Medicare

October 20, 2022

Posted on by Courtney Patterson

QUESTION:
We are currently updating our informed consent forms. Can you remind us of what information should be included on these forms

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
Informed consent is critical to providing quality care, so I commend your efforts to review your forms. In almost every state, the treating provider is responsible for explaining to the patient ˗ in such a way that the patient can understand ˗ (1) the item or service that will be provided, (2) the benefits and risks associated with that care, and (3) any alternatives. In some states, failure to obtain a patient’s informed consent may render the treating provider liable for any injury that results from the rendered care, so be sure to check your state law!

Under the Medicare Conditions of Participation, the medical record must contain documentation of the patient’s informed consent for certain treatments and procedures. The Medicare Conditions of Participation Guidelines offer a detailed explanation of what a properly executed informed consent form should look like. When revising your informed consent forms, be sure that they have at least the following elements:

  • The name of the facility where the care is going to take place;
  • The name of the procedure or treatment for which consent is being given;
  • A statement that the procedure or treatment, including the anticipated benefits and material risks, and alternative treatments, was explained to the patient or the patient’s legal representative;
  • The signature of the patient or their legal representative; and
  • The date and time the informed consent form is signed by the patient or their legal representative.

CMS also states that a well-designed informed consent form may also include:

  • The name of the provider who conducted the informed consent discussion;
  • Date, time, and signature of the person witnessing the patient or their legal representative signing the consent form;
  • An indication or listing of the benefits and material risks of the procedure or treatment discussed; and
  • A statement that physicians and providers who are not physicians, other than the treating provider, including residents, will be involved in the care of the patient and will perform important parts of the procedure or treatment, as allowed under state law and regulations, in accordance with the clinical privileges granted and/or scope of practice.

If in doubt, reach out to Mary Paterni to review whether your informed consent forms comply with state and federal law.

August 11, 2022

Posted on by Courtney Patterson

QUESTION:
Our state Department of Health informed us that we are required to have cameras installed in our chemotherapy unit so that patients receiving treatment can be observed via a monitor at the nurses’ station. Since we will be recording patient care activity, do we need to post signs stating that cameras are in use?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
CMS’s Interpretive Guidelines to the Medicare COPs regarding physical privacy indicate that “audio/video monitoring (does not include recording) of patients in medical surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring,” and the monitors or speakers are not visible or audible to visitors or the public.  However, “video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.”

If the hospital is only monitoring the patients via video and not creating a recording, the patients and their representatives only need to be “aware of the monitoring.” In that case, signs would satisfy the requirement and be an appropriate way to inform them that monitoring is occurring.  On the other hand, if a true “recording” will be made, then a more formal consent would be required by CMS.

It is also important to check state law in these circumstances, as most states have their own laws that govern audio and video recordings that could be applicable.

May 19, 2022

Posted on by Courtney Patterson

QUESTION:
Our hospital is negotiating with health insurers to perform delegated credentialing on their behalf.  The insurers are telling us that we cannot have a hearing officer option for conducting a hearing when providers are subject to certain adverse actions, such as termination of participation on a panel. Is this correct?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
Yes. This is how health insurers interested in delegating credentialing functions to health care providers interpret the Medicare Advantage rules for provider participation.  According to those rules, a health insurer involved in the Medicare Advantage program has to give physicians certain rights when it suspends or terminates the physician’s participation agreement.  Among those rights are the right to receive notice of the reasons for the action and the right to appeal that action. The rules go on to talk about a hearing panel but only state that the insurer (or insurer’s delegate) must ensure that the majority of the hearing panel members are peers of the affected physician.

Now you could follow the constitutional principle of English law that instructs that “everything that is not forbidden is permitted” and go ahead and draft your delegated credentialing policies so that they allow for the hearing officer alternative to using a hearing panel.  However, this may create headaches down the road since health insurers have to perform a pre-delegation audit of your policies and procedures before delegating credentialing and will most likely require a revision to your policies if they permit the hearing officer option. Some providers, such as hospitals, use their existing medical staff credentialing policies and procedures to build off of to put delegated credentialing processes in place. To the extent that a hospital is interested in doing so and its existing Credentials Policy allows for the hearing officer option, it can simply revise its Credentials Policy to indicate that the option is not available when a hearing is offered for delegated credentialing purposes (as opposed to medical staff purposes).

