An October 16, 2018, article in Bloomberg Law’s Health Law & Business, “Anthem Data-Breach Settlement Sets Tone for Privacy Enforcement”, discussed Anthem, Inc.’s recent $16 million data breach settlement with the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR). The 2015 breach compromised the personal information of about 79 million people. Rivkin

On October 18, 2018, the New York Court of Appeals struck down a $199,000 cap on executive compensation for healthcare executives, saying the State Department of Health exceeded its authority. The Court upheld a related cap on executive compensation for healthcare organizations that receive state funding.  The case is Leading Age New York Inc. v

The Albany Business Review recently held a roundtable event to explore the future of a single-payer system, the rising cost of healthcare and the rapid pace of change in the industry. Rivkin Radler Partner Robert H. Iseman was joined by Barry McNamara, President of employee benefits firm Benetech Inc.; and Kelly K. Smith, Vice President

On October 18, 2018, the Federal Trade Commission (FTC) announced a settlement with a California-based physician and the two companies he controlled. The FTC had alleged that Bryn Jarald Henderson, D.O., and his two companies, Regenerative Medical Group and Telehealth Medical Group, earned at least $3.3 million by offering “stem cell therapy” injections initially costing

As cybersecurity threats increase, the need for healthcare providers to conduct periodic security risk assessments as required by the HIPAA Security Rule has become more critical. To assist providers in this task, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology and Office for Civil Rights

On October 3, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The SUPPORT Act is intended to combat the opioid and heroin crisis by reducing use and supply, encouraging recovery, supporting caregivers and families, and driving innovation and long-term solutions. It also includes the expansion

Garmin International, best known in the U.S. for its GPS navigation units, has announced a collaboration with Fitabase to analyze digital health data from Garmin’s wearable devices, including activity trackers and smartwatches. The alliance puts Garmin in direct competition with Apple and Fitbit, both of which use data from their devices in healthcare research.

Fitabase,

On October 23, 2018, the U.S. Department of Labor, Department of Health and Human Services, and Treasury Department issued a proposed regulation that would expand the usability of health reimbursement arrangements (HRAs). The regulation would allow company employees to use HRAs to cover the cost of individual health insurance coverage, subject to certain conditions. The

On November 16, 2018, Geoffrey R. Kaiser will join the faculty of the Practising Law Institute’s Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries.

Jeff will participate on a panel entitled, “Enforcement Trends Impacting the Drug and Device Industries.” Topics covered will include the False Claims Act, the Anti-Kickback Statute, off-label

A federal district court in Illinois, in United States ex rel. Morgan v. Champion Fitness, Inc. et al., No. 1:13-cv-1593 (C.D. Ill, October 19, 2018), recently considered whether the materiality requirement set forth by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States and Massachusetts, ex rel. Escobar, 136 S. Ct. 1989

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from

Healthcare facilities waiting to hear back on Medicare appeals received good news on November 1, when the U.S. District Court for the District of Columbia ordered the U.S. Department of Health and Human Services (HHS) to eliminate its backlog of 426,594 Medicare appeals by 2022. The order, in American Hospital Association, et al., v. Azar,

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that certain policy changes in the Medicare Physician Fee Schedule relating to the documentation, coding and payment structure of Evaluation and Management office/outpatient visits will now be delayed until 2021. The changes were originally set to go into effect on January 1,

On Oct. 31, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update the payment system for home health agencies and improve access to remote patient monitoring technology. The rule will allow home health providers to build the costs of remote monitoring technology into their Medicare reimbursement beginning Jan. 1, 2020.

On October 29, 2018, the Commissioner of the New Jersey Department of Banking and Insurance issued two bulletins confirming that recent federal changes affecting the Affordable Care Act (ACA) don’t supersede New Jersey state law.

Bulletin No. 18-12, captioned “Short-Term, Limited Duration Insurance,” confirms that short-term, limited-duration health insurance plans, which never comply with New

Two dental care companies are the first entities to be placed on the new High Risk – Heightened Scrutiny list created by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) for providers that pose a significant risk to federal healthcare programs and beneficiaries.  Each of the companies settled with the

The December 31 deadline for certain Medicaid providers and third-party billers to certify as to the effectiveness of their compliance program is fast approaching.

New York State Medicaid providers and third-party billing companies who claim, bill, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program or Managed Medicaid payors

The final 2019 Medicare Physician Fee Schedule released on November 1, 2018 by the Centers for Medicare & Medicaid Services (CMS) includes a section entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.” Effective January 1, 2019, physicians may be reimbursed for certain virtual interactions with patients using several new billing codes.

One new

An article in Bloomberg Law’s Health Law & Business, “Allergy Practice Discloses Patient Info to Reporter, Pays $125,000,” discussed a recent HIPAA settlement arising out of a physician’s disclosure of a patient’s protected health information (PHI) to a television reporter. Rivkin Radler’s Eric Fader was quoted in the article.

The settlement was announced on November 26

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

Allergy Associates of Hartford, P.C. has agreed to pay $125,000 to the Office for Civil Rights as a settlement for HIPAA violations. The physician practice has also agreed to implement a two-year corrective action plan to monitor its HIPAA compliance. The Resolution Agreement is available on the U.S. Department of Health & Human Services’ website.

A December 4 article in Bloomberg Law’s Health Law & Business, “Florida Physicians Group Exposed 9,000 Patients’ Data to Web,” discussed a $500,000 HIPAA settlement entered into by Advanced Care Hospitalists (ACH), a Florida physician group, with the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR). Rivkin Radler’s Eric Fader was quoted

In remarks delivered on November 29 at the American Conference Institute’s 35th International Conference on the Foreign Corrupt Practices Act, Deputy Attorney General Rod J. Rosenstein announced that the U.S. Department of Justice (DOJ) had revised its policy concerning individual accountability in corporate cases. That policy, previously set forth in a September 2015 memorandum issued by

The New York State Office of the Medicaid Inspector General (OMIG) has issued updates to its certification process for applicable Medicaid and Managed Medicaid providers, which may have a significant impact on providers who are required to certify by December 31, 2018.

OMIG has expanded its certification to adopt five separate categories listed on the

Advanced Care Hospitalists, PL (ACH), a Florida physician group, has learned that failing to enter into a proper business associate agreement (BAA) with a vendor can be a very costly mistake. As a result of that failure, ACH has paid a penalty of $500,000 to the U.S. Department of Health and Human Services’ Office for

On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former

On December 4, the Federal Trade Commission (FTC) announced the settlement of a complaint against Nobetes Corporation, which marketed and sold a pill that supposedly treats diabetes. The FTC complaint had alleged that the company made false or unsubstantiated health claims, engaged in illegal billing practices, and used deceptive endorsements in the marketing and sale

A recent study by the Office of the National Coordinator for Health Information Technology revealed that most hospitals were still transmitting at least some patient medical records by mail or fax in 2017. The data showed that industry-wide electronic interoperability remains a distant goal.

