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Associate
Matthew Smith
Associate
Matthew Smith
Matt Smith is an Associate focused on M&A, financing and other transactions in the healthcare sector, as well as other healthcare compliance and regulatory matters.
Practice Areas
Experience
Matt Smith advises private equity investors, healthcare companies, and providers on complex regulatory and transactional matters. His practice focuses on structuring healthcare transactions and operations to ensure regulatory compliance, with deep experience in mergers, acquisitions, joint ventures, and corporate reorganizations.
Matt provides strategic counsel on a wide range of healthcare regulatory issues, including corporate structuring, telehealth compliance, reimbursement matters involving commercial payors, Medicare, and Medicaid, as well as state licensing and enforcement risks. He regularly advises on fraud and abuse laws, including the Federal Anti-Kickback Statute, the Stark Law, and the False Claims Act.
His clients span the healthcare spectrum, from private equity-backed healthcare platforms and emerging digital health companies to retail and long-term care pharmacies, hospitals, ambulatory surgery centers, home health and hospice providers, and physician practice groups. Matt partners with clients to navigate regulatory complexities and mitigate risk in high-stakes transactions and operational strategies.
Before joining Massumi + Consoli, Matt practiced healthcare law at Goodwin Procter. Prior to law school, he worked in a business role at a medical device and healthcare IT startup. Matt maintains the same practical, business-oriented perspective in his legal practice.
Education
- University of Kentucky College of Law, J.D.
- Thunderbird School of Global Management, M.B.A.
- Davidson College, B.A.
Bar Admissions
- New York
- Tennessee
News & Insights
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02.11.26
DOJ Fraud Section Year in Review 2025: What Private Equity Sponsors and Their Portfolio Companies Should Know
%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3Eby+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Flewis-zirogiannis-pc%2F%22%3ELewis+Zirogiannis%2C+P.C.%3C%2Fa%3E%2C+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fmichael-r-huttenlocher%2F%22%3EMichael+R.+Huttenlocher%3C%2Fa%3E%2C+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fjoyce-cowan%2F%22%3EJoyce+Cowan%3C%2Fa%3E%2C+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fmatthew-smith%2F%22%3EMatthew+Smith%3C%2Fa%3E+and+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fyoav-gaffney%2F%22%3EYoav+Gaffney%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EI.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0+Introduction%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EIn+January+2026%2C+the+Department+of+Justice+Criminal+Division%E2%80%99s+Fraud+Section+released+its+Year+in+Review+for+2025%2C+a+document+worth+reviewing+for+private+equity+sponsors+and+their+portfolio+companies+across+a+range+of+industries.%C2%A0+The+2025+report+reflects+a+significant+expansion+of+both+the+Fraud+Section%E2%80%99s+mandate+and+resources.+%C2%A0The+Fraud+Section+now+has+more+than+200+attorneys%E2%80%94the+largest+in+its+history%E2%80%94and+has+assumed+the+criminal+portfolio+and+personnel+of+the+former+Consumer+Protection+Branch%2C+uniting+expertise+in+its+effort+to+more+comprehensively+protect+the+American+public.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+numbers+tell+an+interesting+story%3A+the+Fraud+Section+charged+265+defendants+in+2025+%28an+over+10%25+increase+from+the+prior+year%29%2C+with+aggregate+intended+fraud+loss+exceeding+%2416+billion%E2%80%94a+record+and+more+than+double+2024%E2%80%99s+total.%C2%A0+Corporate+accountability+remained+a+central+pillar+of+the+Section%E2%80%99s+work%2C+resulting+in+15+corporate+enforcement+actions%2C+including+12+corporate+resolutions+and+3+corporate+indictments.%C2%A0+These+cases+resulted+in+combined+resolution+amounts+of+approximately+%241+billion.%C2%A0+Notably%2C+for+the+first+time+in+over+15+years%2C+the+Fraud+Section+indicted+corporate+entities+for+criminal+activity%2C+signaling+an+evolving+enforcement+approach.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EFor+private+equity+sponsors+and+portfolio+company+leadership+teams%2C+this+report+offers+a+useful+window+into+where+the+DOJ+is+focusing+its+attention.+%C2%A0Understanding+these+priorities+can+help+inform+investment+decisions%2C+due+diligence+practices%2C+compliance+planning%2C+and+risk+management+discussions+at+both+the+sponsor+and+portfolio+company+levels.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EII.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0+Where+the+DOJ+Is+Focusing%3A+2025+Enforcement+Priorities%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+2025+Year+in+Review+identifies+several+key+enforcement+priorities+across+the+Fraud+Section%26%238217%3Bs+four+litigating+units+which+are+worth+keeping+on+your+radar%3A%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EForeign+Corrupt+Practices+Act+%28FCPA%29+and+Anti-Bribery+Enforcement.%3C%2Fstrong%3E+The+FCPA+Unit%2C+composed+of+over+20+prosecutors%2C+is+responsible+for+investigating+and+prosecuting+violations+of+the+FCPA+and+the+Foreign+Extortion+Prevention+Act+%28FEPA%29.+In+June+2025%2C+the+Deputy+Attorney+General+issued+new+Guidelines+for+FCPA+enforcement%2C+highlighting+four+non-exhaustive+priority+areas%3A+%281%29+investigation+and+prosecution+of+foreign+bribery+conduct+that+facilitates+the+operations+of+cartels+and+transnational+criminal+organizations%3B+%282%29+conduct+that+deprives+U.S.+companies+of+fair+opportunities+to+compete%3B+%283%29+conduct+that+undermines+U.S.+national+security+interests%3B+and+%284%29%C2%A0conduct+involving+substantial+bribe+payments+and+efforts+to+conceal+criminal+schemes.%C2%A0+The+Fraud+Section+brought+three+corporate+enforcement+actions+under+the+FCPA+in+2025%2C+including+the+first+corporate+indictment+in+15+years+against+SGO+Corporation+%28Smartmatic%29+for+alleged+bribery+and+money+laundering+in+connection+with+Philippine+election+contracts.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EHealth+Care+Fraud.%3C%2Fstrong%3E+The+Health+Care+Fraud+%28HCF%29+Unit+had+a+record-setting+year%2C+leading+the+largest+coordinated+nationwide+effort+to+combat+and+deter+health+care+fraud+in+the+Department%E2%80%99s+history.+In+June+2025%2C+the+Department+charged+324+individuals%E2%80%94including+96+licensed+medical+professionals%E2%80%94across+50+federal+districts+and+12+state+jurisdictions%2C+with+alleged+losses+exceeding+%2414.6+billion.%C2%A0+The+report+states+that+ongoing+health+care+fraud+enforcement+priorities+include%3A+protecting+the+public+fisc+through+seizure+and+forfeiture%3B+targeting+foreign+actors%3B+addressing+addiction+rehabilitation+fraud%3B+tackling+prescription+drug+abuse%3B+and+pursuing+corporate+enforcement.+%C2%A0Health+care+sectors+with+specific+enforcement+initiatives+include+wound+care%2C+digital+health+technology%2C+substance+abuse+treatment+providers+and+telemedicine+providers.+%C2%A0Additionally%2C+an+NPA+with+Troy+Health%2C+Inc.%2C+a+Medicare+Advantage+plan+accused+of+enrolling+beneficiaries+without+their+consent%2C+shows+continued+interest+in+Medicare+Advantage+fraud.+%C2%A0In+2025%2C+the+HCF+Unit+seized+more+than+%24568+million+in+assets%2C+the+Centers+for+Medicare+and+Medicaid+Services+%28CMS%29+prevented+more+than+%244+billion+in+fraudulent+payments%2C+and+CMS+suspended+the+billing+privileges+of+205+providers.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EHealth+and+Safety+Enforcement.