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State Board of Health Regulations are Fundamentally Flawed

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by

sherlockj
in ,

by James C. Sherlock

The Northam administration has a robust program for regulation review. It is time to use it to totally overhaul Virginia’s healthcare regulations.

Healthcare facilities and providers in Virginia are subject to dueling regulations — one set for state licensure and another for Medicare/Medicaid certification.

Virginia’s regulations in these cases are not just a waste of time on the government side. The administrative burden on healthcare providers is heavy and entirely unnecessar,y and the regulations violate both Virginia law and the Governor’s executive order on regulations.

It is expensive, counterproductive and in some cases illegal under Virginia law for Virginia to have different regulations for the same facilities and providers, yet we do.

Code of Virginia § 32.1-127.

Virginia regulations must be changed to conform to federal Medicare and Medicaid regulations for long-term-care facilities to comply with the clear direction of Code of Virginia § 32.1-127. That law requires that Virginia regulations for hospitals and nursing homes “conform” to “health and safety standards established under provisions of Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act.”

For example, virtually all of Virginia’s hospitals and hospices and 95% of Virginia’s nursing facilities are certified providers of Medicare or Medicaid or both.

Governor Northam’s Executive Order number 14, Development and Review of State Agency Regulations.

Compliance with that Executive Order, which sets out procedures and requirements to ensure the efficiency and quality of Virginia’s regulatory process, demands changes in Virginia’s current healthcare regulations.

Federal Healthcare Regulations duplicated in the Virginia Administrative Code

Code of Federal Regulations Title 42 – Public Health, Chapter IV Subchapter G – Standards and Certification, contain Medicare and Medicaid regulations for every type of healthcare facility and provider. Examples include Parts:

  • 482 (Hospitals),
  • 483 (States and Long Term Care Facilities),
  • 484 (Home health services),
  • 485 (Conditions of participation: Specialized workers),
  • 486 (Conditions for coverage of specialized services furnished by suppliers),
  • 488 (Survey, certification and enforcement),
  • 489 (provider agreements and supplier approval),
  • 491 (Rural Health clinics),
  • 493 (Laboratory requirements),
  • 494 (End-stage renal facilities),
  • 495 (Electronic health record technology incentive program), and
  • 600.1 SubPart B (Establishment and Certification of State Basic Health Programs)

An Example – Nursing Home Regulations

42 Code of Federal Regulations (CFR) Part 483 – Requirements for States and Long Term Care Facilities regulates Medicare and Medicaid certification pursuant to Title XVIII and Title XIX requirements.

12 VAC 5-371, Rules and Regulations for the Licensure of Nursing Facilities contains Virginia licensure regulations for the same facilities.

The Virginia licensure regulations not only do not conform to their federal certification counterparts, but are weaker across the board.

Ninety-Five percent of Virginia NFs and SNF’s seek certification for Medicare and/or Medicaid and thus must comply with the more stringent federal regulations.

There is no reason that Virginia regulations for licensing the other 5% should be different, and by Virginia law they may not be.

Recommendations

The Commonwealth will be well served if all relevant federal Medicare/Medicaid regulations are incorporated by reference into the Virginia Administrative Code and the parallel Virginia regulations deleted.

Any Virginia-specific regulations not covered by federal regulations or state waivers authorized in federal regulations can be provided as an addendum to the incorporated federal reference.

Budget Savings

These changes will save the work and its costs that have historically been expended in drafting, seeking public comments, resolving disagreements and approving and then periodically reviewing Virginia licensure regulations that are, in the main, at best irrelevant and at worst confusing. The positions engaged in this work can be eliminated.

It will also save a tremendous amount of administrative work for the medical care providers no longer having to comply with one set of regulations for state licensure and another for Medicare/Medicaid certification.

Bottom Line

There is no principled reason to object to creating the conformity that Virginia law demands.

The only opposition could possibly be from organizations who calculate that they benefit financially from Virginia regulations that are weaker than their federal counterparts.