According to the study, 66% of the hospitals surveyed sometimes sent

A December 6 article in Managed Healthcare Executive, “Midterm Election Results: 6 Ways Healthcare Could Change in 2019,” discussed how Congress may attempt to address various healthcare issues next year. Rivkin Radler’s Eric Fader was quoted in the article.

Eric pointed out that the recently enacted Know the Lowest Price Act and Patient Right to Know Drug Prices Act will

A January 2 article in Bloomberg Law’s Health Law & Business, “Here’s Why Your Tax Dollars Are Overpaying for Medicaid,” discussed the Medicaid program’s difficulty in recovering inappropriate payments made by states to doctors. A December 11 report by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) said the lack

On December 12, the U.S. Department of Health and Human Services’ Office of Civil Rights (OCR) issued a Request for Information (RFI) seeking public input on how the HIPAA rules, especially the Privacy Rule, could be modified to promote coordinated, value-based healthcare. A January 1 article in Health Law360 entitled “Health Care Policy Moves To

Evan Krinick authored an article, “The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud,” that was published in the New York Law Journal.  The article discusses recent actions taken by U.S. Attorneys in New York against health care providers under the FCA.

A Connecticut state court ruled in December that an obstetrics and gynecology practice must pay a former patient close to $2 million, the latest round in an 11-year saga in which the case was appealed to the state Supreme Court twice. The defendant medical practice was found to have breached the confidentiality of the plaintiff’s

As of January 1, hospitals are now required to post charges for their standard items and procedures online in an effort to increase price transparency. Section 2718(e) of the Public Health Service Act, part of the Affordable Care Act, requires each hospital in the U.S. “for each year [to] establish (and update) and make public

An article in Relias Media’s Healthcare Risk Management, “Outside Counsel Can Be the Right Choice, but Know When,” discussed when and why it might be appropriate for healthcare organizations to use outside counsel. Rivkin Radler’s Jeffrey Rust was quoted extensively in the article.

Jeff noted that it is especially important to retain outside counsel in

Rivkin Radler’s Jeffrey Rust and Eric Fader will be among the presenters at “The Business of Medicine,” a seminar to be held on Saturday, January 26, 2019, at the Convene conference center, 101 Park Avenue (at 41st Street), New York, New York. Neuro Alert Services LLC, a multistate provider of intraoperative neurophysiologic monitoring services, designed

An article in Relias Media’s Healthcare Risk Management newsletter, “FTC Investigations Could Bring Unwanted Scrutiny to Hospitals,” discussed potential investigations of hospitals’ anti-competitive behavior by the Federal Trade Commission.  Rivkin Radler’s Robert H. Iseman was featured prominently in the article.

Bob noted that hospitals and health systems that are considered “must-have” participants in health insurance plans face

On January 15, New York Attorney General Letitia James announced that Diamond Braces, an orthodontic practice with 10 offices in the State of New York, has settled charges that it allowed uncertified employees to perform orthodontic procedures and then improperly billed the Medicaid program for the procedures. The settlement included $4.5 million in restitution for

Walgreens Boots Alliance, Inc., the operator of the Walgreens pharmacy chain, has agreed to pay $269.2 million in two settlements with the U.S. Department of Justice to resolve fraud allegations. The two cases arose from lawsuits filed by whistleblowers under the False Claims Act and were prosecuted federally by the U.S. Attorney’s Office for the Southern

On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as

Inform Diagnostics, a Texas-based pathology laboratory company, will pay the federal government $63.5 million to resolve allegations that the company violated the False Claims Act (FCA). The U.S. Department of Justice announced the settlement on January 30.

Inform Diagnostics was alleged to have engaged in improper financial relationships with physicians, including providing them with subsidies

On January 28, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new mobile app called “What’s Covered” to help consumers understand which items and services are covered by Medicare. The app is part of the eMedicare Initiative, launched in October 2018 to modernize the delivery of information about the program.

On February 6, the U.S. Department of Justice announced that Greenway Health LLC, a Florida-based developer of electronic health records (EHR) software, will pay $57.25 million as part of a False Claims Act settlement. The United States had alleged that Greenway misrepresented the capabilities of its software product, called “Prime Suite,” causing healthcare providers to submit

In an era of online dialogue, healthcare providers still need to remain alert regarding their obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As tempting as it may be to respond to patients’ criticisms and praise online, healthcare providers, as “covered entities” under HIPAA, should think twice before clicking “post.”

It’s

Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants.

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services both recently released proposed rules regulating so-called information blocking, the practice of interfering with the exchange of electronic health information (EHI). Information blocking, a violation of HIPAA, occurs most commonly when a healthcare provider terminates its

Rivkin Radler’s Employee Benefit Plan Review included a summary of a case in which the U.S. Court of Appeals for the Eleventh Circuit held that an anti-assignment provision in a group health benefit plan barred direct reimbursement to an Atlanta dermatologist. The patient had executed an Assignment of Benefits in favor of the physician, a

As of January 2019, following a months-long break in the cases due to judicial transition, at least 70 lawsuits arising from the accidental destruction of human embryos and eggs were pending in Ohio state courts. The cases highlight the complex questions surrounding the legal status of embryos and, by consequence, theories of liability for the

Yesterday’s Rivkin Rounds post discussed the Proposed Rule on information blocking recently released by the Office of the National Coordinator for Health Information Technology (ONC). The Centers for Medicare & Medicaid Services (CMS) simultaneously released its own 251-page Proposed Rule, addressing some of the same concerns but focused on interoperability and patients’ access to their

An article in the March issue of Healthcare Risk Management discussed a Request for Information (RFI) released in December by the U.S. Department of Health and Human Services’ Office of Civil Rights (OCR). The RFI, which seeks public input on how the HIPAA rules may be modified to promote coordinated, value-based healthcare, was previously discussed

A March 1 article in Long Island Business News entitled “Healthcare: The next frontier” discussed the issues raised at a recent roundtable discussion on the current state of the healthcare industry. The panel included Rivkin Radler partners Robert Iseman and Benjamin Malerba; Dr. Zeyad Baker, ProHEALTH Care Associates’ president and CEO; Jeffrey Kraut, executive vice

At the Federation of American Hospitals’ 2019 Public Policy Conference on March 4, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced the agency’s plan to make dramatic changes to the federal physician self-referral prohibition, commonly known as the Stark Law. The changes are designed to support a value-based model of care in

Fitbit and Solera Health announced on March 6 that they have expanded their partnership that seeks to reduce the prevalence of type 2 diabetes. Solera, an integrated benefit network, will make Fitbit devices available to all Solera patients who participate in the National Diabetes Prevention Program (DPP).

In a study, Solera found that its patients

The World Health Organization (WHO) defines social determinants of health (SDOH) as the conditions in which people are born, grow, live, work and age that are primarily responsible for differences in health status. Rivkin Radler’s Robert Iseman recently penned a Thought Leaders’ Corner column for Population Health News in which he made suggestions regarding how healthcare organizations

A three-month joint investigation of electronic health records (EHR) systems has culminated in a release of a March 18 article in Kaiser Health News (KHN) and Fortune Magazine, “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.” The lengthy, meticulously sourced article calls EHR systems “an unholy mess.”