%3C%2Fstrong%3E+The+newly+formed+Health+and+Safety+Unit+%28HSU%29+focuses+on+ensuring+products+distributed+to+consumers+meet+legal+obligations.+The+HSU+criminally+enforces+the+Federal+Food%2C+Drug%2C+and+Cosmetic+Act+%28FDCA%29%2C+pursuing+offenses+involving+food%2C+prescription+medications%2C+counterfeit+pills%2C+medical+devices%2C+dietary+supplements%2C+and+tobacco.%C2%A0+The+HSU+also+brings+criminal+enforcement+actions+under+the+Consumer+Product+Safety+Act+and+the+Federal+Hazardous+Substances+Act%2C+targeting+dangerous+products+and+the+knowing+failure+by+companies+or+individuals+to+report+defects+or+hazards+presenting+unreasonable+risk+of+death+or+injury+to+consumers.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EMarket%2C+Government%2C+and+Consumer+Fraud.%3C%2Fstrong%3E+The+Market%2C+Government%2C+and+Consumer+Fraud+%28MGC%29+Unit+prosecutes%3A+%281%29+fraud+and+manipulation+harming+U.S.+markets+and+investors%3B+%282%29+schemes+to+defraud+government+programs%2C+evade+tariffs%2C+and+procure+government+contracts+fraudulently%3B+and+%283%29+complex+consumer+fraud+targeting+Americans.+In+2025%2C+the+MGC+Unit+expanded+its+mandate+through+integration+of+the+former+Consumer+Protection+Branch%2C+adding+over+20+consumer+fraud+prosecutors.%C2%A0+Priority+areas+include%3A+securities+fraud+schemes+involving+foreign+issuers+and+variable+interest+entities+%28VIEs%29%3B+trade+and+tariff+fraud%3B+procurement+fraud%3B+and+consumer+investment+scams.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ETrade+Fraud+Task+Force.%3C%2Fstrong%3E+The+MGC+Unit+is+now+part+of+the+cross-agency+Trade+Fraud+Task+Force%2C+which+pursues+enforcement+actions+against+parties+who+seek+to+evade+tariffs+and+other+duties%2C+as+well+as+smugglers+importing+prohibited+goods.+The+MGC+Unit+brought+its+first+corporate+and+individual+trade+fraud+case+in+2025.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EIII.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0+What+This+Means+for+Private+Equity+Sponsors+and+Portfolio+Companies%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+2025+Year+in+Review+offers+several+practical+takeaways+for+private+equity+sponsors+and+their+portfolio+companies%3A%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ECorporate+Liability+and+Indictments%3C%2Fstrong%3E.+One+notable+development+is+the+Fraud+Section%E2%80%99s+renewed+willingness+to+indict+corporate+entities%2C+as+evidenced+by+the+first+corporate+indictments+in+over+15+years.+This+marks+a+departure+from+the+Section%E2%80%99s+traditional+exclusive+reliance+on+Deferred+Prosecution+Agreements+%28DPAs%29+and+Non-Prosecution+Agreements+%28NPAs%29.+%C2%A0This+is+a+shift+worth+noting%3A+the+DOJ+appears+more+willing+to+bring+criminal+charges+against+companies%2C+not+just+individuals%2C+in+appropriate+circumstances.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EIndustry-Specific+Considerations%3C%2Fstrong%3E.+Portfolio+companies+in+certain+sectors+may+want+to+pay+particular+attention+to+these+developments%3A%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EHealthcare%3C%2Fstrong%3E%3A+The+HCF+Unit%E2%80%99s+active+enforcement+year+is+particularly+relevant+for+healthcare+portfolio+companies.+In+addition+to+the+June+Takedown%2C+the+Unit+indicted+two+corporate+defendants+and+resolved+allegations+with+two+others+in+2025%E2%80%94its+first+such+resolutions+in+nearly+a+decade.+Portfolio+companies+providing+skilled+nursing+facilities%2C+telemedicine%2C+durable+medical+equipment%2C+addiction+treatment%2C+pharmaceutical+distribution%2C+Medicare+Advantage+plans+or+services%2C+and+wound+care+may+see+continued+attention.+%C2%A0The+prosecution+of+KBWB+Operations+LLC+%28Atrium+Health+and+Senior+Living%29%2C+which+operated+23+skilled+nursing+facilities+and+resulted+in+a+guilty+plea%2C+%24146+million+in+restitution%2C+and+%248.4+million+in+forfeiture%2C+provides+a+concrete+example+of+the+types+of+cases+the+DOJ+is+pursuing.+%C2%A0An+HCF+Data+Fusion+Center+is+being+created+to+leverage+cloud+computing%2C+artificial+intelligence%2C+and+advanced+analytics+to+identify+emerging+healthcare+fraud+schemes.+%C2%A0The+ability+to+readily+analyze+billing+trends+within+a+subsector+may+be+of+particular+concern+to+investors+in+provider+sectors+that+bill+federal+health+care+programs+%28e.g.%2C+Medicare+and+Medicaid%29.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ELife+Sciences+and+Medical+Devices%3C%2Fstrong%3E%3A+The+Kimberly-Clark+Corporation+resolution+illustrates+the+DOJ%26%238217%3Bs+continued+attention+to+medical+device+companies.+Kimberly-Clark+entered+a+DPA+and+agreed+to+pay+up+to+%2440.4+million+to+resolve+charges+stemming+from+the+sale+of+adulterated+surgical+gowns+that+failed+to+meet+required+fluid-resistance+standards.%C2%A0+The+Aesculap+Implant+Systems+NPA+involving+forged+FDA+documents+and+the+illegal+introduction+of+medical+devices+into+interstate+commerce+is+another+corporate+example+in+this+space.+%C2%A0As+in+healthcare%2C+the+DOJ+also+pursued+individual+violators+in+this+space+in+2025.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EConsumer+Products+and+Manufacturing%3C%2Fstrong%3E%3A+The+integration+of+the+Consumer+Protection+Branch+into+the+Fraud+Section+expands+enforcement+capacity+for+violations+involving+consumer+product+safety%2C+hazardous+substances%2C+and+import+fraud.+The+HSU+will+pursue+companies+that+fail+to+report+defects+or+hazards+posing+unreasonable+risk+of+death+or+injury.%C2%A0+The+prosecution+of+Royal+Sovereign+for+fire+hazard+defects+in+dehumidifiers+and+failure+to+report+those+hazards+is+a+useful+case+study+for+companies+thinking+about+product+safety+compliance.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EInternational+Operations%3C%2Fstrong%3E%3A+Portfolio+companies+with+international+operations%2C+particularly+those+doing+business+with+or+through+foreign+governments%2C+will+want+to+keep+FCPA+compliance+top+of+mind.+The+TIGO+Guatemala+resolution%E2%80%94in+which+the+telecommunications+company+agreed+to+pay+over+%24118+million+in+connection+with+bribery+of+Guatemalan+government+officials%E2%80%94demonstrates+that+subsidiaries+of+international+companies+remain+enforcement+targets.%C2%A0+The+Liberty+Mutual+declination+shows+that+voluntary+self-disclosure%2C+full+cooperation%2C+and+timely+remediation+may+result+in+favorable+outcomes.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EGovernment+Contractors%3C%2Fstrong%3E%3A+Portfolio+companies+with+federal+contracts+should+be+aware+of+continued+procurement+fraud+enforcement.+The+Vistant+and+Apprio+corporate+resolutions%2C+arising+from+a+decade-long+bribery+scheme+involving+a+USAID+contracting+officer+and+over+%24550+million+in+prime+contracts%2C+highlight+the+importance+of+robust+controls+in+this+area.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ECompliance+Program+Expectations%3C%2Fstrong%3E.+The+DOJ%E2%80%99s+Corporate+Enforcement+and+Compliance+%28CEC%29+Unit+has+responsibility+for+evaluating+corporate+compliance+programs+and+determining+whether+independent+compliance+monitors+should+be+imposed.+Last+updated+in+September+2024%2C+the+Evaluation+of+Corporate+Compliance+Programs+Guidance+%28ECCP%29+sets+forth+three+fundamental+questions+for+prosecutors%3A+%28i%29+is+the+corporation%26%238217%3Bs+compliance+program+well+designed%3F+%28ii%29+is+the+program+adequately+resourced+and+empowered+to+function+effectively%3F+and+%28iii%29+does+the+corporation%26%238217%3Bs+compliance+program+work+in+practice%3F%C2%A0+These+questions+offer+a+helpful+framework+for+sponsors+conducting+portfolio+company+reviews+and+for+GCs+and+compliance+teams+assessing+their+own+programs.