Category Archives: Regulatory Developments

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President Signs New Law Allowing Telemedicine Prescribing of Controlled Substances: DEA Special Registration to Go Live

Public Affairs
President Trump just signed into law the “Special Registration for Telemedicine Act of 2018” (the Act), requiring the Drug Enforcement Administration (DEA) to activate a special registration allowing physicians and nurse practitioners to prescribe controlled substances via telemedicine without an in-person exam. The DEA has no more than one year to complete the task.… Continue reading this entry

Health Care Policy Happenings - October 1 - 5, 2018

Public Affairs
In case you missed it, here are some key health care policy headlines from the past week. Congress Legislation and Committee Activity Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell  to President – On Wednesday, the U.S.  Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by … Continue reading this entry

Public Policy August Recess Health Care Newsletter  

Public Affairs
Foley’s  Bipartisan Public Policy Team is pleased to share our Public Policy August Recess Health Care Newsletter  in which we compiled the top health care policy news and legislation from this month. The House was not in session and the Senate came back mid-month to focus on passing appropriation bills and presidential nominations.… Continue reading this entry

CMS Proposes to Ever-So-Slightly Expand Stark Law Exceptions for Compensation Arrangements

The Centers for Medicaid & Medicare Services (CMS) proposes to revise regulations issued pursuant to the Federal physician self-referrals Statute (Stark Law) to harmonize the regulations with the newly enacted Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted on February 9, 2018).… Continue reading this entry

The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers  

pharmacy
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet published (or leaked), the title of the rule itself is rather transparent: Removal of Safe Harbor … Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

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

Medicare Enrollment for Providers No Longer Required Under Medicare Parts C and D

controlled substances
On April 2, 2018, CMS released the Contract Year 2019 Final Rules for Medicare Advantage (MA) and Part D (the MA Final Rule), incorporating changes that support CMS’ stated commitment to supporting flexibility and efficiency throughout the MA and Part D Programs.… 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

Tax Cuts and Jobs Act – New Compensation Tax for Non-Profit Organizations on Excess Compensation and Excess Parachute Payments

Public Affairs
The Tax Cuts and Jobs Act passed late last year and became effective as of January 1, 2018.  The Act includes a new provision that subjects certain “excess compensation” paid by exempt organizations (organizations exempt from income tax under section 501(a) of the Internal Revenue Code (the Code)) to the corporate income tax.… 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

SAMHSA Finalizes Second Round of Changes to Federal Substance Use Disorder Privacy Rule

Policy
New federal regulations published on January 3, 2018, clarify when lawful holders of substance-use disorder records may use and disclose patient identifying information for payment, health care operations, and audits and evaluations. The 2018 regulations address issues that were discussed, but not resolved, in last year’s final rule published on January 18, 2017.… Continue reading this entry

Mandatory Cardiac Episode Payment Program: CMS Proposes Cancellation

hospital
Also Changes Required Participation in the CJR Model   On August 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (Proposed Rule) that, if finalized, would (1) reduce the number of Metropolitan Statistical Areas (MSAs) in which there is mandatory participation in the Comprehensive Care Joint Replacement model (CJR) from … Continue reading this entry

New Jersey’s Telemedicine Law: What Providers Need to Know

new jersey telemedicine
New Jersey has a new telemedicine law, recently signed by Governor Chris Christie. The law cements the validity of telehealth services in the Garden State, establishes telemedicine practice standards, and imposes telehealth coverage requirements for New Jersey Medicaid, Medicaid managed care, commercial health plans, and other State-funded health insurance. After a year of debate in … 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

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Research
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.  Learn what you need to know quickly with these seven questions and answers. What do I Need to Know?… Continue reading this entry

Key Takeaways From FHA’s Health Law Summit

Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state and future direction of the health care industry.… Continue reading this entry

What To Know About New HHS OIG Exclusion Regs

Regulatory-Developments
On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort — a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary … Continue reading this entry

New Hampshire Finalizes Opioid Prescribing Rules

New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic.  Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids to patients in a health care setting, now is the time for New Hampshire hospitals, ambulatory surgical centers, urgent care facilities, and … Continue reading this entry

Eight Things to Know About the New Federal Substance Use Disorder Privacy Rule

A final rule published on January 18 implements the first major revisions to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) since 1987. It finalizes a proposal from last February to modernize the regulations in light of the significant changes in the health care delivery system. On the same day, … Continue reading this entry

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased … Continue reading this entry

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the state of Hawai’i, beginning with January 1, 2017. The waiver was authorized pursuant to Section 1332 of the ACA, which allows … Continue reading this entry

What to Know About new HHS Civil Monetary Penalties

Preparing for the Conversion to ICD-10
More than two years after first proposing regulations, the Office of Inspector General of the U.S. Department of Health and Human Services issued two final rules updating its (1) civil monetary penalty (CMP) regulations, 81 Fed. Reg. 88,334 (Dec. 7, 2016), and (2) safe harbors under the anti-kickback statute (AKS) and beneficiary inducement prohibitions, 81 … Continue reading this entry