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Proposed Rule Would Require Ohio Providers to Accept Standard Authorization Form for Use and Disclosure of Protected Health Information
Dinsmore & Shohl LLP, November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information...

Manufacturer CMP and 340B Ceiling Price Rule to Become Effective on January 1, 2019
Dinsmore & Shohl LLP, November 2018

Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule)...

Obstacles to IPOs Faced by Life Sciences Companies
Lowenstein Sandler LLP, October 2018

Initial public offerings (IPOs) are often seen as attractive by business owners in the life sciences or biotech field, writes Alan Wovsaniker, a partner with Lowenstein Sandler, in an Expert View column on the topic. The need for capital in a life sciences business tend to be great, as the cost to develop new drugs, therapies or medical devices is extremely expensive and it takes many years to receive regulatory approval to market and sell such drugs, therapies or medical devices...

SUPPORT Act Expands Telehealth Treatment for Substance Use Disorders
Dinsmore & Shohl LLP, October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018...

Planning for Privacy in Health Research
MinterEllison, October 2018

Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes...

State Initiatives to Control Drug Prices
Lowenstein Sandler LLP, October 2018

While the Trump administration and Congress have talked a lot about controlling drug prices, and the administration did recently float a much-criticized proposal to require drug companies to include list prices in TV ads, state governments have grown tired of waiting and seized the initiative in this area in imaginative ways. Over the past several years, numerous states have taken a broad variety of measures to control and influence prescription drug spending and prices...

FDA and DEA Approve CBD-Based Epilepsy Medication
Waller, October 2018

Late last month,  the U.S. Drug Enforcement Administration (DEA) issued a final order placing FDA-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V of the Controlled Substances Act of 1970 (CSA). Schedule V of the CSA includes drugs such as Robitussin and Lyrica...

Selling CBD Products is Illegal, Board of Pharmacy Clarifies
Dinsmore & Shohl LLP, October 2018

In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO)...

Three Boston Hospitals Pay Close to $1 Million in HIPAA Settlements for Disclosing Personal Health Information to Film Crews
Dinsmore & Shohl LLP, October 2018

On September 20, 2018, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with three Boston hospitals for disclosing Protected Health Information (PHI) to ABC News documentary filmcrews.[i] In total, the hospitals paid OCR $999,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...

Ownership of Genetic Information and Tissues Under the South African National Health Act
ENSafrica, September 2018

Background The legal and philosophical aspects relating to the concept of “ownership” with respect to human biological material of various kinds has been hotly debated...

OSHA Issues Proposed Rule Regarding Electronic Submission Requirements
Hunton Andrews Kurth LLP, August 2018

The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA.  Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301.  And, establishments with 20 to 249 employees must annually submit their Form 300A...

Healthcare's Deal Boom
MinterEllison, August 2018

"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets...

"QAPI Spells Success for SNFs" Jeff Parrish in McKnight's Long-Term Care News
Waller, August 2018

The skilled nursing sector has seen a significant number of facility divestitures and closures in the last few years. Quite frankly, this negative trend is due in part to a reluctance by some operators to implement clinical-based care standards and a lack of honest self-evaluation to improve the clinical care provided at skilled nursing facilities. Outdated operating models – solely meeting the basic needs of patients – does not bode well for SNF operators to survive...

Patents for Inventions Related to Zika Virus, Chikungunya Virus, and Rare Diseases may have Fast-Track Examination at the BPTO
Veirano Advogados, July 2018

Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System...

Three Things about the Affordable Care Act Employers Need to Focus on Now
Hanson Bridgett LLP, July 2018

The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules...

New System of Processing Customs Destination Certificates for Medical Devices Without a Sanitary Registration
Carey, July 2018

In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164”...

Attorney General Announces Ninth Annual Fraud Takedown Targeting Opioid Epidemic
Dinsmore & Shohl LLP, July 2018

On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings...

Dr. Robot at Your Service: Artificial Intelligence in Healthcare
Lavery Lawyers, June 2018

Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g...

DOL Finalizes Rules to Expand Access to Health Plans for Small Businesses
Hanson Bridgett LLP, June 2018

This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees...

Court Reinstates End of Life Option Act Pending Further Hearings
Hanson Bridgett LLP, June 2018

On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May.  On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law...

Reversing the Ban on Nursing Home Arbitration Agreements
Waller, June 2018

The hits keep coming to plaintiffs’ attorneys seeking to invalidate nursing home arbitration agreements. Last year, the plaintiffs’ bar could smell victory when the Centers for Medicare & Medicaid Services (CMS) announced its new rule banning arbitration clauses in nursing home admission contracts...

The Nuts and Bolts of West Virginia’s Opioid Reduction Act
Dinsmore & Shohl LLP, June 2018

In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B...

Is This the End of the End of Life Option Act?
Hanson Bridgett LLP, June 2018

A New Development on the Subject (Update as of June 15th) Click Here to Read »   A flurry of rulings during the last two weeks of May has generated enormous confusion regarding the status of California's two-year-old End of Life Option Act ("EOLOA"), the law that allows a terminally ill adult with a six-month prognosis to obtain aid-in-dying drugs from a physician, subject to numerous safeguards...

