On March 27, 2018, the United States Court of Appeals for the Fifth Circuit held that a health care provider can seek an injunction in federal court against recoupment by Medicare of alleged overpayments despite not exhausting its administrative appeal remedies, in part because the current delay in scheduling of hearings before an Administrative Law Judge could cause the provider to go out of business before it has an opportunity to exhaust its administrative challenge of the recoupment. This decision could provide a template for other providers facing significant …
Robinson+Cole's Health Law Group
Fifth Circuit Reinstates Provider’s Collateral Challenge to the Medicare Appeal Process
FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products
On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products. The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).
By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two …
CMS Issues National Coverage Determination On Next Generation Sequencing For Advanced Cancer
On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Decision Memo for Next Generation Sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450N). In the memo, CMS concluded that NGS as a diagnostic laboratory test is reasonable, necessary and covered nationally when performed in a CLIA-certified laboratory, ordered by a treating physician, and certain additional patient-status and testing requirements are met. The memo outlines these requirements and specifies the criteria that Medicare Administrative Contractors (MACs) must use to determine coverage for NGS as a diagnostic …
Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts
Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and health care providers, and restrictions on contractual provisions between health care providers and insurance companies.
We recently covered PA 17-241 in our Health Law Pulse, it can be accessed here.…
New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center. In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS). The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework …
Connecticut Enacts Legislation Intended to Curb Opioid Drug Abuse
On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by revising current laws related to controlled substance prescribing and disposal and enacting new laws regarding opioid abuse prevention and treatment.
We recently covered PA 17-131 in our Health Law Pulse, it can be accessed here.…
OIG Publishes Prioritized Recommendations for HHS
The OIG has released the 2017 Compendium of Unimplemented Recommendations, summarizing prioritized recommendations relating to HHS programs and operations. Topping the list are recommendations relating to hospitals, including:
- Reimbursement rates for critical access hospital swing beds should be adjusted to the lower rates for similar services provided in skilled nursing facilities.
- Reimbursement rates for hospital outpatient department procedures should be adjusted to the lower rates for similar procedures conducted in ambulatory surgical centers.
- Medicare should adopt a hospital transfer payment policy to lower hospital reimbursement for beneficiaries who are
Connecticut Enacts Legislation Updating HIV Testing Laws
Connecticut Governor Dannel Malloy recently signed into law Public Act 17-6 (PA 17-6), a bill that makes certain revisions to state laws concerning human immunodeficiency virus (HIV) testing and syringe services programs pursuant to recommendations of the Department of Public Health (DPH). The substantive provisions of this legislation take effect July 1, 2017.
Currently, Conn. Gen. Stat. §19a-90 states that physicians furnishing prenatal care to pregnant women shall take (or cause to be taken) a blood sample within 30 days of the woman’s first examination, and again during the final …
Connecticut Legislature Expands Universe of Available Disciplinary Actions Against Licensed Practitioners
The Connecticut Legislature recently approved Public Act 17-10, a bill that establishes a new disciplinary action that may be taken against certain licensed practitioners in Connecticut, including physicians, physician assistants, nurses, dentists, podiatrists, physical therapists, psychologists, and EMS personnel.…
CMS Issues Proposed IPPS Rule
On April 14, 2017, the Centers for Medicare & Medicaid Services (CMS) released the FY 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule, and Request for Information (Proposed Rule). The Proposed Rule outlines proposed updates to Medicare payment rates under the Inpatient Prospective Payment System (IPPS) and policies for hospital admissions. The goals of the Proposed Rule include relieving regulatory burdens on providers, supporting the doctor-patient relationship, and promoting transparency, flexibility, and innovation in the delivery of care.…
OIG Warns of Scam Using the OIG Hotline Number
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a fraud alert, warning that the OIG Hotline telephone number was being used in scams across the country. According to the OIG, the scammers pose as OIG Hotline employees and alter the caller ID to make it appear as if the call is coming from the OIG Hotline number. The scammer then tries to obtain or verify personal information, which could be used for fraudulent activities such as stealing money from bank accounts.…
CMS Final Rule Streamlines Appeals Process
The Centers for Medicare and Medicaid Services (CMS) recently issued a Final Rule to streamline and address the substantial backlog of Medicare administrative appeals at the Administrative Law Judge (ALJ) and Departmental Appeals Board (DAB)/Medicare Appeals Council levels.