KHN and Fortune have made the

A bipartisan group of U.S. senators is at work on federal “surprise bill” legislation that may be officially proposed within weeks. The proposal will target the common scenario in which an insured individual receives covered healthcare services from an in-network hospital, surgery center, imaging center or laboratory, while an out-of-network healthcare provider also provides non-emergency

A new three-year study at the University of Michigan’s medical center will examine whether data collected on Apple Watch, along with other health information, can be useful in analyzing patients’ health. The MIPACT (Michigan Predictive Activity and Clinical Trajectories) Study has already begun with 1,000 participants, and thousands more patients are expected to enroll over the

New Jersey Governor Phil Murphy announced on March 22 that the state will create its own health insurance exchange for plan year 2021, replacing the federally run healthcare.gov marketplace. Gov. Murphy also gave notice of the change by sending a Declaration of Intent Letter to the federal government’s Center for Consumer Information and Insurance Oversight.

Medtronic PLC self-disclosed last week to the U.S. Food and Drug Administration (FDA) that an unspecified problem in the wireless technology of 19 models of the company’s defibrillators makes them vulnerable to being hacked. The company said it is not aware of any cyberattacks, privacy breaches, or patient harm related to the 750,000 vulnerable devices.

On March 27, the Innovation Center at the Centers for Medicare & Medicaid Services (CMS) announced an artificial intelligence contest. The CMS Artificial Intelligence (AI) Health Outcomes Challenge, in collaboration with the American Academy of Family Physicians and the Laura and John Arnold Foundation, is looking for innovative technology and strategies to predict health outcomes,

New York’s state budget for the 2019-2020 fiscal year, approved by the State Legislature on March 31, included provisions that codify into state law the primary consumer protections of the federal Affordable Care Act. In a public announcement, Gov. Andrew Cuomo said, “We have codified many of the protections of Obamacare, so regardless of what

Researchers at the Ben-Gurion University Cyber Security Research Center in Israel have created malware that could exploit vulnerabilities in MRI and CT scanning equipment to alter patients’ images. The Washington Post discussed the research project in an April 3 article.

In theory, by adding fabricated cancerous nodules to a MRI or CT scan, an attacker

On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety

Rivkin Radler’s Marc Ullman and Steven Shapiro will be addressing the question “What Is the Regulatory Current State of Play With CBD?” on Wednesday, April 10, at the SupplySide East trade show in Secaucus, NJ.  Marc’s article “Regulations Remain Hazy Around CBD Use in Supplements” was recently published in the Spring/Summer 2019 issue of USLAW

On April 5, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-4185-F) that updates the Medicare Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs by promoting innovative plan designs, improved quality, and choices for patients.

The final rule will increase MA plan choices for the 2019

On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements.

Stem-cell therapy involves removing

Amazon announced in a blog post on April 4 that its Alexa voice assistant’s operating environment now complies with HIPAA. Companies that build functions, or skills, for Alexa will now be able to create skills that involve the transmission of users’ protected health information.

The initial group of six participants in an invitation-only program includes

On April 22, U.S. Department of Health and Human Services (HHS) officials announced the introduction of five optional value-based care models for large and small primary care physician practices. The new payment models will incorporate incentives for keeping Medicare patients healthy, as alternatives to traditional fee-for-service payment structures.

Alex Azar, HHS Secretary, and Seema Verma,

An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory

The World Health Organization (WHO) recently issued its first-ever recommendations on how digital health interventions may be used to improve health systems and patient care. Digital communication technologies covered by the report include apps, SMS text messages, and interactive voice response, and may involve the use of mobile devices, tablets, and desktop computers.

The guidance

The U.S. Department of Health and Human Services (HHS) has revised the potential monetary penalties that may be imposed on healthcare providers, health plans and business associates for HIPAA violations. HHS’s notice of enforcement discretion, issued on April 26, reduces the maximum annual penalty for less-severe violations from $1.5 million to as low as $25,000.

The

An April 30 article in Managed Care, “Centene, big in Medicaid managed care, wants to get even bigger,” discussed the business plans of Centene, the largest Medicaid managed care insurer in the U.S.  Rivkin Radler’s Christopher J. Kutner was quoted in the article.

Centene is hoping that its proposed acquisition of WellCare Health Plans will

The U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) recently issued five new FAQs pertaining to software applications that obtain individuals’ electronic protected health information (ePHI). The FAQs describe various scenarios in which HIPAA covered entities may transmit ePHI to apps, including fitness trackers and other wearables.

In short, a covered entity

The New York State Department of Financial Services has filed an amicus brief with the New York Court of Appeals reaffirming its position that a medical professional corporation “is not eligible for reimbursement” under the state’s No-Fault Law “if the provider fails to meet any applicable New York State or local licensing requirement necessary to

Touchstone Medical Imaging has agreed to pay $3 million to settle HIPAA violations after an unsecured computer server exposed the medical records of 300,000 patients on Google in 2014. The U.S. Department of Health and Human Services (HHS) announced the settlement on May 6. Touchstone, based in Franklin, Tennessee, provides diagnostic imaging services in Nebraska,

On May 7, the U.S. Department of Justice (DOJ) introduced important new guidance for government attorneys explaining how DOJ will award credit to defendants who cooperate during a False Claims Act (FCA) investigation through voluntary self-disclosure, remediation (e.g., disciplining wrongdoers or others who failed in oversight, or implementing or improving an effective compliance program) and/or

On May 8, the U.S. Department of Health and Human Services announced a final rule from the Centers for Medicare & Medicaid Services requiring pharmaceutical companies to disclose the list prices of prescription drugs in television advertisements. The rule will apply to all drugs covered by Medicare or Medicaid that cost at least $35 per

On May 10, a new bill was introduced into the New York Senate to expand the state’s medical marijuana program. The overall goal of the bill is to reduce the burdens on patients seeking access to medical marijuana.

The current version of the applicable statute requires that a medical condition be designated as “serious” in

The U.S. Department of Health and Human Services (HHS) announced on May 23 that Medical Informatics Engineering, Incorporated (MIE), an Indiana-based online electronic health records company, had agreed to pay HHS’s Office for Civil Rights (OCR) $100,000 to settle HIPAA violations. MIE’s April 23 Resolution Agreement with HHS also provided for the company to enter

Rivkin Radler’s Eric Fader and Margarita Christoforou edited the “Health Care Privacy and the Health Insurance Portability and Accountability Act of 1996” chapter in the June 2019 edition of the Thomson Reuters Data Security and Privacy Law treatise. Eric has edited this chapter of the treatise since its 2014 edition.

