clients. We have premier capabilities in the life sciences, healthcare, technology, energy, professional services and private funds fields, and in cross-border disputes. The diverse experiences of our lawyers contribute to the exceptional senior-level service we deliver to clients.
Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies | JD Supra
Key Takeaways: On June 28, 2024, in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce (“Loper Bright”), the Supreme Court struck down the doctrine of Chevron deference, ending four decades of judicial deference to agency interpretations of ambiguous statutes. Deference to federal agencies will now be permitted only when Congress has expressly delegated such authority—and even then only as applied to factual determinations.
The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline | JD Supra
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More specifically, the Department of Justice (DOJ), which has authority over the DEA, submitted a formal rescheduling recommendation to the White House following an August 2023 recommendation from the Department of Health and Human Services (HHS) to the DEA to reschedule cannabis.
CMS Proposes Important Enhancements To The New Technology Add-on Payment Program In The FY 2025 IPPS Proposed Rulemaking
On April 10, 2024, CMS published the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule, which contains several key proposals that could provide additional benefits for manufacturers seeking to apply for New Technology Add-on Payments (NTAP) for their technologies.
CMS Proposes Important Enhancements to the New Technology Add-on Payment Program in the FY 2025 IPPS Proposed Rulemaking | JD Supra
Key Takeaways: On April 10, 2024, CMS published the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule, which contains several key proposals that could provide additional benefits for manufacturers seeking to apply for New Technology Add-on Payments (NTAP) for their technologies.
Newest Lawsuit Against the Maryland Cannabis Administration Seeks Injunction for Talbot County Dispensary Lottery Because of Delays and Computer System Errors | Foley Hoag LLP - Cannabis and the Law - JDSupra
Another aspiring cannabis license applicant has filed a lawsuit against the Maryland Cannabis Administration (MCA) and is seeking an injunction that could further delay the issuance of new adult-use cannabis licenses in Maryland.
Litigation Update: Maryland District Court Finds that ‘Dormant Commerce Clause’ Does not Apply to Adult-Use Cannabis in Maryland, Denies Injunction | JD Supra
We have an update about the recent lawsuit challenging the constitutionality of the Maryland Cannabis Administration’s (MCA’s) Social Equity Program.
New Lawsuit Challenges Maryland Cannabis Administration’s Social Equity Program Under ‘Dormant Commerce Clause,’ Seeks Injunction Against Issuing Licenses | Foley Hoag LLP - Cannabis and the Law - JDSupra
According to a Complaint filed on January 26, 2024, in the United States District Court for the District of Maryland, Maryland's adult-use cannabis licensing program, which is currently limited to applicants who qualified for the Social Equity Program, violates the “dormant Commerce Clause” of the Constitution by discriminating against out-of-state applicants.
Maryland's Social Equity Verification Portal Closing And Cannabis License Portal Opening Soon! - - United States
Earlier this week our cannabis attorneys Austin Ownbey and Regina DeSantis were joined by special guest Darrell Carrington from Carrington & Associates, LLC for a webinar to discuss the Maryland Round 1 application process. Key Takeaways: Social Equity Applicants must verify their status November 7! Maryland's Application portal will begin accepting applications on November 13 and closes at 5pm on December 12. Applications must be submitted on MCA-provided templates.
Summit For Health Equity: CMS Initiatives To Advance Health Equity (Video)
Foley Hoag presented our first-ever hybrid half-day Summit for Health Equity in which we – through four presentations and panel discussions – provided an overview and analysis of the latest issues surrounding health equity and social determinants of health in the U.S. The Summit convened multi-disciplinary lawyers and leaders across the healthcare vertical for engaging dialogue and education.
Maryland Cannabis Application Details | JD Supra
Key Takeaways: Maryland’s 30-day application period will open at 12:00 AM Eastern Standard Time (EST), Nov. 13, 2023, and close at 5 PM EST on Dec. 12, 2023. Applications submitted after 5 PM will not be accepted or reviewed by the MCA. The upcoming round of cannabis licensing is limited to Social Equity Applicants and Applicants must verify their status in advance of the licensing round.
Maryland Cannabis Application Details - - United States
Maryland's 30-day application period will open at 12:00 AM Eastern Standard Time (EST), Nov. 13, 2023, and close at 5 PM EST on Dec. 12, 2023. Applications submitted after 5 PM will not be accepted or reviewed by the MCA. The upcoming round of cannabis licensing is limited to Social Equity Applicants and Applicants must verify their status in advance of the licensing round.
Massachusetts Cannabis Business Sues City Over 'Community Impact Fees' - - United States
As readers of this blog are well aware, the uncertainty surrounding the legality and enforceability of Massachusetts' "Community Impact Fees," most recently addressed by An Act Relative to Equity in the Cannabis Industry ("the Act"), which took effect in November of 2022, has led to much consternation in the industry and, in several cases, lawsuits by operators against their host communities. One of the latest of these lawsuits was filed by Pittsfield-based Berkshire Roots.
