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Based upon reporting, it appears that the Trump Administration will be issuing an Executive Order adopting the concept of “Most Favored Nations” as it applies to pharmaceuticals. See my prior blogs:

It appears also that there are arguments now being made opposing this concept. The objections focus on reduced profits for the pharmaceutical companies, reduced revenue to provide for Research and Development, and the potential for significant price rises in other countries.

Obviously, continuation of the same level of revenue, in circumstances where the United States would be paying no more than the lowest price charged for a pharmaceutical anywhere else in the world would require the pharmaceutical companies to raise their prices in many other markets. That effectively would allow them to avoid having to decrease prices in the United States, since the disparity in pricing between the United States and other countries would no longer exist as the result of an increase in prices charged in other countries. .Without raising prices charged outside of the United States, pharmaceutical companies will not have the same revenue flow that permits them to experience both the profit level and ability to conduct very expensive research and development which they have historically enjoyed.

The most likely outcome is a combination of all three, that is, that the price in other parts of the world will be raised, the revenue flow that provides for R&D will be reduced, and the profitability of the pharmaceutical companies will decrease.

However, it has reached the point where the American consumer should no longer bear a disproportionate burden of providing a revenue flow for research and development that is enjoyed by the rest of the world.

Further, it will be interesting to see how the cost of the American health care system will compare with those of other systems, if consumers in other countries begin paying higher prices for pharmaceuticals.

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We gratefully acknowledge the valuable assistance provided by Craig Ismaili, third year law student at Washington University, in the preparation of this blog post.

Nearly two years after the passage of the New Jersey Telemedicine Law (N.J.S.A. 45:1-60-64), the various licensing New Jersey state licensing boards have finally begun proposing regulations to implement the statute.

The State Board of Medical Examiners kickstarted the rule proposals by proposing rules for physicians and podiatrists who use telehealth and telemedicine (N.J.A.C. 13:35-6B) on May 6, 2019. The State Board of Marriage and Family Therapy Examiners also proposed rules for art therapists (N.J.A.C. 13:34D-8.2) on the same day.

As of July 1, 2019, the state boards have issued proposed regulations for various licensed professionals, including:

  • midwives (N.J.A.C. 13:35-2A.18 through 2A.26);
  • psychologists (N.J.A.C. 13:42-13);
  • hearing aid dispensers (N.J.A.C. 13:35-8.21 through 8.28)
  • physical therapists and physical therapy assistants (N.J.A.C. 13:39A-10);
  • athletic trainers (N.J.A.C. 13:35-10.26);
  • orthotists, pedorthotists, prosthetists, and their assistants (N.J.A.C. 13:44H-11);
  • psychoanalysts (N.J.A.C. 13:42A-8);
  • psychologists (N.J.A.C 13:42-13);
  • genetic counselors (N.J.A.C. 13:35-14.19 through 14.26);
  • veterinarians (N.J.A.C. 13:44-4A).
  • licensed acupuncturists (N.J.A.C. 13:35-9.21 through 9.28)
  • nurses (N.J.A.C. 13:37-8A)
  • social workers (N.J.A.C. 13:44G-15).

These regulations vary slightly from one licensing board to another, but they all focus on standards of care, licensee-patient relationships, prescriptions, information security, fraud and abuse, and the provision of health care across state lines.

One broad theme that appears throughout each proposed rule is maintenance of the same standard of care as services provided in person. If a licensee they can’t meet this standard, they must advise the patient to see a provider in person. The telemedicine/health provider must use real-time, two-way communication technologies with a video component, unless they believe they can meet the standard of care of in-person services without video. In that case, they can interact using two-way audio along with technology that permits the transmission of images, diagnostics, and medical information. While the regulations set up a distinction between in person and telemedicine standards, they do not set objective metrics for the quality of telehealth and telemedicine to supplement a provider’s subject belief they can meet that standard.

