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Supreme Court unanimously sides with American Hospital Association, 340B hospitals over outpatient drug reimbursement rates; 340B hospitals estimated to potentially recoup billions of dollarsMore Fifth Circuit, HHS Keep No Surprises Act dispute resolution provision in limbo; Delays expectedMore ESG and health care: Where does it fit?More CMS issues updated guidance for certified facilities on COVID-19 vaccine requirement as public health emergency continuesMore U.S. Supreme Court halts OSHA vaccine-or-test rule; Upholds CMS vaccine mandateMore Legal updates on challenges to CMS vaccination mandate may cause more uncertaintyMore Hold the press! Federal court issues national injunction blocking CMS vaccine mandate for health care workersMore Long-awaited federal vaccine mandates are here!More COVID-19 vaccines now available for most children and all teensMore More federal courts dismiss legal challenges to hospital vaccine mandatesMore Reducing workers’ compensation and OSHA liability during COVID-19 and beyondMore Health care facilities and nursing homes awaiting CMS requirements for staff COVID-19 vaccinationsMore FDA full approval of Pfizer vaccine should reduce risk of employer mandatesMore 2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changesMore CMS proposes changes to Medicare rules governing certain Evaluation and Management visitsMore CMS proposes changes to Stark Law regulations and Open Payments ProgramMore HHS updates interoperability standards to support sexual orientation and gender identityMore Hospital price transparency rule penalties may increaseMore Ohio’s new hospital licensure lawMore Skilled nursing facility operator settles false claims case involving allegations that the company failed to report and return overpaymentsMore Supreme Court makes certiorari determinations on two Medicare-related casesMore First rules implementing surprise medical billing law issuedMore Ohio law governing EMS stroke protocols revised to include new guidelines and trainingMore State of emergency in Ohio liftedMore HHS releases new buprenorphine practice guidelines, relaxing waiver requirementsMore Ohio House Bill 6 affects changes to COVID-19 vaccine and test administration and certain temporary licensesMore CMS begins enforcement of Hospital Price Transparency RuleMore DOJ announces $22 million False Claims Act settlement with the University of Miami for provider-based and lab billing issuesMore CMS proposes changes to Promoting Interoperability program in IPPS RuleMore New ACGME recognition for non-standard training of J-1 exchange visitor physiciansMore Ohio bill codifies changes to reporting requirements for hospitals related to defendant competency issues in criminal casesMore Highlights from the Medicare Program 2022 Proposed Rule for Acute Care Hospitals Inpatient Prospective Payment SystemMore Court upholds Ohio law criminalizing physician participation in abortions based on Down syndromeMore Information blocking compliance – Are you ready for April 5?More Federal court sides with Eli Lilly challenge to HHS expansion of 340B discountsMore Has COVID-19 forced the telehealth genie out of the bottle?More HIPAA Privacy Rule revisions in 2021More Information Blocking in 2021More Status of MFN drug pricing program remains uncertainMore The Stark Law and Anti-Kickback Statute final rules: Top 10 takeawaysMore The uncertain future of the price transparency rule in 2021More Recent kickback cases yield almost $20 million in settlements for the United StatesMore CMS issues mid-build audit determinations for provider-based locationsMore ACGME offers additional COVID-19 guidance for graduate medical education programsMore CLER COVID-19 site visits to be conducted in 2021More Florida pediatrician pleads guilty to conspiring to falsify clinical trial data in research study for asthma medication for childrenMore ODH issues guidance on redistributing COVID-19 vaccine dosesMore CMS to begin reprocessing hospital claims for 2019 clinic visits provided at excepted off-campus provider-based departmentsMore Providers should account for extra doses of COVID-19 vaccines in their vaccination plansMore Court of Appeals rules against hospitals in price transparency caseMore OCR continues aggressive HIPAA Right of Access enforcement activitiesMore Biddle claims are here to stay, the Ohio Supreme Court holdsMore Ohio Department of Health to allow sex marker changes on birth certificatesMore
Second stimulus bill contains “surprise” billing measureMore HHS OCR announces results of most recent round of HIPAA auditsMore CMS announces proposed rule to improve electronic data exchange and streamline prior authorizationMore What health care providers need to know as COVID-19 vaccines arrive in OhioMore Major changes to HIPAA Privacy Rule proposedMore CMS releases Hospital 2021 OPPS final ruleMore Will you be ready when the COVID-19 vaccines arrive?More CMS and OIG finalize major changes to Stark and Anti-Kickback regulations: What health care entities need to knowMore CMS and OIG issue long-awaited final rules changing the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty LawMore New rules in Ohio affecting consult agreements with pharmacistsMore ONC extends Information Blocking compliance deadlinesMore Ohio Medicaid telehealth changes made permanentMore OCR announces second-largest HIPAA breach settlementMore OCR settles five additional cases in HIPAA Right of Access InitiativeMore Ohio Supreme Court rules that the savings statute cannot save a late second filingMore OCR recommends IT asset inventory for HIPAA complianceMore Governor signs qualified immunity bill for COVID-19 related lawsuitsMore COVID-19 Update: CMS announces resumption of survey activitiesMore Medicare to begin requiring orders for repeat COVID-19 and related testsMore CMS issues new COVID-19 guidance, including nursing home staff testing requirementsMore COVID-19 Update: OCR updates guidance on contacting former COVID-19 patients about blood and plasma donation to add health