Category Archives: Health Care

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California: Proposed Legislation Regulating Health Care Rates for Payors and Providers

california
An ambitious California proposal to regulate health care rates and curb long-term health care spending was unveiled last week in Assembly Bill 3087 (Proposed Legislation).  The key concept in the Proposed Legislation is the establishment of an independent commission with the authority to set the rates paid for health care services in most commercial contexts.  … Continue reading this entry

OIG Report: CMS Paid Practitioners for Telehealth Services That Did Not Meet Medicare Requirements

medicaid
The Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) just published a new report on OIG’s review of Medicare payments for telehealth services. The objective of the OIG review was to determine whether or not CMS paid practitioners for telehealth services that met Medicare requirements. The report concluded that, of the sampled claims … Continue reading this entry

Medicaid Drug Rebate Agreements: Changes Require Immediate Action By Pharmaceutical Manufacturers

pharmaceutical
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug manufacturers and the U.S. Department of Health and Human Services (HHS).… Continue reading this entry

FCA's "First to File" Bar Retains Some Teeth

Granston Memo
Health care providers are under constant threat of lawsuits brought by whistleblowers under the federal civil False Claims Act, 31 U.S.C. §§ 3729, et seq. (FCA), the statute under which the government obtains most judgements against providers. These qui tam lawsuits can be costly even where they lack any merit, and counsel for providers are … Continue reading this entry

Top Three Changes in Delaware’s New Proposed Telemedicine Rules

digital health
The Delaware Board of Medicine has issued proposed regulations clarifying certain statutory provisions pertaining to telemedicine and telehealth. As we previously reported, Delaware’s Medical Practice Act imposes certain practice standards for what constitutes an appropriate patient diagnosis and treatment via telemedicine, including the allowable modalities and when an in-person examination is required. The new proposed … Continue reading this entry

HHS to Collect Data From the EMS System: Good Time to Examine Accounting, Cost, Billing, and Collection Systems

While recent legislation impacting the Emergency Medical Services (EMS)/ambulance industry drew attention inside the industry for its reduction in Health and Human Services’ (HHS) spend on non-emergent dialysis transports and the five-year extension of the Medicare add-ons for the EMS industry, the legislation created a new forward-looking reporting obligation. Specifically, as part of the Continuing … Continue reading this entry

New Funding Legislation’s Impact on Health Care Programs

Congress passed a funding bill early this morning just after the February 8th deadline. The new legislation will make several changes to the Medicare program, delay cuts to disproportionate share hospitals, provide two years of funding for community health centers, and renew certain expired or expiring health care programs. The legislation increases government funding caps … Continue reading this entry

DOJ Issues New Memo Limiting Use of Agency Guidance Documents in Civil Enforcement Cases: What It Means for Health Care Enforcement

On January 25, 2018, the U.S. Department of Justice (DOJ) issued a memorandum limiting the use of agency guidance documents in affirmative civil enforcement (ACE) cases.  Stating that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation,” the memorandum strongly discourages DOJ litigators from using noncompliance with agency guidance … Continue reading this entry

CMS Announces an Advanced Alternative Payment Model - BPCI Advanced

On January 9, 2018, The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary bundled payment model program – Bundled Payment for Care Improvement Advanced (BPCI Advanced). The episode payment model, which is a second generation version of the BPCI program, will qualify as an Advanced Alternative Payment Model (APM) under the Quality … Continue reading this entry

Massachusetts Proposed Legislation to Curb Health Care Costs by Regulating Hospital Reimbursement Rates

Massachusetts
In a previous blog post, we began to dissect the new Massachusetts State Senate bill, “An Act Furthering Health Empowerment and Affordability by Leveraging Transformative Health Care,” and focused on a provision that would ban hospitals from billing payors for many common outpatient hospital services.  In this second of a multipart series, we review how … Continue reading this entry

Tax Reform and Tax-Exempt Bonds: Risks Presented by the Tax Cuts and Jobs Act

On November 2, 2017, the “Tax Cuts and Jobs Act” was introduced in the House of Representatives. This act has immediate and far-reaching implications for tax-exempt finance. Among other things, the Tax Cuts and Jobs Act would: Repeal the authority to issue “qualified private activity bonds” after December 31, 2017. These bonds generally include all … Continue reading this entry

Foley Named ACC Outstanding Committee Sponsor of the Year

For the second year in a row, Foley & Lardner LLP was named the Outstanding Committee Sponsor of the Year Award by the Association of Corporate Counsel (ACC) for Foley’s work on behalf of the ACC’s national Health Law Committee. Attorneys Alan Einhorn and Jana Anderson, Foley’s liaisons to the Health Law Committee, were presented … Continue reading this entry

Will the Massachusetts Proposed Legislation on Hospital Outpatient Facility Fees Have a Nationwide Impact?

