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Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.…

CMS Announces Pilot Program for Clinicians to View Claims Data of Medicare Beneficiaries

On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced “Data at the Point of Care” (DPC), a pilot program that will provide clinicians with access to claims data. The pilot program follows on the heels of the recently proposed Interoperability and Patient Access Proposed Rule, which would require regulated health plans to make patient data available through an application programming interface (API). These actions are also part of the MyHealthEData initiative spearheaded by the White House Office of American Innovation.…

Eighth Circuit Affirms Preliminary Injunction Blocking Physician Practice Acquisition in North Dakota

On June 13, 2019, the U.S. Court of Appeals for the Eighth Circuit affirmed a preliminary injunction granted to the Federal Trade Commission (FTC) and North Dakota Attorney General (NDAG) blocking the proposed acquisition of Mid-Dakota Clinic, P.C. (MDC) – a multispecialty physician group in North Dakota – by Sanford Health, a large South Dakota-based health system (Sanford). This decision may foreclose continued pursuit of MDC by Sanford, and represents another success for the FTC in challenging health care consolidation (see our previous analysis of the granting of the injunction …

OIG Issues Alert to Warn of ‘Free’ Genetic Testing Scams Seeking to Steal Information

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and then using the stolen information for purposes of fraudulent billing and/or identity theft.…

OCR Issues Fact Sheet Listing Circumstances in which Business Associates May Face Direct Liability for HIPAA Violations

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct Liability of Business Associates under the Health Insurance Portability and Accountability Act (HIPAA).

The Fact Sheet provides an important reminder to covered entities, business associates, and their counselors regarding the circumstances in which OCR may – and may not – take enforcement actions directly against business associates for …

CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug Benefit Program

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare Advantage and Part D drug programs.

The major provisions are:

  1. Protected classes. The final rule contains an exception to the requirement that Part D sponsors include all Part D drugs in these protected classes

OCR Issues Five New HIPAA FAQs on Health Information Apps

On April 18, 2019, the Department of Health & Human Services Office for Civil Rights (OCR) issued five new FAQs addressing the applicability of HIPAA to the use of software applications (apps) by individuals to receive health information from their providers.

The new FAQs are available here under the Header “Access Right, Apps and APIs.”

In the FAQs, OCR:

  • Emphasizes that an individual’s right to access her/his protected health information (“PHI” or “ePHI”) under HIPAA generally obligates a covered entity to send PHI to a designated app, even if the

Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements

The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems (EHRs). The respective settlements enable recovery by DOJ of over $100 million, and immediately precede the government’s recent proposal of new rules to promote the interoperability of EHRs. The settlements thus serve as an important reminder of the importance of adhering to federal fraud and abuse laws and regulations as hospitals and other health care providers continue to implement EHR …

OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care

On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) with the goals of removing “regulatory obstacles” and decreasing “regulatory burdens” in furtherance of the health care industry’s transition to value-based care models.

In the RFI, OCR requests input on whether and how the HIPAA regulations (i) can be modified to remove regulatory obstacles and burdens to efficient care coordination and …

Advanced Care Hospitalists Settles with OCR for $500,000  for Alleged HIPAA Violations

The Office for Civil Rights has announced that it has settled with Lakeland, Florida based Advanced Care Hospitalists (ACH) for $500,000 for allegations of an impermissible disclosure of protected health information by one of its business associates. ACH provides contract internal medicine physicians to nursing homes and hospitals.

