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.
Medicare’s DMEPOS Competitive Bidding Round 2021 is now in full effect as of January 1, 2021. (See previous articles about what CBID Round 2021 is all about).
DME providers either participated in the process with hopes of being awarded a bid, or they abstained from doing so. Of those who participated, with Medicare’s recent bid winner announcements, bid winners were happy and bid losers, well not so much – as only those providers awarded a contract could service a Medicare Part B beneficiary for competitively bid product(s) for patients residing in competitive bid areas (“CBA”).
Now what? What are the options for the relationships between ‘winners’ and ‘losers’ in moving forward, if any? Let’s briefly discuss subcontracting. read more
A recent Department of Justice $500,000 settlement with a cardiology practice underscores the need for ensuring tighter compliance by medical practices. There, the practice billed Medicare for cardiology procedures for which interpretive reports were also required. Medicare paid for the procedures, but upon audit, CMS could not find the requisite interpretive reports. The False Claims Act case settled for $500,000, but it’s likely that (1) the reimbursement by Medicare was far less, and (b) the legal fees behind the settlement weren’t too far behind the settlement amount! Had the practice self-audited each year, would they have found the discrepancy?
Medical practices have felt the weight of price compression and regulatory load more than probably any segment in the healthcare sector. They are doing far more for far less. And regulations expand faster than viruses! Hence, many have a strategy of regulatory compliance that can best be characterized as a combination of facial compliance (“We bought the manual and put it on the shelf”) and hope (“They’re not really serious about this, are they?”). Unless you’re part of a practice of more than 20 doctors, it’s likely that you can do more to ensure regulatory compliance.
When an overpayment is identified in Medicare Part A or B claims, providers can contest the overpayment amount by using the Medicare administrative appeals process. Because of the large difference between overpayment amount in a sample from an extrapolated amount, the OIG states that it is critical for the review process during an appeal to be fair and consistent. In the first and second levels of Medicare appeals (redetermination and reconsideration) extrapolated overpayments are reviewed by MAC (Medicare Administrative Contractors) and by QICs (Qualified Independent Contractors).
The OIG audit was to make sure that the MACs and the QICs reviewed the appealed extrapolated overpayments consistently and in compliance with CMS requirements.
What OIG found was that CMS did not always provide sufficient guidance and oversight to ensure that these reviews were performed in a consistent manner. The most significant inconsistency identified was the use of a type of simulation testing that was performed only by a subset of contractors. The test was associated with at least $42 million in extrapolated overpayments that were overturned in fiscal years 2017 and 2018. read more
The newest relief for small business and health care providers was passed by the Senate on April 21st, by the House on April 23rd, and became law on April 24, 2020. This new Act, provides for $484 billion in additional relief to small businesses and healthcare providers. $100 billion of the relief has been allocated to the Department of Health and Human Services and of that amount $75 billion is earmarked “to reimburse health care providers for health related expenses or lost revenues that are attributable to the coronavirus outbreak.” The remaining $25 billion will be used for expenses to research, develop, validate, manufacture, purchase, administer, and expand capacity for COVID-19 test to effectively monitor and suppress COVID-19.
The $75 billion provided under the Act will remain available until expended and will be used to prevent, prepare for, and respond to coronavirus to reimburse necessary expense or lost revenues incurred as a result of COVID-19. However, if a health care provider has already had expenses or lost revenues incurred due to COVID-19 reimbursed from other sources or that other sources are obligated to reimburse (like the CARES Act), any funds received from the $75 billion cannot be used as a “double dip” by that health care provider.
A big difference for health care providers with this Act, is that unlike the CARES Act that provided a direct deposit to health care providers based on Medicare fee for services reimbursement, no application necessary, this Act requires the health care provider to apply for relief funds. Eligible health care providers include public entities, Medicare or Medicaid enrolled suppliers and providers, profit and not-for-profit entities that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 (so as to accommodate the “lost revenues” provision, this could mean any patient treated since January 31, 2020, and is not necessarily limited to patients treated for COVID-19 symptoms without testing confirmation). Health care providers should act quickly and apply for funds as soon as possible as the HHS Secretary will review applications and make payments on a rolling basis. Payment may be a pre-payment, prospective payment, or a retrospective payment as determined by the HHS Secretary. Health care providers must submit an application that includes statements justifying the need of the provider for the payment. The provider must have a valid tax id number (could be an individually enrolled physician). As with the CARES Act, HHS will have the ability to audit how relief funds are expended and must start reporting obligations of funds to the House and Senates Committees on Appropriations within 60 days from the date of enactment of this Act. Reporting will continue every 60 days thereafter. read more
The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services. The waivers apply only to financial relationships and referrals related to COVID. The circumstances and conditions under which the waivers apply are strictly and narrowly described. Moreover, the waivers have no impact in the presence of fraud or abuse. With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–
the federal requirement that the DHS be provided in the same building as the physician office is waived; and
the financial relationship limitations between the physician (or family member) and the DHS provider is waived.