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EVoluntary+Self-Disclosure+Benefits%3C%2Fstrong%3E.+The+Corporate+Enforcement+Policy+%28CEP%29+provides+significant+benefits+for+companies+that+voluntarily+self-disclose+misconduct.+In+2025%2C+the+Department+revised+the+CEP+to+describe+the+path+to+a+declination+based+on+a+timely+voluntary+self-disclosure%2C+cooperation%2C+and+remediation.+The+Liberty+Mutual+declination+illustrates+these+benefits%3A+the+company+voluntarily+self-disclosed+FCPA+violations+involving+bribes+totaling+approximately+%241.47+million+to+Indian+government+officials%2C+fully+cooperated%2C+conducted+a+thorough+root-cause+analysis%2C+separated+personnel+involved%2C+and+made+significant+compliance+improvements%E2%80%94resulting+in+a+declination+with+only+disgorgement+of+%244%2C699%2C088+rather+than+criminal+charges.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3E%C2%A0%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ECompensation+Clawbacks+and+Incentives%3C%2Fstrong%3E.+The+Pilot+Program+on+Compensation+Incentives+and+Clawbacks+requires+companies+entering+criminal+resolutions+to+implement+and+report+on+compliance-related+criteria+in+their+compensation+and+bonus+systems+during+the+resolution+term.+This+program+also+allows+for+possible+fine+reductions+based+on+corporate+efforts+to+recoup+compensation+from+culpable+employees.%C2%A0+Private+equity+sponsors+may+want+to+discuss+these+requirements+with+compensation+committees+and+HR+leadership+at+portfolio+companies%2C+particularly+when+structuring+management+incentive+plans%2C+as+the+program+demonstrates+the+DOJ%E2%80%99s+continued+focus+on+individual+accountability.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3E%C2%A0%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EIndividual+Accountability%3C%2Fstrong%3E.+The+Pilot+Program+on+Voluntary+Self-Disclosures+for+Individuals%2C+launched+in+April+2024%2C+details+circumstances+in+which+the+Department+will+offer+non-prosecution+agreements+to+individuals+who+voluntarily+disclose+original+information+about+certain+criminal+conduct+involving+corporations%2C+fully+cooperate%2C+and+pay+applicable+restitution+or+disgorgement.+This+program+is+worth+understanding%2C+as+it+may+encourage+employees+with+knowledge+of+misconduct+to+come+forward.+%C2%A0Strong+internal+reporting+channels+can+help+ensure+issues+are+identified+and+addressed+internally+first.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3E%C2%A0%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EMonitor+and+Reporting+Obligations%3C%2Fstrong%3E.+The+DOJ+reported+39+active+resolutions+with+Fraud+Section-imposed+reporting+obligations+in+2025%2C+with+33+corporate+entities+under+self-reporting+requirements+and+6+under+independent+monitorships.+The+May+2025+Revised+Memorandum+on+Selection+of+Monitors+clarified+factors+prosecutors+must+consider+when+determining+whether+a+monitor+is+appropriate+and+how+to+tailor+the+scope+of+a+monitor%26%238217%3Bs+review.%C2%A0+For+companies+that+do+find+themselves+in+a+resolution%2C+these+ongoing+obligations+are+worth+factoring+into+planning.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EIV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0+Practical+Considerations+Going+Forward%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EGiven+these+developments%2C+private+equity+sponsors+and+portfolio+company+senior+management+teams+may+want+to+consider%3A%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EPre-Acquisition+Due+Diligence%3C%2Fstrong%3E.+For+private+equity+sponsors+evaluating+potential+investments%2C+the+DOJ%E2%80%99s+enforcement+priorities+provide+useful+guidance+in+evaluating+investment+decisions+and+shaping+due+diligence+protocols+around+potential+compliance+risks.+Particular+focus+should+be+placed+on+compliance+with+the+FCPA%2C+trade+sanctions%2C+health+care+fraud+and+abuse+laws%2C+FDA+regulations%2C+consumer+product+safety+requirements%2C+and+tariff+obligations.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EPortfolio+Company+Compliance+Assessments%3C%2Fstrong%3E.+Private+equity+sponsors+may+want+to+consider+conducting+periodic+compliance+assessments+across+their+portfolio.+The+ECCP+framework+offers+a+useful+benchmark+for+these+reviews+as+well+as+for+GCs+looking+to+assess+the+strength+of+their+programs.%C2%A0+This+assessment+should+include+evaluation+of+program+design%2C+adequacy+of+resources+and+empowerment%2C+and+real-world+effectiveness.+%C2%A0Special+attention+should+be+paid+to+companies+operating+in+the+priority+enforcement+areas+identified+in+the+2025+report%3A+health+care%2C+life+sciences%2C+consumer+products%2C+government+contracting%2C+and+businesses+with+international+operations.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EVoluntary+Self-Disclosure+Assessment+and+Readiness%3C%2Fstrong%3E.+The+revised+CEP%E2%80%99s+emphasis+on+voluntary+self-disclosure+as+the+path+to+declination+is+worth+understanding%2C+particularly+for+companies+thinking+about+how+they+would+respond+if+potential+misconduct+were+identified.+Companies+benefit+from+having+clear+internal+reporting+mechanisms%2C+investigation+protocols%2C+and+decision+frameworks+for+evaluating+whether+voluntary+self-disclosure+is+appropriate+when+potential+misconduct+is+identified.+%C2%A0The+Liberty+Mutual+outcome+demonstrates+the+benefits+of+timely+disclosure%2C+full+cooperation%2C+and+appropriate+remediation.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ECompensation+and+Clawback+Provisions%3C%2Fstrong%3E.+The+DOJ%E2%80%99s+Pilot+Program+on+Compensation+Incentives+and+Clawbacks+is+worth+considering+when+private+equity+sponsors+and+portfolio+company+boards+review+executive+compensation+arrangements.+Incorporating+compliance-related+criteria+and+clawback+provisions+may+be+worthwhile.%C2%A0+Such+provisions+may+also+provide+fine+reduction+benefits+in+the+event+of+a+resolution.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EInternational+Operations+Review%3C%2Fstrong%3E.+Portfolio+companies+with+international+operations%2C+particularly+those+involving+government+customers+or+operating+in+higher-risk+jurisdictions%2C+may+benefit+from+periodic+FCPA+and+anti-bribery+compliance+reviews.+The+FCPA+Guidelines%E2%80%99+focus+on+conduct+involving+cartels+and+transnational+criminal+organizations%2C+unfair+competitive+advantages%2C+national+security+implications%2C+and+substantial+bribe+payments+can+help+inform+risk+assessment+priorities.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EProduct+Safety+and+Regulatory+Compliance%3C%2Fstrong%3E.+For+portfolio+companies+manufacturing+or+distributing+consumer+products%2C+medical+devices%2C+pharmaceuticals%2C+or+food+products%2C+this+is+a+good+time+to+review+product+safety+compliance+programs%2C+including+defect+reporting+obligations+under+the+Consumer+Product+Safety+Act+and+FDA+regulations.+The+HSU%E2%80%99s+focus+on+knowing+failures+to+report+defects+or+hazards+underscores+the+importance+of+timely+reporting+and+remediation.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ETrade+Compliance+Programs%3C%2Fstrong%3E.+With+the+establishment+of+the+Trade+Fraud+Task+Force+and+the+MGC+Unit%26%238217%3Bs+first+trade+fraud+case+in+2025%2C+companies+engaged+in+international+trade+may+want+to+take+a+fresh+look+at+tariff+and+customs+compliance+programs.+This+is+particularly+important+given+current+trade+policy+developments+and+heightened+tariff+enforcement.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EOngoing+Monitoring+and+Board+Reporting%3C%2Fstrong%3E.