Among other changes to the appeals process, the Final Rule:
- Permits the designation of Medicare Appeals Council decisions as precedential, in order to provide clarity
- Gives attorney adjudicators certain authority that had been previously reserved to the ALJs, including the authority to decide appeals that can be determined without a hearing, to
Appeal Filed in Case Ordering HHS to Reduce Backlog of ALJ Appeals
The Secretary of the U.S. Department of Health & Human Services (HHS) has appealed a ruling by United States District Court Judge James E. Boasberg that had required HHS to make substantial reductions in its current backlog of cases pending before Administrative Law Judges (ALJ) (Notice of Appeal, U.S. Court of Appeals, District of Columbia Circuit, Case No. 17-5018). In his Memorandum Decision filed December 5, 2016, Judge Boasberg had ordered HHS to achieve a 30% reduction in the current backlog of cases pending at the ALJ level by December …
TCPA Violations Claimed Against San Diego Hospital
Rady Children’s Hospital-San Diego (Hospital) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls to consumers’ cell phones. The complaint states that “[the Hospital], either directly or through their agents, illegally contacted plaintiffs and the class members via their cellular telephones by using an ATDS [(i.e.,an automated telephone dialing system)], thereby causing plaintiffs and the class members to incur certain cellular telephone charges or reduce cellular telephone time for which plaintiffs and …
Second Circuit Denies En Banc Rehearing in Microsoft Email Case
On January 24, 2016, the U.S. Court of Appeals for the Second Circuit denied the Department of Justice’s request for an en banc rehearing in In the Matter of a Warrant to Search a Certain Email Account Controlled and Maintained by Microsoft Corp. a/k/a Microsoft Corp. v. United States (No. 14-2985). The denial leaves in place a controversial decision by a three judge panel that quashed a warrant obtained by the DOJ under the Stored Communications Act (SCA) seeking the contents of a Microsoft customer’s emails. The majority panel …
CMS Updates Home Health Agency Conditions of Participation
On January 13, 2017, the Centers for Medicare and Medicaid Services (CMS) published a Final Rule updating the home health agency (HHA) Conditions of Participation (CoPs). HHAs only have until July 13, 2017 to implement these extensive changes. CMS revised the CoPs to focus on a “patient-centered, data-driven, outcome-oriented process that promotes high quality patient care at all times for all patients.”
Below are some of the most significant changes to the CoPs for home health agencies (HHAs) — the Final Rule:…
CMS Final Rule on Episode Payment Models and Revisions to CJR Model
In December, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (Final Rule) implementing new and revised episode payment models (EPMs) developed by the CMS Innovation Center. The Final Rule continues CMS’ transition of Medicare payment methodologies away from fee-for-service and towards value-based payments, including by incentivizing care coordination efforts and tying payments to quality improvement.
New EPMs: The Final Rule implements three new EPMs for episodes of care surrounding (i) acute myocardial infarction (AMI); (ii) coronary artery bypass graft (CABG); and (iii) surgical hip/femur fracture treatment …
Medicare Shared Savings Program (MSSP) Track to Incentivize Assumption of Risk
On December 20, 2016, CMS announced the formation of a new participation track under the Medicare Shared Savings Program (MSSP) – the Medicare ACO Track 1+ Model – which will start in 2018. Accountable care organizations (ACOs) participating in this model will agree to accept more limited downside risk than ACOs participating in Track 2 or Track 3 of the MSSP, and will be eligible to share up to 50% of savings from care provided to a prospectively assigned beneficiary population. This model will qualify as an Advanced Alternative Payment …
New Anti-Kickback Safe Harbors and Exceptions to CMP Law
On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).
Local Transportation Safe Harbor
This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met. An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health …
OIG Issues Favorable Advisory Opinion for Cost-sharing Waivers and Stipends in a Clinical Research Study
On December 13, 2016, the Office of Inspector General (OIG) issued a favorable Advisory Opinion to a university health system (the Requestor) for two arrangements relating to a federally-funded clinical research study designed by a physician-employee (the Study):
- a proposal to waive the cost-sharing obligations of Study participants (Participants) for medically necessary health care services received under the Study protocol (the Proposed Arrangement), and
- payment of a stipend to Participants for the time and effort required to participate (the Current Arrangement).
OIG Recommends More Monitoring of Hospital Compliance With Two-Midnight Rule
The Office of Inspector General (OIG), Health & Human Services recently released a report detailing its analysis of hospital compliance with the Centers for Medicare & Medicaid (CMS) “two-midnight” rule during fiscal year 2014, which allows Medicare payment for inpatient claims only if the treating physician expects that the patient will require hospital services at least two midnights. The two-midnight policy was implemented by CMS to, in part, reduce inconsistent use of inpatient and outpatient hospital stays and address improper payment for short inpatient stays. The OIG found that hospitals …
OIG Increases Nominal Value for Gifts to Beneficiaries
In a Policy Statement by the Office of Inspector General (OIG), Health & Human Services released December 7, 2016, the OIG updated its long-standing interpretation of the term “nominal value” with regard to gifts to federal health care program beneficiaries that do not comprise “remuneration” under section 1128A(a)(5) of the Social Security Act. The OIG now interprets nominal value as having a retail value of no more than $15 per item and $75 in the aggregate per patient annually, as long as the items are not cash or cash equivalents. …
FDA Guidance on Cybersecurity in Medical Devices
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR part 806), which require device manufacturers and importers to report certain device corrections and removals to the FDA. Most actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “routine updates and patches” that do not require advance notification or reporting. However, actions taken by manufacturers to correct device cybersecurity vulnerabilities and exploits that …
FDA Final Rule on Postmarketing Safety Reporting for Combination Products
On December 20, 2016, the Food and Drug Administration (FDA) published regulations (Final Rule) establishing postmarketing safety requirements for combination products, which are products comprised of:
(1) a drug and a device;
(2) a device and a biological product;
(3) a biological product and a drug; or
(4) a drug, a device, and a biological product.
“Postmarketing safety” involves manufacturing events, device malfunctions, and events causing injury to users, and the reporting requirements relating to product and patient safety arising from these events. …