These regulations are also designed to address potential difficulties faced in establishing a provider-patient relationship, because of the remoteness of the digital relationship between provider and patient. In all of the regulations, a licensed telemedicine provider will be required to review their patient’s medical history prior to their first encounter with the patient, though providers may look at the history before or during subsequent interactions. Licensed providers will also be required to provide contact information to a patient, for themselves or another licensee, for at least 72 hours after the provision of services.

Another problem presented by the remote relationship between provider and patient is the scope of prescriptive authority of providers. These regulations allow providers to issue a prescription through telemedicine or telehealth, but providers may not issue the prescription based solely on the responses to an online questionnaire unless they have already established a licensee-patient relationship. Providers may not prescribe Schedule II controlled substances without evaluating the patient in-person first, and after prescribing they must evaluate the patient every three months while the prescription is active. Certain boards have put in place additional restrictions on services offered or prescriptive authority, presumably because of the difficulty of providing the same standard of care remotely. For example, the Acupuncture Examining Board prohibits acupuncturists from prescribing the patient to insert needles into their own body.

Finally, these proposed rules regulate the cross-border practice of telehealth and telemedicine. The proposed regulations require licensees to determine where the patient is located and record that location in the patient’s record. In other words, ignorance of the patient’s location will not be enough to allow providers to provide services to patients in New Jersey without a state license.

If you considering providing telehealth service as a New Jersey licensed provider or are an out-of-state provider and are considering providing telehealth services to patients/residents in New Jersey, please consult with counsel to ensure that the arrangement and you are in compliance with the telemedicine regulations.

All proposed rules include a 60-day comment period, after which the agency proposing the rule can adopt the proposal without change or with changes pursuant to rulemaking procedures. Stay tuned to this blog for any updates or changes made to these regulations before they are adopted.

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Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 16, 2019:

Special Note: June 16, 2019 contained 6 proposed rules to establish telemedicine regulations for various licensed professionals.

  • On June 16, 2019, at 51 N.J.R. 912(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, proposed new rules that establish telemedicine regulations that are applicable to licensed midwives. See N.J.A.C. 13:35-2A.18-2A.26.
  • On June 16, 2019, at 51 N.J.R. 916(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, proposed new rules that establish telemedicine regulations that are applicable to licensed athletic trainers. See N.J.A.C. 13:35-10.26 through 10.33.
  • On June 16, 2019, at 51 N.J.R. 916(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Genetic Counseling Advisory Committee proposed new rules that establish telemedicine regulations that are applicable to licensed genetic counselors. See N.J.A.C. 13:35-14.19 through 14.26.
  • On June 16, 2019, at 51 N.J.R. 926(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners proposed new rules that establish telemedicine regulations that are applicable to licensed physical therapists and licensed physical therapy assistants. See N.J.A.C. 13:39A-10.
  • On June 16, 2019, at 51 N.J.R. 931(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners proposed new rules that establish telemedicine regulations that are applicable to licensed practicing psychologists. See N.J.A.C. 13:42-13.
  • On June 16, 2019, at 51 N.J.R. 946(a), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board of Examiners proposed rules that establish telemedicine regulations that are applicable to licensed orthotists, orthotist assistants, pedorthists, prosthetists, prosthetist assistants, prosthetist-orthotists, and prosthetist-orthotist assistants. See N.J.A.C. 13:44H-11.

Other Rule Proposals and Adoptions:

