OCR Hits Advanced Care Hospitalists with $500,000 Fine for HIPAA Violations

By Linn Foster Freedman on Posted in Health Information Technology, HIPAA

The Office for Civil Rights has announced that it has fined Lakeland, Florida based Advanced Care Hospitalists (ACH) $500,000 for 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 of 2011 and June of 2012, ACH engaged an individual who claimed to be a representative of Doctor’s First Choice Billings, Inc. (First Choice), which provides medical billing services. Although the individual used First Choice’s website and company affiliation, the owner of First Choice denied that the individual was employed by First Choice, and stated that the services were provided without the knowledge or permission of First Choice. Continue Reading

In Amicus Brief, Government Discourages Supreme Court Review of Pro-Relator Ninth Circuit FCA Decision, but Pledges to Seek Dismissal of Case Upon Remand

By Conor Duffy on Posted in Department of Justice, False Claims Act, FDA, Fraud and Abuse, Government Enforcement, Medicare and Medicaid, Pharmaceuticals and Biologics, Reimbursement

On November 30, 2018, the Solicitor General of the United States filed a long-awaited amicus brief in response to the U.S. Supreme Court’s request for the government’s view of the False Claims Act (FCA) case U.S. ex rel. Campie v. Gilead Sciences, Inc. (see here for previous analysis of the Ninth Circuit decision in the case, and here for discussion of the Supreme Court’s request).

In its brief, the Solicitor General states that the conclusion of the Ninth Circuit – that “the fact of continued government payments did not by itself require dismissal of [the relator’s FCA] claims at the pleading stage” – was “correct and consistent with decisions issued by other circuits in comparable circumstances” and as a result no further review is warranted. The Solicitor General’s brief appears to advocate for a more narrow reading of the Ninth Circuit decision than many commenters have undertaken, explaining that “the relevance of a governmental payment decision turns on whether the government had ‘actual knowledge’ of violations at the time of payment” but in this case it is disputed what the government knew about alleged violations and when it learned about such violations. Continue Reading

CMS Proposes Revised Prescription Drug Regulations to Lower Drug Prices and Reduce Out of Pocket Expenses

By Melissa (Lisa) Thompson on Posted in Life Sciences, Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law

The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations.  The Proposed Rule was published on November 30, 2018. The Proposed Rule is intended to help lower drug prices for health and drug plans and reduce out-of-pocket costs for MA and Part D enrollees. Major provisions include: Providing Plans with increased flexibility in managing drug formularies. Current policy requires Part D formularies to include all drugs in the following categories: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics; except in limited circumstances. The Proposed Rule includes three exceptions, allowing: (1) broader use of prior authorization and step therapy; (2) exclusion of drugs that are only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclusion of drugs with a price increase beyond an inflation-based threshold relative to a baseline month and year.

Continue Reading

OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion

By Nathaniel Arden on Posted in Advisory Opinions, Fraud and Abuse, Government Enforcement, Medicare and Medicaid, Office of Inspector General, Pharmaceuticals and Biologics, Reimbursement

On November 16, 2018, the Office of the Inspector General of the Department of Health and Human Services (OIG) posted an unfavorable Advisory Opinion No. 18-14 regarding an arrangement where a vendor (Requestor) of a commonly used drug would supply free doses of the drug to hospitals for treatment of inpatients with a rare and serious form of epilepsy (Proposed Arrangement). The drug is not separately reimbursable in the inpatient setting. As a result, and according to the Requestor, many hospitals do not stock sufficient quantities of the drug and are reluctant to administer the drug due to insufficient reimbursement from government and commercial payers. Continue Reading

2019 Physician Fee Schedule Rule Review: Off-Campus Provider-Based Hospital Departments

By Erica Youngerman on Posted in Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Rule), which includes modifications to Medicare payment policies and rates.

One area that is discussed in the rule is with regards to the payment of certain items and services when provided by certain off campus provider based hospital departments. As per Section 603 of the Bipartisan Budget Act of 2015, certain items and services, when provided by certain off-campus provider-based hospital departments, are not to be paid under the Hospital Outpatient Prospective Payment System (OPPS) as same are not considered covered outpatient department services under OPPS for payment purposes. In lieu of OPPS, CMS established in calendar year 2017 that the Medicare Physician Fee Schedule (PFS) would be the payment system for most of these items and services when furnished by certain off-campus provider-based hospital departments. Under the PFS, these items and services being furnished by these certain off-campus provider-based hospital departments are paid using a PFS Relativity Adjuster. In the Rule, CMS has made the PFS Relativity Adjuster for calendar year 2019 match the amount from calendar year 2018, which was 40 percent of the OPPS payment rate.

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

By Nawa Lodin on Posted in Health Information Technology, Legislation, Medicare and Medicaid, Telehealth

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 visit is warranted. Currently, these types of services would be bundled into the payment for the resulting visit, such as through an evaluation and management visit code. However, not all of these communications lead to an office visit. Subsequently, there is no service the communication can be bundled into. CMS believes that these communications are becoming more frequent and more effective at addressing patient concerns. CMS goes so far as to state that “better practitioners” are leveraging technology to furnish check-ins and mitigate unnecessary office visits. Continue Reading

2019 Physician Fee Schedule Rule Review: Supervision Requirements for Radiologist Assistants Reduced

By Conor Duffy on Posted in Academic Medical Centers, Commercial Health Insurance, Government Enforcement, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

In its 2019 Medicare Physician Fee Schedule Final Rule (PFS Rule), CMS finalized a regulatory change that updates supervision requirements for Registered Radiologist Assistants and Radiology Practitioner Assistants (collectively, RAs) to reduce the level of supervision necessary to perform diagnostic tests reimbursable by Medicare. Specifically, the PFS Rule revises 42 C.F.R. § 410.32(b) to provide that RAs may perform certain diagnostic tests that would otherwise require a personal level of supervision under direct supervision instead, to the extent permitted by state law and regulations. Continue Reading

2019 Physician Fee Schedule Rule Review: Use of Telehealth Expanded

By Nathaniel Arden on Posted in Health Information Technology, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Telemedicine

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 telemedicine demonstration project. The originating site must also be one of a specific type of facility, such as a hospital, physician’s office or skilled nursing facility. With respect to telehealth services used to treat a substance use disorder or co-occurring mental health disorders, the interim final rule removes the originating site geographic restrictions and permits a patient’s home to be an originating site. When the patient’s home is used as the originating site for telehealth services, Medicare will pay no facility fee. The interim final rule is effective for telehealth services performed on or after July 1, 2019. CMS is requesting comments on the interim final rule, and the comment period closes January 22, 2019. Continue Reading

2019 Physician Fee Schedule Rule Review: Option to Extend MSSP Agreements for Currently-Expiring ACOs Finalized

By Conor Duffy on Posted in Accountable Care Organizations, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Stark Law, Telemedicine

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Physician Fee Schedule Final Rule (PFS Rule), which contains a number of significant substantive changes to Medicare payment practices and policies. The PFS Rule will be officially published in the Federal Register on November 23, 2018. The PFS Rule also includes an interim final rule implementing amendments to federal telehealth regulations to maintain consistency with recent changes to the Social Security Act to address the opioid crisis enacted in October 2018 through the SUPPORT for Patients and Communities Act. Continue Reading

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities

By Melissa (Lisa) Thompson on Posted in Academic Medical Centers, Advisory Opinions, Clinical Research, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Office of Inspector General

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the University’s foundation, under substantially identical terms. Continue Reading

LexBlog