Healthcare Law Blog

Part I Medicaid Webinar A Success – Register Now for Part II!

On Wednesday, August 20, the McBrayer Health Care Group, along with panelists from the Kentucky Primary Care Association and the Primary Care Centers of Eastern Kentucky, hosted a free webinar entitled, “Medicaid: Getting Paid & Keeping It.”

Part I of the webinar provided an overview of the Medicaid administrative appeal process, the Dispute Resolution Meeting (“DRM”), appeal of the DRM decision, and settlement. In addition, McBrayer attorneys weighed in on the “top issues” they encounter when helping providers work through the complicated reimbursement process. Attendees received real-world advice about what to challenge when an overpayment demand is received and saw examples of actual letters received by others in the industry.

Part II of the webinar is scheduled for Wednesday, August 27 from 12-1:30pm, EST. This session will discuss federal Medicaid audit authority, what to do if you’re contacted by a Medicaid Integrity Contractor (“MIC”), and opportunities to contest a MIC’s auditor’s adjustment/denials/identification of overpayment.

Attendees of Part I will automatically be enrolled in Part II. If you missed Part I, but would like to take part in next week’s webinar, sign up here: https://attendee.gotowebinar.com/register/6389912240505419777.

Services may be performed by others.

This article does not constitute legal advice.

FDA Issues Guidance for Drug & Device Companies’ Social Media Interactions

In June, the U.S. Food and Drug Administration issued two draft guidance documents for the pharmaceutical and medical device industries related to social media. The guidance is part of an asserted effort by the FDA to provide more clarity regarding how drug and device manufacturers may appropriately communicate through Internet platforms.

The first document, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, addresses advertising and promotional communications concerning prescription drugs and medical devices on sites where character space is limited, such as Twitter and sponsored search engine results. The guidance specifies, among other things, that each “tweet” must include both benefits and risks of the promoted drug and should include a hyperlink to a more comprehensive list of risks and side effects.

The other draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, addresses how manufacturers may correct certain misinformation posted by independent third parties and in chat rooms. As long as the information appears on a site not controlled by the company, the FDA does not mandate that a company correct the misinformation. If, however, the company chooses to correct the misinformation, they must follow certain protocol as outlined in the guidance.

Manufacturers may submit comments regarding the draft guidance documents to the FDA until September 16, 2014. While the guidance is solely issued for pharmaceutical and medical device companies, all providers must use caution when using social media to promote their services, practice group, a certain procedure, etc. In 2013, the Kentucky Board of Medical Licensure adopted the Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”) that was issued by the Federation of State Medical Boards (“FSMB”). See more on the adoption here.

The unintended consequences of social media can lead to real consequences, as even seemingly innocent and inconspicuous postings and interactions can result in costly and serious repercussions. Inappropriate postings or patient-physician communications can lead to violations of HIPAA and the Kentucky Medical Practice Act, licensing violations, or even fraud and abuse charges (i.e., physicians pay money to third parties to promote their services through online media platforms). The FDA guidance, even if not binding on a particular health care profession, is still informative and can serve as a great reference tool in policymaking.

If you are a health care provider and have questions about drafting or implementing social media policies for your health care organization, contact a McBrayer healthcare attorney today.

Services may be performed by others.

This article does not constitute legal advice.

Preparing for Round Two, Continued

Earlier this week, information about OCR Phase 2 HIPAA audits was provided. Today, let’s take a look at how to prepare if your entity is selected for an audit:

• Confirm that a recent comprehensive Risk Assessment has been completed and documented.
• Confirm that all action items identified in the Risk Assessment have received attention and have been completed (or are in the process of being completed).
• Verify that policies are up-to-date, including breach notification procedures, notice of privacy practices, and responses to patient requests.
• Ensure that a current list of business associates (and their contact information) is readily available.

Because Phase 2 does not consist of on-site visits, there will not be an opportunity for dialogue with auditors. Therefore, it is crucial to ensure that documentation alone shows a complete picture of an entity’s compliance efforts. All documents should be carefully reviewed, dated, and signed before turned over to an auditor. While providing extraneous information is not recommended, it is important to double-check that all requested and necessary information is submitted.