On that note, a major advantage not measurable in dollar terms will be the de-politicalization of the health care regulatory process in the General Assembly and the Department of Health.

The changes can be made quickly and easily, and should be accomplished immediately.

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Comments

21 responses to “State Board of Health Regulations are Fundamentally Flawed”

  1. djrippert Avatar
    djrippert

    And yet, despite the massive (and redundant) regulatory regime we still make critical unforced errors like letting hospitals discharge patients back to nursing homes without COVID-19 tests.

    https://www.virginiamercury.com/2020/07/07/virginia-still-allows-hospitals-to-move-some-patients-to-nursing-homes-without-covid-19-testing-despite-pleas-from-providers/

    1. sherlockj Avatar
      sherlockj

      You are talking about the administration of regulations. VDH is utterly incompetent on that score. That department has an uninterrupted record of failure.

  2. LarrytheG Avatar
    LarrytheG

    I see this kind of thing at the local level also.

    We’ll see the County lawyer step up and say that some county code language has to be changed to conform to changes in the State code.

    And I’ve notice with some DEQ regs that they have to conform to EPA language or else the EPA language controls. For instance, on Chesapeake Bay regs… there is Federal then each state promulgates their own in conformity with umbrella EPA rules.

    I don’t know if this is the same thing Jim is talking about or not but it’s totally true – if you’re doing something that involves Fed and State rules, you better get a professional because there are so many moving parts.

  3. djrippert Avatar
    djrippert

    And yet, despite the massive (and redundant) regulatory regime we still make critical unforced errors like letting hospitals discharge patients back to nursing homes without COVID-19 tests.

    https://www.virginiamercury.com/2020/07/07/virginia-still-allows-hospitals-to-move-some-patients-to-nursing-homes-without-covid-19-testing-despite-pleas-from-providers/

    1. sherlockj Avatar
      sherlockj

      You are talking about the administration of regulations. VDH is utterly incompetent on that score. That department has an uninterrupted record of failure.

  4. LarrytheG Avatar
    LarrytheG

    I see this kind of thing at the local level also.

    We’ll see the County lawyer step up and say that some county code language has to be changed to conform to changes in the State code.

    And I’ve notice with some DEQ regs that they have to conform to EPA language or else the EPA language controls. For instance, on Chesapeake Bay regs… there is Federal then each state promulgates their own in conformity with umbrella EPA rules.

    I don’t know if this is the same thing Jim is talking about or not but it’s totally true – if you’re doing something that involves Fed and State rules, you better get a professional because there are so many moving parts.

  5. sherlockj Avatar
    sherlockj

    Cutting the number of regulations by 50% by eliminating the Virginia counterparts of federal regulations makes sense to everyone but the lobbyists and the politicians they fund.

    Doing just that would contribute mightily to the integrity of state government. I can think of no other step other than state campaign finance limits that would make such a difference.

    1. Nancy_Naive Avatar
      Nancy_Naive

      You could indeed simply use federal regulation and eliminate any duplicate state regulations that don’t involve specific modifications, e.g., fed requires reporting to CDC, and the state mod requires VDH too.

      But then, the drawback is constant monitoring of the federal regulations for a change to determine any undesirable effects on what the state wants.

      Sadly, having duplicate regulations means the state has to do less work even if it means the regulated party has to do twice the work.

      1. LarrytheG Avatar
        LarrytheG

        There’s a lot to understand about the interplay between Federal law and regulation and state laws and regulations especially with regard to what is the sole domain of the states.

        For instance, WHY do the Feds regulate nursing homes in the first place? What’s the justification? It did not start out that way, right?

        1. Nancy_Naive Avatar
          Nancy_Naive

          Follow the money…

        2. sherlockj Avatar
          sherlockj

          Nancy, that is a good point. That is why I have recommended that the state incorporate the federal regulations by reference specifically to avoid the issue you raise – having to update the state regulation every time the federal regulation is updated.

          As for “undesirable effects on what the state wants”, that simply does not matter when the providers are also regulated by Medicare/Medicaid standards. They have to comply with the strictest regulation, which is always the federal regulation in my extensive experience reviewing both .

