6 ms·

The CFR is made up of regulations. Usually when people refer to "laws" in a U.S. context they are referring to statutes.

tannhauser23 11y ago
No no no, regulations have the force of law, and if you violate them you can be fined, jailed, banned from the industry, etc. This is serious.
- aczerepinski 11y ago
  I'm really not sure about that. There are so many conditions spanning when documents need to be signed, how to clean a nursing bag, when to hold meetings, what credentials personnel need to hold, how close to the floor/ceiling supplies can be stored. What are some examples of COP violations leading to jail time?
  - hguant 11y ago
    Law - what is put together by Congress and signed by the President. This can involve tasking Federal agencies to do a specific task, referred to as a mandate. Regulation - How the Agency turns its mandate, which is often broadly stated and sometimes nebulous, into concrete actions and policies. An example - I worked at the DOJ as an intern. There was a law passed to provide benefits to the families of public safety officers who died in the line of duty. What those benefits are? Who qualifies as a public safety officer? If a fire fighter gets in a car crash on his was home from a shift, does that qualify? The answers to these questions are determined by lawyers and experts in equal measure - the experts to determine what should be done to solve the problem, the lawyers to make sure the agency actually has the power to enact the policies the experts recommend. To put it in OOP terms, regulations are instances of law. The stuff you mentioned - who is allowed to sign form 22a, minimum size of cleaning closets - is still law. The agencies also have the power to determine penalties for breaking regulations, not all of which involve going to jail. This power is again derived from what powers Congress assigns them when it writes the law.
    - aczerepinski 11y ago
      These are rules for being a Medicare participating provider and the consequence of violating them is that you can't bill Medicare. I want to see one example of an individual doing time or even paying a fine for failing a CMS condition. There are providers who don't bill Medicare, don't undergo CMS surveys, and don't follow the COPs. You guys are going overboard in calling it "the law."
      - jforman 11y ago
        A lab at Cleveland Clinic was placed in Immediate Jeopardy status a few months ago. They voluntarily stopped some services temporarily and were fined $600,000. http://www.beckershospitalreview.com/quality/cms-fines-cleveland-clinic-hospital-for-lab-deficiencies.html http://www.beckershospitalreview.com/quality/cms-fines-cleve... Whether or not regulations are technically "laws" is beside the point, and arguing about it so much is pedantic. The feds show up with a gun and have full authority to fine you or even padlock your lab (which has happened plenty of times). Theranos is in plenty of legal (or regulatory, who cares) hot water right now, whatever you call it.
        sandebert 11y ago
        Relevant Family Guy. https://youtu.be/OpbdGnJbneE https://youtu.be/OpbdGnJbneE
        aczerepinski 11y ago
        Thanks for posting (and to seanccox who posted a similar link). I'm wrong, and it appears the lab business is different from other health care businesses where most surveys contain deficiencies and everybody just keeps working.
  - DannyBee 11y ago