March 10, 2022

Posted on by Courtney Patterson

QUESTION:

Is the “No Surprises Act” in effect?  I heard that a court enjoined it.  Is the No Surprises Act limited to Emergency Care?  Can you give me an example of how the Act works?  What recourse do I have if I do not agree with the amount that the insurer pays me under this Act?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The No Surprises Act and its implementing regulations (the “Act”) have been in effect since January 1, 2022.  The Act prohibits emergency department physicians and the facility from billing a patient an out-of-network fee for emergency care provided at any hospital Emergency Department and, if permitted by your state, any free-standing emergency department, regardless of whether the hospital or emergency department physicians participate in the patient’s insurance network.

The Act also prohibits balance billing a patient for non-emergency services provided in an in-network hospital by certain out-of-network physicians, including all traditional hospital-based physician specialties.  A physician can get a patient’s waiver of their rights under the No Surprises Act by using the notice and consent form provided by CMS for (1) certain non-emergency services and (2) post-stabilization services.  However, out-of-network physicians cannot obtain waivers for non-emergency services provided at an in-network hospital if they provide traditional hospital-based ancillary services (such as pathology), diagnostic services (including lab and x-ray); services provided by hospitalists, assistant surgeons, or intensivists; or if there are no in-network physicians on the hospital’s medical staff who can provide the care needed by the patient.  The waiver will also not apply to any emergent conditions that arise during a non-emergency service to which the patient provided his/her consent and waiver to be balance billed.

This section of the Act is best exemplified by one of the questions and answers provided by CMS’s Center for Consumer Information & Insurance Oversight:

Rhonda is a 50-year-old female with employer-sponsored health insurance who discovers a lump in her breast.  Her primary care provider orders a mammogram, which shows a suspicious mass. She is referred to the local in-network hospital’s outpatient department for a biopsy.  The biopsy is reviewed and found to be negative for malignant cells by a pathologist who happens to be out of network.

How much can the pathologist bill Rhonda under the rules of the No Surprises Act? 

ANSWER
Under the No Surprises Act, the pathologist is banned from billing Rhonda more than the in‑network cost-sharing amounts, as determined by her health plan.  The pathologist, as an ancillary service provider, is banned from obtaining consent from the individual to waive these balance billing protections.

In the past, the pathologist could bill the out-of-network patient his/her usual and customary charge.  The patient would submit the bill to her insurer and the insurer would pay the provider the out-of-network rate and the pathologist could then balance bill the patient for any amount not covered by insurance – NO MORE.  The No Surprises Act regulations also prohibits the pathologist from obtaining the patient’s consent to waive these rights (although, as described above, certain other specialties can obtain the patient’s waiver for (1) certain non-emergency services and (2) post-stabilization services).

As stated above, the pathologist cannot bill the patient more than the pathologist would bill the patient if the patient was in-panel.  The pathologist must then bill the insurance carrier.  If the pathologist is not happy with the amount paid by the insurer, the pathologist must negotiate with the plan for 30 business days.  If the pathologist is still not happy with the amount being offered by the plan, the pathologist must go to arbitration to determine the amount of payment.

However, on February 23, 2022, a federal court has enjoined the CMS provider/health plan arbitration process (but only the arbitration process – the rest of the No Surprises Act regulations are in full force and effect).  That arbitration process created a presumption that the amount that the provider should be paid is the “Qualified Payment Amount” (“QPA”), which is typically the median rate the insurer would have paid for the service if provided by an in-network provider or facility.

The regulations also limited the information that can be presented to the arbitrator and specifically prohibited the arbitrator from considering the provider’s usual and customary charges for an item or service, the amount the provider would have billed for the item or service in the absence of the Act, or the reimbursement rates for the item or service under Medicare or Medicaid.  Finally, the arbitration is “baseball-type” arbitration, which means that the arbitrator must pick one of the amounts proposed – the arbitrator does not have the discretion to split the difference or to choose an amount other than the amount proposed by the provider or by the health plan.

The federal court enjoined this arbitration process from going into effect.  However, the court did not provide any guidance as to how disputed fees are to be resolved while this case is on appeal, or how payment disputes are to be resolved until new regulations are promulgated.