plansMore CMS to require a positive COVID-19 viral test result for additional 20 percent Medicare paymentMore Deadline approaching to submit promoting interoperability hardship exception to avoid payment adjustmentMore Court of appeals rules that HHS has the authority to cut 340B hospitals’ Medicare payments for outpatient drugs by 28.5 percentMore COVID-19 Update: CMS waivers continue as public health emergency extended, debate grows on which waivers should become permanentMore HIPAA settlement highlights importance of mobile device encryptionMore Wide-ranging executive orders regarding pharmaceutical pricing and availabilityMore Medicare program resuming fee-for-service audits and DMEPOS prior authorization program paused during COVID-19 pandemicMore IRS moves CHNA due dates to December 31, 2020More SAMHSA announces changes to substance abuse treatment records in 42 CFR Part 2More D.C. Circuit upholds Medicare policy of paying hospital outpatient provider-based locations and physician offices the same, reversing lower courtMore Telehealth services expanded in Ohio by new executive orderMore CMS announces restart of Review Choice Demonstration for Ohio home health agenciesMore The FTC and the DOJ finalize new vertical merger guidelinesMore ACGME sponsoring institution emergency categorizationMore Anticipating COVID-19 enforcement action: Risks for providersMore COVID-19 Update: OCR issues guidance on contacting former COVID-19 patients about blood and plasma donationMore Medicare to require prior authorization for certain outpatient department services starting July 1, 2020More Increased reimbursement for hospital stays for Medicare beneficiaries with COVID-19 diagnosis likely to lead to audits and False Claims lawsuitsMore CMS issues first of two final rules changing the Medicare Advantage and Medicare Prescription Drug ProgramMore Expanded CMS survey activities to begin, nursing home survey activities to increaseMore All surgeries and procedures may resume, according to Ohio governorMore Surprise COVID-19 medical bills: What providers can and cannot doMore Transition to a single graduate medical education (GME) accreditation systemMore COVID-19 Update: Ohio issues final plan for health care isolation centersMore ACGME issues procedures for investigation and enforcement of non-compliance with its COVID-19 requirementsMore CMS issues nursing homes best practices toolkit to combat COVID-19More COVID-19 Update: Final rule adopted requiring long-term care facilities to report COVID-19 dataMore COVID-19 Update: CMS allows hospitals to provide swing bed servicesMore COVID-19 Update: Providers beware – OCR reiterates that HIPAA restrictions on disclosures to the media apply during the pandemicMore COVID-19 Update: The impact of COVID-19 on health care private equity due diligenceMore COVID-19 Update: New CMS changes that impact medical educationMore COVID-19 Update: Medicare to waive more testing, telehealth, hospital requirementsMore COVID-19 Update: ODH issues order allowing providers to resume some non-essential surgeries and proceduresMore COVID-19 Update: CMS issues explanatory guidance on Stark Law blanket waiversMore COVID-19 recovery: Financial aid and resources for hospitals and health care providersMore COVID-19 recovery: Legal considerations for hospitals and health systems planning for post-pandemic operationsMore Clinical research flexibilities during the COVID-19 public health emergencyMore COVID-19 Update: CMS and ONC delay interoperability rulesMore COVID-19 Update: ODH announces elective surgery orderMore COVID-19 Update: Beware of cooperation in the labor marketMore COVID-19 Update: Pandemic implications for GME programsMore COVID-19 Update: CMS issues guidelines on providing non-emergent and non-COVID-19 health careMore COVID-19 Update: Providers participating in COVID-19 clinical trials now eligible for MIPS creditMore COVID-19 Update: CMS issues guidance on transferring long-term care residentsMore COVID-19 Update: CMS and Ohio Board of Pharmacy issue new and updated regulatory waiversMore COVID-19 Update: New Ohio orders require nursing homes and residential care facilities to notify residents of COVID-19 cases and require first responders to be told of COVID-19 casesMore COVID-19 Update: DOL, HHS and Treasury issue FAQs for group health plans and insurers on COVID-19 testing and provider visitsMore ONC interoperability rule: Notable exceptions to upcoming information blocking prohibitionMore COVID-19 Update: OCR announces HIPAA enforcement discretion for community-based testing sitesMore COVID-19 Update: OCR issues bulletin on civil rights laws during public health emergencyMore COVID-19 Update: OIG extends Kickback Statute protection to arrangements covered by blanket COVID-19 Stark law waiversMore COVID-19 Update: Data sharing requests and orders for hospitalsMore COVID-19 Update: New guidance on HIPAA issuesMore COVID-19 Update: CMS issues new 1135 blanket waiversMore COVID-19 Update: HHS issues 18 blanket waivers of enforcement of Stark lawMore COVID-19 Update: Health care provisions of the federal stimulus billMore COVID-19 Update: How Ohio's coronavirus emergency bill impacts health care providersMore COVID-19 Update: Cost-report reimbursement impact of expanding hospital inpatient bed capacityMore COVID-19 Update: HHS implements president’s executive order to prevent medical resource hoardingMore CMS delays activation of systematic validation edits for OPPS providers with multiple service locations until further noticeMore COVID-19 Update: CMS announces relief for providers participating in quality reporting programsMore COVID-19 Update: ODI issues bulletin on out-of-network coverage for coronavirus testing and treatmentMore COVID-19 Update: ODM issues emergency telemedicine ruleMore