    Okay. So, this is a pretty heated debate :) As someone kinda correctly identified, here is what happens: Agencies are either directed by congress to make certain regulations, or more broadly delegated rulemaking authority. They exercise that rulemaking authority through an administrative rulemaking and publishing process that ends up with stuff in the CFR. This part is simple. You can find a parallel table GPO/etc conveniently publishes, of which USC code gave rulemaking authority for which CFR parts here: https://www.gpo.gov/help/parallel_table.pdf https://www.gpo.gov/help/parallel_table.pdf I honestly feel bad for the person who has to keep that up to date. Now, the larger question that was asked - can you be sentenced to jail for violating a CFR. The answer is "yes". You will likely be charged with some USC violation, whose regulations/etc are interpreted through some CFR regulations. a good example of a law that has criminal penalties and CFR regulations is HIPAA. See the aptly titled "who goes to jail" - http://www.ehcca.com/presentations/HIPAA3/malone_2.pdf http://www.ehcca.com/presentations/HIPAA3/malone_2.pdf Notice the regulations are in the CFR, violations of them are explicitly punishable under USC (IE "knowingly and in violation of the regulation ...."). With criminal penalties. Now, this is not the same as the related question of "can you be sentenced to jail by the FCC for violating the CFR. The answer to this is "well, maybe". The courts these agencies set up, and their administrative law judges, tribunals, whatever, are generally known as article I courts. The current state of the law on article I courts is kind of a mess. In general, they have some power, but if it involves deprivation of life liberty or property, it must at a minimum meet various requirements (including being reviewable by a standard article III court). Honestly, this is a super-complex and super-esoteric topic to get into on hacker news. So yeah, you should worry about the CFR, but you maybe shouldn't worry the FCC will throw you in jail. It'll be federal prosecutors instead :)
    - aczerepinski 11y ago
      Has any individual ever been charged for violating a Condition of Participation?
      - seanccox 11y ago
        I'm not sure if this is what you are asking for, but here goes: "Rustom Ali, Ph.D. appealed a January 13, 2005 decision by Administrative Law Judge (ALJ) Keith W. Sickendick. Sonali Diagnostic Laboratory, DAB CR1267 (ALJ Decision). The ALJ Decision upheld the actions by the Centers for Medicare & Medicaid Services (CMS) revoking the certificate issued to Dr. Ali's laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and imposing a civil money penalty of $10,000 per day for the period August 4-6, 2001. The appealed actions were based on a review by the Arizona Department of Health (the State agency) finding deficiencies at Sonali Diagnostic Laboratory (Sonali) that posed immediate jeopardy to patient health and safety." http://www.hhs.gov/dab/decisions/dab2008.htm http://www.hhs.gov/dab/decisions/dab2008.htm "Based on the foregoing discussion, we affirm and adopt the ALJ's Findings of Fact and Conclusions of Law and affirm the ALJ's decision to uphold CMS's revocation of Sonali's CLIA certificate and imposition a $30,000 CMP. By operation of 42 U.S.C.§ 263a(i)(3), Dr. Ali is subject to the two-year prohibition on owning or operating a CLIA-certified laboratory."
lobster_johnson 11y ago
But regulations are derived from statutes. What's more, they are enforceable in the same way as statutes. Regulations have what is referred to as the "force and effect of law".

