November 18, 2019 | Blog | By Brian Dunphy, Rachel Yount
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. Perhaps most importantly, CMS broadened the list of Covered Recipients. Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions. CMS also consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs. Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
CMS Ignores the Courts: 2020 Hospital Outpatient Prospective Payment System Final Rule Includes 340B Rate Cuts Already Ruled Unlawful
November 14, 2019 | Blog | By Ellyn Sternfield, Daryl Berke
The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, which finalizes a proposed reduction in Medicare Part B reimbursement for certain drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B drug discount program. Through the final rule, CMS purports to continue Medicare reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. That ruling, and a Court-imposed stay of the cuts, are the subject of a just-argued appeal. For a detailed walk-through of the litigation up to this point, please see our prior blog post.
HHS Proposes Sweeping Changes to AKS and Stark Law, Part 4: Modifications to Key Stark Law Terminology and a New Stark Law Exception
November 13, 2019 | Blog | By Karen Lovitch, Rachel Yount, Matt Mora
This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the Department of Health & Human Services (HHS). The proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) offers new and revised definitions on key Stark Law terms, some of which CMS has previously neglected to define or provide significant guidance. In addition, CMS proposes a new Stark Law exception for limited remuneration to a physician, which offers health care entities more flexibility for unwritten, short-term compensation arrangements with physicians.
November 12, 2019 | Blog | By Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd
As the Legislature approaches the Holiday recess, health care costs and access continue to be at the forefront of the agenda. The Baker Administration released the VALUE Act on October 18th and the Senate filed the PACT Act on November 7th.
November 7, 2019 | Blog | By Michelle Caton, Elizabeth Conti
Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In response to that crisis (and at Congress’s urging), the FDA formed the interagency Drug Shortages Task Force (Task Force) to study the issue. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the consequence of economic factors driven by private and public business practices. Those practices, according to the report, disrupt the supply chain availability of marketed pharmaceuticals. The report offers recommendations to provide a framework for stakeholders to address the underlying economic factors leading to drug shortages.
October 31, 2019 | Blog | By Kristen Marotta, Joanne Hawana
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an extensive application and review by the resident state. Failure to secure appropriate licensing before shipping these kinds of products in interstate commerce can lead to a variety of unwanted scrutiny and negative effects. For instance, the Washington Department of Health has recently been investigating a complaint alleging that Sun Pharmaceuticals distributed medicine samples without the proper license.
The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further Regulatory Pressure
October 25, 2019 | Blog | By Joanne Hawana, Benjamin Zegarelli
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA) announcement on October 24, 2019 likely came as no surprise. But to stakeholders in this industry, it was certainly unwelcome news and may portend a coming wave of unapproved drug enforcement actions by the FDA.
HHS Proposes Sweeping Changes to AKS and Stark Law, Part 3: Personal Services and Management Contracts, Outcomes-Based Payments, and Warranties
October 23, 2019 | Blog | By Karen Lovitch, Theresa Carnegie, Rachel Yount
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Below is an in-depth summary of the Office of Inspector General’s (OIG) proposed modifications to the safe harbors for personal services and management contracts, which includes a proposed new provision protecting outcomes-based payments. We also cover the OIG’s proposed modifications to the warranties safe harbor.
HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records
October 21, 2019 | Blog | By Karen Lovitch, Dianne Bourque, Theresa Carnegie, Rachel Yount
On October 17, 2019, the Department of Health & Human Services published two proposed rules that, if finalized, would implement significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This post is the latest installment in our blog series covering these proposed rules.
October 15, 2019 | Blog | By Theresa Carnegie, Matt Mora, Michelle Caton
As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if finalized, would implement sweeping changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). The proposed rules seek to reduce barriers to value-based contracting in several ways, including: (1) creating new safe harbors to the AKS; (2) adding new exceptions to the Stark Law; and (3) retooling existing AKS safe harbors, along with the Civil Monetary Penalties rules regarding beneficiary inducements. Below are key takeaways from both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
October 14, 2019 | Blog | By Nili Yolin
Last week, the New York State Department of Financial Services released a proposed amendment to the regulations promulgated under the State’s Emergency Medical Services and Surprise Bills law (the SBL), which adds additional notice requirements for insurers and out of network (OON) providers.