Massachusetts Cannabis Business Sues City Over ‘Community Impact Fees’
As readers of this blog are well aware, the uncertainty surrounding the legality and enforceability of Massachusetts’ “Community Impact Fees,” most recently addressed by An Act Relative to Equity in the Cannabis Industry (“the Act”), which took effect in November of 2022, has led to much consternation in the industry and, in several cases, lawsuits by operators against their host communities. One of the latest of these lawsuits was filed by Pittsfield-based Berkshire Roots.
Massachusetts Cannabis Business Sues City Over ‘Community Impact Fees’ | JD Supra
As readers of this blog are well aware, the uncertainty surrounding the legality and enforceability of Massachusetts’ “Community Impact Fees,” most recently addressed by An Act Relative to Equity in the Cannabis Industry (“the Act”), which took effect in November of 2022, has led to much consternation in the industry and, in several cases, lawsuits by operators against their host communities. One of the latest of these lawsuits was filed by Pittsfield-based Berkshire Roots.
Maryland Cannabis Administration Releases Additional Information, Access to Social Equity Verification Portal | JD Supra
On Friday, September 8, the Maryland Cannabis Administration (MCA) Office of Social Equity released additional information for its upcoming initial licensing round, including the social equity verification portal, application timeframe and deadlines, and the number of licenses available per county. The first round of licensing is limited to Social Equity Applicants.
Maryland Cannabis Administration Releases Additional Information, Access To Social Equity Verification Portal - - United States
On Friday, September 8, the Maryland Cannabis Administration (MCA) Office of Social Equity released additional information for its upcoming initial licensing round, including the social equity verification portal, application timeframe and deadlines, and the number of licenses available per county. The first round of licensing is limited to Social Equity Applicants.
Maryland Cannabis Administration Releases Additional Information, Access to Social Equity Verification Portal
On Friday, September 8, the Maryland Cannabis Administration (MCA) Office of Social Equity released additional information for its upcoming initial licensing round, including the social equity verification portal, application timeframe and deadlines, and the number of licenses available per county. The first round of licensing is limited to Social Equity Applicants.
Maryland Releases Eligibility Criteria For Social Equity Applicants For Fall 2023 Cannabis License Application Period - - United States
Maryland's eligibility criteria to be considered a social equity applicant: An interactive map of the Disproportionately Impacted Areas in Maryland, qualifying public schools that remain open and institutions of higher education, is available on the Office of Social Equity's (OSE) website. The OSE also provided the lists as PDFs: public schools, higher education institutions, and zip codes.
Maryland Releases Eligibility Criteria for Social Equity Applicants for Fall 2023 Cannabis License Application Period | JD Supra
Key Takeaways: Maryland’s eligibility criteria to be considered a social equity applicant: An interactive map of the Disproportionately Impacted Areas in Maryland, qualifying public schools that remain open and institutions of higher education, is available on the Office of Social Equity's (OSE) website. The OSE also provided the lists as PDFs: public schools, higher education institutions, and zip codes.
Are You Prepared For Adult-Use Cannabis To Start In Maryland? (Video) - - United States
What license holders and aspiring license holders need to know. In Maryland, starting July 1, all adults 21+ will be able to purchase cannabis from licensed dispensaries and Maryland's cannabis industry will never be the same. The state is currently preparing to launch this new program, to convert the current medical cannabis industry to an adult-use market, and to fulfill its goals for economic growth, representation, and social equity in Maryland.
Summary: Amendments to Maryland House Bill 556 and Senate Bill 516 | JD Supra
Key Takeaways: Amendments to Maryland House Bill (HB) 556, and its companion Senate Bill (SB) 516, provide clarification on essential provisions for persons or entities interested in participating in the cannabis industry in Maryland. Both bills have crossed over and are expected to quickly pass the other chamber, and once a compromise version passes both chambers, it is expected that Governor Wes Moore (D) will sign into law.
Summary: Amendments to Maryland House Bill 556 and Senate Bill 516
Key Takeaways: Amendments to Maryland House Bill (HB) 556, and its companion Senate Bill (SB) 516, provide clarification on essential provisions for persons or entities interested in participating in the cannabis industry in Maryland. Both bills have crossed over and are expected to quickly pass the other chamber, and once a compromise version passes both chambers, it is expected that Governor Wes Moore (D) will sign into law.
SUMMARY: Maryland House Bill 556 | JD Supra
March 15, 2023 To embed, copy and paste the code into your website or blog: Recently introduced Maryland House Bill 556 contains essential provisions for persons or entities interested in participating in the cannabis industry in Maryland. On or before July 1, 2023, all current medical cannabis licensees in Maryland would be allowed to convert their licenses to medical and adult use. There would be a limited number of several types of new licenses issued.