COVID-19 Update: OMHAS issues emergency telemedicine ruleMore COVID-19 Update: Extending Medical Staff appointment/privilege periods during the coronavirus outbreakMore COVID-19 Update: FDA announces policies to increase availability of coronavirus testingMore COVID-19 Update: Ohio Pharmacy Board issues guidance regarding practice of pharmacyMore COVID-19 Update: President Trump expands Medicare telehealth benefits during coronavirus outbreakMore COVID-19 Update: Telehealth – waiver of HIPAA requirements and expanded flexibilityMore COVID-19 Update: HHS issues EMTALA waiver for actions necessitated by COVID-19More COVID-19 Update: HHS issues limited 72-hour HIPAA waiver for hospitalsMore COVID-19 Update: OMHAS issues guidance for opioid treatment programsMore COVID-19 Update: What the president’s declaration of national emergency means for health care facilitiesMore COVID-19 Update: Preparedness for long-term care facilitiesMore COVID-19 Update: Survey suspension FAQsMore COVID-19 Update: CMS issues EMTALA guidanceMore COVID-19 Update: Ohio confirms first casesMore HHS releases final rules on interoperability and information blockingMore COVID-19 Update: Reimbursement issues – Who is picking up the tab for coronavirus testing?More CMS announces actions to address the spread of COVID-19More Medicare Administrative Contractors request hospitals to verify practice locationsMore Coronavirus: Patient privacy implicationsMore PA appellate court holds that physician credentialing file is not protected by the state peer review privilegeMore Clinical trials and Medicare billing: Avoiding false claims liabilityMore Court confirms that federal enactments regarding “never events” and “hospital acquired conditions” don’t alter elements that plaintiffs must prove in medical negligence claimsMore EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violationsMore Best practices for resolving patient incapacity issuesMore Changes coming to the Stark Law and Anti-Kickback Statute regulationsMore Could new Individual Coverage HRAs replace your group health plan?More Proposed vertical merger guidelines have finally arrivedMore Roadmap to an effective compliance investigationMore The new price transparency rule: Are you ready?More New hospice care program rules effective January 23, 2020More CMS announces reduced psychiatric hospital burden with new survey processMore Ohio Department of Health issues draft amendments to Certificate of Need rulesMore Federal court denies American Hospital Association review of CMS 2020 site-neutral payment cuts for hospital off-campus provider-based locationsMore CMS proposes new Stark Law exception for limited remuneration to a physicianMore OIG proposes changes to existing Anti-Kickback Statute safe harborsMore
CMS announces continuation of second year of site-neutral payment cutsMore CMS clarifies the process for correcting mistakes under the Stark LawMore CMS and OIG propose three new value-based care exceptions to remove value-based payment barriersMore CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of cybersecurity technology and servicesMore Tentative settlement resolves antitrust claims against health system on the eve of trialMore CMS proposes to change the way group practices can pay profit shares to physicians under Stark LawMore CMS proposes to recalibrate the scope and application of the Stark regulationsMore CMS proposes changes to and clarifications of key Stark Law termsMore
CMS and OIG issue long-awaited rules proposing changes to the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty LawMore Recent Stark Act decision could have significant impact for employed physicians compensated based on personal productivityMore CMS to survey hospitals about acquisition costs for 340B drugsMore Post-acute providers beware: Providing free staff or services to hospitals could land you in hot water…or worse!More Federal court invalidates CMS site-neutral payment cuts for hospital off-campus provider-based locationsMore Hazardous waste pharmaceuticals rulemakingMore OCR begins HIPAA right of access enforcement initiativeMore Recent OIG audit report on duplicate Medicare payments for drugs prescribed to hospice patients shows tension between OIG and CMS on whether CMS has gone far enough to prevent duplicate paymentsMore Ohio Budget Bill changes Ambulatory Surgical Facility definition: Now captures facilities operating within a hospitalMore Attorney General Yost announces multistate data breach settlement with PremeraMore CMS proposes payment cuts for hospital clinic visits in off-campus provider-based departmentsMore Anxiety and autism voted down: Not added as qualifying conditions for medical marijuanaMore Ohio budget bill provides significant changes to Certificate of Need lawsMore DeWine signs Executive Order allowing emergency rule changes as part of Ohio’s “Behavioral Health Redesign”More CMS issues hospice payment rate final rule for FY2020More CMS proposes changes to SNF/NF compliance program requirementsMore Could relief from the Medicare cuts in reimbursement for 340B drugs be coming soon for hospitals?More OIG says Part D contracts cost Medicare as much as $75 million in lost drug manufacturer rebates in one yearMore HHS publishes fact sheet on direct liability of business associates under HIPAAMore DOJ updates guidance on evaluating the effectiveness of corporate compliance programsMore CMS draft guidance on hospital co-location offers narrow sharing of hospital spaceMore Ohio EPA initiates rulemaking process for hazardous waste pharmaceuticalsMore Behavioral Health Redesign provisional measures extendedMore Duke University to pay $112 million in research fraud settlementMore ODH provides guidance on inpatient palliative care to non-hospice patientsMore Hospitals with off-campus provider-based departments: Check your PECOS enrollment fileMore CMS directive orders state agencies to increase weekend surveys of skilled nursing facilitiesMore Clinical trial agreements: Hidden risks of poorly negotiated CTAsMore CMS and ONC release proposed rules on interoperability and information blockingMore Proposed California drug pricing program could shift 340B drug reimbursement away from hospitalsMore The Eliminating Kickbacks in Recovery Act of 2018: A new federal kickback law affecting the substance abuse treatment communityMore H.B. 7 