February 3, 2022

Posted on by Courtney Patterson

QUESTION:
What’s all this I hear about “appropriate use criteria” that Medicare will use to determine payment for outpatient imaging?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The Protecting Access to Medicare Act of 2014 (a/k/a “PAMA”) established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.  Examples of such advanced imaging services include:  CT, PET and MRI scans.  Under this program, at the time a practitioner orders an advanced diagnostic imaging service for a Medicare beneficiary, he/she, or clinical staff acting under his/her direction, will be required to consult a qualified Clinical Decision Support Mechanism.  CDSMs are electronic portals through which appropriate use criteria can be accessed.

The program won’t go into effect until January 1, 2023 or the January 1 after the current public health emergency ends, whichever is later.  And it only applies to services in a physician’s office, hospital outpatient department (including the emergency department), an ambulatory surgical center or an independent diagnostic testing facility and whose claims are paid under the physician fee schedule, hospital outpatient prospective payment system or ambulatory surgical center payment system.  So (at least for now) it does NOT apply in critical access hospitals.

For more information, check out the CMS website.

October 10, 2019

Posted on by hortyspringer

QUESTION:        The five medical staffs in our system are thinking about unifying.  Are there any particular steps we need to follow and any changes we need to make to our bylaws?

 

ANSWER:          In May 2014, CMS revised the Medicare Conditions of Participation to allow a multi-hospital system to have a unified and integrated Medical Staff.  There are several steps that must be taken in the integration process.  First, the system must ensure that there is nothing in the state hospital licensing statutes or regulations that would prohibit the medical staffs of separately licensed hospitals from integrating into a single staff.

Second, the Board (and there must be a single Board) must document in writing its decision to use  a unified medical staff model.  This decision would be conditioned on acceptance by the hospitals’ medical staffs to opt-in to an integrated medical staff model.

Third, the medical staff of each of the hospitals must take a separate vote to opt in or opt out of the unified medical staff.  The vote at each hospital must be governed by the respective medical staff bylaws in effect at the time.  Only voting members of the medical staff who hold privileges to practice on site at the hospital may participate in the vote.

Fourth, the unified medical staff will also want to adopt new medical staff bylaws and related policies.  The new bylaws should take into account the unique circumstances of each hospital, including any significant differences in the patient populations and the clinical services that are offered at each hospital.

Importantly, the new bylaws must also include a process by which the voting members of the medical staff who exercise clinical privileges at the hospital may vote to opt out of the unified medical staff in the future.

September 19, 2019

Posted on by hortyspringer

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QUESTION:        What is the significance of the CMS “Pathways to Success” program for ACOs in the Medicare Shared Savings Program?

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ANSWER:            At the end of 2018, the Centers for Medicare & Medicaid Services (“CMS”) redesigned the Medicare Shared Savings Program.  Although the Medicare Shared Savings Program had been in operation since 2012, it had failed to generate the kinds of cost savings that CMS hoped to manifest.  “Pathways to Success” was intended to accelerate the process of transitioning Accountable Care Organizations (“ACOs”) to performance-based risk models.

Among other things, the Pathways to Success program implemented certain kinds of “risk tracks” that offer different mixtures of risk and reward.  Each risk track balances factors such as the potential for financial rewards (in the form of shared savings), the risk of financial penalties (in the form of shared losses), and the opportunity to qualify as an Advanced Alternative Payment Model (which provides certain benefits for individuals subject to the MIPS program).

There are many different variables that govern an ACO’s performance and opportunities under the Shared Savings Program, which means that a full discussion of the program details falls well outside the scope of this article.  The key takeaway to understand is that Pathways to Success was designed to accelerate ACOs to take on higher levels of financial risk and responsibility.  This is yet another example of the ongoing federal effort to promote population health while simultaneously combating the growth of health care expenditures.

To learn more about the Medicare Shared Savings Program, click here.

 

April 4, 2019

Posted on by hortyspringer

QUESTION:        Do the Medicare Conditions of Participation place any requirements on the use of standing orders?

 

ANSWER:            Yes, they do.  The Centers for Medicare & Medicaid Services (“CMS”) have established multiple requirements for compliant use of standing orders in the hospital setting.  For example, each standing order must be reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership prior to use.  CMS emphasizes that this should be a “multi-disciplinary collaborative effort.”  Crucially, each standing order must have clearly identified specific criteria that govern when it will be executed.  CMS is very clear:  “Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.”