  • On June 16, 2019, at 51 N.J.R. 911(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners of Ophthalmic Dispensers and Ophthalmic Technicians proposed amendments to its continuing education rules to impose new standards for continuing education courses to require two credits be in statutes and rules governing the practice of ophthalmic dispensing and at least five credits be in topics relevant to the practice of ophthalmic dispensing. The Board also proposed to amend the rule, so that ophthalmic dispensers could take no more than two credits of continuing education in topics related to management, sales, or marketing. Proposed amendments to N.J.A.C. 13:33-6.1 would require newly licensed ophthalmic dispensers to complete one credit of continuing education in blood borne pathogens. During the 2021-2022 biennial renewal period, currently licensed ophthalmic dispensers would also be required to complete one credit in blood borne pathogens. N.J.A.C. 13:33-6.1.
  • On June 16, 2019, at 51 N.J.R. 922(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed to delete N.J.A.C. 13:37-7.2(b), which requires that an applicant for certification as an advanced practice nurse shall have completed his or her education no more than two years prior to submitting an application to the New Jersey State Board of Nursing. The Board has found that several otherwise qualified candidates have not been able to obtain certification due to this requirement. The Board believes that the requirement in N.J.A.C. 13:37-7.1 that applicants hold current certification from a national certifying agency will ensure that applicants are competent to practice as advanced practice nurses in a safe and effective manner, even if they completed their education more than two years ago.
  • On June 16, 2019, at 51 N.J.R. 923(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed a new rule that would authorize and regulate electronic prescriptions by advanced practice nurses to licensed pharmacies. The new rule citation is N.J.A.C. 13:37-7.9B.
  • On June 16, 2019, at 51 N.J.R. 924(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Nursing proposed new regulations at N.J.A.C. 13:37-7.10A that effectuates the statute that permits APNs to dispense narcotic drugs for maintenance treatment or detoxification treatment if he or she has met the training and registration requirements at 21 U.S.C. 823. The APN’s collaborating physician is not required to meet the federal training and registration requirements as long as the joint protocol between the APN and collaborating physician includes the physician’s written approval for the APN to dispense such drugs. The APN is also permitted to prescribe services for the treatment of substance abuse disorder.
  • On June 16, 2019, at 51 N.J.R. 925(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Pharmacy proposed to amend the regulations which set forth criteria for sources of continuing education. The Board proposes to delete the provision which allows a pharmacist to seek Board approval for continuing education credit for attendance at a program or course that is not offered by the American Council of Pharmaceutical Education (ACPE)-approved provider or that has not been pre-approved by the Board.
  • On June 16, 2019, at 51 N.J.R. 930(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners proposed an amendment to the rules governing the continuing education requirements for licensed psychologists that would require one of the 40 required continuing education credits to be on topics concerning prescription opioid drugs every biennial renewal period. These topics would have to include the risks and signs of opioid abuse, addiction, and diversion. The requirement would commence with the biennial renewal period beginning of July, 1, 2019. The proposed amendment is to N.J.A.C. 13:42-10.20(b).
  • On June 16, 2019, at 51 N.J.R. 942(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed a new amendment to regulations that would require a licensed audiologist or licensed speech-language pathologist to complete the online jurisprudence orientation at each biennial license renewal period. See N.J.A.C. 13:44C-4.1.
  • On June 16, 2019, at 51 N.J.R. 943(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed an amendment to the regulations that would prohibit hand-written certificates of completion of continuing education. Under the proposed amended regulation, the certificate of completion shall indicate whether the program, course, seminar or webinar, teleconference, lecture or in-services workshop was presented at the licensee’s place of employment. See N.J.A.C. 13:44C-6.3.
  • On June 16, 2019, at 51 N.J.R. 943(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee proposed an amendment to the scope of practice regulations which would permit a licensed speech-language pathologist to perform Fiber Optic Endoscopic Examination of Swallowing (FEES) when a physician who completed training in endoscopic examinations during post-residency is present. The original rule only allowed FEES to be performed when a physician who was trained in endoscopic exams during residency was present. The proposed amendment would allow for physicians who are trained in residency and post-residency. See N.J.A.C. 13:44C-7.2A.
  • On June 16, 2019, at 51 N.J.R. 945(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Social Work Examiners proposed amendments to continuing education requirements for licensed and certified social workers to require a licensee to complete at least one of the prescribed contact hours of continuing education in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion. This would apply for the biennial period commencing on September 1, 2018. See N.J.A.C. 13:44G-6.2.
  • On June 16, 2019, at 51 N.J.R. 945(b), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board of Examiners proposed a new regulation to establish standards as to when the Board may consider an application for licensure abandoned. An application for a license will be deemed abandoned if an applicant has not submitted all the information and documentation required to obtain a license and one year has elapsed since the last notice was sent to the applicant regarding the deficiencies in his or her application. If an application is deemed abandoned, the Board will close the application without notice and dispose of any information or documentation submitted by the applicant pursuant to the Division of Consumer Affairs’ record retention plan. An applicant whose application has been deemed abandoned may reapply for licensure. See N.J.A.C. 44H-3.5A.
  • On June 16, 2019, at 51 N.J.R. 1056(a), the Department of Human Services, Division of Medical Assistance and Health Services, adopted new regulations that align ambulatory surgery center (ASC) service reimbursement methodology under the Medicaid/NJ Family Care Program to procedure lists and classification systems established by CMS. See N.J.A.C. 10:66-1.5 and 5.1.
  • On June 16, 2019, at 51 N.J.R. 1057(a), the Department of Banking and Insurance adopted a notice of readoption of regulations that establish the admission procedures and financial reporting requirements that are necessary to implement N.J.S.A. 17:47B-1 et seq., which governs Captive Insurance Companies. See N.J.A.C. 11:28.
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Here are the most recent health care related regulatory developments as published in the New Jersey Register on June 3, 2019:

  • On June 3, 2019, at 51 N.J.R. 877(a), the Department of Human Services, Division of Medical Assistance and Health Services, readopted the rules at N.J.A.C. 10:54, Physician Services. The rules provide the standards for approval of physicians as independent providers of services, within their licensed scope of practice, to New Jersey Medicaid/NJ FamilyCare fee-for-service beneficiaries. The rules also identify covered and non-covered physician services under the fee-for-service Medicaid/NJ FamilyCare program. DMAHS has identified the need for amendments to the rules. However, they were too significant for the readoption. The anticipated amendments may include substantive and technical amendments to the chapter to either implement, or memorialize compliance with, the provisions of Federal and State regulatory requirements, including, but not limited to, the Patient Protection and Affordable Care Act (PPACA). Once the review is completed, a separate rulemaking containing proposed amendments will be published in the New Jersey Register. The readopted rules would stay in effect for a seven year period.
  • On June 3, 2019, at 51 N.J.R. 878(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments at N.J.A.C. 13:35-2-A, relating to the limited licenses of midwives. There are new definitions of “certified midwife,” “certified nurse midwife” and “consulting physician.”
  • On June 3, 2019, at 51 N.J.R. 880(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to the rules regarding the CME requirements. The amended regulations specify required CME topics for the 100 CME credits to be completed by licensees in two categories of CME credits (Category I and Category II). Two (2) of the 40 Category I credits must be a program or topic related to end-of-life care and one (1) of the 40 Category I credits must be in program or topic concerning prescription opioids, including responsible prescribing practices, alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion. (N.J.A.C. 13:35-6.15)
  • On June 3, 2019, at 51 N.J.R. 894(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy Examiners adopted certain amendments to N.J.A.C. 13:39 permitting wound debridement by physical therapists only after communication with patient’s physician or podiatrist and permits general supervision of physical therapy assistants by physical therapists. General supervision requires that a physical therapist is available at all times by telecommunications but is not required to be on-site for direction and supervision.
  • On June 3, 2019, at 51 N.J.R. 897(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Social Work Examiners adopted an amendment correcting N.J.A.C. 13:44G-8.1 to correct an internal reference in the Clinical Supervision section.
  • On June 3, 2019, at 51 N.J.R. 897(b), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to N.J.A.C. 13:45A-35 to require the permanent inclusion of gabapentin to the list of prescriptions on the PMP list that must be electronically transmitted to the Division by New Jersey licensed pharmacies and registered out-of-State pharmacies.
  • On June 3, 2019, at 51 N.J.R. 899(b), the Commissioner of the Department of Health published a notice that postponed the certificate of need call for applications for transplantation.
  • On June 3, 2019, at 51 N.J.R. 899(c), the Department of Health, Public Health Services Branch, Division of Medicinal Marijuana issued a Request for Applicants for entities that seek authority to apply for a permit to operate an alternative treatment center.
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Here are the most recent health care related regulatory developments as published in the New Jersey Register in May, 2019:

  • On May 6, 2019, at 51 N.J.R. 543(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Art Therapist Advisory Committee proposed regulations to adopt licensing standards and regulations for art therapists. The new rules would be codified at N.J.A.C. 13:34D-1.1 et. seq.
  • On May 6, 2019, at 51 N.J.R. 561(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed rule amendments and new rules addressing telehealth and telemedicine provided by physicians and podiatrists. The proposed regulations require physicians and podiatrists to hold a Board-issued license if they are physically located in New Jersey and are providing health care services by means of telemedicine or telehealth, or if they are physically located outside of New Jersey and are providing health care services by means of telemedicine or telehealth to patients located in New Jersey. The proposed new rule also states that a healthcare provider in another state who uses communications technology to consult with a New Jersey licensee and who is not directing patient care will be deemed as not providing health care services in New Jersey and will not be required to obtain a license in New Jersey. There are also proposed regulations that address standard of care, establishment of licensee-patient relationships, prescriptions, medical records, HIPAA compliance, and establishment of protocols to prevent fraud and abuse.
  • On May 20, 2019, at 51 N.J.R. 709(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Marriage and Family Therapy Examiners, Alcohol & Drug Counselor Committee proposed rule amendments to require State licensed clinical alcohol and drug counselors to hold a current Certified Clinical Supervisor (CCS) credential from an International Certification Reciprocity Consortium (ICRC) member board (a certification authority that is a member of the International Certification Reciprocity Consortium of Alcohol and Other Drug Abuse, Inc., a credentialing organization) in order to be deemed a qualified clinical supervisor. The public comment period closed on July 20, 2018. There are substantial changes proposed to N.J.A.C. 13:34C-6.2, 6.2A and 6.3.
  • On May 20, 2019, at 51 N.J.R. 713(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners proposed a new subsection to permit licensees to obtain up to 10 hours of CME credits by providing medical care outside of their offices to low-income patients. Licensees will obtain one continuing education credit for every two hours spent providing such care. Proposed new subsection specifies that credit hours obtained by providing volunteer medical services will not count towards the 40 credit hours required in Category I courses. Under the new subsection, the Board would have the authority to deny a licensee the opportunity to obtain credits through volunteer medical services if the licensee has to complete continuing education credit hours to maintain competence or to address developments in science or technology. The rule proposal would amend N.J.A.C. 13:35-6.15.
  • On May 20, 2019, at 51 N.J.R. 714(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners, Hearing Aid Dispensers Examining Committee proposed new rules to effectuate the telemedicine statute and to provide rules for hearing aid dispensers at N.J.A.C. 13:35-8.21-8.28. The proposed regulation states that a hearing aid dispenser must hold a license issued by the Hearing Aid Dispensers Examining Committee if he or she (1) is located in New Jersey and provides health care services to any patient located in or out of New Jersey by means of telemedicine or telehealth; or (2) is located outside of New Jersey and provides health care services to any patient located in New Jersey by means of telemedicine or telehealth. Notwithstanding the foregoing, a healthcare provider located in another state who consults with a licensee in New Jersey through the use of information and communications technologies, but does not direct patient care, will not be considered as providing health care services to a patient in New Jersey and will not be required to obtain licensure in New Jersey in order to provide such consultation.
  • On May 20, 2019 at 51 N.J.R. 732(a), the Department of Health, Public Health Services Branch, Division of Medicinal Marijuana readopted with amendments the medical marijuana rules at N.J.A.C. 8:64. The amendments included amended N.J.A.C. 8:64-5.1, which would allow the public to petition for additional “debilitating medical conditions” and permit the Commissioner to establish additional “debilitating medical conditions” outside of the petition-making process.
  • On May 20, 2019, at 51 N.J.R. 769(a), the Department of Law and Public Safety, Division of Consumer Affairs, Occupational Therapy Advisory Council adopted amended and new rules. The new rules address eligibility, licensure procedures, temporary licenses, scope of practice, supervision, general obligations, professional conduct, professional records and fees. The rules are located at N.J.A.C. 13:44K Subchapter 2.
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The State of Florida has passed legislation authorizing the residents of the State of Florida to be able to order and receive prescription medicine from locations outside of the United States. What is undisputed is the fact that many prescriptions are cheaper in many other countries, if not all other countries, than they are in the United States.