          Let’s look at who determines “what the state wants”.

          State politicians make a lot of money in campaign donations voting laws that require regulations.

          Officially, the Virginia Department of Health does not write regulations. The Board of Health does. See § 32.1-12. Regulations, variances and exemptions.

          Virginia also has a law that packs the Board of Health with industry insiders that make sure nothing makes it into a Virginia regulation that they don’t like.

          Ҥ 32.1-5. Appointment of members; terms and vacancies.
          There shall be a State Board of Health which shall consist of 15 residents of the Commonwealth appointed by the Governor for terms of four years each. Two members of the Board shall be members of the Medical Society of Virginia, one member shall be a member of the Virginia Pharmaceutical Association, one member shall be a member of the State Dental Association, one member shall be a member of the Virginia Nurses’ Association, one member shall be a member of the Virginia Veterinary Medical Association, one member shall be a representative of local government, one member shall be a representative of the hospital industry, one member shall be a representative of the nursing home industry, one member shall be a representative of the licensed health carriers responsible under Title 38.2 for a managed care health insurance plan, one member shall be a corporate purchaser of health care, two members shall be consumers, one member shall have public environmental health expertise, and one member shall be a representative of the emergency medical services community recommended by the State Emergency Medical Services Advisory Board.”

          Now, Larry, in answer to your question:
          The Secretary of Health and Human Services and for him the Center for Medicare/Medicaid Services regulates the nursing home industry because they are primary providers of services to Medicare and Medicaid beneficiaries. To do that they must be certified as compliant with federal regulations. The skilled nursing facilities are largely funded by Medicare patients and the nursing facilities by Medicaid beneficiaries.

          Contrast that to assisted living facilities, which are not paid for with Medicare or Medicaid funds. Those are regulated solely by the state. Buyer beware.

          Only 5% of Virginia’s nursing facilities – 15 total – are not certified for Medicare or Medicaid or both. That is the only constituency for state regulations. There is no public purpose to hold those facilities to weaker standards than the other 95%.

          The twist is that VDH, like all state health departments, inspects skilled nursing/nursing facilities for both Medicare/Medicaid certification and for state licensure. I have written multiple essays here that document that they are very bad at it, and regularly do not cite nurse staffing deficiencies in Medicare/Medicaid certification surveys that are otherwise documented by payroll-based data. That gives the Virginia nursing home industry a excellent odds of not being fined when they violate those standards.

          1. LarrytheG Avatar
            LarrytheG

            So, if the Federal govt pays for something it then has the authority to regulate it and takes precedence over the state’s authority?

            I think that’s true.. just thinking about all the other areas like highways and housing, hospitals,

            but perhaps not for OSHA, ADA, and EPA ? That authority is not because of federal funding.

          2. sherlockj Avatar
            sherlockj

            Your assessment below is correct, Larry. Call it the golden rule. The supremacy clause applies when state laws conflict with federal laws.

          3. Nancy_Naive Avatar
            Nancy_Naive

            Money, of course, being the root, not of all evil, but of supremacy.

            Just ask any VMI cadet, oh circa 1985, what it means to be the recipient of public funding.

  6. Dick Hall-Sizemore Avatar
    Dick Hall-Sizemore

    Jim Sherlock has argued before that the state regulations do not conform to the Medicaid and Medicare regulations, as required by state law, and, therefore are illegal. In making this argument, he either forgets or ignores an important word in the state statue. Sec. 32.1-127 requires that the VDH regulations “shall be in substantial conformity” to, among others, the Medicare and Medicaid regulations.

    There is a legal difference between “conformity” and “substantial conformity”. The latter term allows for variation. Indeed, after providing the goal (or requirement) for “substantial conformity”, the section goes on to list 24 specific topics or areas that the regulations should cover. No doubt, some of these topics are outside the Medicare and Medicaid regulations.

