John Wyand

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Healthcare Entities Must Still Comply with 2023 Privacy Laws

As we head into the fourth quarter, US businesses need to assess their progress in preparing for sweeping changes to the California Consumer Privacy Act (“CCPA”) that become effective January 1, 2023, and with compliance with four new state consumer privacy laws (in Colorado, Connecticut, Utah and Virginia) that become effective throughout 2023 (collectively, “2023 … Continue Reading

Biden Administration 60-day Regulatory Freeze

On Wednesday, January 20, 2021, President Biden’s chief of staff, Ronald A. Klain, circulated a memorandum (memo) to the heads of federal executive departments and agencies outlining an Executive Action implementing a 60-day freeze on any new or pending regulations. This is a customary practice for new administrations. The freeze allows the administration to conduct … Continue Reading

Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues

On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her … Continue Reading

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, … Continue Reading

USDA’s Hemp Production Program Advances

On January 29, 2020, the comment period closed for the United States Department of Agriculture (USDA) interim final rule, published on October 31, 2019, to establish the Domestic Hemp Production Program. The comment period, which the USDA extended by 30 days, received over 4,000 comments from interested parties, including states, tribal governments, and hemp industry … Continue Reading

Major Milestone for Hemp Production: USDA Issues Interim Final Rule

On October 31, the US Department of Agriculture (USDA) published an interim final rule to establish the Domestic Hemp Production Program. This program, as required by the 2018 Farm Bill, attempts to clarify the regulatory framework for individuals hoping to capitalize on the production and sale of domestic hemp. The interim final rule requires states … Continue Reading

Court Sides with Hospitals on CMS Site Neutral Payment Rule for Hospital Outpatient Departments

In a ruling on September 17, 2019 by Judge Rosemary M. Collyer, the U.S. District Court for the District of Columbia vacated portions of a 2018 Centers for Medicare & Medicaid Services (CMS) rule that reduced Medicare payments for clinic-visit services at off-campus hospital outpatient departments (HOPDs). By rulemaking, on January 1, 2019, CMS instituted … Continue Reading

Medical Imaging Company Pays $3 Million Data Security Fine

A medical imaging company is paying for its flawed data security system. In addition to its system failures, the company failed to investigate and respond properly when alerted to problems by the FBI. As a result, the Office of Civil Rights imposed a $3 million penalty and required a corrective action plan. This yet another … Continue Reading

HHS Proposes Changes to the Discount Safe Harbor Framework to Realign Incentives and Put Downward Pressure on Drug Prices

On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication … Continue Reading

CMS Proposes to Lower Drug Prices and Reduce Out-of-Pocket Drug Spending with Respect to Medicare Coverage

On Friday, November 30, 2018, the US Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) to revise Medicare Part D (Part D) and Medicare Advantage (MA) regulations to promote health plan negotiation of lower drug prices and to reduce out-of-pocket spending for enrollees. The Proposed Rule contains four areas of … Continue Reading

Federal Court Held HHS Lacks the Authority to Impose Dramatic 340B Reimbursement Rate Reduction

On December 27, 2018, the provider community scored a major victory when the U.S. District Court for the District of Columbia held that the Medicare statute did not authorize the Department of Health and Human Services (“HHS”) to impose a nearly 30% reduction in 340B Reimbursement rates. The legal implications of this decision may be … Continue Reading

Justice Department Allots Additional US$70 Million to Battle Opioid Crisis

In tandem with President Trump’s signing of H.R. 6, (now former) US Attorney General Jeff Sessions announced new Department of Justice (DOJ) funding awards aimed at curbing drug trafficking and supporting youth impacted by America’s opioid epidemic. At DOJ’s first-ever National Opioid Summit, Sessions and Deputy Attorney General Rod Rosenstein highlighted sustained federal law enforcement efforts … Continue Reading

Congress' Extensive Opioid Legislation Becomes Law

On Wednesday, October 24, President Trump signed the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) into law. The bill signing occurred three weeks following Congress’ overwhelming approval of the measure, and nearly one year since the Trump Administration deemed America’s opioid crisis a federal … Continue Reading

Senate Overwhelmingly Clears Bipartisan Opioid Package

Nearly three months following House passage of a legislative proposal related to America’s opioid epidemic, the Senate overwhelmingly cleared its own comprehensive, bipartisan package to address the crisis. On Monday, September 17, senators replaced the House-passed text with a substitute amendment and approved The Opioid Crisis Response Act of 2018 (H.R. 6) by a vote … Continue Reading

FCC COMMENCES INQUIRY ON ESTABLISHING $100-MILLION TELEHEALTH PILOT PROGRAM

FCC COMMENCES INQUIRY ON ESTABLISHING $100M TELEHEALTH PILOT PROGRAM On August 2, 2018, The Federal Communications Commission has unanimously approved a Notice of Inquiry (“NOI”) to establish a $100-million  telehealth pilot program. FCC seeks to identify how the agency can “help advance and support the movement in telehealth towards connected care everywhere and improve access … Continue Reading

House Panel Examines 340B Legislative Reforms

On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading

DOL Issues Final Rule Expanding Access to Association Health Plans

On June 21, 2018, the US Department of Labor (DOL or the Department) published its final rule, amending the definition of “employer” under section 3(5) of the Employee Retirement Income Security Act (ERISA) to allow for the establishment of group or association health plans (AHPs) (Final Rule). Similar to a corresponding proposed rule issued earlier … Continue Reading

Squire Patton Boggs Attorneys Publish Practical Law Practice Note on State Legalized Marijuana Businesses and Access to the Bankruptcy Code

The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading

PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC

PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC Majority Of Federal Communications Commission (FCC) Supports 40%+ Annual Increase In Rural Health Care Program Funding – Following on a proposal to review annual funding for the FCC’s Rural Health Care Program (RHCP), which currently provides $400 million in annual subsidies for telecommunications … Continue Reading

Right to Try Investigational Drugs Signed Into Law

Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading

House Energy and Commerce Committee Clears Opioid-Related Measures

On Thursday, May 17, the House Energy and Commerce Committee (E&C) cleared 32 additional opioid-related measures during its second markup on the issue. In total, E&C has now advanced 57 bills to combat the opioid overdose crisis. While most measures were easily approved on a bipartisan basis, committee members disagreed over a number of bills … Continue Reading

The New Federal Blueprint to Lower Drug Prices

On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges: Excessively high drug prices Seniors and government programs overpaying for drugs High out-of-pocket costs for consumers Lack of transparency in drug pricing Free-riding by … Continue Reading

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29 The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as … Continue Reading
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