Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
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FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Amendments). Through the public meeting and docket, FDA is seeking comments on how elements of the approval process for innovator and generic drugs, including exclusivities and other provisions created by the Hatch-Waxman Amendments or other FDA regulatory provisions, have been used in ways that “inappropriately” hinder generic competition.
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Prescription Drug Pricing & Government Price Reporting
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HOPPS Proposed Rule Recommends Big Changes to 340B Program

The Centers for Medicare & Medicaid Services (CMS) has released its annual proposed update to the hospital outpatient prospective payment system (HOPPS) for calendar year 2018 (the Proposed Rule). The official version of the Proposed Rule will be published in the Federal Register on July 20, 2017, and comments are due on September 11, 2017.

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Health Care Delivery System Reform, Hospitals and Acute Care
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45 Hospital and Health Care Executives Outline the Hospital of the Future

Health Care partner Tom Jeffry, and 44 other health care executives, spoke to Becker’s Hospital Review about the key trends disrupting the traditional hospital and how institutions can prepare for the future. “Looking towards the future, hospitals will devote more space and technology to accommodate advances in diagnostics and surgical procedures. New technologies will continue to reduce inpatient admissions as well as the number of days inpatients remain in the hospital. Hospitals will continue to have patient beds, but future hospitals will be more likely to have the same or fewer beds in private rooms that will accommodate more in-room services,” said Tom. 

In this article, Becker’s Hospital Review identified the following five key trends:

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Hospitals and Acute Care, Office of Inspector General Developments
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South Carolina Hospital Settles With OIG Over Alleged EMTALA Violations Involving Psychiatric Emergencies

AnMed Health, a hospital located in South Carolina, recently agreed to pay almost $1.3 million dollars and enter into a settlement agreement with the HHS Office of Inspector General (OIG) to resolve allegations that it violated the Emergency Medical Treatment and Labor Act (EMTALA) by failing to provide appropriate screening examinations and stabilizing treatment to patients who presented to the emergency department with psychiatric conditions.

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HIPAA / Health Privacy & Security
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Bitcoin for Care: Healthcare Hopping on the Blockchain

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

Earlier this year, Abid Hospital in Pakistan began accepting PakCoin (a cryptocurrency similar to Bitcoin) as payment for healthcare services, paving the way for innovative medical payment solutions in Asia. Only a handful of other healthcare providers around the world accept Bitcoin, including a private hospital in Poland and several forward thinking medical practices here in the United States. Aside from using Bitcoin or other blockchain technology for payment, there are a number of cutting edge ideas emerging for use of blockchain in the healthcare industry. 

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Pharmaceutical & Device Compliance
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FDA Issues Draft Guidance For Product Identifier Requirements

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017. According to the FDA, the “draft guidance describes FDA’s intention with regard to enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act” (DSCSA). Specifically, this guidance addresses manufacturers’ product identifier and verification requirements, which, under the law, begin November 27, 2017. The product identifier consists of the standardized numerical identifier, lot number and expiration date for the unit of drug (or homogenous case).

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Pharmaceutical & Device Compliance
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Will Opioid Manufacturers Become the Next Big Tobacco?

With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction. Missouri recently joined this list, filing suit against the leading opioid manufacturers for violating the state’s Medicaid fraud and consumer protection statutes.

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Pharmaceutical & Device Compliance
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FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition. FDA will be working with the Federal Trade Commission to identify and publicize any such practices that the FTC finds to be anticompetitive.

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E-Health, HIPAA / Health Privacy & Security
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OCR’s Quick-Response Checklist for Cyber Attacks Useful for Responding to Petya Ransomware Blitz

Earlier this year, ransomware known as Wannacry crippled Britain’s National Health Service and spread across the globe affecting many other organizations, large and small. Now, many organizations are grappling with a new onslaught caused by similar ransomware dubbed Petya. Wannacry and Petya are among a spate of recent ransomware attacks affecting hospitals and other healthcare providers.

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Certification, Accreditation & Licensure
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It’s About Time: Medicare Providers, Suppliers, and CLIA Laboratories No Longer Required to Write Plan of Correction on Right Side of Form 2567

In a move that practically all Medicare providers, suppliers, and Clinical Laboratory Improvement Amendments laboratories will welcome, the Centers for Medicare & Medicaid Services has declared that Plans of Correction and Allegations of Compliance no longer must be input directly onto the Statement of Deficiencies form (also known as “Form 2567”). This announcement formally came on June 16, 2017, when the Director of the CMS Survey & Certification Group issued a memorandum to the Directors of the State Survey Agencies providing guidance for the new format of POCs and AOCs.

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