Phase 2 audits set to occur in 2016 will focus on the Security Standard’s encryption and decryption requirements, facility access controls, breach reports and complaints. It is never too early to start considering what protocols, training, and procedures will need to be implemented in anticipation of a possible audit related to these items.

In the event you are selected for a Phase 2 audit and have any questions about your responsibilities or what you can do to ensure a smooth process, contact a McBrayer healthcare attorney today.

Services may be performed by others.

This article does not constitute legal advice.

Are You Ready for Round Two?

In February 2014, the Health and Human Services Office of Civil Rights (“OCR”) announced its plans to send pre-audit surveys to between 550 and 800 entities during the summer in preparation for Phase 2 HIPAA compliance audits. After collecting information from those surveyed, OCR will select about 400 of those entities for actual HIPAA audits. Those audits will begin this fall – which is quickly approaching. More >

DOJ Intervenes In Case Involving ACA’s 60-Day Overpayment Rule

Recently, the Department of Justice (“DOJ”) intervened in a qui tam whistleblower suit in the US District Court for the Southern District of new York, which involves Continuum Health Partners and several Mount Sinai-related hospitals. United States ex. Rel. Kane v. Continuum Health Partners, Inc. et al, (Civil Action, No. 11-2325(ER)). While DOJ intervention in whistleblower cases is not unusual, this case is significant because the DOJ’s complaint specifically alleges that the defendants failed to return Medicaid overpayments within 60 days, as required by the Affordable Care Act (“ACA”). The case is one of the first to explore the issues and interpret the requirements of the 60-Day Rule. More >

Update: CMS Issues Revised Guidance on Hospice & Part D Prior Authorization Process

A few weeks ago, we discussed CMS’ newly-issued guidance establishing a prior authorization process for Hospice and Part D providers (read more here). As our previous blog post emphasized, soon after its March 10 implementation, advocacy groups, Hospice associations, and Members of Congress began urging CMS to suspend the process. According to opponents, the prior authorization requirement creates a barrier for beneficiaries to access necessary medications and leaves them to navigate complicated payor disputes in the midst of their terminal illnesses. More >

Labs & Referring Physicians Take Note of OIG’s Special Fraud Alert

Recently, the U.S. Department of Health & Human Services, Office of Inspector General (“OIG”) issued a Special Fraud Alert (“Alert”) entitled, “Laboratory Payments to Referring Physicians.” The Alert focuses on (1) Specimen Processing Arrangements and, (2) Registry Arrangements. These arrangements, according to the OIG, pose substantial risks for fraud and abuse under the federal Anti-Kickback Statute. More >

New Part D Regulations Face Increased Scrutiny from Advocacy Groups & Congress

On March 10, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to Part D Plan Sponsors and Medicare Hospice Providers entitled, "Part D Payment for Drugs for Beneficiaries Enrolled in Hospice – Final 2014 Guidance" (“Guidance”).   The Guidance, effective since May 1, 2014, requires a prior authorization process for Hospice and Part D providers to determine their respective responsibility for drug coverage. The Guidance followed a 2012 OIG report entitled "Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice,” which found that Medicare Hospice patients’ medications were sometimes paid for by Part D rather than by the patient’s Hospice program. More >

New Law Affecting APRNs Takes Effect Today

Today, Senate Bill 7, signed by Governor Beshear on February 26, 2014, becomes effective. The new law allows for an Advanced Practice Registered Nurse (“APRN”) to request to discontinue a Collaborative Agreement for Prescribing Authority for Non-Scheduled drugs (“CAPA-NS”) after having a CAPA-NS in place for four years. Specifically, the new law states: More >

Have You Reviewed Your Existing Business Associate Agreements?

Pursuant to the HIPAA Final Omnibus Rule (“Final Rule”), covered entities and their business associates were required to enter into new business associate agreements (“BAAs”) or modify existing BAAs by Sept. 23, 2013. However, existing BAAs that (i) were entered into on or before Jan. 25, 2013; (ii) met the requirements that were applicable prior to the promulgation of the Final Rule; and (iii) were not modified after March 26, 2013, have until Sept. 23, 2014 to be updated. That deadline is quickly approaching. More >