As noted in Opting Out of Medicare Part I, opting out of Medicare may be an option for some physicians and practitioners. After determining whether you are eligible for opt-out or if it is financially feasible, there are a few other considerations. Part I discussed the Private Contract a physician must enter into with each Medicare beneficiary he or she treats; here, we will address the opt-out affidavit and other nuances of opting out. Let’s get started!
The Medicare Opt Out Affidavit
Provisions in an Opt Out Affidavit are similar to provisions that must be included in the opted out physician’s or practitioner’s private contract with Medicare beneficiaries. The opt-out affidavit must state that the physician or practitioner will only provide services to Medicare beneficiaries with whom they have a written and signed private contract and that the physician or practitioner will not submit claims to Medicare on behalf of Medicare beneficiaries. Medicare does allow for an exception here, but that is only when an opted out physician or practitioner treats a Medicare beneficiary who is not under private contract, and that beneficiary presents with a medical emergency or urgent care problem. Keep in mind, that if a Medicare beneficiary presents with a medical emergency or urgent care problem, the physician or practitioner cannot require that patient to sign a private contract at that time.
On May 19, 2018, Delray Beach medical spa owner Jennifer Aspen was booked into the Palm Beach County Jail and charged with practicing medicine without a license. Ms. Aspen is the manager of Mermaid’s Skin & Wellness, a medical spa located in Delray Beach, Florida. The charges against Ms. Aspen stem from the fact that a Delray Beach police officer presented to Mermaid’s Skin & Wellness for a testosterone shot. Ms. Aspen stated to the officer that she would perform the injection. Ms. Aspen is a certified nursing assistant in the State of Florida. Her license is currently listed as “delinquent” on the Department of Health’s website, meaning that (as of today) she failed to renew her license after its May 30, 2018 expiration date. Certified nursing assistants are not generally allowed to administer testosterone in the State of Florida.
One of the legal issues that presents frequently in our office is med spa compliance; who can open and operate a medical spa if it is just a cash business, meaning that it does not submit claims for reimbursement to any government or commercial payor. Misunderstandings run rampant in the medical spa industry and many times patients are administered treatment from persons who are not supposed to be providing it.
President Trump has stated that one of his greatest priorities is to reduce the price of prescription drugs. Alex Azar II, secretary of the Department of Health and Human Services (“HHS”), believes that while the United States’ system enabled it to become a world leader in the development of cutting edge drugs is also one that has not prioritized the needs of its own citizens.
On May 11, 2018 Trump directed his Administration to fix the injustice of high drug prices to ensure they come down, and unveiled his “blueprint” to put “American Patients First” though a 44 page document released on HHS’ website.
Pharmacy Benefit Managers (PBMs), previously largely unknown ‘middlemen’ in the U.S. pharmaceutical industry, whose impact on our healthcare system is just slowly beginning to emerge from the shadows, have been taking a lot of flak from independent pharmacy owners, politicians, and the media for being a cause of the high drug costs that the Trump Administration has vowed will be reduced.
In 2012, the American Hospital Association (AHA) along with three member hospitals filed a lawsuit against the U.S. Department of Health and Human Services (HHS) for the agency’s failure to meet the 90 day decision requirement at the Administrative Law Judge (ALJ) level known as the Office of Medicare Hearings and Appeals (OMHA). Through the years, the case has moved back and forth between a federal district court and federal appeals court in the District of Columbia. Most recently in March, a federal district court judge ordered the AHA to expand on its suggestions it has made over the course of its litigation for how HHS can clear the ever-growing backlog and additionally, explain why the current procedures are insufficient.
The recent petition for Declaratory Statement filed with the Department of Children and Families on behalf of our client focuses on one thing: whether the FARR certification requirements for Recovery Residences also apply to facilities licensed by DCF to provide Day and Night treatment with community housing and to Res-5 housing.
Attorneys from the Florida Healthcare Law Firm will hold a live call to present an urgently needed update regarding FARR certification.
The recent petition for Declaratory Statement filed with the Department of Children and Families on behalf of Amethyst Recovery Center focuses on one thing: whether the FARR certification requirements for Recovery Residences also apply to facilities licensed by DCF to provide Day and Night treatment with community housing and to Res-5 housing. A review of FARR recovery residence certification shows that there is significant conflict with DCF requirements for licensure of treatment facilities that have a housing component. There are no referrals to and from the community housing component of Day and Night or for Res 5: patients are simply housed under the DCF licensed component while in treatment. Referrals from Recovery Residences to addiction treatment facilities are generally made for individuals who are seeking treatment, not for housing.
