Category Archives: Healthcare Law

Subscribe to Healthcare Law RSS Feed

Arkansas and Kentucky Halt Medicaid Work Requirements

On April 10, 2019, the Department of Justice filed notices[1] appealing two District Court rulings that struck down Medicaid work requirements in both Kentucky[2] and Arkansas[3] to the U.S. Court of Appeals for the District of Columbia Circuit. The rulings, issued on March 27, 2019, by Judge James E. Boasberg of the Federal District Court … Continue Reading

Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the 340B Program

If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services (“HRSA”) finally updated the Office of Pharmacy Affairs 340B Information System website (the “340B Website”) to allow 340B Drug … Continue Reading

OIG Advisory Opinion No. 19-03: The OIG Puts the Healthcare Benefits of Free In-Home Care and the Risks of Patient Steering in the Balance

OIG Advisory Opinion No. 19-03 On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge support to patients. The OIG determined that it would not impose sanctions under either the Civil … Continue Reading

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating … Continue Reading

TRICARE: Defense Health Agency Issues Request for Information Regarding Formulary Management – Submission Deadline: February 5, 2019

The Defense Health Agency (DHA), which manages the TRICARE health care benefits, has issued a Request for Information (RFI) regarding inpatient-clinic administered pharmaceuticals formulary management.  In other words, responding vendors have the opportunity to shape the standard list of drugs prescribed across all military medical treatment facilities (MTFs), as well as the broader program administering … Continue Reading

The Eliminating Kickbacks in Recovery Act: An Altered Landscape for Financial Relationships with Clinical Laboratories

Section 1822 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, includes the “Eliminating Kickbacks in Recovery Act of 2018” (“EKRA”). Although EKRA was created to address “patient brokering,” the practice by recovery homes and treatment facilities … Continue Reading

Reforming America’s Healthcare System Through Choice and Competition: The Trump Administration Recommends Healthcare De-Regulation

On December 3, 2018, the U.S. Department of Health and Human Services (“HHS”), in collaboration with the Departments of the Treasury and Labor, the Federal Trade Commission, and several offices within the White House, produced a 119-page report outlining recommendations to reform the healthcare system. This report is in response to Executive Order 13813, in … Continue Reading

OCR Seeks Ideas on HIPAA Rule Changes to Promote Value-Based Care and Coordinated Care

The Office for Civil Rights (“OCR”) issued a request for information (“RFI”) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations (the “HIPAA Rules”) that may impede the transformation to value-based health care or that limit or discourage coordinated care among individuals and covered entities … Continue Reading

Blog Series Part 7: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for 2020 and 2021

Part C and Part D Quality Rating System The November 1, 2018 proposed rule issued by the Centers for Medicare & Medicaid Services (“CMS”) includes enhancements and substantive changes to the Star Rating System in order to increase the stability and predictability of the Medicare Advantage program (aka “Part C”) and the Medicare Prescription Drug … Continue Reading

Blog Series Part 6: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service and Medicaid Managed Care Programs for Years 2020 and 2021

Dual Special Needs Plans This part 6 of our 7 part series focuses on the provisions regarding dual special needs plans (“D-SNPs”) released by the Centers for Medicare and Medicaid Services (“CMS”) in the proposed rule issued on November 1, 2018 (the “Proposed Rule”). D-SNPs enroll individuals who are entitled to both Medicare and medical … Continue Reading

The New California Regulatory Scheme for Pharmacy Benefit Managers

California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). [1] The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to register with the California Department of Managed Health Care (“DMHC”) and provide new disclosures to the purchasers of their services. The bill will … Continue Reading

Blog Series Part 5: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for 2020 and 2021

Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a proposed rule issued November 1, 2018 (the “Proposed Rule”), was to implement new Social Security Act provisions that … Continue Reading

Blog Series Part 4: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021

Quality Improvement Programs The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change involves a clarification regarding the accreditation “deeming” standard for Medicare Advantage (“MA”) quality improvement programs. The second change, also related to … Continue Reading

Blog Series Part 3: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021

Medicare Advantage and Part D Preclusion List The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the manner in which providers are to be included on CMS’ Medicare Advantage and Part D “Preclusion List”, providers’ appeal rights prior … Continue Reading

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan sponsors (“PDPs”), Medicaid managed care organizations (“MCOs”), and the providers and suppliers that contract with them (the “Proposed Rule”). CMS anticipates that the … Continue Reading

Congress Passes “SUPPORT for Patients and Communities Act” — A Rare Example of Bi-Partisanship

In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described in the Proclamation, the goal of Awareness Week is to “raise awareness about the prescription opioid and heroin epidemic and to consider … Continue Reading

The VA MISSION Act: Enhancing Healthcare for Veterans

On Wednesday, June 6, 2018, President Trump signed into law the “John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Networks Act” a.k.a. the VA MISSION Act of 2018 (“VAMA”), a $52 billion reform bill aimed at improving access to, and the quality of, medical services … Continue Reading

In a Unanimous Vote, the Opioid Crisis Response Act of 2018 Makes it Onto the Legislative Calendar

As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of 2018 (the “Bill”) was placed on the Senate Legislative Calendar after a unanimous vote out of … Continue Reading

California Superior Court Judge Orders Department of Public Health to Make Names and Personal Home Addresses of Approximately 180,000 Health Care Workers Available to SEIU; Union Organizing Activities Likely to Spike

A California Superior Court judge recently issued an order granting the Service Employees International Union’s (“SEIU”) petition for writ of mandate under the California Public Records Act (“CPRA”) and ordered the California Department of Public Health (“CDPH”) to produce the names and personal home addresses of approximately 180,000 healthcare employees who hold licenses or certificates … Continue Reading

CMS Rolls Out Provider Appeals Settlement Efforts

(as first posted in the Hospice Log Blog on April 12, 2018) This year CMS is rolling out two new programs aimed, finally, at helping to settle certain types of pending provider reimbursement appeals. The programs are the Low Volume Appeals Initiative and Settlement Conference Facilitation. As pointed out on the Hospice Law Blog before, CMS’ longstanding … Continue Reading
LexBlog

By scrolling this page, clicking a link or continuing to browse our website, you consent to our use of cookies as described in our Cookie and Advertising Policy. If you do not wish to accept cookies from our website, or would like to stop cookies being stored on your device in the future, you can find out more and adjust your preferences here.

Agree