effective March 20More A 60-Day Overpayment Refund Rule updateMore CMS and the Ohio Department of Health surveys: Active enforcement and increased transparencyMore Federal court overturns 340B Drug Discount Program reimbursement cuts – future still uncertainMore HHS regulatory sprint to coordinated care: Will meaningful changes make it across the finish line?More Not conducting exit interviews on your departing employees? You should be!More ODH alignment recommendations for 2019 CHNA processMore TCJA excise tax on excess executive compensation for nonprofitsMore U.S. hospitals will continue to grapple with GDPR compliance in 2019More Using social media to detect workers’ compensation fraudMore Coming soon: Changes to Ohio law governing hospices’ provision of palliative care and new requirements for hospitals to identify patients needing palliative careMore DOJ moves to dismiss 11 False Claims Act casesMore Best practices for resolving incapacity issues, including navigating the probate court process for establishing guardianshipsMore HHS releases voluntary cybersecurity guidance for health care organizationsMore New standard authorization forms must be accepted by health care providers in OhioMore Congress enacts all payor kickback law for recovery homes, clinical treatment facilities and clinical laboratories, despite concerns about overbreadth and uncertainty of lawMore Failure to terminate access of departing employee leads to HIPAA penaltyMore The Ohio medical marijuana patient registry is now open: Are you ready?More $24 million settlement resolves False Claims and Stark Law violations involving improper physician arrangementsMore HIPAA settlement highlights need for caution when speaking with mediaMore OIG, DOJ put hospice providers under a microscopeMore FDA proposes waiver of informed consent requirements for minimal risk trialsMore 2018 updates to the NPDB GuidebookMore CMS finalizes site-neutral payment for clinic visits but declines to finalize clinical families payment limitationMore CMS expands reimbursement cuts on 340B drugsMore Ohio’s new cybersecurity safe harbor law takes effectMore Medical professionals required to report suspected elder abuse, neglect or exploitationMore OIG report finds Ohio Department of Medicaid made payments for deceased beneficiariesMore 340B litigation update: Both Ceiling Price Rule delay and 340B rate cuts face legal challengesMore Lights, camera, HIPAA! HHS announces settlement related to “Boston Med”More Important clarification regarding compliance with certain Stark Law exceptionsMore Are you prepared for uncompensated care S-10 audits?More 340B Drug Pricing Program spawns two antitrust lawsuitsMore FDA issues guidance on use of EHR data in clinical researchMore 340B Drug Pricing ProgramMore Federal appeals court rules against the American Hospital Association’s challenge to the $1.6 billion in Medicare 340B cutsMore Personal liability trend continues: Health care CEO gets jail time for fraud schemeMore DOJ conference remarks provide insight into government priorities related to health careMore Judge upholds fourth largest HIPAA penalty of $4.3 million for Texas cancer centerMore New guidance from OCR regarding protected health informationMore Health system to pay $18 million to settle FCA lawsuitMore Deadline approaching to submit meaningful use hardship exception to avoid payment adjustmentMore Recent hospice settlements highlight where things can go wrongMore DEA imposters targeting physicians and pharmaciesMore Mental health provider faces False Claims Act lawsuit due to alleged unlicensed, untrained and unsupervised personnelMore CMS proposes to eliminate requirement for written inpatient admission ordersMore Pennsylvania case reminds Ohio hospitals of the importance of adhering to provisions of peer review statuteMore Recent 340B program developmentsMore Collection and destruction of controlled substances recovered from hospital patients and visitorsMore Certification requirements for Ohio OTPsMore The three-day rule for treating acute withdrawal symptomsMore Ohio seeks to become the first state to receive a 1332 waiver of the individual mandateMore Prescriber rules for opioidsMore EMTALA screening for behavioral health patientsMore Extended mental health care in the ED: What’s a facility to do?More Liability risks at every port along the opiate streamMore Rules on confidentiality of substance use disorder patient records recently changedMore Staffing and billing issues to avoid under Ohio scope of practice rules for mental health professionalsMore Bipartisan Budget Act of 2018 repeals therapy caps: What does it mean for hospital outpatient therapy departments?More Strange, and ultimately dangerous, credentialing scenarios highlight the need for MSPs’ roles to protect the publicMore Civil and criminal penalties increased for fraud and abuseMore Important updates from the IRS for exempt organizationsMore CMS releases new and updated tips on billing for various servicesMore CMS now allows medical student documentation for E/M billingMore CMS plans complete overhaul of EHR incentive programs, announces new patient access initiativesMore Doctor pleads guilty to providing protected health information to drug makerMore Ohio Board of Pharmacy releases proposed rules on pain management and office-based opioid treatment clinicsMore EHR Incentive Program attestation deadline for hospitals extended to March 16, 2018More Keeping up with NIH rules impacting research involving human subjectsMore Reminder: Notice of 2017 small HIPAA breaches due to HHS soonMore CMS releases updated resource documents for Hospice Quality Reporting ProgramMore $350 million FCA verdict against nursing facility operator vacatedMore