New material in this year’s

On May 28, the Centers for Medicare and Medicaid Services (CMS) issued a final rule to improve and modernize the Programs of All-Inclusive Care for the Elderly (PACE). The rule is the first major change to the program since 2006. CMS expects that the changes will help incorporate current best practices in the care rendered

In a 7-1 decision, the U.S. Supreme Court ruled on June 3 that the Department of Health and Human Services (HHS) may not adjust the rates it pays hospitals for serving low-income patients without first giving them an opportunity to comment on the changes. The Medicare Act requires public notice and a 60-day comment period

More than 40 physicians, clinicians and researchers from Harvard Medical School, Massachusetts General Hospital and other institutions issued a 16-page Statement of Concern to Massachusetts lawmakers requesting that the Commonwealth’s Cannabis Control Commission suspend processing new business licenses and conduct a public health assessment of its “Social Equity Program.” These practitioners are criticizing the inadequacy

On June 6, the Center for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) regarding its Patients over Paperwork Initiative. CMS is seeking public input on ways to reduce administrative and regulatory burdens on healthcare providers, with an overall goal of reducing healthcare costs and increasing the time providers spend with their

The U.S. Department of Justice announced on June 5 that Arizona-based opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle civil and criminal kickback charges. Last month, Insys’s founder and former CEO John Kapoor was found guilty on federal racketeering charges arising out of a bribery scheme that rewarded the company’s sales managers

Three of the largest pharmaceutical companies in the U.S. filed suit on June 14 against the U.S. Department of Health and Human Services (HHS), claiming that HHS doesn’t have the power to compel companies to include list prices of prescription drugs in television advertisements. HHS’s new rule is set to take effect on July 9.

A physician who operated weight-loss clinics in Georgia is facing 33 months in prison after pleading guilty to Conspiracy to Unlawfully Dispense Controlled Substances (Oxycodone), according to a June 13 press release issued by the U.S. Department of Justice. Dr. Johnny Di Blasi was arrested at Miami International Airport as he was attempting to flee

The U.S. Food and Drug Administration (FDA) released a Consumer Update regarding cannabidiol (CBD) on June 14. Observing that CBD “seems to be available almost everywhere,” the FDA noted that the science, safety, and quality of CBD-containing products are unproven and said that it is working to learn more about the safety of CBD.

Unapproved

New York State Attorney General Letitia James announced on June 13 that her office had sent cease-and-desist letters to 44 pharmacies that violated the law requiring them to maintain drug retail price lists. State law requires each pharmacy to maintain a list of prices for the 150 most commonly prescribed drugs, update the list at

The Centers for Medicare & Medicaid Services (CMS) expects to release proposed revisions to the federal physician self-referral prohibition (Stark Law) before Labor Day, according to Kim Brandt, CMS’s principal deputy administrator for operations. Brandt was speaking at an industry conference. Potential Stark Law changes were recently discussed here.

CMS had requested input from the

FiercePharma reports that patients in doctor’s office waiting rooms who use the office Wi-Fi network may now receive targeted pharmaceutical ads on their smartphones. Semcasting, Inc., a Massachusetts-based data provider, uses a technology called Smart Zones that can deliver messages to the entire audience at a business’s IP address.

The digital ad delivery is far

A new federal regulation that would have required companies to disclose wholesale prices of prescription drugs in television advertisements was rejected by a federal court on July 8, one day before the rule would have taken effect. Amgen Inc., Eli Lilly & Co. and Merck & Co. Inc. had filed suit challenging the rule, claiming

A New York anesthesiologist was indicted on July 9 for conspiring with pharmacies and medical equipment suppliers to defraud the Medicare program and other insurers. Anna Steiner, also known as Hanna Wasielewska, allegedly wrote prescriptions for drugs and durable medical equipment for patients supposedly seen via telemedicine without ever having actually examined or evaluated the

With the political battle over the future of the Affordable Care Act (ACA) dragging on in Washington, a number of states have recently taken steps to protect their residents from potential instability in the health insurance market. New Jersey is setting up its own state health insurance exchange to replace the federally run healthcare.gov marketplace,

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently issued new guidance on its HIPAA FAQs webpage regarding permissible use and disclosures of protected health information (PHI) by health plans for purposes of care coordination and continuity of care. Health plans are covered entities under HIPAA.

The guidance explains that,

In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce

On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes.

The HemoCare device was designed by

LabCorp announced on July 22 that it is now offering blood tests directly to consumers online. The clinical lab giant’s “Pixel by LabCorp” platform previously offered self-directed test kits for colorectal cancer and diabetes screening, as well as lipid panels. The service is not currently offered in New York, New Jersey, Maryland or Rhode Island.

Based on a recent audit of payments under New York’s Medicaid program, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) estimated in a report that the state made hundreds of millions of dollars in payments to ineligible or “potentially ineligible” beneficiaries.

The audit examined payments to “non-newly eligible” beneficiaries, meaning

On July 23, companion legislation was introduced in the House and Senate by Senator Kamala Harris of California and New York Congressman Jerrold Nadler to legalize and tax marijuana at the federal level. The tax revenue from this legislation would support job training, substance abuse treatment, literacy programs, and other services for communities that have been

As parents and healthcare providers prepare for the start of the new school year, there are now more than 26,000 students who will need to get vaccinated as New York has eliminated exemptions from vaccinations due to religious beliefs. New York Public Health Law §§ 2164 and 2165 require students to be immunized against diphtheria,

The New York State Department of Health (DOH) recently revised its policy regarding the review and approval process for Certificate of Need (CON) applications for ambulatory surgery centers (ASCs).

The DOH’s current public need criteria favor the approval of new ASCs because they allow patients to obtain safe, low-cost and convenient surgical services outside a

On August 6, health insurer MVP Health Care announced an affiliation with Alliance for Better Health to address so-called social determinants of health in the Albany, New York area. The newly formed independent practice association (IPA), Healthy Alliance Independent Practice Association, is one of the first IPAs in the U.S. to focus exclusively on social

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Fraud Alert on August 13 regarding a genetic testing scam targeting Medicare beneficiaries. The scammers will offer a “free” screening for genetic testing but then submit a claim to Medicare, which will likely deny the claim as medically unnecessary. The

On July 29, the Center for Medicare and Medicaid Services (CMS) released its proposed revisions to the Medicare Physician Fee Schedule for 2020. The Proposed Rule was published in the Federal Register on August 14.

CMS proposed to add three new codes for treatment of opioid use disorder to the list of services that are

The Centers for Medicare & Medicaid Services (CMS) announced on August 15 that health plans offered on health insurance exchanges will be ranked using a five-star quality rating system for the 2020 plan year open enrollment period that begins on November 1, 2019. The ratings will appear on both state-based exchanges and the federal exchange,

A recent study of 51 healthcare providers and 3,003 institutions, published last week on the medRXiv website, revealed widespread noncompliance with HIPAA requirements regarding patients’ right of access to their own medical records. The study was conducted on behalf of Ciitizen Corporation, a medical records storage platform for patients.

