Medicare

March 22, 2018

Posted on by hortyspringer

QUESTION:        A patient is asking the hospital staff to allow him to use medical marijuana that he obtained in compliance with state law.  Should we let him?

ANSWER:            This is a tough question especially in light of the recent, increased, legal acceptance on a state level of both medical and recreational marijuana.  The patient in the question is claiming that he obtained the medical marijuana in compliance with state law.  In such a situation, you should ask yourself a number of questions.  First, does your state law protect facilities or staff that permit medical marijuana use?  For example, Maine law states that hospitals and staff members will not be liable for facilitating the use of medical marijuana by certified, admitted patients, as long as the marijuana is not smoked or vaped.  Second, does your state law require a hospital to accommodate a patient’s use of medical marijuana?  Minnesota has a law on the books that says, in part, “no [health care] facility shall unreasonably limit a patient’s access to or use of medical cannabis to the extent that use is authorized by the patient.”

Even if the answer to these first two questions is “yes,” you have to ask yourself if you are willing to accept the legal risk under federal law.  Marijuana is a Schedule 1 controlled substance under the federal Controlled Substance Act.  Regardless of state laws to the contrary, it is still a violation of federal law to manufacture, possess or prescribe marijuana for either medical or recreational purposes.  The Medicare Conditions of Participation (“COPs”) for hospitals state “drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.”  The COPs do not anticipate that Schedule 1 controlled substances will be stored or distributed in hospitals.  The applicable regulations and the Interpretive Guidelines to the COPs only refer to Schedule 2-5 substances.

Some hospitals have accepted the risk and permit patients to bring their own medical marijuana into the hospital for administration.  At least one of those hospitals has put the following safeguards in place:

  • Hospital staff (such as nurses and pharmacists) are not permitted to assist with dispensing or administering medical marijuana. The drug must be self-administered.
  • The hospital is required to verify that the patient is registered with the state’s medical marijuana program.
  • The hospital must provide a safe for the storage of medical marijuana in the patient’s room. Hospital employees do not access the safe or handle the medical marijuana at any time.
  • The medical marijuana must be in liquid or capsule form, and must have been provided by an in-state dispensary.

That being said, such safeguards do not protect you from CMS disapproval or sanctions.  Although it is a fascinating topic with numerous legal issues to consider, the fact is that marijuana continues to be a Schedule 1 drug under federal law.  Consequently, there is risk that CMS could take action based on the COPs.

September 7, 2017

Posted on by hortyspringer

QUESTION:        I heard that CMS is planning to cancel its upcoming episode payment models.  Is this true?

ANSWER:            Yes.  In mid-August, CMS issued a proposed rule that would cancel its upcoming episode payment models (“EPMs”) and cardiac rehabilitation incentive payment model.  The rule also proposed revisions to the existing Comprehensive Care for Joint Replacement model (“CJR program”).  This proposal marks a significant change of course for the agency’s regulatory agenda, given that CMS had previously expressed an intent only to delay these models, not cancel them outright.

The upcoming EPMs would have affected Medicare beneficiaries undergoing services related to acute myocardial infarctions, coronary artery bypass grafts, and surgical hip/femur fracture treatment.  The rule has not been finalized, so the ultimate fate of these payment models remains uncertain.  CMS will continue to accept comments (as part of the standard notice and comment rulemaking process) on this proposal until October 16, 2017.

If the proposed rule is finalized, it will also give hospitals participating in the CJR program a one-time opportunity to exit the program.  This is likely the beginning of a future trend away from mandatory payment models (such as the CJR program) in favor of voluntary value-based payment programs.

We continue to recommend that you build flexibility into your planning processes to account for this uncertainty in CMS’s rulemaking activities.

The proposed rule is available here.

June 15, 2017

Posted on by hortyspringer

QUESTION:        What’s this I hear about the penalties for EMTALA violations being doubled?  Haven’t we suffered enough?

ANSWER:            I agree about the suffering, but sorry, that’s not going to affect the doubling of the EMTALA civil monetary penalties.

As difficult as EMTALA can be, until a few months ago, it had actually been years since the federal government issued a new EMTALA regulation, guideline or bulletin.  But that’s not a complaint; EMTALA compliance is difficult enough with the existing rules, let alone any new ones.