+Regular+monitoring+and+board-level+reporting+on+compliance+matters+remains+a+best+practice.+The+DOJ%E2%80%99s+oversight+of+39+active+resolutions+with+reporting+obligations+is+a+reminder+that+compliance+is+an+ongoing+commitment%2C+not+a+one-time+exercise.%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0+Conclusion%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+DOJ+Fraud+Section%26%238217%3Bs+2025+Year+in+Review+reflects+an+active+and+evolving+enforcement+environment.+%C2%A0The+record-setting+activity%2C+expansion+into+new+areas+like+consumer+protection+and+trade+fraud%2C+and+renewed+willingness+to+indict+corporations+all+suggest+that+compliance+deserves+continued+attention+at+the+board+and+management+level.+%C2%A0For+private+equity+sponsors+and+portfolio+company+senior+management%2C+the+report+offers+helpful+insight+into+the+DOJ%E2%80%99s+current+thinking+and+priorities%E2%80%94information+that+can+inform+thoughtful+investment+decisions%2C+compliance+planning%2C+and+risk+management.+%C2%A0We+are+happy+to+discuss+any+of+these+developments+in+more+detail+and+how+they+may+relate+to+your+specific+situation.%3C%2Fspan%3E%3C%2Fp%3E%0A04.29.25State and Federal Shifts: Key Regulatory Trends for Healthcare Investors
%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EBy+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fjoyce-cowan%2F%22%3EJoyce+Cowan%3C%2Fa%3E+and+%3Ca+href%3D%22https%3A%2F%2Fmcllp.com%2Fpeople%2Fmatthew-smith%2F%22%3EMatthew+Smith%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3ESummary%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EHealthcare+private+equity+faces+crosswinds%3A+aggressive+legislation+and+regulation+in+many+states+and+a+largely+unpredictable+but+possibly+more+permissive+federal+regulatory+environment.+Executive+branch+initiatives+under+the+Trump+Administration+aim+to+dismantle+regulatory+barriers+and+promote+competition.+How+these+federal+efforts+will+play+out+and+impact+healthcare+investing+is+still+sorting+out.+Deregulatory+efforts%2C+such+as+the+delete+%26%238220%3B10-for-1%26%238221%3B+regulation+executive+order+and+large+scale+HHS+restructuring%2C+could+impact+new+investments%E2%80%94but+also+inject+volatility+into+the+market.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EMeanwhile%2C+states+are+moving+swiftly%2C+expanding+healthcare+transaction+notification+laws+and+even%2C+in+the+case+of+Massachusetts%2C+imposing+direct+fraud+liability+on+investors.+Although+the+FTC+appears+more+permissive+under+new+leadership%2C+the+healthcare+sector+remains+a+top+priority+for+enforcement.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EWith+evolving+requirements+on+both+fronts%2C+private+equity+investors+must+be+nimble%2C+attuned+to+state+developments%2C+and+prepared+for+heightened+scrutiny.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EIn+Depth%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EWhile+federal+policy+developments+remain+uncertain%2C+state-level+action+continues+to+reshape+the+healthcare+private+equity+landscape+%E2%80%94+and+investors+should+take+note+of+developments+on+both+fronts.+Scrutiny+of+healthcare+private+equity+investment+remains+a+priority+at+the+state+level%2C+with+additional+state+legislation+already+in+2025.+Meanwhile%2C+the+federal+focus%2C+particularly+at+the+Federal+Trade+Commission+%28FTC%29%2C+may+shift+away+from+private+equity%2C+even+as+healthcare+remains+a+targeted+sector.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EState+laws+scrutinizing+healthcare+investors+continue+to+evolve%2C+and+some+are+becoming+more+aggressive.+Massachusetts+is+implementing+changes+to+its+False+Claims+Law%2C%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref1%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn1%22%3E%5B1%5D%3C%2Fa%3E+which+imposes+liability+on+private+equity+investors+for+failing+to+report+violations%2C+and+at+least+one+other+state+is+considering+similar+changes.+Additionally%2C+states+are+increasingly+adopting+health+care+transaction+notification+laws%2C+which+vary+significantly+in+their+requirements+and+can+materially+impact+private+equity+transactions.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EOther+brewing+federal+moves+are+likely+to+create+both+opportunities+and+challenges+for+healthcare+investors+as+further+details+emerge.+The+Trump+Administration%E2%80%99s+establishment+of+the+Anticompetitive+Regulations+Task+Force+and+the+issuance+of+several+executive+orders+specifically+aim+to+dismantle+regulations+that+hinder+market+competition%2C+particularly+in+highly+regulated+sectors+such+as+healthcare.+Concurrently%2C+other+developments+at+the+federal+level%2C+including+the+creation+of+the+Department+of+Government+Efficiency%2C+the+reorganization+of+the+Department+of+Health+and+Human+Services%2C+and+uncertain+funding+levels+for+the+Medicare+and+Medicaid+programs%2C+are+contributing+to+considerable+upheaval+and+reshaping+the+healthcare+regulatory+environment.+Investors+who+monitor+these+changes+closely+will+be+better+positioned+to+respond+strategically+as+the+landscape+evolves.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Ch3%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EFederal+Environment%3C%2Fspan%3E%3C%2Fh3%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+federal+environment+for+healthcare+private+equity+presents+more+questions+than+answers.+The+FTC+may+be+more+permissive+in+asserting+jurisdiction+and+regulating+dealmaking+activity%2C+but+funding+levels+for+federal+health+care+programs%2C+particularly+Medicaid%2C+remain+unclear.+The+Trump+Administration%E2%80%99s+broad+re-organization+of+HHS+and+its+deregulatory+initiative+are+likely+to+impact+the+healthcare+space%2C+but+it+is+too+early+to+predict+the+specific+impacts.+The+deregulatory+efforts+and+reorganization+had+no+clear+impact+on+the+proposed+payment+regulations+released+by+the+Centers+for+Medicare+%26amp%3B+Medicaid+Services+%28CMS%29+in+April.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref2%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn2%22%3E%5B2%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EA.+Antitrust%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EDespite+the+focus+in+the+past+few+years+on+federal+antitrust+enforcement+in+the+healthcare+private+equity+arena%2C+the+FTC+now+is+poised+to+permit+more+deals%2C+while+retaining+its+right+to+review.+Previously%2C+the+FTC+had+targeted+healthcare+private+equity.+In+2023%2C+the+FTC+sued+U.S.+Anesthesia+Partners%2C+Inc.+%28USAP%29+and+minority+private+equity+owner+Welsh+Carson+for+allegedly+monopolizing+the+Texas+anesthesia+market+through+a+series+of+acquisitions%2C+leading+to+higher+prices.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref3%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn3%22%3E%5B3%5D%3C%2Fa%3E+The+federal+district+court+dismissed+claims+against+Welsh+Carson+because+its+minority%2C+non-controlling+interest+was+found+not+to+constitute+an+%3Cem%3Eongoing%3C%2Fem%3E+violation+of+antitrust+laws.+The+allegations+against+USAP+were+allowed+to+proceed.+There+was+no+allegation+that+the+initial+acquisition+by+Welsh+Carson+was+a+violation+of+antitrust+laws%2C+and+the+Court+held+Welsh+Carson%E2%80%99s+minority%2C+non-controlling+ownership+interest+could+not+make+it+liable+under+Section+13%28b%29%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref4%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn4%22%3E%5B4%5D%3C%2Fa%3E+for+subsequent+acquisitions+by+USAP+that+were+anti-competitive%3A+%E2%80%9Cif+the+FTC+wants+to+recover+for+a+past+violation%E2%80%94where+an+entity+%E2%80%98has+been%E2%80%99+violating+the+law%E2%80%94it+must+use+Section+5%28b%29+%5Bof+the+FTC+Act%5D.