    The idea of just amending the state regulations to say, “The Medicaid and Medicare regulations are hereby incorporated” is an appealing one. But, why amend the regulations to conform to the federal standards, which are minimum standards? Why not adopt more stringent standards in order to provide more protection to Virginia residents in nursing homes and hospitals? Based on the number of deaths from COVID-19 in nursing homes, it would seem that they need to be more stringent. I suspect that the adjective “substantially” was included in the Virginia Code at the behest of the healthcare industry in order to keep the state regulations from being tougher than the federal ones.

    But let’s say that the VDH does just that: incorporates by reference the federal regulations. (That is assuming it can do so legally. I am not sure if it can.) That is not going to eliminate regulatory activity in this area. There are those 24 enumerated topics in the Code section that, in some cases, go beyond the federal regulations. And the General Assembly is constantly adding to the list. In 2020 alone, there were six pieced of legislation amending the section and which may require regulatory action. They dealt with:
    1. Protocols related to physical therapists (HB 763)
    2. Registration with the Sex Offender Registry (SB 579)
    3. Dispensation of cannabidol oil (SB 185)
    4. Definitions of hospitals related to abortions (HB 980; SB 733)
    5. Discharge plans involving “other parent” instead of “father” of infant (HB623)
    6. Protocol for treatment of individuals experiencing substance use related emergency (SB 903)

    Incorporating the federal standards is not going to result in a decrease in the need for staff to handle the regulatory process. The General Assembly will provide them enough work to keep busy.

    1. LarrytheG Avatar
      LarrytheG

      similar issue as the count/city level. Many times, I notice on the agenda of the BOS – a change to the county ordinances that is required because of a change to State law or regulation.

      One might wonder why local, state and Feds duplicating but I suspect it has to do with the way that governance works…and yes, each subordinate governance can elect to have more than the minimum state regs.

      And they can get into trouble like Stafford County did by instituting stricter standards for cemetaries than VDH rules, which, in turn, violates US rules.

      ” Justice Department Files Lawsuit Against Stafford County, Virginia, Over Blocking of Islamic Cemetery

      The Justice Department today announced that it has filed a lawsuit alleging that Stafford County, Virginia, violated the Religious Land Use and Institutionalized Persons Act (RLUIPA) by enacting overly restrictive zoning regulations prohibiting an Islamic organization from developing a religious cemetery on land it had purchased for that purpose.

      The United States’ complaint alleges that this requirement is far more restrictive than the Virginia Department of Health’s 100-foot distancing standard, has no legitimate health justification, imposes a substantial burden on the association’s religious exercise, and is not narrowly tailored to achieve a compelling governmental interest. “

      1. Dick Hall-Sizemore Avatar
        Dick Hall-Sizemore

        One reason for local governments incorporating state laws boils down to money. If a law enforcement officer is going to cite someone for a traffic infraction or some other violation, he can cite the local ordinance or state code. If he cites the local ordinance, the revenue from the fine goes into the local treasury; if she uses the state code, the money goes into the State Literary Fund. State law makes it easy for localities wishing to use their ordinaces, rather than state law. Localities can incorporate certain state statues into their local ordinances by reference, thereby avoiding having to amend their local ordinances every time the state law changes. (See Sec 46.2-1313)

  7. sherlockj Avatar
    sherlockj

    Dick, your comment is a complete non sequitur to my essay.

    You ask “But, why amend the regulations to conform to the federal standards, which are minimum standards?

    I wish they were indeed minimum standards. However, there is not a single Virginia standard that I can find that is more stringent than federal standards for the same facility or provider. Virtually all of Virginia’s are less stringent. That is why the lobbyists lobby.

    Do you seriously think Virginia healthcare providers would lobby for more stringent standards unless they provide competitive advantages for incumbents?

    I wrote: “The Commonwealth will be well served if all relevant federal Medicare/Medicaid regulations are incorporated by reference into the Virginia Administrative Code and the parallel Virginia regulations deleted.”

    You list issues that are not covered by federal regulations and infer that I do not know that and that my proposal does not allow for that.