According to the press release, between November 2011 and June 2012, ACH engaged an individual who claimed to be a representative of Doctor’s First Choice Billings, Inc., which provides medical billing services. Although the individual used First Choice’s website and company affiliation, …

2019 Physician Fee Schedule Rule Review: CMS Recognizes “Virtual Check-Ins” and “Store and Forward” Remote Service Offerings

On November 1, 2018, the Centers for Medicare & Medicaid Services issued a final rule that updated payment policies and rates under the Medicare Physician Fee Schedule (PFS). This rule also formalized two types of remote service offerings known as “virtual check-ins” and “store and forwards.” In an effort to increase access for Medicare beneficiaries, CMS has recognized and finalized a code to provide separate payment for communication technology “virtual check-in” service. The purpose of these services are “brief check-ins” using communication technology to evaluate whether or not an office …

2019 Physician Fee Schedule Rule Review: Use of Telehealth Expanded

Telehealth for Treatment of Substance Use Disorders

As part of the CY 2019 Medicare Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period to expand the use of telehealth for the treatment of substance use disorders and co-occurring mental health disorders. Existing law provides for reimbursement of telehealth services only if the originating site is located in a rural health professional shortage area, is not in a metropolitan statistical area or is an entity that participates in a federal …

Medicare Proposes Revised Telehealth Services and Payments

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies.  The Proposed Rule contains several provisions that address the growing use of telehealth. CMS noted that it had received many suggestions regarding the expansion of access to telehealth as well as appropriate pay for the same, in response to its call for comments in the CY 2018 Medicare physician fee schedule (PFS) proposed rule.…

Connecticut Legislature Operationalizes New Health Oversight Agency: The Office of Health Strategy

On May 14, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-91 “An Act Concerning the Office of Health Strategy” (PA 18-91), a bill that operationalizes the Office of Health Strategy (OHS), a new health oversight agency in Connecticut. OHS is a division of the Department of Public Health (DPH) “for administrative purposes only” that was provisionally established by the Connecticut General Assembly within the budget implementer bill passed in a special session in late 2017 and accorded responsibility for developing and implementing a …

CMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D).  The Final Rule includes, among other provisions:

  • Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in Medicare Advantage, Cost Plans, and PACE: The Final Rule eliminates the MA and Part D prescriber and provider enrollment requirement.  Instead, CMS is compiling a “Preclusion List” of prescribers, individuals, and entities that: (1) are currently revoked from Medicare, under

FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two …

Connecticut Supreme Court Recognizes Common-Law Cause of Action for Unauthorized Disclosure of Confidential Medical Information

In a long-awaited decision concerning the confidentiality of medical records and patient privacy, the Connecticut Supreme Court recently concluded that the physician-patient relationship establishes a duty of confidentiality to a patient in Connecticut, and that unauthorized disclosure of confidential information obtained for the purpose of treatment in the course of that relationship gives rise to a cause of action in tort, unless the disclosure is otherwise permitted by law.

In Byrne v. Avery Center for Obstetrics and Gynecology, P.C., the Court considered – for a second time – the …

CMS Issues Guidance on Texting Patient Information

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) published a memo to state survey agency directors clarifying its position on the use of text messaging among health care providers. In its memo, CMS stated that it does not permit texting of patient orders by health care providers, as texting of patient orders does not comply with the applicable Medicare conditions of participation (COPs), specifically 42 C.F.R. § 489.24. Instead of texting patient orders, CMS states that its preference is for health care providers to either hand-write …

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. …

Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts

Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and health care providers, and restrictions on contractual provisions between health care providers and insurance companies.

We recently covered  PA 17-241 in our Health Law Pulse, it can be accessed here.…

Senate Proposes Expanded Use of Telehealth

On May 18, 2017, the Senate Finance Committee voted to move forward a bill entitled the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S870), which would increase access to telehealth services in the home.

Telehealth is the use of electronic information and telecommunications technology to support remote clinical healthcare, patient and professional health related education and other healthcare delivery functions. …

EHR Vendor Settles False Claims Act Suit for $155 Million

Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers …

Massachusetts Issues Mass HIway Regulations

Massachusetts recently released a final regulation concerning its health information exchange, which became effective February 10, 2017. Under this regulation, Provider Organizations are required to connect to Massachusetts’ statewide health information exchange known as the Mass HIway. Provider Organizations include Massachusetts acute care hospitals, community health centers, and medical ambulatory practices. These regulations continue the push toward increased interoperability of patient medical records across health care providers, in an effort to improve the ability of a provider to see the full medical picture of a patient.

Provider Organizations must connect …

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