The risk involved is whether or not those prescription drugs, that are ordered from other places than the United States, will meet the safety standards set for drugs within the United States. Even in those circumstances where the drugs originate in the United States and are shipped to a foreign country, there is a risk as to whether or not their handling complies with the necessary requirements to assure no contamination.

This problem can be avoided if we were, as I pointed out in prior blogs (https://njhealthcareblog.com/2018/12/19/pharmaceuticals/; https://njhealthcareblog.com/2018/11/08/pharmaceutical-pricing-update-to-may-17-2018-blog/; http://njhealthcareblog.com/2018/05/17/pharmaceutical-pricing/), to adopt a Most Favored Nations approach.  Under that approach, you would not need to buy prescription drugs outside of the United States, since the price of such prescription drugs, within the United States, would be equal to the lowest price in any other location.  This approach eliminates a number of issues that would confront the consumer.

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This is a continuation of our attempt to analyze the various single payor health care proposals that are being made during this election cycle. A possible model, irrespective of how it is characterized or described, is the single payor model used by the Veterans Administration (hereinafter “VA”).  That is a possible model because it uses a federal budget-driven approach.  If the government is going to provide health care, it is going to have to have a statutory, as well as budgetary, structure under which that health care will be provided.

It is not clear from any of the discussions of a single payor system so far, whether or not the actual provider of the health care will be a government employee or will be a government contractor. If the government is the sole payor either by regulation or by contract, it will be making arrangements with various providers (whether they are hospitals, ambulatory care centers, nursing homes, physicians or other health care providers) for the provision of care to those covered by the government program.

If it is a budgetary-driven program, then the structure and incentives need to be examined and may significantly impact the actual delivery of the care. For instance, if the program provides $X, then the incentives for those administering the program will be to be able to deliver as much care as possible, to as many people as possible, within the budgetary constraints.  That creates significant alternatives to those administering the program.  It may be that there are tradeoffs between the quality and the quantity of care that the program is able to provide under the budgetary constraints.  The more care that a provider can provide at a particular cost level, the more likely it will be that an increased number of patients can receive that care.  So a tradeoff may result between trying to avoid providing the most expensive care (which may limit the amount of care that can be provided), versus providing a less expensive alternative that would provide an opportunity to provide a greater amount of care to a greater number of people.

It also is not clear what the level of costs may be and whether or not certain administrative elements and their associated costs can be eliminated for various health care providers. Will they be provided a lump sum to take care of a population, which could eliminate billing and the costs associated with billing and collections, or will there be some other alternative which would require them to bill for the services?

There is also the possibility that the care will be provided by government employees at government institutions, as is done, to a large extent, by the VA today. Currently, many of the physician caregivers at the government institutions are not employees of the government, but are contractors and paid accordingly.

If one were to look at the VA, one could see issues regarding the number of patients who are waiting for care and, of course, the widely reported “scandals” involving the long waiting lists for care at various VA locations. If there is no copay and no payment for the care on the part of the patient, then what will the mechanism be under which a person will decide that they need care?  What will be the mechanism to allocate resources to determine who actually will receive the care versus who will not receive the care?  That is an issue that is currently facing the VA and certainly might be an issue facing any system of government-provided health care.