Clinical research compliance alert: Common Rule updated, effective date delayedMore Reminder: Hospitals must use QualityNet for attestation in 2018More Antitrust enforcement priorities for 2018More CMS imposes massive cuts on 340B program; Hospital associations’ legal challenge dismissedMore CMS Quality Payment Program: Are you ready for round two?More HIPAA access versus authorizationMore Hospice compliance: OIG Work Plan, quality reportingMore Incident reports and peer reviewMore Low Volume Appeals settlement option announcedMore Off-campus provider-based hospital outpatient departments: Challenges and options in 2018More Opioid prescribing and potential liability will impact providers in Ohio and across the nation in 2018More New cybersecurity threats with potential to impact health care industry identifiedMore To text or not to text? CMS issues guidanceMore Oncology firm to pay $26 million to settle FCA allegationsMore Annual deadline to seek new property tax exemption approachesMore DOJ announces FCA enforcement priorities at HCCA conferenceMore CMS cuts CY 2018 payment rates to non-excepted off-campus provider-based departmentsMore Cardiology practice settles 60-Day Overpayment case under the False Claims Act for double damagesMore Human subject protections in clinical research: OHRP and whistle blower protectionsMore Ohio apology statute covers admissions of faultMore Revocation 2017-31014: First revocation for failure to comply with Section 501(r)More Hospice in the government’s cross-hairsMore HRSA announces 340B information system outage beginning August 15More For CY 2018, Meaningful Use reporting period is once again 90 daysMore Human subject protections in clinical research: Monitoring compliance with the Common RuleMore National Health Care Fraud Takedown charges more than 400 defendants with $1.3 billion in false billingsMore AG issues advisory opinion regarding CNPs and acute care practiceMore Kentucky court allows on-site inspection of electronic medical records in malpractice caseMore Hospital fined nearly $1.3 million for multiple EMTALA violations involving psychiatric patientsMore TJC revises pain assessment and management requirements for accredited hospitalsMore ODH establishes new requirements for medical directors of adult cardiac catheterization and open heart surgery servicesMore Recent cases spotlight research misconduct in clinical researchMore eClinicalWorks to pay $155 million for misrepresenting its Meaningful Use certification and making kickback paymentsMore Ohio Supreme Court rejects “quantity of charity care” argument in property tax exemption caseMore CMS revises process and forms for reporting Stark Law violationsMore The consequences of “gun jumping” in mergers and acquisitionsMore Accreditation changes may cause trouble for hospital-based sleep centersMore Ohio takes steps to limit prescription of opiates for acute painMore First federal court finds collection of documents meets Stark Law writing requirementMore HIPAA enforcement actions highlight importance of maintaining and auditing security practicesMore OIG publishes Resource Guide for measuring compliance program effectivenessMore As statutorily intended and judicially recognized, a negligent credentialing claim Is a medical claimMore Sorry seems to be the hardest word: Ohio’s apology statute for healthcare providersMore Pharmacy loyalty program results in $50 million settlementMore False Claims Act: 2016 year in review and 2017 look aheadMore CHNA requirements notice #6: State encourages allocation of community benefit expenditures to activities that support community health objectivesMore Three notable HIPAA enforcement actions in 2017More CHNA requirements notice #5: State encourages partnerships in conducting the CHNAMore CHNA requirements notice #4: State encourages selection of evidence-based strategies from SHIPMore CHNA requirements notice #3: State encourages inclusion of at least one core metric from SHIP in CHNAMore CHNA requirements notice #2: CHNA must address at least two health priorities identified in the State Health Improvement PlanMore CHNA requirements notice #1: 2017 CHNA deadlines for Ohio tax-exempt hospitalsMore A look behind the curtain: Life under a corporate integrity agreement for one public health care providerMore Is your tax-exempt hospital ready for the 2017 CHNA deadline?More Court blocks proposed merger of insurance giantsMore Advanced practice registered nurses in Ohio – Major changes coming in April!More CMS issues guidance on correct use of “PN” and “PO” modifiers in hospital off-campus provider-based departmentsMore 2016 False Claims Act cases result in over $4.7 billion in recovery for Department of JusticeMore Micro hospital fails to meet the definition of a hospital for Medicare enrollmentMore Senate passes 21st Century Cures Act – Provider-based mid-build exception one step closerMore 2017 OPPS final rule – Generally good news for providers regarding provider-based locationsMore What do President-Elect Trump’s HHS and CMS picks mean for health care reform?More Plenty of activity in the health care false claims arenaMore 2017 OIG Work Plan summaryMore Assessing the impact of the election on health care reformMore 2017 OPPS final rule – Site-neutral payments for new off campus provider-based departmentsMore 2017 OPPS final rule – Meaningful Use rulesMore CMS awards next round of RAC contractsMore Did you know? CMS has offered to resume Medicare appeals settlementsMore New initiative from CMS to reduce medical record review for clinicians participating in certain Advanced Alternative Payment ModelsMore Registries seeking to join CMS Repository for public health data must apply by October 31More CMS announces additional opportunities for clinicians to qualify as Advanced APMs under MACRAMore OCR releases HIPAA guidance on cloud computing servicesMore MACRA Final Rule solidifies new physician reimbursement modelMore Make sure your prescribers are in compliance with OARRS opioid prescription rulesMore Joint Commission accredited organizations must now provide advance written notice of significant changesMore Tenet to pay over $513M for kickback scheme involving pregnant patientsMore Compliance deadline approaching for Section 1557 nondiscrimination requirementsMore Former CEO settles allegations amid further Tuomey falloutMore South Carolina Medical Center pays Department of Justice $17 