The waiver also contains specific examples of waived interactions between providers and hospitals, including— read more
HHS found that a home health agency incorrectly billed Medicare and did not comply with Medicare Billing requirements for beneficiaries that were not homebound and for others that did not require skilled services at all.
In August and September 2018, physicians and the owner of a home health agency were each sentenced on multiple counts of conspiracy and healthcare fraud and ordered to pay $6.5 million in restitution. One physician was sentenced to 132 months in prison following trial. A physician who pled guilty was sentenced to 27 months in prison following a guilty plea. The home health agency owner was sentenced to 42 months in prison. The defendants paid and received kickbacks in exchange for patients and billed Medicare more than $8.9 million for services that were medically unnecessary, never provided, and/or not otherwise reimbursable. Additionally, certain defendants provided prescriptions for opioid medications to induce patient participation in the scheme.
In September 2018, the co-owner and administrator of a home health agency was sentenced to 24 months in prison, ordered to pay over $2.2 million in restitution, and ordered to forfeit over $1.1 million. The co-owners participated in a home healthcare fraud conspiracy that resulted in Medicare paying at least $2.2 million on false and fraudulent claims. The owners and their co-conspirators paid kickbacks to doctors and patient recruiters in exchange for patient referrals, billed Medicare for services that were medically unnecessary, and caused patient files to be falsified to justify the fraudulent billing.
Back in February 2018, the owner of more than twenty home health agencies was sentenced to 240 months in prison and ordered to pay $66.4 million in restitution, jointly and severally with his co-defendants, after pleading guilty to one count of conspiracy to commit health care fraud and wire fraud. A patient recruiter for the home health agencies, who also owned a medical clinic and two home health agencies of her own, was sentenced to 180 months in prison. Another patient recruiter, who also was the owner of two home health agencies, was sentenced to 115 months in prison. These conspirators paid illegal bribes and kickbacks to patient recruiters in return for the referral of Medicare beneficiaries many of whom did not need or qualify for home health services. Medicare paid approximately $66 million on those claims.
Illegal kickbacks in exchange for referrals of Medicare beneficiaries, lack of medical necessity for home health services, failing to meet the guidelines, fraudulent billing, billing for services beneficiaries did not receive and fraudulent documentation continues to plague the home healthcare industry.
In a fraudulent operation that the Department of Justice calls, “unprecedented”, elderly or disabled patients nationwide were lured into providing their DNA for testing in a widespread genetic testing fraud scheme powered by a large telemarketing network. The doctors involved were paid to write orders prescribing the testing without any patient interaction or with only a brief telephone conversation.read more
A Final Rule recently issued by CMS will require Medicare, Medicaid, and CHIP (Children’s Health Insurance Program) providers and suppliers to disclose current and previous affiliations (direct or indirect) with a provider or supplier that: (1) has uncollected debt; (2) has been or is excluded by the OIG (Office of Inspector General) from Medicare, Medicaid or CHIP, or (3) has had its billing privileges with either of these three programs denied or revoked. Such provider affiliations may lead to enrollment being denied if it poses a risk to fraud, waste or abuse. read more
Monday, April 29, 2019, the Florida House and Senate came to agreement on a new Telehealth bill (HB 23). If signed by Governor DeSantis, the bill will become effective July 1, 2019.
The bill creates two new statutes: Section 456.47 and Section 627.42396, and amends Section 641.31.
Section 456.47 sets forth the standards of practice for telehealth providers, authorizes the use of telehealth encounters for patient evaluations, and allows certain providers to prescribe certain controlled substances in limited circumstances. The bill also allows non-physician providers to use telehealth without being deemed to be practicing medicine without a license. Further, the bill sets forth record keeping requirements and registration for out-of-state telehealth providers. It authorizes the Department of Health to establish rules for telehealth, including exemptions from registration requirements, and to set up disciplinary action against telehealth providers that violate the law or rules. read more
Over the past several months, the Centers for Medicare & Medicaid Services (CMS) has taken a number of steps that show an awareness of the regulatory burden placed upon participants in the government’s health care programs, and even some willingness to consider reducing those burdens. While it remains to be seen whether the recent proposals will have measurable results, the following actions can still be viewed with guarded optimism.
Proposed Changes to Medicare
In July, 2018, CMS proposed significant changes to Medicare, to be included in rules that take effect in 2019. These changes cover physician fee schedules, streamlining Evaluation & Management (E&M) billing, advancing “virtual care,” decreasing drug costs, revising the MIPS program and establishing the MAQI demonstration project. The agency also asked for comments on price transparency issues. read more