tannhauser23 11y ago

No no no, regulations have the force of law, and if you violate them you can be fined, jailed, banned from the industry, etc. This is serious.

aczerepinski 11y ago
I'm really not sure about that. There are so many conditions spanning when documents need to be signed, how to clean a nursing bag, when to hold meetings, what credentials personnel need to hold, how close to the floor/ceiling supplies can be stored. What are some examples of COP violations leading to jail time?
- hguant 11y ago
  Law - what is put together by Congress and signed by the President. This can involve tasking Federal agencies to do a specific task, referred to as a mandate. Regulation - How the Agency turns its mandate, which is often broadly stated and sometimes nebulous, into concrete actions and policies. An example - I worked at the DOJ as an intern. There was a law passed to provide benefits to the families of public safety officers who died in the line of duty. What those benefits are? Who qualifies as a public safety officer? If a fire fighter gets in a car crash on his was home from a shift, does that qualify? The answers to these questions are determined by lawyers and experts in equal measure - the experts to determine what should be done to solve the problem, the lawyers to make sure the agency actually has the power to enact the policies the experts recommend. To put it in OOP terms, regulations are instances of law. The stuff you mentioned - who is allowed to sign form 22a, minimum size of cleaning closets - is still law. The agencies also have the power to determine penalties for breaking regulations, not all of which involve going to jail. This power is again derived from what powers Congress assigns them when it writes the law.
  - aczerepinski 11y ago
    These are rules for being a Medicare participating provider and the consequence of violating them is that you can't bill Medicare. I want to see one example of an individual doing time or even paying a fine for failing a CMS condition. There are providers who don't bill Medicare, don't undergo CMS surveys, and don't follow the COPs. You guys are going overboard in calling it "the law."
    - jforman 11y ago
      A lab at Cleveland Clinic was placed in Immediate Jeopardy status a few months ago. They voluntarily stopped some services temporarily and were fined $600,000. http://www.beckershospitalreview.com/quality/cms-fines-cleveland-clinic-hospital-for-lab-deficiencies.html http://www.beckershospitalreview.com/quality/cms-fines-cleve... Whether or not regulations are technically "laws" is beside the point, and arguing about it so much is pedantic. The feds show up with a gun and have full authority to fine you or even padlock your lab (which has happened plenty of times). Theranos is in plenty of legal (or regulatory, who cares) hot water right now, whatever you call it.
      - sandebert 11y ago
        Relevant Family Guy. https://youtu.be/OpbdGnJbneE https://youtu.be/OpbdGnJbneE
      - aczerepinski 11y ago
        Thanks for posting (and to seanccox who posted a similar link). I'm wrong, and it appears the lab business is different from other health care businesses where most surveys contain deficiencies and everybody just keeps working.
- DannyBee 11y ago
  Okay. So, this is a pretty heated debate :) As someone kinda correctly identified, here is what happens: Agencies are either directed by congress to make certain regulations, or more broadly delegated rulemaking authority. They exercise that rulemaking authority through an administrative rulemaking and publishing process that ends up with stuff in the CFR. This part is simple. You can find a parallel table GPO/etc conveniently publishes, of which USC code gave rulemaking authority for which CFR parts here: https://www.gpo.gov/help/parallel_table.pdf https://www.gpo.gov/help/parallel_table.pdf I honestly feel bad for the person who has to keep that up to date. Now, the larger question that was asked - can you be sentenced to jail for violating a CFR. The answer is "yes". You will likely be charged with some USC violation, whose regulations/etc are interpreted through some CFR regulations. a good example of a law that has criminal penalties and CFR regulations is HIPAA. See the aptly titled "who goes to jail" - http://www.ehcca.com/presentations/HIPAA3/malone_2.pdf http://www.ehcca.com/presentations/HIPAA3/malone_2.pdf Notice the regulations are in the CFR, violations of them are explicitly punishable under USC (IE "knowingly and in violation of the regulation ...."). With criminal penalties. Now, this is not the same as the related question of "can you be sentenced to jail by the FCC for violating the CFR. The answer to this is "well, maybe". The courts these agencies set up, and their administrative law judges, tribunals, whatever, are generally known as article I courts. The current state of the law on article I courts is kind of a mess. In general, they have some power, but if it involves deprivation of life liberty or property, it must at a minimum meet various requirements (including being reviewable by a standard article III court). Honestly, this is a super-complex and super-esoteric topic to get into on hacker news. So yeah, you should worry about the CFR, but you maybe shouldn't worry the FCC will throw you in jail. It'll be federal prosecutors instead :)
  - aczerepinski 11y ago
    Has any individual ever been charged for violating a Condition of Participation?
    - seanccox 11y ago
      I'm not sure if this is what you are asking for, but here goes: "Rustom Ali, Ph.D. appealed a January 13, 2005 decision by Administrative Law Judge (ALJ) Keith W. Sickendick. Sonali Diagnostic Laboratory, DAB CR1267 (ALJ Decision). The ALJ Decision upheld the actions by the Centers for Medicare & Medicaid Services (CMS) revoking the certificate issued to Dr. Ali's laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and imposing a civil money penalty of $10,000 per day for the period August 4-6, 2001. The appealed actions were based on a review by the Arizona Department of Health (the State agency) finding deficiencies at Sonali Diagnostic Laboratory (Sonali) that posed immediate jeopardy to patient health and safety." http://www.hhs.gov/dab/decisions/dab2008.htm http://www.hhs.gov/dab/decisions/dab2008.htm "Based on the foregoing discussion, we affirm and adopt the ALJ's Findings of Fact and Conclusions of Law and affirm the ALJ's decision to uphold CMS's revocation of Sonali's CLIA certificate and imposition a $30,000 CMP. By operation of 42 U.S.C.§ 263a(i)(3), Dr. Ali is subject to the two-year prohibition on owning or operating a CLIA-certified laboratory."

lobster_johnson 11y ago

But regulations are derived from statutes. What's more, they are enforceable in the same way as statutes. Regulations have what is referred to as the "force and effect of law".