million to settle False Claims Act case alleging employment agreements violate Stark lawMore Government sends a $2.95 million warning to health care providers with announcement of settlement in 60-day overpayment rule caseMore CMS delays implementation of the NOTICE Act and MOON form requirementMore OCR announces new plan to investigate HIPAA breaches affecting fewer than 500 individualsMore OCR announces record HIPAA settlementMore IRS guidance on health plan cash opt-out arrangementsMore Is your organization compliant with the new ACA non-discrimination final rule?More Proposed Rule Implementing Section 603 of the Bipartisan Budget Act of 2015 Dashes Hospitals’ HopesMore Caps on noneconomic damages again found to be constitutional; Affordable Care Act approved in reducing economic damagesMore OCR launches HIPAA Phase 2 Audits and announces deadline and focus areasMore CMS proposes big changes to EHR meaningful useMore CMS proposes to implement Balanced Budget Act's site-neutral payments for new off-campus provider-based departmentsMore Penalties in health care fraud cases to nearly double on August 1, 2016More Historic multi-jurisdiction health care fraud investigation results in over 300 arrests related to $900 million in fraudulent billingMore Supreme Court clarifies basis for liability under the False Claims ActMore Recent false claims cases and settlementsMore United States House of Representatives v. Burwell: An uncertain future for cost-sharing subsidiesMore Does your compliance function measure up? The OIG’s revised criteria for permissive exclusionMore First denial of tax-exempt status to a non-Medicare Shared Savings Program ACOMore The Department of Justice alleges two hospitals unlawfully agreed to restrict marketing in each other’s primary areaMore U.S Department of Homeland Security issues alert on hospital ransomware attacksMore Recent false claims settlements and case developmentsMore OIG reports hospices inappropriately billed Medicare $268 million for general inpatient careMore Ohio Supreme Court rules that patient medical record not defined by what is kept by hospital’s medical records departmentMore CMS proposes increased requirements to the provider enrollment processMore OCR announces launch of HIPAA Phase 2 auditsMore Failure to execute a BAA results in $1.55 million fine for Minnesota hospital systemMore Got Medicare Part A appeals? A new pilot program might be right for you!More Hospitals: Are you ready to give NOTICE?More New guidance and information from OCR and ONC on patient access to medical informationMore CMS releases new cycle of provider revalidations and new revalidation toolsMore U.S. Supreme Court deals a blow to all payer claims databasesMore A smorgasbord of false claims settlements to start off 2016More Hackers demand ransom from California hospitalMore False Claims Act: 2015 year in review and 2016 look aheadMore CMS publishes final 60-day overpayment rule for self-identified overpaymentsMore Supreme Court to rule on implied certification liability under the False Claims ActMore New modifier and POS code for off-campus provider-based departments mandatory starting January 1, 2016More Medicare’s "Two-Midnight Rule” – Where are we now after all of the rulemaking?More HIPAA settlement with University of Washington Medicine highlights need for organization-wide risk analysisMore Highlights of the 2016 OIG Work PlanMore Employed physician arrangements in the government's crosshairsMore CMS finalizes new exceptions and clarifications to Stark LawMore Budget Bill Blues: The reimbursement equalization of hospital off-campus provider-based locations and independent health care facilitiesMore CMS and OIG finalize waivers for Medicare Shared Savings Program ACOsMore Ohio Medicaid adopts three-day windowMore Tuomey – Case closed!More The DOJ announces huge False Claims Act settlement with Adventist Health SystemMore Finalized Stage 3 Rule means big changes for meaningful use starting in 2015, especially for hospitalsMore Department of Justice wins federal court ruling on 60-day overpayment ruleMore Two-Midnight Rule update: CMS issues proposed rule to clarify when inpatient admissions are appropriate for payment under Medicare Part AMore $237 million judgment against Tuomey Healthcare upheld by federal appeals courtMore ICD-10: Lack of code specificity in first year will not cause claims denialsMore Health law subsidies upheld by the U.S. Supreme CourtMore OIG issues Fraud Alert to warn physicians about the risks of compensation arrangementsMore HHS OIG and industry leaders release joint guidance for health care boardsMore Physician compensation problems cost Texas hospital over $21 millionMore
Everything you wanted to know about the “doc-fix” bill, but were afraid to askMore 10 years after the Deficit Reduction Act: a look at state false claims statutesMore CMS releases Stage 3 Meaningful Use proposed ruleMore Services performed by inappropriate staff members could lead to False Claims liabilityMore Lessons Learned – How compliance officers can better protect their organizations (Part 5)More Lessons Learned – How compliance officers can better protect their organizations (Part 4)More CMS announces one-year delay in final 60-day overpayment ruleMore Lessons Learned – How compliance officers can better protect their organizations (Part 3)More Hospitals must start Medicare EHR participation in 2015 to earn incentivesMore Appellate Court upholds divestiture after health care system acquires large physician groupMore Anthem discloses largest ever health care industry cyber attackMore Lessons Learned – How compliance officers can better protect their organizations (Part 2)More CMS to consider shortening meaningful use reporting period for 2015More Lessons Learned – How compliance officers can better protect their organizations (Part 1)More CMS makes big changes to RAC programMore Don't let this be you: Provider agrees to a $150,000 HIPAA settlement in potential security breach matterMore CMS finalizes provider enrollment safeguards and tables fraud whistleblower