%E2%80%9D%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref5%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn5%22%3E%5B5%5D%3C%2Fa%3E+The+related+administrative+suit+offers+some+insight+into+the+current+FTC+commissioners+thinking+on+private+equity.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+administrative+suit+alleged+the+initial+acquisition+of+USAP+by+Welsh+Carson+and+subsequent+roll+up+acquisitions+by+USAP+were+in+violation+of+Section+5+of+the+FTC+Act+and+settled+on+January+17%2C+2025.+Unsurprisingly%2C+the+FTC%E2%80%99s+consent+order+with+Welsh+Carson+imposed+restrictions+on+its+ownership+and+control+over+USAP.+The+opinion+of+FTC+Chair+Lina+M.+Kahn+in+January+2025+highlights+previous+FTC+views+regarding+the+anticompetitive+role+of+private+equity.+Chair+Kahn%E2%80%99s+opinion+emphasized+the+need+for+regulatory+measures+to+prevent+similar+%E2%80%9Cschemes%E2%80%9D+in+the+future.+In+contrast%2C+the+concurring+opinion+of+Commissioner+Andrew+N.+Ferguson%2C+now+the+chair+of+the+FTC+under+the+Trump+Administration%2C+highlights+Ferguson%E2%80%99s+view+that+the+Welsh+Carson+settlement+was+a+routine+enforcement+action%2C+criticizing+the+focus+on+private+equity+and+asserting+that+the+antitrust+analysis+remains+consistent+%3Cem%3Eregardless+of+investor+type%3C%2Fem%3E.+If+Chairman+Ferguson%E2%80%99s+statement+regarding+Welsh+Carson+reflects+the+FTC%E2%80%99s+current+attitude+to+healthcare+private+equity+%28and+private+equity+more+generally%29%2C+it+is+possible+that+even+larger+transactions+with+greater+consolidation+within+a+sector+or+subsector+may+receive+more+permissive+FTC+reviews.+Nonetheless%2C+Chair+Ferguson+has+stated+that+%E2%80%9Ctwo+of+his+top+priorities%E2%80%9D+are+promoting+competition+in+%E2%80%9Clabor+and+healthcare+markets.%E2%80%9D%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref6%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn6%22%3E%5B6%5D%3C%2Fa%3E+Despite+any+more+permissive+deal+environment+at+the+FTC%2C+Chairman+Ferguson%E2%80%99s+statements+suggest+healthcare+will+continue+to+be+a+target+for+antitrust+enforcement.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EB.+Deregulation%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+Trump+Administration+established+the+Anticompetitive+Regulations+Task+Force+under+the+United+States+Department+of+Justice%E2%80%99s+Antitrust+Division+to+play+a+role+in+identifying+and+eliminating+regulations+across+all+economic+sectors+that+hinder+free+market+competition.+This+Task+Force+is+part+of+a+broader+deregulatory+agenda+aimed+at+fostering+a+competitive+and+innovative+market+environment+across+various+sectors%2C+including+healthcare%2C+housing%2C+transportation%2C+food+and+agriculture%2C+and+energy.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref7%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn7%22%3E%5B7%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EExecutive+Order+14192%2C+signed+on+January+31%2C+2025%2C+mandates+that+for+each+new+regulation+a+federal+agency+issues%2C+at+least+ten+prior+regulations+must+be+identified+for+elimination.+This+%E2%80%9C10-for-1%E2%80%9D+requirement+aims+to+manage+and+control+the+cost+of+planned+regulations+through+a+rigorous+regulatory+budgeting+process.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref8%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn8%22%3E%5B8%5D%3C%2Fa%3E+The+order+emphasizes+reducing+unnecessary+regulatory+burdens+to+secure+economic+prosperity+and+national+security.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref9%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn9%22%3E%5B9%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EExecutive+Order+14219%2C+signed+on+February+19%2C+2025%2C+directs+federal+agencies+to+review+existing+regulations+within+their+sole+or+joint+jurisdiction+%28potentially+extending+to+state+regulations%29+and+identify+those+existing+regulations+that%2C+among+other+criteria%2C+%E2%80%9Cimpose+significant+costs+upon+private+parties+that+are+not+outweighed+by+public+benefits%E2%80%9D+or+%E2%80%9Cimpose+undue+burdens+on+small+businesses+and+impede+private+enterprise+and+entrepreneurship.%E2%80%9D%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref10%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn10%22%3E%5B10%5D%3C%2Fa%3E+Pursuant+to+OMB+guidance+released+on+April+9%2C+2025%2C+agencies+should+identify+these+regulations+within+60+days+and+must+submit+a+report+within+30+days+thereafter+to+the+OMB%E2%80%99s+Office+of+Information+and+Regulatory+Affairs.+In+their+reports+to+OMB%2C+agencies+must+identify+any+regulations+identified+in+the+60-day+review+that+have+not+been+targeted+for+repeal+along+with+an+explanation+of+why+such+regulations+are+not+being+targeted.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref11%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn11%22%3E%5B11%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EExecutive+Order+14267%2C+issued+on+April+9%2C+2025%2C+mandates+that+agency+heads%2C+in+consultation+with+the+FTC+Chair+and+Attorney+General%2C+identify+and+recommend+the+rescission+or+modification+of+regulations+that+create+monopolies%2C+create+barriers+to+entry%2C+limit+competition+%28including+in+procurement%29%2C+or+%E2%80%9Ccreate+or+facilitate+licensure+or+accreditation+requirements+that+unduly+limit+competition%2C%E2%80%9D+adding+a+layer+of+specificity+to+the+deregulatory+efforts.+Within+70+days%2C+agencies+must+provide+a+list+of+regulations+identified+by+the+review+to+the+DOJ+and+FTC.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref12%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn12%22%3E%5B12%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EPursuant+to+the+same+Executive+Order%2C+the+FTC+issued+a+Request+for+Information+%28RFI%29+that+invites+public+comment+on+federal+regulations+that+harm+competition+by+May+27%2C+2025.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref13%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn13%22%3E%5B13%5D%3C%2Fa%3E+The+RFI+seeks+input+from+various+stakeholders%2C+including+consumers%2C+businesses%2C+and+academics%2C+to+identify+regulations+that+create+monopolies%2C+limit+competition%2C+or+impose+unnecessary+barriers+to+market+entry.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref14%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn14%22%3E%5B14%5D%3C%2Fa%3E+On+April+11%2C+the+Office+of+Management+and+Budget+%28OMB%29+issued+its+even+broader+RFI+soliciting+%E2%80%9Cideas+for+deregulation+from+across+the+country%E2%80%A6+to+identify+rules+to+be+rescinded+and+provide+detailed+reasons+for+their+recission.%E2%80%9D+The+broader+RFI+from+the+OMB+appears+to+seek+to+identify+both+state+and+federal+regulations+in+any+sector+in+line+with+its+priorities+and+is+accepting+comments+through+May+12%2C+2025.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref15%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn15%22%3E%5B15%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+Trump+Administration+has+emphasized+that+the+primary+goal+of+these+deregulatory+initiatives+is+to+alleviate+unnecessary+regulatory+burdens+and+foster+a+competitive+market+environment.+The+mechanisms+employed+through+the+Executive+Orders+include%3A%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cul%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3E10-for-1+Requirement%3A%3C%2Fstrong%3E+Agencies+must+identify+ten+existing+regulations+to+repeal+for+every+new+regulation+proposed%2C+ensuring+a+net+reduction+in+regulatory+costs.