    Read again my statement: “Any Virginia-specific regulations not covered by federal regulations or state waivers authorized in federal regulations can be provided as an addendum to the incorporated federal references.”

    I honestly could not care less whether positions are eliminated at VDH. I just wish they were competent.

    1. Dick Hall-Sizemore Avatar
      Dick Hall-Sizemore

      No, I do not think the health care industry would lobby for more stringent regulations. But, as you and many have said, the GA should stop kowtowing to the lobbyists.

      My main point was that state law does not require “conformity” to federal regulations as you have often asserted. It requires “substantial conformity”, which is a different legal standard entirely.

      As for your caring about positions being eliminated, I was responding to your claim that your recommendations would save a lot of administrative work and “the positions engaged in this work can be eliminated.”

  8. Reed Fawell 3rd Avatar
    Reed Fawell 3rd

    J. Sherlock says: “Dick, your comment is a complete non sequitur to my essay.”

    Perhaps this explains Dick’s confusion.

    Interesting facts about Railroad Tracks & Space Shuttles

    Railroad Tracks

    The U.S. Standard railroad gauge (distance between the rails) is 4 feet, 8.5 inches.

    That’s an exceedingly odd number. Why was that gauge used?

    Because that’s the way they built them in England, and English expatriates designed the U.S. Railroads.

    Why did the English build them like that?

    Because the first rail lines were built by the same people who built the pre-railroad tramways, and that’s the gauge they used.

    Why did ‘they’ use that gauge then?

    Because the people who built the tram ways used the same jigs and tools that they had used for building wagons, which used that wheel spacing.

    Why did the wagons have that particular odd wheel spacing?

    Well, if they tried to use any other spacing, the wagon wheels would break on some of the old, long distance roads in England, because that’s the spacing of the wheel ruts.

    So, who built those old rutted roads?

    Imperial Rome built the first long distance roads in Europe (including England) for their legions. Those roads have been used ever since.

    And the ruts in the roads?

    Roman war chariots formed the initial ruts, which everyone else had to match for fear of destroying their wagon wheels.

    Since the chariots were made for Imperial Rome, they were all alike in the matter of wheel spacing.

    Therefore, the United States standard railroad gauge of 4 feet, 8.5 inches is derived from the original specifications for an Imperial Roman war chariot.

    In other words, bureaucracies live forever.

    So the next time you are handed a specification, procedure, or process, and wonder, ‘What horse’s ass came up with this?’, you may be exactly right.

    Imperial Roman army chariots were made just wide enough to accommodate the rear ends of two war horses.

    Now, the twist to the story:
    When you see a Space Shuttle sitting on its launch pad, you will notice that there are two big booster rockets attached to the sides of the main fuel tank.

    These are solid rocket boosters, or SRBs The SRBs are made by Thiokol at their factory in Utah.

    The engineers who designed the SRBs would have preferred to make them a bit larger, but the SRBs had to be shipped by train from the factory to the launch site.

    The railroad line from the factory happens to run through a tunnel in the mountains and the SRBs had to fit through that tunnel.

    The tunnel is slightly wider than the railroad track, and the railroad track, as you now know, is about as wide as two horses’ behinds.

    So, a major Space Shuttle design feature of what is arguably the world’s most advanced transportation system was determined over two thousand years ago by the width of a horse’s ass.

    And you thought being a horse’s ass wasn’t important!

    Now you know, Horses’ Asses control almost everything.

    Explains a whole lot of stuff, including Dick’s comment, doesn’t it.

  9. LarrytheG Avatar
    LarrytheG

    Here’s an interesting list of cities and counties Chesapeake Bay Preservation regulations where the state establishes the baseline and localities can adopt as-is or add to but they must have.

    https://www.deq.virginia.gov/Programs/Water/ChesapeakeBay/ChesapeakeBayPreservationAct/LocalGovernmentOrdinances.aspx

    I’ve heard interesting discussions at the BOS level where they ask why they have to do these regs… why can’t they choose to not do them….

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