rewardsMore CMS proposes rule to strengthen accountable care organizationsMore HRSA withdraws proposed 340B “Mega Reg” in favor of future agency guidanceMore CMS extends CEHRT hardship exception deadline for eligible professionals and eligible hospitalsMore OIG releases the 2015 work planMore Ebola Virus Disease (EVD) preparation: Common sense planningMore OIG proposes new AKS safe harbors and expands CMPsMore CMS releases open payments data to the publicMore CMS issues new and updated FAQs related to its appeals settlement offer to hospitalsMore Recent false claims cases and settlementsMore OIG report finds noncompliance with Ohio hospice licensure requirementsMore OIG Audit uncovers erroneous Medicaid EHR incentive paymentsMore New Ohio law requires informed consent for prescribing opioids to minorsMore CMS offers settlement to resolve appeals backlog for denials of short stay inpatient claimsMore Alabama health system and clinics to pay $24.5 million to settle alleged diagnostic imaging schemeMore CMS and ONC finalize rule allowing options for CEHRTMore Hospital system discloses HIPAA breach affecting 4.5 million individualsMore Obstetric services requirement under DSH: Are your hospital’s DSH funds in jeopardy?More DOJ intervenes in False Claims Act suit over ACA’s 60-day overpayment ruleMore OIG proposes expansion and changes to civil monetary penalty regulations, including proposed penalty for failure to timely refund overpaymentsMore CMS issues proposed rule to eliminate the requirement for physician certification of most hospital inpatient staysMore New CMS interactive tool helps providers understand CEHRT proposed ruleMore Recent False Claims settlements, case developments and communications from the Office of Inspector GeneralMore $800,000 HIPAA settlement in alleged medical record dumping matterMore OIG proposed rule: No statute of limitations on certain exclusion actions and other significant changes to exclusion authorityMore HHS sends two new HIPAA reports for 2011-2012 to CongressMore Fraud takes no vacations: Summer vacation season brings new False Claims and health care fraud casesMore CMS and ONC proposed rule provides 2014 CEHRT flexibility for meaningful usersMore CMS issues new meaningful use attestation guidelinesMore CMS final rule changes provider and supplier conditions of participationMore $4.8M paid in largest HIPAA settlement to dateMore CMS issues proposed payment rules for inpatient hospital and long-term care hospital prospective payment system for 2015 fiscal yearMore Antitrust lessons from recent FTC successes in challenging hospital acquisitions in Ohio and IdahoMore Ohio enacts new law revising the peer review statuteMore New Ohio law for reporting newborns diagnosed as opioid dependentMore ACA collection efforts: Requirements for tax-exempt hospitalsMore CMS issues new and updated EHR FAQsMore AHIMA issues position statement on copy and paste in EHRsMore Important changes to CTP Formulary: Amendment to standard care arrangements required by April 1, 2014More Florida hospital system agrees to record-setting False Claims Act settlementMore FTC reaffirms strong concerns regarding hospital consolidationsMore CMS updates and clarifies "two-midnight" rule: More Guidance on Reviewing Hospital Claims for Patient StatusMore Eligible hospitals act now!More CMS issues guidance on the probe and educate audits performed under the "two-midnight" ruleMore HHS issues guidance on HIPAA and sharing information related to mental healthMore OIG releases its 2014 work planMore Meaningful <i>and true</i> – Former hospital executive faces criminal indictment for false meaningful use attestationMore Ohio law changed to permit advanced practice nurses and physician assistants to admit patients to hospitals under certain conditionsMore Recent False Claims settlement should serve as important reminder to all hospitalsMore Annual breach reporting deadline March 1More CMS extends EHR incentive program attestation deadlineMore CMS delays review of “two-midnight” rule until after September 30, 2014More
With the support of the American Hospital Association, hospitals initiate a challenge to the “two-midnight” ruleMore Federal Court holds that a physician is considered an “employee” for purposes of the EMTALA whistleblower protectionMore Ohio State Medical Board issues new rules on terminating the physician-patient relationship and notifying patients when a physician leaves a practiceMore Assignment of requests for administrative law judge hearings of denied Medicare claims suspended for at least two yearsMore 2013 year in review and 2014 forecastMore Ohio law revised to allow greater access to medical information under a durable power of attorney for health careMore OIG and CMS extend EHR donation exceptions even longer than proposed and add other changesMore New Law Requires Surgeons Performing Mastectomies in a Hospital to Follow Specific Guidance and Referral StandardsMore Ohio Supreme Court Upholds the Controlling Board's Medicaid ExpansionMore The Impact of Medicare’s "Two-Midnight" RuleMore Meaningful Use Deadline Extended One YearMore OIG Finds OCR Lacking in Oversight and Enforcement of HIPAA Security RuleMore CMS Announces Increased Provider Enrollment Fee for 2014More Department of Justice Announces Health Care False Claims Act SettlementsMore Health Management Associates Repays CMS $31 MillionMore CMS Issues Additional Guidance on "Two-Midnight" RuleMore Lawsuit Challenging Medicaid Expansion Filed in Ohio Supreme CourtMore Controlling Board authorizes expanded Ohio Medicaid program and challenge filed in Ohio Supreme CourtMore The Tuomey Saga – The Latest ChapterMore CMS Delays Review of “Two-Midnight” RuleMore No Rest for the Weary: The Feds Have Been Busy Fighting Health Care Fraud!More Medicaid Expansion Group Reaches Next Step in Initiated Statute ProcessMore A New Breed of Whistleblower? Consulting Company Turns in its Own Health Care Client for Alleged False ClaimsMore CMS Implements New Conditions for Payments Related to Inpatient Hospital AdmissionsMore Center for Improvement in Healthcare Quality attains deeming authorityMore New OIG Opinion Leaves Door Open to New Preferred Hospital Networks Without Violating Kickback StatutesMore The Journey of Medicaid Expansion from the Affordable Care Act to OhioMore Tuomey Fights Back Against False Claims VerdictMore Summer is Here and the HEAT is On! The Government’s Health Care Fraud Prevention and Enforcement Action Team Has Been Busy!More OIG Advisory Bulletin Provides Clarification Regarding Exclusion from Federal Health Care ProgramsMore 89 People Arrested Nationwide in Health Care Fraud StingMore