Day and Night Treatment Providers with community housing may make referrals for individuals who have completed inpatient treatment, requiring them to step down to an outpatient provider. Many times, clients desire to live in a recovery residence to maintain their sobriety. In that case, it would be appropriate for the Day and Night Treatment Provider to refer to a FARR-certified recovery residence.
When asked about why Amethyst filed for clarification, Pamela Springer, Chief Operating Officer with Amethyst Recovery Center stated, “Amethyst supports FARR’s mission and the State of Florida’s requirement for recovery residence certification. However, thus far, DCF has indicated to Amethyst Recovery Center that it does not require FARR certification for licensed community housing. FARR has stated to us and other providers that Day and Night treatment with community housing must obtain FARR certification or they will be in violation of the law. This is the reason we sought clarification from DCF”.
If history teaches anything, it’s to learn from it. The addiction treatment industry can’t afford to sit idly by and watch. Uniform application of the law is essential to avoid unfair, unreasonable and unintended results. Step up; show up. Register for FREE: https://attendee.gotowebinar.com/register/4977722626987986435 and stand up for your rights under Florida law.
Jumping into the stem cell industry can be an exciting venture. However, with this emerging industry comes a mine field of legal pitfalls and potential problems. The keys to a successful business not only include selecting a strong product and building strong relationships with clients but being able to navigate the regulatory framework that accompanies this type of product.
FDA regulations require establishments that perform one or more steps in the manufacturing process of HCT/Ps (i.e. Human Cells, Tissues, and Cellular and Tissue-Based Products) to register and submit a list of products with the agency. If so, you have five days to register after beginning operations. When I mention “manufacturing” to clients they usually interject with “I only want to distribute.” Good point. However, the FDA defines “manufacture” as any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue. These registrations must be updated annually and in the event of a change of ownership, within 30 days of the change.
State licensed addiction treatment facilities with licenses that include community housing are confused about whether they have to also be certified by the Florida Association of Recovery Residences (FARR) by July 1, 2018. Attorney Karina Gonzalez has filed a petition with the Department of Children and Families (DCF) to clarify the issue. A fairly recent state law (397.4873, Fla. Stat.) requires addiction treatment service providers in Florida to refer clients only to recovery residences certified by FARR.
FARR is a private, non-governmental entity approved by DCF to develop and administer a voluntary certification program for recovery residences. FARR has taken the position that it has also been approved to develop and administer a voluntary certification program for DCF-licensed community housing providers. “We think,” attorney Gonzalez said, “they’ve got it wrong. It makes no sense to stack the FARR certification requirement on top of existing state licensure.”
There are a rash of blogs, bulletins, memos, e-mails relaying that Florida DCF licensed Day/Night with Community Housing licensees (D/N with Community Housing) must be certified by FARR by July 1, 2018 in order to refer or accept referrals and not be sanctioned. The referral prohibitions in 397.4873 (2), Fla. Stat. show they apply after July 1, 2018 when a licensed service provider is referring to that provider’s wholly owned subsidiary. But there is no requirement for certification when the licensee, the entity licensed by DCF to provide services, is not a wholly owned subsidiary.
As of June 12th, Florida Healthcare Law Firm has served a Petition for Declaratory Statement on the Agency by a Day/Night with Community Housing licensee to seek clarification on whether Voluntary Certification of Recovery Residences administered by FARR under 397.487 Fla. Stat. applies to a licensed D/N with Community Housing program when the community housing is owned by the same service provider.Other D/N with Community Housing and Res 5 providers have a narrow window of opportunity to intervene in the action and work alongside FHLF to get clarification from DCF and potentially avoid FARR sanctions.
In CMS’ latest “MLN Connects” newsletter, the agency discusses the Comprehensive Error Rate Testing (CERT) program and the top five documentation errors committed by providers. Providers should pay close attention when CMS releases these types of notices. If selected for CERT review, providers are subject to potential action such as post-payment denials, payment adjustments, or other actions depending on the results of the review. Therefore, providers should ensure they fully understand Medicare’s documentation requirements and how to meet these demands.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.