The researchers sent record requests to

The Manhattan U.S. Attorney’s Office recently announced that the U.S. Department of Justice has intervened in a whistleblower suit against Life Spine Inc., an Illinois-based manufacturer of spinal implants, devices and equipment. The lawsuit, which seeks damages and civil penalties under the False Claims Act (FCA), claims that Life Spine paid millions of dollars in

On August 16, the New York State Department of Health (DOH) announced the issuance of emergency regulations regarding medical exemptions for school vaccinations. The new regulations went into effect immediately upon their issuance.

Historically, New York State provided two exemptions for state-mandated vaccinations, one for religious considerations and the other for medical reasons. In June

Rivkin Radler’s Eric Fader will be speaking at the American Society of Neurophysiological Monitoring’s Fall Symposium in Boston, September 14-15. The Symposium’s theme is “Improving the Quality of Neuromonitoring Practice” and Eric’s presentation will be entitled “Current Legal Issues in IONM: Minimizing Risks.” Eric is one of the few healthcare attorneys in the U.S. with

The U.S. Department of Health and Human Services (HHS) announced on September 9 that Bayfront Health St. Petersburg (Bayfront), a 480-bed Florida hospital, has paid HHS’s Office for Civil Rights (OCR) $85,000 to settle a potential violation of HIPAA’s right of access provisions. Bayfront’s Resolution Agreement with HHS also provided for the company to enter into a one-year

Mayo Clinic announced a 10-year strategic partnership with Google that aims to “accelerate the pace of health care innovation through digital technologies.” Mayo Clinic intends to use advanced cloud computing, data analytics, machine learning and artificial intelligence (AI) to improve its delivery of care, including, for example, using AI-enabled digital diagnostics to advance virtual care.

As it had done for previous hurricanes, the U.S. Department of Health and Human Services (HHS) recently issued a HIPAA Bulletin providing for a limited waiver of HIPAA sanctions and penalties for covered entities in Puerto Rico, Florida, Georgia, South Carolina and North Carolina in the aftermath of Hurricane Dorian.

Such waivers are primarily intended

On September 5, the Centers for Medicare & Medicaid Services (CMS) announced the issuance of a final rule that will allow the agency to deny or revoke a healthcare provider’s or supplier’s federal program enrollment if it is “affiliated” with another previously revoked organization. The rule had originally been proposed more than three years ago.

Last week, the 11th Circuit Court of Appeals handed down its long-awaited decision in United States v. AseraCare, Inc. The case, brought under the False Claims Act (FCA) and argued way back in March 2017, alleged that AseraCare, a for-profit multi-state hospice chain, had submitted false claims to the Medicare program for patients who were

On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and

The online appointment booking service Zocdoc has received a favorable Advisory Opinion from the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) confirming that Zocdoc’s new per-click or per-booking fee model does not violate the federal Anti-Kickback Statute (AKS). Without AKS concerns, Zocdoc may now allow Medicare, Medicaid, and other federal

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 19-05) involving a proposed transaction with an excluded individual. Healthcare entities and providers must always use caution when contemplating proposed transactions with an individual who is excluded from participating in Medicare, Medicaid or other federally

As Medicare open enrollment approaches, the Centers for Medicare & Medicaid Services (CMS) announced on August 27 the launch of a redesigned Medicare Plan Finder tool. This new tool makes it easier for customers to compare pricing, coverage, and drug plans of Medicare, Medicare Advantage, Medigap, and Part D programs. The Plan Finder tool is

Last week, Pillo Health announced a collaboration with Stanley Black & Decker to assist elderly people and their caregivers. The companies’ Pria “personal medication assistant” (or, alternatively, “smart healthcare companion”) can dispense a week’s worth of pills on a prearranged schedule and also provides alerts, two-way video calling capability, and real-time monitoring via a mobile

The U.S. Department of Justice (DOJ) kicked its healthcare fraud enforcement activities into high gear last week, unveiling charges against hundreds of individuals and companies for paying kickbacks and billing for unnecessary drugs, supplies and tests. The cases, which alleged nearly $1.5 billion in fraudulent claims to Medicare, Medicaid and private insurers, targeted specialty pharmacies,

A recent settlement between a Texas dental practice and the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) demonstrates that healthcare providers must think twice before sharing any information on social media that can be linked to a patient.

OCR investigated Elite Dental Associates of Dallas after receiving a patient complaint

The U.S. Department of Justice (DOJ) recently announced fraud charges against 35 individuals in five federal districts for defrauding Medicare of more than $2.1 billion in medically unnecessary genetic testing. The announcement of the coordinated actions, which involved dozens of telemedicine companies and genetic testing laboratories, eight physicians and two nurse practitioners, was foreshadowed by a Fraud

As part of the U.S. Department of Health and Human Services’ “Regulatory Sprint to Coordinated Care,” the U.S. Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) coordinated their efforts in issuing proposed changes to the federal fraud and abuse laws which prohibit certain patient referrals. The changes are intended

On October 10, the New York State Department of Financial Services released a proposed amendment to the state’s Out-of-Network Law. If approved, the amendment would require insurance companies and healthcare providers to comply with several new requirements to better protect consumers from “surprise” medical bills.

Insurers that receive a claim for services rendered by a

In an October 21 blog post titled “The Future of Medicare Program Integrity,” Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma described a new five-pronged approach to combat waste, fraud, and abuse in the Medicare program. The five “pillars” of the initiative are:

• Stop bad actors. CMS works with the Office of

Steven Shapiro will be a speaker on a webinar offered by the American Herbal Products Association (AHPA) entitled “Compliance with FDA’s Revised Nutrition Labeling Regulations for Herbal Supplements.” Scheduled for October 29 from 1-3 pm, the program will offer an overview of new federal nutrition labeling requirements, which take effect Jan. 1, 2020, for manufacturers

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on October 23 that Jackson Health System (JHS) in Miami has received a civil money penalty of $2,154,000 for violations of HIPAA’s Security and Breach Notification Rules. OCR Director Roger Severino said, “OCR’s investigation revealed a HIPAA compliance program that had

The U.S. Department of Justice (DOJ) announced on October 28 that Sanford Health, a hospital in Sioux Falls, South Dakota, will pay $20.25 million to settle a whistleblower lawsuit alleging violations of the False Claims Act and federal Anti-Kickback Statute. Two surgeons at the hospital filed the suit alleging that the hospital allowed another surgeon

Spinal implant manufacturer Life Spine Inc. and two of its executives have settled their False Claims Act case by agreeing last week to pay the federal government $6 million. As discussed here, the company and executives had been accused of paying kickbacks to surgeons to use the company’s products.

In addition to paying $5.5 million

The Center for Medicare & Medicaid Innovation, part of the Centers for Medicare & Medicaid Services, recently released its Request for Applications for the new “Primary Care First” payment model. The program will now begin in 2021 rather than the 2020 start date that was originally proposed in April, as discussed here. CMS said it

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on November 5 that the University of Rochester Medical Center (URMC) agreed to pay $3 million to settle violations of the HIPAA Privacy and Security Rules. URMC is one of the largest health systems in New York State, with more than

The U.S. Department of Health and Human Services (HHS) recently released a new version of its security risk assessment (SRA) tool that helps smaller healthcare providers conduct and document risk assessments, as required by the HIPAA Security Rule. The update incorporates new features to make the tool more user-friendly.

