On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics
Managed Care
Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities
By Yelena Greenberg & Guest Contributor on
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the federal 340B Drug Pricing Program. The Act: (a) requires the Commissioner of Social Services to convene a working group to evaluate the myriad issues affecting the 340B Program and opportunities for the state to support the 340B Program; and (b) prevents pharmacy benefit managers (PBMs) from incorporating certain contract provisions in agreements with qualifying Covered Entities under the 340B Program that lower reimbursement to such Covered Entities, among other restrictions.Continue Reading Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities
FTC Takes Action to Block Hospital Transactions in Utah and New Jersey
On June 2, 2022, the Federal Trade Commission announced a pair of antitrust enforcement actions to block pending health system transactions that, according to it, would harm competition in the provision of inpatient general acute care hospital services.Continue Reading FTC Takes Action to Block Hospital Transactions in Utah and New Jersey
Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce
To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to provide services (in person or via telemedicine) to patients in Massachusetts. Order 2021-13 extends prior DPH orders which authorized issuance of temporary licenses for certain health care providers and renewal or reactivation of certain temporary licenses.
Continue Reading Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce
Connecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers
On June 23, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-2 “An Act Concerning Provisions Related To Revenue And Other Items To Implement The State Budget For The Biennium Ending June 30, 2023” (PA 21-2). PA 21-2 makes various changes to Connecticut law as part of implementing the Governor’s budget, including, in pertinent part, a change to statutory requirements that apply to contracts between health carriers (insurers) and participating health care providers. This provision of PA 21-2 takes effect October 1, 2021.
Continue Reading Connecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers
Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules
By Melissa (Lisa) Thompson & Conor Duffy on
Posted in Fraud and Abuse, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Hospitals and Health Systems, Managed Care, Medicare and Medicaid, Office of Inspector General, Pharmacy Law, Physicians and Allied Health Professionals, Stark Law, Telehealth, Telemedicine
On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations. The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.
The full text of each rule is available below.
- Final Physician Self-Referral Law Rule, Centers for Medicare & Medicaid Services (CMS): https://public-inspection.federalregister.gov/2020-26140.pdf
- Final AKS Rule and Beneficiary Inducements CMP Regulations, Office of Inspector General (OIG): https://public-inspection.federalregister.gov/2020-26072.pdf
- Final Rule on Rebate/Point-of-Sale Price Reductions Safe Harbor, OIG: https://public-inspection.federalregister.gov/2020-25841.pdf?utm_campaign=pi+subscription+mailing+list&utm_source=federalregister.gov&utm_medium=email
Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic
By Conor Duffy on
Posted in Academic Medical Centers, Ambulance, Ambulatory Surgical Centers (ASC), Commercial Health Insurance, COVID-19, EMTALA, Government Enforcement, Hospitals and Health Systems, Legislation, Managed Care, Medical Staff and Peer Review, Pharmacy Law, Physicians and Allied Health Professionals, Reimbursement, Telemedicine
On July 14, 2020 Connecticut Governor Lamont issued Executive Order No. 7HHH, in which the Governor modified state law to enable the Commissioner of the Department of Public Health (DPH) to temporarily suspend licensure, registration and certification requirements for certain DPH-regulated practitioners for the duration of the state public health and civil preparedness emergency. Notably, in that Executive Order, the Governor stated that “healthcare providers from outside Connecticut have greatly enhanced the provision of healthcare services in Connecticut during the COVID-19 pandemic and thereby fundamentally improved the state’s ability to protect public health at critical time.”
Continue Reading Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic
Connecticut Expands Scope of Practice for Advanced Practice Registered Nurses
By Robinson+Cole's Health Law Group on
Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-98 “An Act Concerning The Scope Of Practice Of Advanced Practice Registered Nurses” (PA 19-98), which generally expands the scope of practice for Connecticut-licensed advanced practice registered nurses (APRNs). Among other things, PA 19-98 addresses matters related to medical records, emergency treatment, insurance coverage, and workers’ compensation, as further described below. PA 19-98 becomes effective October 1, 2019.
Continue Reading Connecticut Expands Scope of Practice for Advanced Practice Registered Nurses
CMS Announces Pilot Program for Clinicians to View Claims Data of Medicare Beneficiaries
On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced “Data at the Point of Care” (DPC), a pilot program that will provide clinicians with access to claims data. The pilot program follows on the heels of the recently proposed Interoperability and Patient Access Proposed Rule, which would require regulated health plans to make patient data available through an application programming interface (API). These actions are also part of the MyHealthEData initiative spearheaded by the White House Office of American Innovation.
Continue Reading CMS Announces Pilot Program for Clinicians to View Claims Data of Medicare Beneficiaries
OIG Issues Favorable Advisory Opinion Regarding Health Plan’s Incentive Payment Program
On October 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a Medicaid managed care organization’s (Requestor) proposal to pay incentives to its network providers who meet benchmarks for increasing the amount of early and periodic screening, diagnostic, and treatment (EPSDT) services provided to Medicaid beneficiaries (Proposed Arrangement).
Continue Reading OIG Issues Favorable Advisory Opinion Regarding Health Plan’s Incentive Payment Program