There is also the question of who determines which providers can provide care to an individual patient. Supporters of the Affordable Care Act made the statement that “if you like your doctor, you can keep your doctor.” In some instances, this turned out to be incorrect.  The question for any government-run program, will be how will the government allocate patient access to various providers.

So far, these questions have neither been asked nor addressed. They are critical to any analysis of a single payor health care system.

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According to the Henry K. Kaiser Foundation, 33% of all Medicare beneficiaries are enrolled in a Medicare Advantage Plan.  https://www.kff.org/tag/medicare-advantage/.  A previous blog post [http://njhealthcareblog.com/2019/03/13/health-care-issues-2020-election/] authored by Frank Ciesla provides a summary of the different Medicare plans. This blog post will give you a sense of Medicare Advantage.

Medicare Part C Coverage is called “Medicare Advantage” or “MA”.  The MA is an alternative to traditional Medicare.  It is a private health plan, such as an HMO or PPO, which includes all Medicare-covered Part A and Part B benefits, except hospice services.  MA Plans also may provide supplemental benefits, such as vision and dental care, podiatry, chiropractic services and gym memberships. The Medicare Advantage Plan receive payments from the federal government to provide all Medicare covered benefits to enrollees. For each person who chooses to enroll in a Part C Plan, Medicare pays the plan a set amount every month without regard to the actual number and nature of services used by the member (“capitation”). The organizations contracted to offer Medicare Advantage benefits must meet Medicare conditions of participation requirements and are required to report data to CMS on a variety of measures.

Before enrolling into a MA plan, the beneficiary must enroll in Medicare Parts A and B.   Each MA plan can charge different out-of-pocket costs and can have different rules for how a recipient gets services, such as whether a recipient must have a referral to see a specialist or if the recipient has to go to doctors, facilities, or suppliers that belong to the plan for nonemergency or non-urgent care. Plans are required to use any additional payments to provide “supplemental benefits” to enrollees in the form of lower premiums, lower cost sharing, or benefits and services not covered by traditional Medicare. Supplemental benefits are interpreted by CMS as being items or services (1) not covered by traditional Medicare, (2) that are primarily health related, and (3) for which the MA plan must incur a direct medical cost.

In April 2018, CMS issued a Call Letter (2019 Final Call Letter) which discusses a reinterpretation of the statute to expand the scope of the primarily health related supplemental benefits standard.  Under the new interpretation, CMS would allow supplemental benefits if they are used to diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional/psychological impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.  Supplemental benefits must be medically appropriate and recommended by a licensed provider as part of a care plan if not directly provided by one.

Starting in 2019, Medicare Advantage plans have the option to build in some supplemental benefits that fall into the realm of home and community-based long-term care. Some of the new long-term care options include adult day-care services, in-home assistance with custodial care or activities of daily living, respite care benefits for caregiver home safety modifications like bathroom grab bars, wheelchair ramps, and stair rails, non-emergency transportation services so that members can get to their doctor’s appointments and in-home meal delivery. Before we get excited for Uber/Lyft or DoorDash we will need to wait and see whether these are covered services under MA plans that are offered in New Jersey.

2019 Call Letter: https://www.cms.gov/MEDICARE/HEALTH PLANS/MEDICAREADVTGSPECRATESTATS/DOWNLOADS/ANNOUNCEMENT2019.PDF.

2020 MA Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/2020-medicare-advantage-and-part-d-rate-announcement-and-final-call-letter-fact-sheet

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Here are the most recent health care related regulatory developments as published in the New Jersey Register in April, 2019:

  • On April 1, 2019, 51 N.J.R. 452(a), the Department of Human Services, Division Of Medical Assistance and Health Services proposed amendments to N.J.A.C. 10:74, Managed Health Care Services for Medicaid and NJ FamilyCare Beneficiaries. The proposed readoption regulates the enrollment of Medicaid and NJ FamilyCare beneficiaries into managed care as a health care delivery system and the provision of services by a managed care organization (MCO) to these beneficiaries. Notably, there are new proposed definitions of “Comprehensive Waiver” and “MLTSS”.
  • On April 1, 2019, 51 N.J.R. 473(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Optometrists adopted amendments to N.J.A.C. 13:38-7.3, requiring optometrists to complete, at a minimum, one credit for educational programs or topics that concern the prescription of hydrocodone, or the prescription of opioid drugs in general, including responsible prescribing practices, the alternatives to the use of opioids for the management and treatment of pain, and the risks and signs of opioid abuse, addiction, and diversion.
  • On April 1, 2019, at 51 N.J.R. 481(a), the Department of Banking and Insurance, Division of Insurance, Office of the Commissioner published a notice regarding the minimum deposit requirements for Health Maintenance Organizations (HMOs) and 3.3% increase in the medical component of the CPI for all urban consumers in the New York-Northern New Jersey-Long Island region and the Philadelphia-Wilmington-Atlantic City region as reported by the United States Department of Labor, Bureau of Labor Statistics Existing HMOs shall make adjustment for their minimum net worth no later than July 1, 2019. The required deposit shall be made no later than July 1, 2019, pursuant to N.J.A.C. 11:24-11.4(e) to include the specific CPI adjustment.
  • On April 1, 2019, at 51 N.J.R. 481(b), the Department of Banking and Insurance, Division of Insurance, Office of the Commissioner published a notice regarding the minimum net worth requirements for Health Maintenance Organizations (HMOs) and 3.3% increase in the medical component of the CPI for all urban consumers in the New York-Northern New Jersey-Long Island region and the Philadelphia-Wilmington-Atlantic City region as reported by the United States Department of Labor, Bureau of Labor Statistics Existing HMOs shall make adjustment for their minimum net worth no later than July 1, 2019. The required deposit shall be made no later than July 1, 2019, pursuant to N.J.A.C. 11:24-11.4(e) to include the specific CPI adjustment.
  • On April 15, 2019, at 51 N.J.R. 501(b), the Department of Banking and Insurance, Division of Insurance, Office of the Commissioner adopted amended rules regarding permissible network deductibles and network coinsurances in contracts issued by HMOs that provide out-of-network benefits for emergency and urgent care. See rule at N.J.A.C 11:22.
  • On April 15, 2019, at 51 N.J.R. 509(a), the Department of Health, Office of the Commissioner published a notice of cancellation of a certificate of need call for new specialized long-term care beds for severe behavior management. The call for CN applications was scheduled for January 2, 2019.The Department has determined there is not a need for new specialized long-term care beds for severe behavior management at this time. On January 2, 2018, the Department had issued a certificate of need call for additional specialized long-term care beds for severe behavior management at 50 N.J.R. 260(b). In response to this call, the Department received applications from several applicants, which are currently under review by the Department. The next scheduled call for new specialized long-term care beds for severe behavior management will be January 2, 2020. The Department will continue to monitor the utilization and availability of specialized long-term care beds for severe behavior management and, should the need arise, issue a future call for these services prior to January 2, 2020.
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Here are the most recent health care related regulatory developments as published in the New Jersey Register in March 2019:

  • On March 4, 2019, at 51 N.J.R. 363(b), the Higher Education Student Assistance Authority adopted rules regarding partial tuition reimbursement for medical students that pursue a residency in psychiatry and agree to practice full-time as a psychiatrist in an underserved area in New Jersey and/or in a State psychiatric hospital for a period of one to four years in return for the tuition reimbursement provided under the reimbursement program. The participant may not be simultaneously participating in either the Primary Care Practitioner Loan Redemption Program, or in the Federally administered National Health Service Corps Loan Repayment Program. The rule citation is N.J.A.C. 9A:10-3.
  • On March 18, 2019, at 51 N.J.R. 409(a), the Department of Community Affairs, Office of the Commissioner, readopted the rules related to the DCA regarding government records. The rules were readopted without amendment. The rule citation is N.J.A.C. 5:3.

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