The SRA tool, available on HHS’s

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on November 7 that it imposed a $1.6 million monetary penalty against the Texas Health and Human Services Commission for violations of the HIPAA Privacy and Security Rules. The Commission operates several health and public need facilities and also administers many

On November 15, the U.S. Department of Health and Human Services (HHS) announced the release of two healthcare price transparency rules. One is a final rule requiring hospitals to make available online all standard charges for items and services, including discounted rates negotiated with third-party payers. The second is a proposed rule that would require

The U.S. Department of Justice (DOJ) announced on November 15 that Sutter Health, a northern California health system, agreed to pay a total of $45.6 million to settle allegations that it violated the Stark Law in submitting claims to Medicare for services. Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio), whose physicians referred patients to Sutter, also

The 11th Circuit Court of Appeals recently reversed a Florida lower court decision that dismissed class action claims under the Florida Deceptive and Unfair Trade Practices Act, the Illinois Consumer Fraud and Deceptive Business Practices Act, and the New York General Business Law alleging that the defendants defrauded the putative class by selling adulterated dietary

On November 25, the U.S. Food and Drug Administration announced the issuance of warning letters to 15 companies that it says are violating the Federal Food, Drug, and Cosmetic Act by selling cannabidiol (CBD) products. The FDA’s views on the recent CBD marketing frenzy have been no secret, as previously discussed here. The FDA also

Eric Fader contributed to Healthcare Risk Management’s HIPAA Regulatory Alert, which appeared in the publication’s December 2019 issue. The Alert outlines the best practices that will help avoid common HIPAA violations. Eric discusses the events that might trigger a regulatory action and the kinds of violations that may affect the severity of the penalties and fines.

The annual December 31st deadline for certain Medicaid providers and third-party billers to certify as to the effectiveness of their compliance program is fast approaching.

New York State Medicaid providers and third-party billing companies who claim, bill, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program or Managed Medicaid

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on November 27 that Sentara Healthcare agreed to pay $2.175 million to settle allegations that it failed to properly report a breach of protected health information. Sentara operates 12 acute care hospitals and provides other types of care at more than

The U.S. Department of Justice’s campaign against genetic testing scams continues and the latest accused lab owner is set to plead guilty. Ravitej Reddy, the owner of Personalized Genetics in Pittsburgh and Med Health Services Management in nearby Monroeville, was charged in November with paying kickbacks in a conspiracy to induce referrals for $127 million

A Florida primary care and pain management practice that calls itself Korunda Medical Institute has paid the federal government $85,000 to settle a violation of HIPAA’s right of access provisions. The U.S. Department of Health and Human Services (HHS) announced the settlement on December 12.

A Korunda patient filed a complaint with HHS’s Office for

Sutter Health, a northern California health system, will pay $575 million to settle allegations that it violated federal antitrust laws. The settlement comes on the heels of Sutter’s recent $45 million settlement of alleged Stark Law violations, as discussed here.

Under the preliminary settlement, which is pending court approval, Sutter will be required to reform

A December 16 report by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) estimated that the Centers for Medicare & Medicaid Services (CMS) made tens of millions of dollars of inflated Medicare electronic health record (EHR) incentive payments over a four-year period. OIG examined a sample of 99 payments made

Rivkin Radler’s Evan Krinick authored an article for the New York Law Journal, “The Broad Reach of the Medicare Fraud Strike Forces.” The article discusses recent strike force actions in New York and New Jersey that targeted a variety of healthcare fraud schemes.

Alabama’s DCH Health System is facing a federal lawsuit filed by some former patients who allege it was negligent in discovering and responding to a ransomware attack on its computer system. In addition to negligence, the complaint accuses DCH of invasion of privacy, breach of contract and breach of fiduciary duty, among other things. The

In an effort to provide further clarity to school administrators, healthcare professionals and families, the U.S. Department of Education and the Office for Civil Rights at the U.S. Department of Health and Human Services recently released updated joint guidance addressing the application of the Family Educational Rights and Privacy Act (FERPA) and the HIPAA Privacy

The U.S. Department of Justice (DOJ) announced last week that in the fiscal year ended September 30, 2019, it obtained more than $3 billion in total recoveries from civil cases brought under the False Claims Act (FCA). The total, a slight increase from the $2.9 billion recovered in the prior fiscal year, included both settlements

The U. S. Department of Justice (DOJ) announced on January 15 that ResMed Corp., a San Diego-based manufacturer of durable medical equipment, will pay $37.5 million to the federal government to settle five qui tam (whistleblower) cases under the False Claims Act (FCA) alleging that ResMed paid kickbacks to DME suppliers, sleep labs and other

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) approved a proposed arrangement whereby a hospital would offer discounted training to employees of one of the hospital’s referral sources, a local fire department.

The hospital is part of a non-profit health system that offers clinical training

New Jersey Governor Phil Murphy recently signed into law a package of nine bills that will preserve for state residents many of the provisions of the Affordable Care Act (ACA) even if the ACA itself is ultimately found unconstitutional. The new laws continue a trend among Democratic states that was previously discussed on Rivkin Rounds

New York Gov. Andrew Cuomo’s 2020 State of the State Agenda includes a proposal entitled “strengthening the oversight of physicians and other medical professionals to protect patients.” The proposal includes reforms to the procedures of the state Department of Health’s Office of Professional Medical Conduct (OPMC).

The most controversial portion of the proposal would allow

On January 31, a federal court in Massachusetts dismissed a lawsuit brought by the National Federation of the Blind (NFB) against Epic Systems Inc., that claimed that Epic’s electronic health records (EHR) software discriminates against blind hospital employees. The NFB had sued Epic on behalf of NFB members who allegedly suffered adverse employment actions because

In response to a recent federal court decision, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has modified its guidance regarding certain obligations imposed on covered entities when responding to individuals’ requests to send their protected health information (PHI) to third parties. In short, covered entities are no longer required

The U.S. Department of Health and Human Services (HHS) recently issued a Bulletin confirming that healthcare entities’ HIPAA obligations continue to apply even in public health emergencies. The February 2020 “HIPAA Privacy and Novel Coronavirus” Bulletin reminds HIPAA covered entities and their business associates that HIPAA Privacy Rule and Security Rule requirements remain in place

The HIPAA Breach Notification Rule requires that smaller data breaches – those involving fewer than 500 patient records – must be reported to the U.S. Department of Health and Human Services (HHS) no later than 60 days after the end of the calendar year in which the breach occurred. This year, the reporting deadline is

A recent article in Part B News, “Court throws out fee policies for medical record sharing; watch for new rules,” discussed the recent court decision in Ciox Health, LLC v. Alez Azar, et al., which led to the U.S. Department of Health and Human Services modifying its guidance regarding charging fees for access to patient

A recent article in HIPAA Journal, “Ransomware Attacks Have Cost the Healthcare Industry at Least $157 Million Since 2016,” discussed a new study by Comparitech that examined ransomware attacks on the healthcare industry. In the past three years, at least 172 ransomware attacks on healthcare entities in the U.S. have affected 1,446 facilities, providers and

On February 25, the American Medical Association (AMA) announced the release of its new Patient Records Electronic Access Playbook. The 100-page guide is intended to help physician practices navigate the legal and practical requirements of providing patients with access to their electronic health information.