+%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref16%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn16%22%3E%5B16%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EIncremental+Cost+Reduction%3A%3C%2Fstrong%3E+Agencies+are+directed+to+ensure+that+the+total+incremental+cost+of+new+regulations+is+significantly+less+than+zero%2C+promoting+cost+savings+and+efficiency.+%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref17%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn17%22%3E%5B17%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3Cli%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Cstrong%3EPublic+Engagement%3A%3C%2Fstrong%3E+The+FTC%E2%80%99s+RFI+encourages+public+participation+in+identifying+anticompetitive+regulations%2C+including+specifically+consumers%2C+workers%2C+businesses%2C+startups%2C+potential+market+entrants%2C+investors%2C+and+academics.+%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref18%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn18%22%3E%5B18%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fli%3E%0A%3C%2Ful%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EIt+is+unclear+how+these+federal+deregulatory+efforts+will+play+out+within+healthcare+sectors%2C+but+past+statements+from+the+FTC+offer+some+guidance+on+which+regulations+the+FTC+may+consider+anticompetitive.+Within+healthcare%2C+the+stated+focus+of+the+deregulatory+effort+is+on+eliminating+regulations+that+discourage+low-cost%2C+high-quality+care+and+encourage+overbilling+and+consolidation.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref19%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn19%22%3E%5B19%5D%3C%2Fa%3E+In+the+past%2C+the+FTC+has+submitted+comments+on+state+legislation+that+it+considers+could+impact+competition+and+consistently+opposed+state+certificate-of-need+%28CON%29+laws.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref20%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn20%22%3E%5B20%5D%3C%2Fa%3E+CON+laws+require+healthcare+providers+to+obtain+state+approval+before+expanding+facilities+or+services+and+may+be+implicated+by+changes+of+ownership+or+control.+Further%2C+the+FTC+has+encouraged+broader+scope+of+practice+laws+for+practitioners+such+as+nurse+practitioners+and+optometrists+to+encourage+competition+in+the+primary+care+and+eye+care+markets%2C+supported+telehealth%2C+and+encouraged+states+to+allow+competition+among+accrediting+or+certification+bodies.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref21%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn21%22%3E%5B21%5D%3C%2Fa%3E+In+discussions+linked+to+the+Task+Force%E2%80%99s+website%2C+experts+discussed+additional+potentially+anti-competitive+regulations+including+any+willing+provider+laws%2C+network+adequacy+regulations%2C+and+medical+loss+ratio+regulations.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref22%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn22%22%3E%5B22%5D%3C%2Fa%3E+Investors+may+take+the+opportunity+to+submit+proposals+for+deregulation+in+accordance+with+the+RFIs.+As+the+OMB+and+FTC+analyze+the+submissions%2C+it+may+become+clearer+if+these+regulations%2C+or+other+areas+of+healthcare+regulations%2C+are+likely+to+be+impacted.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EC.+CMS+%26amp%3B+MA+Plans%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EUnder+the+Trump+Administration%2C+Medicare+Advantage+%28MA%29+plans+may+receive+more+emphasis+from+CMS%2C+the+federal+agency+within+HHS+that+provides+health+coverage+in+conjunction+with+States+through+Medicare%2C+Medicaid%2C+the+Children%E2%80%99s+Health+Insurance+Program%2C+and+the+Health+Insurance+Marketplaces.+Medicare+Advantage+%28MA%29+plans+are+Medicare+plans+offered+by+private+insurers+rather+than+by+CMS.+In+its+role+as+the+nation%E2%80%99s+largest+buyer+of+healthcare+services%2C+many+of+CMS%E2%80%99s+standards+and+practices+are+applicable+outside+Medicare+because+other+private+payors+piggyback+on+CMS+requirements.+Mehmet+Oz%2C+M.D.+was+recently+confirmed+as+the+director+of+CMS+on+April+3%2C+2025.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref23%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn23%22%3E%5B23%5D%3C%2Fa%3E+Dr.+Oz+has+consistently+expressed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+is+in+line+with+President+Trump%E2%80%99s+Executive+Order+on+workforce+optimization+and+involves+a+comprehensive+overhaul+of+the+department%E2%80%99s+operations.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref34%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn34%22%3E%5B34%5D%3C%2Fa%3E+While+less+directly+relevant+for+the+environment+impacting+healthcare+transactions%2C+the+structural+changes+at+HHS+impact+the+environment+in+which+many+healthcare+providers+operate+generally+and+could%2C+for+example%2C+slow+the+review+of+transactions+requiring+CMS+approval+%28%3Cem%3Ee.g.%3C%2Fem%3E%2C+Medicare+changes+of+ownership%29.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EA+key+component+of+this+transformation+is+the+significant+reduction+of+the+HHS+workforce+from+82%2C000+to+62%2C000+full-time+employees.+This+reduction+is+being+achieved+through+voluntary+resignation+programs+with+further+reductions+in+force%2C+targeting+duplicative+and+redundant+functions+within+the+department.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref35%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn35%22%3E%5B35%5D%3C%2Fa%3E+The+restructuring+also+involves+the+consolidation+of+twenty-eight+divisions+into+fifteen%2C+centralizing+core+functions+such+as+Human+Resources%2C+Information+Technology%2C+and+Procurement+to+eliminate+inefficiencies.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref36%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn36%22%3E%5B36%5D%3C%2Fa%3E+The+reductions+in+force+may+lengthen+deal+timelines+when+involving+%E2%80%9Cchanges+of+ownership%E2%80%9D+or+enrollments%2C+as+these+require+approval+of+CMS+personnel.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThis+is+not+the+only+change+shaking+things+up+at+HHS.+A+newly+created+Administration+for+a+Healthy+America+%28AHA%29+will+consolidate+several+agencies%2C+including+the+Office+of+the+Assistant+Secretary+for+Health%2C+Health+Resources+and+Services+Administration%2C+and+others%2C+to+better+coordinate+health+resources+for+low-income+Americans.+The+AHA+will+focus+on+areas+such+as+Primary+Care%2C+Maternal+and+Child+Health%2C+and+Mental+Health.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref37%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn37%22%3E%5B37%5D%3C%2Fa%3E+Additionally%2C+the+restructuring+seeks+to+refocus+the+Centers+for+Disease+Control+and+Prevention+%28CDC%29+on+outbreak+response+and+preparedness%2C+with+the+Administration+for+Strategic+Preparedness+and+Response+being+transferred+to+the+CDC+for+a+net+loss+of+1%2C400+personnel.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref38%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn38%22%3E%5B38%5D%3C%2Fa%3E+The+creation+of+a+new+Assistant+Secretary+for+Enforcement+is+intended+to+enhance+oversight+and+combat+waste%2C+fraud%2C+and+abuse+within+federal+health+programs+including+oversight+of+the+Departmental+Appeals+Board+%28DAB%29%2C+Office+of+Medicare+Hearings+and+Appeals+%28OMHA%29%2C+and+Office+for+Civil+Rights+%28OCR%29.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref39%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn39%22%3E%5B39%5D%3C%2Fa%3E+The+upheaval+at+HHS+caused+by+the+reorganization+and+workforce+optimization+could+prove+a+challenging+environment+to+implement+the+Administration%E2%80%99s+deregulatory+agenda+as+well+as+other+initiatives+at+HHS.