So it’s interesting that the Office of Inspector General (the “OIG”) came out in December 2016 with some new regulations.  The OIG revised its regulations concerning penalties, including civil monetary penalties (“CMPs”), that it can impose for EMTALA violations.  These new rules were released in the OIG’s Final Rule concerning Medicare and State Health Care Programs; Fraud and Abuse; and Revisions to the OIG’s CMP Rules.

These new OIG regulations didn’t create new EMTALA responsibilities to be carried out.  Instead, they simply addressed the OIG’s penalty rules.  The most eye-popping of these concern the amount of the CMPs, now adjusted per inflation.

By the Act itself, which went into force in 1986, the OIG can fine hospitals with 100 beds or more and physicians up to $50,000 per EMTALA violation.  Hospitals under 100 beds can be fined $25,000 per violation.

Noting that those figures have never been adjusted for inflation over the past 30-plus years, the OIG adjusted.  Now, hospitals with 100 beds or more and physicians can be fined up to $103,139 per violation.  Hospitals under 100 beds can be fined up to $51,570 per EMTALA violation.

The OIG did not revise the EMTALA-stated penalty amounts themselves; the EMTALA regulations still describe CMPs for $50,000 and $25,000.  This is an inflation-adjusted increase detailed in another HHS-published document regarding CMPs.  (A $50,000 penalty doesn’t get you as much in 2017 as it did back in 1986.)

The OIG has not suddenly become “penalty hungry” when it comes to hospitals, on-call physicians, and other EMTALA matters.  The OIG suggested these clarifications in proposed regulations it issued back in May 2014.  Both the Affordable Care Act and the Medicare Prescription Drug, Improvement and Modernization Act enhanced the OIG’s authority to impose CMPs and to exclude individuals from participating in federal health care programs.  This was the OIG taking advantage of those two statutes to clean up and clarify its EMTALA penalty rules.

As the new CMPs basically double the penalty amount, it’s also important to understand that the OIG’s CMPs apply to each EMTALA violation, and a hospital or a physician can violate EMTALA more than once in the care of a single patient.  It’s not uncommon for an EMTALA wrongdoing to include multiple violations.  With CMPs of now roughly $100,000 per EMTALA violation, a hospital can find itself with the potential for some pretty stiff fines.

April 27, 2017

Posted on by hortyspringer

QUESTION:        Our hospital policies allow almost anyone to order outpatient services, regardless of whether they are a member of the Medical Staff or not.  Is this a problem?

ANSWER:            This poses compliance issues under the Medicare Conditions of Participation (“CoPs”).  The CoPs only allow outpatient services to be ordered by practitioners who meet certain conditions.  The ordering practitioner must be (1) responsible for the patient, (2) licensed in the state where he or she provides care to the patient, (3) acting within his or her scope of practice under state law, and (4) authorized by state law and policies adopted by the Medical Staff (with approval from the governing body) to order the applicable outpatient services.

Your Medical Staff policies can reflect a determination as to whether practitioners who are not on your Medical Staff are permitted to order outpatient services.  However, these policies must address how you will verify that the referring/ordering practitioner meets the requirements in the CoPs.  You will need to keep documentation to show that you have complied with the CoPs (e.g., documents showing that you checked the ordering practitioner’s license).

If you permit allied health professionals not affiliated with your hospital to order outpatient services, you may have to do a significant amount of work.  Be sure to check their scope of practice to make sure they are permitted to order the service in question.  In addition, be sure to follow the laws of your own state!

You may decide that certain orders should be permitted only by individuals with specific hospital privileges.  The Interpretive Guidelines give the example of requiring practitioners to have hospital privileges before they can place an order for outpatient chemotherapy services.  If you do this, be sure to delineate these terms clearly in your policies.

September 8, 2016

Posted on by hortyspringer

QUESTION:         An HMO that our hospital is negotiating a contract with is insisting on language that would require all of our board members and employees to receive specific “fraud, waste and abuse” training applicable to Medicare Parts C and D. Do we have to agree to this?