CBO Releases Highly Anticipated Report on Trump's ObamaCare Repeal Bill; 23 Million Americans Projected to Lose Insurance by 2026
Waller, May 2018

Earlier this year, the Congressional Budget Office (CBO) released its report on the direct spending and revenue effect of H.R. 1628, the American Health Care Act of 2017 (AHCA), as passed by the House of Representatives. CBO made this estimate in conjunction with the Joint Committee on Taxation...

Health Law Vitals
Haynes and Boone, LLP, May 2018

Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc...

Seventh Circuit Issues Strong Endorsement of Learned Intermediary Doctrine in Medical-Device MDL
Patterson Belknap Webb & Tyler LLP, April 2018

The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician...

Government May Change Course on Reimbursements for FSEDs
Waller, April 2018

In recent months, the influential Medicare Payment Advisory Commission (MedPAC) voted unanimously to reduce reimbursement rates for some urban, free-standing emergency departments (FSEDs). MedPAC is the independent congressional agency that advises Congress on issues affecting the Medicare program. While MedPAC’s recommendation is just that — a recommendation — its advice typically serves as a harbinger of Congressional action...

5 of the Biggest Myths About GDPR Data Protection - and Why You Shouldn't Believe Them
Waller, March 2018

You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact...

FDA Draft Guidance Proposes Risk-Based Regulatory Scheme for Drug Products Labeled as Homeopathic
Haynes and Boone, LLP, March 2018

More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities...

New ERISA Disability Benefit Claims and Appeals Rules Take Effect April 2, 2018
Hanson Bridgett LLP, March 2018

New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018.  According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA)...

Department of Justice Announces Task Force to Combat Prescription Opioid Crisis
Dinsmore & Shohl LLP, March 2018

Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis.  According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct...

Why Telehealth was a Big Winner in New Budget Deal
Waller, February 2018

Hidden in the details of the Bipartisan Budget Act of 2018 are some key telehealth provisions that are receiving praise from many industry groups and could mark a significant development for Medicare telehealth policy. The new legislation promotes telehealth in several ways. Tele-stroke. Medicare currently only covers tele-stroke services for patients located in rural health professional shortage areas and counties not classified as a metropolitan statistical area...

Enhanced Nurse Licensure Compact Implemented in 29 States
Dinsmore & Shohl LLP, February 2018

Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation...

Medical Board Seeks Non-Disciplinary Program for Providers Suffering From Mental and Physical Conditions
Dinsmore & Shohl LLP, February 2018

The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses.  Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process...

Two DOJ Memos to Impact Health Care False Claims Act Litigation
Dinsmore & Shohl LLP, February 2018

As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena.  The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C...

HHS announces $3.5 million HIPAA settlement with Fresenius resolving five breach reports
Dinsmore & Shohl LLP, February 2018

Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules...

Amazon Sets Out to Tackle Healthcare Costs
Waller, February 2018

This week we learned that Amazon, Berkshire Hathaway and J.P. Morgan Chase have joined forces to tackle employee healthcare costs.  This announcement marks yet another chapter in some employers' frustration with our nation’s healthcare system.  Employees are equally tired of the increasing cost of healthcare eating away what should be their wage increases even as employers pay for ever increasing health insurance premiums...

State Medical Board of Ohio Proposes Changes to Medical Laser Rules
Dinsmore & Shohl LLP, January 2018

The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio.  While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services...

IRS Extends Deadline for Providing Health Coverage Forms to Employees, but not the IRS Filing Deadline
Hanson Bridgett LLP, January 2018

Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees...

New Rules Would Expand Access to Association Health Plans for Small Businesses
Hanson Bridgett LLP, January 2018

Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees...

CAFC sides with Sandoz, Amgen’s State Claims Preempted by BPCIA
Dinsmore & Shohl LLP, December 2017

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015)...

New Decree on Healthy Life Habits Enters Into Force
Carey, December 2017

Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication...

Shifting Consumer Expectations in Healthcare - Its an Empowerment Game
MinterEllison, December 2017

How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice...

Ohio Pharmacy Board Releases Guidance on How to Issue a Valid Prescription
Dinsmore & Shohl LLP, December 2017

Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances...

California Medical Staff Reporting Update
Hanson Bridgett LLP, November 2017

Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805...

Long-Term Care Requirements of Participation - Phase 2 Implementation Effective November 28, 2017
Hanson Bridgett LLP, November 2017

The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2...

California Statutes Expanded to Include Peer Review Protections and Requirements for Licensed Midwives
Hanson Bridgett LLP, November 2017

On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California...

Health Law Vitals - A Healthcare Newsletter from Haynes and Boone, November 2017
Haynes and Boone, LLP, November 2017

View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function...

POTUS Trump Looks to Halt CSR Payments
Waller, October 2017

President Donald Trump announced that the federal government will halt payments known as cost share reduction (CSR) payments. The CSR payments amounted to approximately $7 billion this year, and served as a subsidy to enable lower-income Americans to afford health insurance coverage...

Michigan Gets Recommendations for Medical Marijuana Rules, New Advisory Panel Members
Dykema, October 2017

Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month...

 

 

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