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EF.+Department+of+Government+Efficiency%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+Trump+Administration+established+a+Department+of+Government+Efficiency+%28DOGE%29+to+advance+%E2%80%9Cthe+President%E2%80%99s+18-month+agenda%E2%80%9D+as+a+temporary+organization+that+will+terminate+on+July+4%2C+2026.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref40%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn40%22%3E%3Csup%3E%5B40%5D%3C%2Fsup%3E%3C%2Fa%3E+Each+federal+agency+is+required+to+establish+a+DOGE+team%2C+typically+consisting+of+a+team+lead%2C+an+engineer%2C+a+human+resources+specialist%2C+and+an+attorney%2C+to+coordinate+with+DOGE+and+advise+on+implementing+its+agenda.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref41%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn41%22%3E%3Csup%3E%5B41%5D%3C%2Fsup%3E%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+Executive+Order+does+not+clearly+define+the+purposes+or+remit+of+DOGE.+Rather%2C+DOGE+is+tasked+with+implementing+a+%E2%80%9CSoftware+Modernization+Initiative%E2%80%9D+to+improve+federal+software+and+IT+systems%2C+promoting+interoperability+among+agency+networks%2C+but+the+order+contains+few+other+specific+directives.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref42%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn42%22%3E%3Csup%3E%5B42%5D%3C%2Fsup%3E%3C%2Fa%3E+All+agency+heads+must+provide%2C+to+the+maximum+extent+allowed+by+law%2C+%E2%80%9Cfull+and+prompt+access+to+all+unclassified+agency+records%2C+software+systems%2C+and+IT+systems.%E2%80%9D+The+DOGE+initiative+also+involves+accessing+unclassified+agency+records+and+systems%2C+with+a+focus+on+IT+and+HR+management%2C+procurement%2C+real+property%2C+and+agency+operations.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref43%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn43%22%3E%3Csup%3E%5B43%5D%3C%2Fsup%3E%3C%2Fa%3EAs+DOGE%E2%80%99s+changes+are+ongoing%2C+it+is+contributing+to+the+uncertainty+around+federal+policy+towards+healthcare+private+equity.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Ch3%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EState+Environment%3C%2Fspan%3E%3C%2Fh3%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EWhile+the+regulatory+and+legislative+environment+for+private+equity+transactions+is+unique+in+each+state%2C+many+states+are+moving+in+similar+ways+to+address+policy+concerns+about+private+healthcare+investment.+More+states+are+adopting+health+care+transaction+notification+laws+that+target+non-provider+investors+such+as+private+equity+funds.+Massachusetts+has+extended+liability+for+certain+healthcare+violations+to+investors+who+knew+about+violative+conduct+but+did+not+report%2C+and+Connecticut+is+considering+a+similar+change+to+its+fraud+and+abuse+law.+With+these+new+requirements+and+added+liability+exposure%2C+states+are+increasingly+asking+investors+to+justify+their+investments+on+public+policy+grounds.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EA.+Health+Care+Transaction+Notification+Laws%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EStates+are+increasingly+adopting+health+care+transaction+notification+laws.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref44%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn44%22%3E%5B44%5D%3C%2Fa%3E+Healthcare+investors+are+aware+of+the+change+of+ownership+%28CHOW%29+filing+requirements+that+often+accompany+transactions+involving+licensed+healthcare+entities.+While+CHOW+filings+assist+regulators+in+oversight+of+licensed+or+enrolled+entities%2C+the+newer+health+care+transaction+notification+laws+focus+on+state-specific+policy+concerns+beyond+licensure+compliance.+Health+care+transaction+notification+laws+are+often+explicitly+attempting+to+scrutinize+private+equity+investment+in+the+healthcare+sector%2C+particularly+healthcare+providers.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cimg+loading%3D%22lazy%22+decoding%3D%22async%22+class%3D%22size-medium+wp-image-2803+aligncenter%22+src%3D%22https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-300x177.jpg%22+alt%3D%22%22+width%3D%22300%22+height%3D%22177%22+srcset%3D%22https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-300x177.jpg+300w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-1024x605.jpg+1024w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-768x454.jpg+768w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-1536x907.jpg+1536w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FMap-2048x1210.jpg+2048w%22+sizes%3D%22auto%2C+%28max-width%3A+300px%29+100vw%2C+300px%22+%2F%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+emerging+requirements+vary+by+state.+Some+states%2C+such+as+New+Mexico+and+Oregon%2C+require+written+approval+from+governmental+authorities+before+a+transaction+may+close+and+allow+conditions+on+future+operations+to+be+imposed+on+reviewed+transactions.+Others%2C+such+as+Illinois+and+Indiana%2C+primarily+require+advance+notice+without+explicit+approval+or+conditions.+Information+to+be+submitted+includes+details+about+the+parties+involved%2C+the+nature+of+the+transaction%2C+and+its+anticipated+impact+on+healthcare+costs%2C+access%2C+quality%2C+or+competition.+Covered+transactions+range+from+providers+%28%3Cem%3Ee.g.%3C%2Fem%3E%2C+hospitals+and+physician+practices%29+to+management+services+organizations+and+health+insurers.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cimg+loading%3D%22lazy%22+decoding%3D%22async%22+class%3D%22size-medium+wp-image-2802+aligncenter%22+src%3D%22https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-300x252.jpg%22+alt%3D%22%22+width%3D%22300%22+height%3D%22252%22+srcset%3D%22https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-300x252.jpg+300w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-1024x859.jpg+1024w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-768x644.jpg+768w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-1536x1288.jpg+1536w%2C+https%3A%2F%2Fmcllp.com%2Fwp-content%2Fuploads%2F2025%2F04%2FStates-Chart-2-2048x1718.jpg+2048w%22+sizes%3D%22auto%2C+%28max-width%3A+300px%29+100vw%2C+300px%22+%2F%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+importance+of+these+laws+for+a+particular+transaction+hinge+on+the+finer+points.+Some+requirements+apply+only+to+specific+provider+types+or+those+exceeding+certain+revenue+thresholds%2C+some+states+require+the+reporting+of+significantly+more+information+%28including+on+a+post-closing+basis%29+than+other+states%2C+and+some+states+require+a+review+of+the+transaction+%28while+others+only+authorize+a+review%29.+The+requirements+are+also+in+flux.+At+least+one+faces+a+legal+challenge+and+amendments+to+several+are+pending.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref57%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn57%22%3E%5B57%5D%3C%2Fa%3E+Further%2C+additional+states+are+considering+similar+laws.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref58%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn58%22%3E%5B58%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EOregon+has+one+of+the+strictest+transaction+notification+laws%2C+requiring+prior+approval+of+%E2%80%9Cmaterial+change+transactions%E2%80%9D+of+certain+healthcare+entities.+An+Oregon+%E2%80%9Cmaterial+change+transaction%E2%80%9D+must+have+significant+revenue%3A+one+party+involved+must+average+at+least+%2425+million+in+revenue+in+the+preceding+three+fiscal+years+and+the+other+party+must+have+averaged+%2410+million+in+the+preceding+three+fiscal+years+or+be+projected+to+have+%2410+million+in+revenue+in+its+first+full+year.