October 10, 2019 | Blog | By Karen Lovitch, Theresa Carnegie, Rachel Yount
On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued by the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which aims to promote value-based care and ease regulatory burden on health care providers, particularly with respect to the AKS and the Stark Law.
October 9, 2019 | Blog | By Benjamin Zegarelli
On September 26, 2019, FDA released a six revised digital health guidances. The primary objective of these revisions was to bring the guidances into alignment with the software function exemptions described in Section 3060 of the 21st Century Cures Act (the “Cures Act”). The medical device community has anticipated these changes since Congress passed the Cures Act almost three years ago in December 2016.
September 30, 2019 | Blog | By Elizabeth Conti
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the authority to compel drug manufacturers from disclosing drug prices in direct-to-consumers television advertisements (DTC rule). On September 23, 2019, HHS filed its appeal in the D.C. Circuit against plaintiffs Merck & Co., Eli Lilly and Co., and Amgen Inc. The brief argues that the district court erred in holding that HHS lacks the statutory authority through the Social Security Act (SSA) to force the DTC rule upon drug manufacturers because they are not direct participants in the Medicare and Medicaid programs.
September 27, 2019 | Blog | By Eli Greenspan
Congress has just days to pass a continuing resolution to avoid a government shutdown and extend a number of key public health programs. Meanwhile, policymakers are holding hearings and considering a series of drug pricing proposals around negotiation within Medicare and other policies. We cover this and more in this week's preview, which you can find by clicking here.
Third Circuit Says the FCA Does Not Guarantee A Hearing When DOJ Seeks to Dismiss Declined FCA Cases
September 24, 2019 | Blog | By Nicole Henry
The Court of Appeals for the Third Circuit recently weighed in on a relator’s right to a hearing where the government moves to dismiss a declined qui tam case, holding that the False Claims Act (FCA) does not guarantee a relator an in-person hearing before their declined FCA cases may be dismissed.
Compounding Pharmacy and Private Equity Firm Owner Agree to $21 Million Settlement to Resolve FCA Allegations
September 20, 2019 | Blog | By Xavier Hardy, Karen Lovitch
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden Inc. (RLH), and two PCA executives to resolve a pending False Claims Act (FCA) case. As discussed in a previous post regarding DOJ's decision to intervene, this case is notable because a private equity firm does not typically find itself subject to FCA action, and it is reported to be the first case against a private equity firm in which DOJ has chosen to intervene.
September 18, 2019 | Blog | By Kristen Marotta
Employers and retail giants alike are increasingly inserting mental health into the broader, public conversation around individual healthcare and employee benefits. Various U.S. employers are rolling out employee-based benefit programs to improve employees’ mental health and overall well-being.
September 17, 2019 | Blog | By Joanne Hawana
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials, according to the General Accountability Office (GAO). Of those 23 company policies, GAO reports that nineteen of them stated that the manufacturer would consider individual requests for expanded access to their drug candidates, while the remaining four companies stated that such requests would not be considered at the present time. Moreover, approximately half of those companies who would be open to meeting a patient’s request for expanded access also noted expressly in their policies that additional procedures would need to be followed, including review of the request by the Food and Drug Administration (FDA) and an institutional review board (IRB). The GAO study – released on September 9, 2019 – was conducted in response to a congressional mandate (included in the FDA Reauthorization Act of 2017) for the investigative body GAO to review the agency’s actions to facilitate patient access to investigational drugs.
September 16, 2019 | Blog | By Eli Greenspan, Alexander Hecht
This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November. This will give policymakers and appropriators enough time to hash out differences in funding priorities as well as work on policies addressing drug pricing, surprise billing, and funding for public health programs. The surprise billing issue is really heating up with outside stakeholder groups weighing in and Congress carefully considering its next steps. We cover this and more in this week's preview, which you can find by clicking here.
Explore Other Viewpoints:
- Arbitration, Mediation & Alternate Dispute Resolution
- Bankruptcy & Restructuring
- Class Action
- Complex Commercial Litigation
- Consumer Product Safety
- Debt Financing
- EB-5 Financing
- Education & Nonprofits
- Employment, Labor & Benefits
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Products Liability & Complex Tort
- Project Development & Finance
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations