Category Archives: Regulatory Developments

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

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Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.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

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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

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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

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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

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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

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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

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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

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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

CMS Finalizes Mandatory Cardiac Care Bundled Payment Model and More

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On December 20, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (the Final Rule) which includes three new mandatory episode-based payment programs for cardiac care, as well as the expansion of the Comprehensive Care for Joint Replacement Model (CJR). The models are implemented by the CMS Innovation Center, under authority … Continue reading this entry

Top 5 Takeaways from New Michigan Telehealth Law

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Michigan is ringing in 2017 with a new telehealth law. Governor Rick Snyder signed into law SB 0753 on December 21, 2016, imposing new telehealth practice standards, including restrictions on prescribing controlled substances via telemedicine. The new Michigan telemedicine law will take effect March 21, 2017 (a 90-day delay from signature to effective date).  Previously, … Continue reading this entry

21st Century Cures Act Provides Some Welcome Relief

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The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the long-anticipated relief for Medicare “site-neutrality” policies relating to off-campus outpatient hospital departments (“OCODPs”), certain cancer hospitals, and long-term care … Continue reading this entry

Medical marijuana might be legal, but you won't get a prescription this way

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Below is an article that originally appeared in the South Florida Business Journal, featuring Foley Partner, Nate Lacktman. The Florida Board of Medicine proposed on Dec. 8 a regulation that will, at least for the foreseeable future, divert the paths of two industries emerging into Florida’s business mainstream: medical marijuana and telemedicine. It’s been proposed … Continue reading this entry

Florida: No Telemedicine Exams for Medical Marijuana

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The Florida Board of Medicine issued a proposed amendment, on December 8, 2016, to its telemedicine regulations to clarify that physicians may not order medical cannabis or low-THC cannabis via telemedicine. The Board’s current telemedicine rules were originally issued in the Spring of 2014. The amendment would add a new Section (5) to the Standards for Telemedicine … Continue reading this entry

New Presidency Will Compel Action in Key Areas of Health Care in 2017

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As we enter the final stretch of the U.S. presidential election, health care remains one of the most contested issues with great potential for change, particularly to existing insurance and patient care systems. Compounding matters is the opening of enrollment season for exchange plans, which places the already hotly debated Affordable Care Act (ACA) at … Continue reading this entry

OPPS Final Rule Finalizes Limits for Off Campus Departments

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Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule will cause new (non-grandfathered) hospital off-campus outpatient departments to no longer be reimbursed under the Medicare Outpatient Prospective Payment System (OPPS). … Continue reading this entry

California Targets Surprise Medical Bills, Follows on the Heels of New York and Florida

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Governor Brown approved a new law last Friday that limits patient exposure to so-called surprise medical bills.  AB 72 caps the cost-sharing obligations of patients who unexpectedly receive care from non-contracted providers during or because of a stay at an in-network facility.  The law limits cost sharing for covered services to in-network amounts unless the … Continue reading this entry

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

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Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue: EpiPen’s classification as a generic drug for purposes of the Medicaid Drug Rebate Program (“MDRP”).  Resolution of the classification issue carries significant risk for segments of … Continue reading this entry

The Top 10 Things you Need to Know About Voluntary Disclosures and Government Refunds

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In February 2016, CMS issued the highly anticipated Final Rule on reporting and returning Medicare Part A and B overpayments. The Final Rule was meant to clear up some of the confusion among providers regarding such overpayments. Summarized below is our Top 10 list of the things you need to know:… Continue reading this entry

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

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The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were finalized in October 2015, clarified in December 2016, and effective as of January 14, 2016, apply to all health IT products and services certified to the 2014 Edition … Continue reading this entry

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

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Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have … Continue reading this entry

Mid-Year 340B Program Update

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Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the … Continue reading this entry

CMS Expands Mandatory Bundled Payments to Cardiac Care

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On Monday July 25, 2016, CMS proposed new models that expand mandatory participation in bundled payments and continue CMS’s initiative to shift Medicare payments from fee for service to alternative payment models.  Coming just as the Comprehensive Care for Joint Replacement (CJR) initiative gets underway, the new models are, according to CMS, intended to reward … Continue reading this entry

CMS Proposes New Medicare Telehealth Coding Rules

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The Centers for Medicare and Medicaid Services (CMS) issued its proposed Medicare Physician Fee Schedule (PFS) for CY 2017 on July 7, 2016. In it, CMS would require practitioners to use a new place of service (POS) code to report telehealth services. The proposed rule also includes several new covered telehealth services. If enacted, the proposed rules are … Continue reading this entry

IRS Denies Exempt Status for Non-MSSP Accountable Care Organizations

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In April, the IRS released a private letter ruling denying section 501(c)(3) status to an accountable care organization (“ACO”) that contracted with third-party payers outside of the Medicare Shared Savings Program (“MSSP”). I.R.S. Priv. Ltr. Rul. 2016-15-022 (Jan. 15, 2016). The ACO was formed by a non-profit, tax-exempt health system to coordinate a clinically integrated … Continue reading this entry