ANSWER:            Not if you are a hospital. Federal regulations at 42 C.F.R. §§422.503 and 423.504 specify the requirements for Medicare Advantage Organizations and Prescription Drug Plan Sponsors to implement an effective compliance program. This includes a requirement that so-called “first tier, downstream and related entities” (“FDRs”) satisfy general compliance program training requirements, as well as fraud, waste, and abuse training.

However, FDRs enrolled in Medicare Part A or B (like hospitals) or accredited as suppliers of DMEPOS are exempt from FWA training and education certification requirements, but not the general compliance training requirement.

For more information, see the CMS website, at https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ComplianceProgramPolicyandGuidance.html

March 17, 2016

Posted on by hortyspringer

QUESTION:        Occasionally, a physician on our medical staff will want to treat a family member.   Medical staff leadership does not think this is a good idea, but we have not expressly addressed this in any of our documents.  If we allow it, can the physician bill for the services he provides to a family member?

ANSWER:           The American Medical Association (“AMA”) has taken a strong stance against the treatment of family members by a physician.  The AMA’s Opinions on Practice Matters, E-8.19 Self?Treatment or Treatment of Immediate Family Members, includes the following statement:

Physicians generally should not treat themselves or members of their immediate families. Professional objectivity may be compromised when an immediate family member … is the patient; the physician’s personal feelings may unduly influence his or her professional medical judgment, thereby interfering with the care being delivered. Physicians may fail to probe sensitive areas when taking the medical history or may fail to perform intimate parts of the physical examination. Similarly, patients may feel uncomfortable disclosing sensitive information or undergoing an intimate examination when the physician is an immediate family member…. If tensions develop in a physician’s professional relationship with a family member, perhaps as a result of a negative medical outcome, such difficulties may be carried over into the family member’s personal relationship with the physician….

Since this issue has come up, or even if it hasn’t, we recommend that you add language to your rules and regulations to address it.

With respect to your second question, it is important for physicians to know that they cannot bill Medicare for services provided to family members. Medicare policy clearly states that the treatment of certain family members is not to be reimbursed by Medicare or any Medicare Advantage program.  The following relationships are included in the definition of family members:

  • Husband and wife;
  • Natural or adoptive parent, child, and sibling;
  • Stepparent, stepchild, stepbrother, and stepsister;
  • Father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, and sister-in-law;
  • Grandparent and grandchild; and
  • Spouse of grandparent and grandchild.

While this is a Medicare policy, many other insurance companies have adopted this as part of their contractual policies with providers.

July 2, 2015

Posted on by hortyspringer

QUESTION:        We are in the process of buying a Medicare provider. Can you provide any guidance on Medicare’s Change of Ownership (“CHOW”) process?

ANSWER:             Yes. Medicare has made it practically impossible to acquire any provider without assuming that provider’s Medicare Provider Number. As a result, you will have to follow Medicare’s CHOW process.

The CHOW process requires both the Seller and the Buyer to complete a CMS Form 855-A for each Medicare Provider Number. (It is not unusual for one provider to have several Medicare Provider Numbers.) You will also need to obtain a new NPI number that will correspond to each Medicare Provider Number.

The Buyer and the Seller’s completed Forms, 855-A, with all attachments, must be sent to the Medicare Contractor. Please be sure to provide all information requested in the required format. When they ask for a zip code +4 or the date in an mm/dd/year format, they mean it! If you have to provide any supplemental information, then you also have to have a new certification statement (Section 15 of Form 855-A) signed and dated by an “Authorized Official.” An “Authorized Official” is defined in the 855-A as an individual who has the authority to make the changes in that submission and to commit the Buyer to fully abide by the statutes, regulations and program construction of the Medicare Program.

Once the Medicare carrier approves the application, it will be sent to CMS’s Regional Office for their review and comment. Once approved, the Regional Office will issue an approval to the provider, the Medicare Contractor and the State.

This process takes time, so plan accordingly. Also since the Buyer will be assuming the Seller’s provider number, the acquisition agreement should address the rights of the Buyer in the event of an overpayment that was caused by the Seller’s pre-closing operation of the provider but is not discovered until after the Closing Date.

Did you notice how many of this week’s cases involved employed physicians? We did!

Please join Henry, Charlie and Rachel in Las Vegas on October 15-17 for the Institute on Employed Physicians and Their Impact on the Medical Staff.