Note that there is some ambiguity in the term “standing order,” and CMS recognizes this.  Consequently, it is possible that some of your pre-printed and electronic order sets could fall outside the scope of this regulation.

As part of your compliance efforts, we recommend periodically reviewing your policies on standing orders, order sets, and protocols for patient orders to ensure compliance with the Conditions of Participation and with state law.  We also recommend periodic compliance audits of medical records to verify that your policies are being implemented appropriately.

September 20, 2018

Posted on by hortyspringer

QUESTION:        What are the responsibilities of our hospital’s Board of Directors (“Board”) with regard to oversight responsibilities of the Medical Staff?

ANSWER:            Although it is important to check your state laws and standards set forth by your accrediting organization, a good starting point would be to refer to the Medicare Conditions of Participation (“Medicare CoPs”) pertaining to the Board’s responsibilities, including its oversight responsibilities of the medical staff.  For instance, the Medicare CoPs place the ultimate responsibility for quality of care provided at a hospital and monitoring the care provided to patients on the Board.  Among others, the Medicare CoPs require the Board to define criteria for and appointing members to the medical staff, grant clinical privileges, ensure the existence and approval of medical staff bylaws, and approve various services in the hospital.  Ultimately, the Board holds the responsibility for the quality of patient care in the hospital.  The Board and medical staff engage to provide effective credentialing, privileging, and peer review and quality management processes.

Although responsibilities provided by the Medicare CoPs are extensive, do not forget to consult your applicable state laws as well as the standards of your accrediting organization, which may dictate further oversight responsibilities of the Board.

April 12, 2018

Posted on by hortyspringer

QUESTION:        Our hospital believes that it has received Medicare Part A and Part B reimbursement to which it is not entitled.  Must the hospital immediately return the money that it owes?

ANSWER:            While the hospital must refund overpayments of Medicare Part A and Part B reimbursement to which it is not entitled, you have 60 days from the date in which you identify the overpayment to refund the money.  However, even the federal government understands that you must be given a certain period of time to accurately identify whether an overpayment has occurred and to quantify the amount of that overpayment.

The Affordable Care Act’s overpayment rule for Medicare Parts A and B went into effect on March 23, 2010.  However, final regulations were not published until February 12, 2016 (the “Overpayment Rule”).  (See, 42 C.F.R. §401.301 to §401.305.)  We should note that the Overpayment Rule described in this response is limited to Medicare Part A and Part B claims.  There is a separate overpayment rule for Medicare Part C and Part D claims.

The Overpayment Rule requires providers to repay any overpayments of Medicare Part A and Part B payments within 60 days of the overpayment being “identified.”  However, the Overpayment Rule does not define exactly when an overpayment has been “identified,” which has caused a certain amount of confusion as to when the 60-day repayment period begins to run.

The Preamble to the Overpayment Rule recognized that the “identification” process will take time.  CMS appears to want to afford providers a certain amount of flexibility and recognizes that part of the identification process is quantifying the amount of the overpayment, which requires a reasonable and diligent investigation.  At the same time, CMS expects providers to use “reasonable diligence” and stated that “a total of 8 months (6 months for timely investigation and 2 months for reporting and retaining) is a reasonable amount of time, absent extraordinary circumstances affecting the provider, supplier or the community.”  However, it should be noted that while this time period was discussed in the Preamble, CMS did not include it in the final Overpayment Rule.

The Overpayment Rule also makes it clear that the repayment period is six years from the date that the overpayment is received.  So, you should see if similar overpayments were made at any time during this six-year look-back period.  The Overpayment Rule then provides that a Self-Disclosure to either the OIG’s Self-Disclosure Protocol or the Stark Self-Referral Disclosure Protocol (“SRDP”) is an exception to the 60-day repayment obligation.  The Overpayment Rule states that if a provider makes a Self-Disclosure to either the OIG or CMS, then no overpayment is due the government until the Self-Disclosure has been resolved (despite the fact that it typically takes years to resolve a Self-Disclosure).

What is important to keep in mind is that once an overpayment has been identified, the hospital must act.  If the hospital knows, or should know, that it has received an overpayment, but fails to repay the overpayment within the 60-day period required by the Overpayment Rule, the hospital could be alleged to violate the False Claims Act.