The Playbook discusses relevant provisions of HIPAA and points out many

An article in the March issue of Healthcare Risk Management, “Develop Plan for Responding to Adverse Events,” discussed the importance of hospitals preparing in advance for how to respond to an unexpected death, serious accident or possible malpractice. Rivkin Radler’s David Richman was quoted in the article. To read it, click here.

On March 2, New York Gov. Andrew Cuomo announced new regulations on New York health insurers regarding coverage for coronavirus testing and related matters. The State Department of Financial Services (DFS) directive requires insurers to waive cost sharing for COVID-19 testing at emergency room, urgent care and office visits. In addition, Medicaid patients will not

The “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020,” signed into law by the President on March 6, includes provisions waiving Medicare’s geographic restrictions on telehealth during a public health emergency. This will enable healthcare providers to provide care via telehealth in urban and rural areas as well as in patients’ homes within the “emergency

Rivkin Radler’s Evan Krinick authored a March 6 article in the New York Law Journal, “Second Circuit Cases May Affect Insurers’ Ability To Fight No-Fault Fraud,” that discussed two pending cases relating to New York no-fault insurance carriers. Both cases involve a healthcare provider that filed hundreds of new arbitration proceedings or collection lawsuits against

The Cannabis Regulation and Taxation Act proposed by New York Gov. Andrew Cuomo, and the Marijuana Regulation and Taxation Act under consideration by the State Legislature, would mandate social and economic equity programs as part of legalizing adult-use marijuana in New York, to ensure that communities that have been disparately impacted by the “War on

Over the past week, the Centers for Medicare & Medicaid Services (CMS) has issued a flurry of guidance documents and FAQs regarding COVID-19 for healthcare providers in private practice, hospitals, nursing homes, hospices and dialysis facilities, and for Medicare Advantage and Part D insurance plans. The guidance includes how to bill and collect for coronavirus

The Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) have finalized two highly anticipated rules that are intended to give patients “unprecedented safe, secure access to their health data.”

ONC will establish a certification process for application programming interfaces (APIs) that will meet certain interoperability

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by making deceptive or scientifically unsupported claims about their ability to treat Coronavirus (COVID-19). The companies targeted, (1) Vital Silver, (2) Quinessence

As it has previously done for specific geographic areas affected by hurricanes, on March 15, the U.S. Department of Health and Human Services (HHS) issued a HIPAA Bulletin providing for a limited waiver of HIPAA sanctions and penalties for covered entities during the current COVID-19 (coronavirus) public health emergency.

Such waiver is primarily intended to

The Centers for Medicare & Medicaid Services (CMS) has created a “Current Emergencies” page on its website that compiles links to the agency’s recent press releases and guidance regarding coronavirus in one place. CMS has already issued more than 30 press releases and guidance documents in March alone and there are too many to summarize,

In an effort to limit the spread of the COVID-19 (coronavirus) outbreak, the Centers for Medicare & Medicaid Services (CMS) on March 17 announced the expansion of Medicare coverage for telehealth nationwide, effective immediately. CMS will temporarily pay clinicians to provide telehealth services for Medicare beneficiaries residing anywhere in the U.S. so that those who

In response to the COVID-19 public health emergency, on March 16 New York City Mayor Bill de Blasio signed an Emergency Executive Order ordering the closing of restaurants, bars, gyms, and entertainment venues, and suspending numerous regulations and laws that require public meetings and hearings within the City. The Order also includes a direction to

On March 17, the New York State Department of Financial Services (DFS) announced the issuance of a new emergency regulation requiring insurance companies in the state to waive cost-sharing, including deductibles, copayments, and coinsurance, for in-network telehealth visits, whether or not related to coronavirus. The new regulation will “encourage New Yorkers to seek medical attention

In order to ensure the safety and health of its workforce and regulated industry, on March 18, the U.S. Food and Drug Administration (FDA) announced that it was suspending routine domestic facility inspections in order to limit potential exposure to COVID-19 for investigators and workers at facilities. FDA had previously announced that it was suspending

Responding to the Coronavirus public health emergency, the Secretary of Health and Human Services (HHS) has waived certain requirements of the Medicare, Medicaid and Children’s Health Insurance Program (CHIP), including requirements relating to the Stark Self-Referral Law (“Stark”), the HIPAA privacy regulations and the Emergency Medical Treatment and Labor Act (EMTALA). This action was taken

New York Gov. Andrew Cuomo has issued a number of Executive Orders aimed at temporarily facilitating the ability of healthcare professionals to practice in New York State and aid hospitals in the care and treatment of coronavirus patients. Gov. Cuomo has also been directly soliciting healthcare professionals from all forms of practice to supplement hospital

Rivkin Radler has launched a Coronavirus Resource Center on the firm’s website. All of the firm’s COVID-19-related articles and blog posts, across our many practice groups, are now compiled in one place for easy reference. We’ll continue adding to the Resource Center as the pandemic continues.

The Centers for Medicare & Medicaid Services (CMS) has released an updated edition of its Medicare Learning Network Telehealth Services booklet. The publication, targeted at Medicare fee-for-service providers, outlines Medicare’s telehealth reimbursement policies for 2020. There is also a short summary of the expanded telehealth benefits available to Medicare beneficiaries during the current COVID-19 outbreak,

On March 22, the U.S. Department of Justice (DOJ) announced its first action against COVID-19 fraudsters: a civil complaint seeking an injunction ordering the website coronavirusmedicalkit.com to shut down while an investigation into the site’s operators continues. A more detailed discussion of the DOJ’s action may be found here.

Amidst concerns over the rapid spread of COVID-19, on March 24, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Policy and Response Frank Yiannas issued a statement advising Americans that “there is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19.” Yiannas noted

Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by the Senate on March 25 relate to laboratory diagnostic testing for the COVID-19 virus.