CMS Rings in the New Year with Updated Guidance on ‘In Lieu of Services and Settings’ (ILOS) in Medicaid Managed Care | JD Supra
Welcome back! We hope everyone had a great start to 2023. A new year provides an opportunity to look back on previous successes and identify areas for growth (this said, we certainly don’t expect everyone to make—let alone adhere to—a “new year’s resolution!”).
Section 1983’s Private Right of Action Might Live to See Another Day: An Overview of Oral Arguments in HHC v. Talevski | JD Supra
[Co-Authora: Tyrus Jackson and Kian Azimpoor] On the morning of November 8, while many Americans were still casting their votes and getting ready for Election Night parties, the Supreme Court heard oral arguments for Health & Hospital Corporation of Marion County v. Talevski. At issue in Talevski is whether a Medicaid beneficiary can file a “Section 1983” civil rights suit in federal court to seek relief for violation of the 1987 Federal Nursing Home Reform Act (FNHRA).
Section 1983’s Private Right of Action Might Live to See Another Day: An Overview of Oral Arguments in HHC v. Talevski
On the morning of November 8, while many Americans were still casting their votes and getting ready for Election Night parties, the Supreme Court heard oral arguments for Health & Hospital Corporation of Marion County v. Talevski. At issue in Talevski is whether a Medicaid beneficiary can file a “Section 1983” civil rights suit in federal court to seek relief for violation of the 1987 Federal Nursing Home Reform Act (FNHRA).
HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers | JD Supra
Key Takeaways: In late September, an Administrative Dispute Resolution (ADR) panel for the Health Resources and Services Administration (HRSA), within the Department of Health and Human Services (HHS), issued its first decision. The panel dismissed a claim from the National Association of Community Health Centers (NACHC) against two pharmaceutical manufacturers, Sanofi-Aventis and AstraZeneca, regarding the manufacturers’ decision to restrict sales of 340B drugs to contract pharmacies.
Summary And Considerations On CMS' RFI On ‘Access To Coverage And Care In Medicaid & CHIP'
United States: Summary And Considerations On CMS' RFI On ‘Access To Coverage And Care In Medicaid & CHIP' 18 April 2022 Foley Hoag LLP Your LinkedIn Connections with the authors The Medicare and Medicaid programs themselves are not old enough to qualify for Medicare coverage (quick history lesson: President Lyndon Johnson signed the Social Security Amendments into law on July 30, 1965, and the Medicaid program launched on January 1, 1966; note that CMS traces the origin of its programs back...
Summary and Considerations on CMS’ RFI on ‘Access to Coverage and Care in Medicaid & CHIP’ | JD Supra
The Medicare and Medicaid programs themselves are not old enough to qualify for Medicare coverage (quick history lesson: President Lyndon Johnson signed the Social Security Amendments into law on July 30, 1965, and the Medicaid program launched on January 1, 1966; note that CMS traces the origin of its programs back to President Theodore Roosevelt’s advocacy for social insurance).
Supreme Court Hears Arguments On 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference' - Food, Drugs, Healthcare, Life Sciences - United States
United States: Supreme Court Hears Arguments On 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference' 14 December 2021 Foley Hoag LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term.
Supreme Court Hears Arguments on 340B Outpatient Payment Cuts-and Discusses ‘Chevron Deference’
Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term. Last week, the Court heard oral arguments for two noted cases: during Monday’s (November 29) arguments for Becerra v.
Supreme Court Hears Arguments on 340B Outpatient Payment Cuts—and Discusses ‘Chevron Deference’ | JD Supra
Over the summer, my colleague Tom Barker discussed how the Supreme Court was planning to hear several health care cases during the October 2021 term. Last week, the Court heard oral arguments for two noted cases: during Monday’s (November 29) arguments for Becerra v.
New State Health Official Letter Extends Post-PHE Processing Timelines, Implements Redetermination Requirement | JD Supra
We’ve previously discussed the numerous flexibilities CMS offered state Medicaid programs to respond to local outbreaks and address health concerns associated with the COVID-19 public health emergency (PHE).
Summer Reruns: ‘340B Contract Pharmacy Saga' Back In The Spotlight As OGC Withdraws Advisory Opinion
United States: Summer Reruns: ‘340B Contract Pharmacy Saga' Back In The Spotlight As OGC Withdraws Advisory Opinion 28 June 2021 Foley Hoag LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.
Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion
Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies. Given the link between the Medicaid drug rebate program and 340B, we at Medicaid and the Law cover relevant 340B topics for our readers.
‘Objective Falsity' And The FCA: An Ongoing Circuit Split
United States: ‘Objective Falsity' And The FCA: An Ongoing Circuit Split 15 March 2021 Foley Hoag LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. The False Claims Act ("FCA") is a Federal statute originally enacted in 1863 as a response to fraud from defense contractors during the American Civil War.
Show More
loading
Actions
Is this you?
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.Get in touch with Regina
Contact Regina, search articles and posts on X, monitor coverage, and track replies from one place.
Learn more about Muck Rack