The Tuomey Saga Continues – Jury Rules that Tuomey Violated the Stark Law and False Claims ActMore Health Care Fraud Enforcement Remains Hot as HEAT Continues Aggressive Enforcement of Health Care Laws in 2013More Doctor’s Sympathetic Statement to Patient Cannot Be Used as Evidence of LiabilityMore OIG Updates Self-Disclosure Protocol and Confirms OIG’s Position on PenaltiesMore Community Health Needs Assessment Requirements Spelled Out by IRS, Treasury DepartmentMore Healthcare Integrity and Protection Data Bank Merging with the National Practitioner Data BankMore HHS and CMS Propose to Amend Regulations Permitting Donation of EHR Items and ServicesMore FTC files antitrust challenge to hospital system's acquisition of primary care physician group practiceMore Ignoring Possible Billing Errors May be Enough to Support a "Reverse" False Claims LawsuitMore Health Care Providers Take Note: Your Contract With An HMO May Require Affirmative Action Compliance, Even If It Doesn’t Say SoMore CMS Conditions of Participation: Try, try againMore Drum Beat of Health Care False Claims Act Settlements Continued in FebruaryMore Government Announces Record-Breaking Returns from Health Care Fraud EnforcementMore U.S. Supreme Court rules for FTC in hospital merger caseMore Ohio Governor Kasich Discusses Budget, Taxes, Education and Health Care Reform During the 2013 State of the StateMore Analysis of Final HIPAA Omnibus Rule: Notice of Privacy PracticesMore Analysis of Final HIPAA Omnibus Rule: Research, GINA, Hybrid Entities and Other Miscellaneous ProvisionsMore Analysis of Final HIPAA Omnibus Rule: Enforcement ProvisionsMore Proposed gainsharing program passes federal antitrust reviewMore 2013 Already an Active Year in Health Care False Claims Act SettlementsMore Analysis of the Final HIPAA Omnibus Rule: Individual Rights Regarding Restrictions and AccessMore Analysis of Final HIPAA Omnibus Rule: Business Associates and Business Associate AgreementsMore HHS Releases New Sample HIPAA Business Associate AgreementMore Analysis of the Final HIPAA Omnibus Rule: Changes to Marketing, Sale of PHI and Fundraising RequirementsMore Once More Into the Breach: Major Changes to the HIPAA Breach Notification RequirementsMore What You Will and Won’t Find in the Final Omnibus HIPAA RuleMore HHS Issues Final Omnibus HIPAA RuleMore Federal Appeals Court Rules that a Medicare Recovery Audit Contractor’s Decision to Reopen a Claim for Review is Beyond Judicial ScrutinyMore CMS Issues Final Rule Implementing Stage 2 of Meaningful UseMore Medicare Recovery Audit Prepayment Review to Begin on August 27, 2012More Urgent Care Facility Chain Settles False Claims Act Lawsuit for $10 MillionMore Medicare Conditions of Participation: The good, the bad and the unsureMore U.S. Supreme Court Upholds the Affordable Care ActMore HIPAA Audit Protocols and OCR’s Plan Future HIPAA Audits – OCR Has a Plan, Despite What GAO SaysMore Supreme Court will hear case involving FTC’s challenge to the merger of only two hospitals in Albany, GeorgiaMore Ohio’s New Law on Health Information ExchangesMore Abbott Labs Settlement Highlights Importance of Taking Employee Complaints SeriouslyMore Two Major Health Care Companies Pay $137.5 Million and $3.8 Million, Respectively, to Settle Violations Against the False Claims ActMore Medicare Shared Savings Program Fraud and Abuse Waivers: Common Questions and ConcernsMore First Enforcement Action Under HITECH Breach Rules Results in $1.5M Settlement by Blue Cross Blue Shield of TennesseeMore Requirements For Ordering Hospital Outpatient Services Clarified By CMSMore 'Tis the Season to [Not] Give KickbacksMore ACOs Take Two: Major Changes in Final RegulationsMore Multiple Government Agencies and Departments Make Coordinated Release of Final Medicare ACO RulesMore Proposed Rule Modifies HIPAA's Accounting of Disclosures RequirementsMore Designated representative may sign APN standard care arrangement on behalf of collaborating physicianMore Two Companion Rules Completing the Stage 1 Criteria for the Electronic Health Record Incentive Program ReleasedMore What changed in the revised Common Rule?The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form must be posted on a publicly available federal website within a specific time frame. The consent form must have been used to enroll subjects in order to satisfy this new provision.
When did the revised Common Rule go into effect?The revised Common Rule is effective July 19, 2018; note that from July 19, 2018 through January 20, 2019 institutions are not permitted to implement the entirety of the revised Common Rule.
Why the Common Rule was updated?Last year, the Common Rule was revised for the first time since its publication in 1991 in order to strengthen protections for study participants and lighten administrative workloads for researchers. High on the list of priorities is helping people make better decisions about whether to participate in a clinical trial.
When must a transitioned study comply with the requirements of the revised Common Rule?Transitioned studies must comply with the entirety of the 2018 Requirements on and after January 21, 2019 (except for the cooperative research provision at §46.114(b), for which compliance is required on and after January 20, 2020).
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How did the 2022 revisions to the “common rule” relax regulations on social science research?
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