Within Division A of the CARES Act, titled “Keeping Workers Paid and Employed, Health Care System Enhancements, and Economic Stabilization,” there are four sections

On March 27, New York Gov. Andrew Cuomo issued an order requiring all “non-essential” construction in the State to shut down, with the exception of (i) emergency projects necessary to protect the health and safety of building occupants; and (ii) projects that would be unsafe to shut down when incomplete, which may continue until they

The Families First Coronavirus Response Act (FFCRA), signed into law on March 18, provides for the right to two different types of leave: “public health emergency leave” under a section of the FFCRA called the Emergency Family and Medical Leave Expansion Act, and paid sick time under a section of the FFCRA called the Emergency

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, made some substantial changes to the confidentiality rules for substance abuse and mental health records to bring them in line with HIPAA confidentiality rules. Among the changes, a covered entity or business associate may now use or disclose substance

Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) will help people with substance use disorders and the healthcare professionals who care for them. The Substance Abuse and Mental Health Services Administration will receive $425 million to address mental health and substance use disorder needs as a result of

On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response. This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA agency

On March 30, the Secretary of the U.S. Department of Health and Human Services issued blanket waivers of certain requirements of the federal physician self-referral law (Stark Law), retroactive to March 1, in response to the COVID-19 crisis. A detailed discussion of the waivers may be found here.

New York Gov. Andrew Cuomo issued an executive order on March 23 expanding resources to healthcare workers. The goal is to meet the treatment demands of coronavirus patients and, most significantly, provide healthcare providers with protection against lawsuits for medical malpractice and other potential liability. Executive Order 202.10 grants immunity to all physicians, physician assistants,

As healthcare providers continue to fight the coronavirus outbreak, many practices are suffering major disruptions due to the cancellation of elective surgeries and office visits, among other things. In an effort to lessen the financial hardships facing these providers, on March 28 the Centers for Medicare & Medicaid Services (CMS) announced an expansion of its

On April 3, the U.S. Food and Drug Administration (FDA) posted a notice that it has created a special email address in order to assist importers who are experiencing delays bringing COVID-19-related supplies into the U.S. According to the notice, the primary reason for the delays is confusion relating to the difference between personal and commercial

On April 6, Rivkin Radler’s Robert Iseman presented a COVID-19 Business Briefing on the Paycheck Protection Program that was created under the Coronavirus Aid, Relief and Economic Security Act (CARES Act). Administered by the U.S. Small Business Administration, the Paycheck Protection Program will make up to $349 billion in loans available to small businesses that

On April 6, Rivkin Radler’s Eric Fader presented a COVID-19 Business Briefing on Telehealth. The Briefing covered recent developments in federal and state law and policy, and changes in private insurers’ policies, that have been aimed at encouraging the use of telehealth during the current public health emergency.

This Business Briefing was the second in

An article in the April issue of Healthcare Risk Management, “Surgeon Sues Health System for ‘Forced Referrals’,” discussed a whistleblower lawsuit filed against a Florida health system. Rivkin Radler’s Geoffrey Kaiser was quoted in the article.

Jeff pointed out that if a surgeon is an employee of a health system, requiring him to refer his

In the latest installment of Rivkin Radler’s COVID-19 Business Briefing Series, held on April 14, Geoffrey Kaiser and Ada Kozicz presented on the recent issuance by the U.S. Department of Health and Human Services (HHS) of blanket Stark Law waivers for certain types of business arrangements, intended to help address the current health emergency. On

An April 15 article in Law360, “Tenn. Hospital Bankruptcy May Be the First of Many,” discusses the impact of the coronavirus pandemic on the financial well-being of U.S. hospitals and health systems. Rivkin Radler’s James Lagios, Robert Iseman and Stuart Gordon collaborated on the article.

The article points out that in recent years, U.S. hospitals

An April 13 article in Part B News, “Seeking a lifeline: COVID-19 loans, advance payments on offer, but watch terms,” discussed programs under which healthcare providers can seek financial assistance during the COVID-19 pandemic, including Medicare’s Accelerated and Advance Payment Program and the U.S. Small Business Association’s Paycheck Protection Program (PPP). Rivkin Radler’s Robert Iseman

On April 7, the Centers for Medicare & Medicaid Services announced that it had paid out over $34 billion under the Medicare Accelerated and Advance Payment Program to healthcare providers affected by the coronavirus public health emergency. Two days later, the figure had grown to $51 billion.

CMS announced an expansion of the program on

On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by Dr. Staley

Two recent decisions of the Department of Health and Human Services Office for Civil Rights (OCR) illustrate that age and disability status cannot be used as blanket criteria for denying access to health care services, even during a pandemic. This should serve as a warning to healthcare providers about the risks in making triage decisions

After a teaser on Twitter and a verbal preview during a press conference, President Trump has signed an executive order preventing certain foreign nationals from receiving an immigrant visa for the next 60 days. The purpose of the order is protecting United States workers from competition from foreign workers. In reality, however, the order will

Although Executive Order 202.10 gave health care providers some immunity for COVID-19 related care, this immunity does not extend to actions by the Justice Center for the Protection of People with Special Needs (“Justice Center”). A provider or facility could be prosecuted for allegations of abuse or neglect by the Justice Center for actions taken during this

The New York State Department of Health has issued a General Information System (GIS) message clarifying the impact of COVID-19 related payments on Medicaid eligibility determinations.

The GIS confirms that pursuant to sections 2104 and 2201 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 certain pandemic-related payments will not impact Medicaid

In 1969, noted economist Milton Friedman coined the term “helicopter money” to describe the monetary policy of injecting liquidity into the market, much like dropping money to people from helicopters, as an alternative to quantitative easing. The CARES Act, popularly referred to as the Provider Relief Fund is a “helicopter” that dropped a lot of

On April 26, the Centers for Medicare and Medicaid Services (CMS) announced that it will no longer accept new applications from physician practices, medical equipment suppliers, and other providers for its Advance Payment Program. CMS will continue to accept applications from hospitals for loans under its Accelerated Payment Program but will be reevaluating the amounts

On April 27, the U.S. Supreme Court ruled in favor of commercial health insurers that were seeking $12 billion under the Affordable Care Act’s risk corridor program, acknowledging that the ACA “obligated the government to pay the full amount of risk corridor payments.”

The ACA established the risk corridor program to mitigate the risks assumed

On April 24, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published responses to certain frequently asked questions and further explained its application of administrative enforcement authorities to arrangements directly connected to the COVID-19 pandemic.

OIG stated that it is accepting inquiries regarding application of its administrative

On April 30, the Centers for Medicare & Medicaid Services (CMS) announced numerous regulatory waivers and rule changes to, among other things, expand Medicare beneficiaries’ access to coronavirus testing and telehealth services. CMS also made changes to address financial concerns that had been raised by many accountable care organizations (ACOs).

The changes included adding behavioral

Rivkin Radler’s Geoffrey R. Kaiser authored an article for Law360 entitled “False Claims Act, Medical Necessity and Government Regulation of Medicine.” The full article can be found here.

In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the form of certain suspended or waived requirements applicable to facilities licensed by the Office of People with Development Disabilities (OPWDD).

By several

A May 15 article in Law360, “What to Watch as COVID-19 Cash Crunch Fuels Hospital M&A,” discussed the wave of hospital mergers due to the coronavirus pandemic and its financial impact on healthcare facilities. The article also addressed possible antitrust enforcement actions against hospitals that must merge to remain financially viable. Rivkin Radler’s Robert Iseman