In some states, including the Commonwealth of Massachusetts, “site neutrality” for outpatient hospital reimbursement is factoring into state-specific health reform and cost containment initiatives. This potentially goes well-beyond Medicare’s limitation of reimbursement at new off-campus outpatient hospital departments under Section 603 of the Bi-partisan Budget Act of 2015. Since Massachusetts’ state health reform law was … Continue reading this entry

Graham-Cassidy Proposal Falls Short on Votes While Other Deadlines Loom

Efforts to replace the Affordable Care Act (ACA) with the Graham-Cassidy legislation were unsuccessful as lawmakers rushed to meet the September 30th deadline when the Senate would have lost its current reconciliation vehicle.  Changes to the bill were incorporated in order to gain Republican support from a number of holdouts, but with Senator Susan Collins … Continue reading this entry

Medicare Claims Appeals: D.C. Circuit Reverses and Remands in Case Seeking Relief From Processing Delays

Summary of AHA v. Price, 2017 U.S. App. LEXIS 14887 (D.C. Cir. Aug. 11, 2017)   On August 11, 2017, the D.C. Circuit reversed the district court and held that the district court abused its discretion by ordering the Secretary of HHS to clear the backlog of administrative appeals of denied Medicare reimbursement claims within … Continue reading this entry

Alaska’s Telemedicine Business Registry: What You Need to Know

telemedicine business registry
Alaska’s Department of Commerce, Community, and Economic Development has finalized new regulations to create a special Telemedicine Business Registry for health care providers delivering telemedicine services in the Frontier State. The regulations in Title 12, Chapter 02 of the Alaska Administrative Code were effective on April 28, 2017 and implement provisions of Alaska SB 74 … Continue reading this entry

Lessons Learned from 2017 OCR HIPAA Enforcement Actions

So far 2017 is proving to be an active year for Health Insurance Portability and Accountability Act (HIPAA) enforcement. This comes on the heels of 2016, which saw an unprecedented level of enforcement actions, with 13 total settlements and nearly a 300 percent increase in total collected fines over 2015. To date in 2017, nine … Continue reading this entry

The Ball is in the SEC’s Court: What Health Care Borrowers Can Do While Waiting on Changes to Rule 15c2-12

On March 1, 2017, the Securities and Exchange Commission (SEC) issued Release No. 34-80130 (the Release) proposing several amendments to its Rule 15c2-12 (the Rule) that would add two new events to the list of events that must be included in the continuing disclosure undertakings of municipal issuers or obligors (Borrowers) of municipal bonds. These … Continue reading this entry

The Office of the National Coordinator Releases Guidance on Recent International Ransomware Campaign

With the news of the newest international ransomware campaign that is currently affecting some organizations within the Health Care sector, it is important to not only educate staff on necessary precautions, but also be aware of steps to take in the instance you are infected by a ransomware attack. The following information was distributed  today … Continue reading this entry

Opioid Crisis Initiating New State Gift Ban Laws

pharmaceutical
The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and administer drugs by manufacturers, wholesalers, or agents of manufacturers or wholesalers of prescription drugs.… Continue reading this entry

Senate Releases Repeal and Replace Legislation on ACA: The Better Care Reconciliation Act of 2017

After weeks of secrecy, the Senate has released a discussion draft of legislation that is the counterpart of the American Health Care Act (AHCA) previously passed by the House.  The Senate legislation, entitled the Better Care Reconciliation Act of 2017 or BCRA, closely tracks the language in AHCA. Foley Attorneys are continually monitoring and analyzing … Continue reading this entry

Senate Sets Timeline to Take up Repeal and Replace Legislation on ACA

With Congress returning to Washington, D.C. from its Memorial Day work period, Senators are focusing heavily on the timeline and details of legislation that would significantly alter the Affordable Care Act (ACA). Over the last week, many senior Senators have expressed skepticism regarding whether they can pass a bill, but Senate Republican Leader Mitch McConnell … Continue reading this entry

New FDA Commissioner Hits the Ground Running

FDA
Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf … Continue reading this entry

17 Measures Every Health Care Organization Should Consider to Reduce the Risk of Cyber-Intrusions

cybersecurity
The importance of privacy in the health care industry starts at the most basic level between a patient, a doctor, and the doctor’s laptop computer. The levels of importance and complexity increase exponentially when you look at entire networks of payers and providers. The amount of data produced and stored in these organizations is staggering … Continue reading this entry