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref59%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn59%22%3E%5B59%5D%3C%2Fa%3E+Health+care+entities+subject+to+review+include+individual+health+professionals%2C+hospitals%2C+carriers+offering+health+benefit+plans%2C+Medicare+Advantage+plans%2C+coordinated+care+organizations%2C+and+other+entities+primarily+providing+health+care+services%2C+excluding+long-term+care+facilities+and+certain+licensed+facilities.+The+Oregon+Health+Authority+%28OHA%29+may+condition+approvals+on+certain+operational+requirements+to+ensure+transactions+align+with+public+interest+goals%2C+such+as+maintaining+access+to+affordable+health+care+%28%3Cem%3Ee.g.%3C%2Fem%3E%2C+a+proposed+acquisition+of+substantially+all+the+non-clinical+assets+of+a+physician+practice+and+ambulatory+surgical+center+by+a+PE-backed+MSO+was+approved+with+conditions+including+that+the+MSO+could+not+enter+into+employment+agreements+with+any+clinical+personnel+and+must+continue+to+serve+Medicare+patients%29.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref60%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn60%22%3E%5B60%5D%3C%2Fa%3E+Required+submissions+include+detailed+transaction+information%2C+financial+statements%2C+the+terms+of+the+agreement%2C+and+definitive+documentation+of+the+transaction.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref61%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn61%22%3E%5B61%5D%3C%2Fa%3E+Post-closing%2C+entities+must+notify+the+OHA+of+transaction+completion+and+comply+with+follow-up+analyses+conducted+one%2C+two%2C+and+five+years+after+the+transaction+to+assess+compliance+and+impact.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EParties+to+transactions+in+Indiana%2C+for+example%2C+have+less+onerous+requirements.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref62%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn62%22%3E%5B62%5D%3C%2Fa%3E+Indiana+requires+notice+be+provided+to+the+Indiana+Attorney+General+%28AG%29+90+days+in+advance+of+any+mergers%2C+acquisitions%2C+or+asset+sales+of+health+care+entities%2C+which+include+private+equity+partnerships+that+invest+in%2C+or+any+business+that+provides%2C+diagnostic%2C+medical%2C+surgical%2C+dental+treatment%2C+or+rehabilitative+care.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref63%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn63%22%3E%5B63%5D%3C%2Fa%3E+However%2C+the+requirement+applies+only+when+the+combined+entities+and+holdings+exceed+%2410+million.+While+Indiana+AG+has+separate+antitrust+enforcement+authorities%2C+the+Indiana+statute+provides+the+AG+with+authority+to+delay+transactions+beyond+the+90-day+notice+period%2C+does+not+require+the+Indiana+Attorney+General+to+produce+a+report%2C+and+the+information+reporting+requirements+are+minimal.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3E%3Cstrong%3EB.+Fraud%2C+Waste+and+Abuse+Liability%3C%2Fstrong%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EAn+amendment+to+the+Massachusetts+False+Claims+Act+%28MFCA%29+creates+new+direct+risk+for+healthcare+investors.+Like+its+Federal+and+many+state+counterparts%2C+the+MFCA+imposes+liability+on+any+individual+or+entity+who+submits+false+claims+to+Massachusetts+government+employees%2Fagents+or+to+be+paid+with+Massachusetts+state+funds+%28including+Medicaid%29.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref64%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn64%22%3E%3Csup%3E%5B64%5D%3C%2Fsup%3E%3C%2Fa%3E+Since+January+8%2C+2025%2C+however%2C+certain+investors+%28including+interests+held+by+private+equity+funds+or+private+equity+professionals%29%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref65%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn65%22%3E%5B65%5D%3C%2Fa%3E+in+an+entity+that+violates+the+MFCA+and+who+%E2%80%9Cknow%E2%80%9D+about+the+violation+may+be+subject+to+liability+unless+the+investor+reports+the+violation+to+the+state+within+60+days.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref66%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn66%22%3E%5B66%5D%3C%2Fa%3E+The+applicable+Massachusetts+definition+of+%E2%80%9Cknow%E2%80%9D+includes+actual+knowledge%2C+deliberate+ignorance%2C+and+reckless+disregard+of+the+truth.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref67%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn67%22%3E%5B67%5D%3C%2Fa%3E+This+duty+to+report+could+subject+an+investor+to+MFCA+liability+for+a+%28reckless+or+deliberately+ignorant%29+failure+during+diligence+to+%E2%80%9Cidentify%E2%80%9D+MFCA+violations%2C+though+future+regulations%2C+case+law%2C+or+guidance+may+narrow+the+reach+of+the+MFCA+amendments.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EAs+of+April+2025%2C+the+Connecticut+General+Assembly+is+considering+similar+changes+to+the+Connecticut+False+Claims+Act.%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_ednref68%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_edn68%22%3E%5B68%5D%3C%2Fa%3E%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Ch3%3E%3Cspan+style%3D%22color%3A+%23be9b64%3B%22%3EConclusion%3C%2Fspan%3E%3C%2Fh3%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+first+few+months+of+the+Trump+Administration+have+clearly+brought+tremendous+change+in+many+areas+of+the+economy+and+promises+of+transformative+change+to+many+aspects+of+the+healthcare+sector.+But+the+details+of+the+coming+changes+for+healthcare+investment+landscape%2C+particularly+the+deregulatory+efforts+and+structural+changes+at+HHS%2C+have+not+been+made+publicly+available+and+are+likely+to+take+some+months+to+implement.+Thus%2C+the+federal+environment+is+marked+by+uncertainty%2C+with+potential+substantive+changes+in+the+FTC%E2%80%99s+approach+to+reviewing+transactions.+Aggregate+federal+healthcare+spending+levels%2C+particularly+for+state+Medicaid+programs%2C+seem+unlikely+to+increase%2C+but+the+tumult+in+Washington+makes+predictions+at+the+Federal+level+difficult.+States%2C+meanwhile%2C+are+pushing+ahead+with+their+agendas.+Healthcare+investors+can+expect+more+states+to+adopt+or+strengthen+healthcare+transaction+notification+laws%2C+but+it+is+not+yet+clear+whether+more+States+will+follow+Massachusetts+in+imposing+liability+on+healthcare+investors.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3EThe+regulatory+environment+for+healthcare+private+equity+is+becoming+increasingly+complex%2C+with+significant+developments+at+both+federal+and+state+levels.+The+Trump+Administration%26%238217%3Bs+deregulatory+initiatives+may+create+new+opportunities+in+the+healthcare+sector+if+regulations+are+rescinded+that+favorably+change+market+dynamics%2C+but+those+opportunities+may+look+different+across+the+country.+As+states+impose+additional+hurdles+on+health+care+transactions+and+subject+healthcare+investors+to+additional+risk%2C+the+individual+state+regulatory+environment+will+be+an+increasingly+important+factor+in+investment+decisions.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%26nbsp%3B%3C%2Fp%3E%0A%3Ch3%3E%3Cspan+style%3D%22color%3A+%23c2c2c2%3B%22%3ENotes%3C%2Fspan%3E%3C%2Fh3%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_edn1%22%3E%3C%2Fa%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+href%3D%22%23_ednref1%22%3E%5B1%5D%3C%2Fa%3E+%3Cem%3ESee+%3C%2Fem%3EMass.+Gen.+Laws+Ann.+12+%C2%A7+5A+%26amp%3B+5B.%3C%2Fspan%3E%3C%2Fp%3E%0A%3Cp%3E%3Cspan+style%3D%22color%3A+%237f7f7f%3B%22%3E%3Ca+style%3D%22color%3A+%237f7f7f%3B%22+name%3D%22_edn2%22%3E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